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CompletedNCT01923740ABSORB CHINAUpdated Dec 4, 2019Results posted

A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

An interventional study of XIENCE V EECSS and Absorb BVS System in Coronary Artery Disease, Coronary Artery Stenosis and Coronary Disease, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

02

Conditions studied

  • Coronary Artery Disease
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Stenosis

Keywords

  • Absorb™ BVS
  • Angioplasty
  • Bioabsorbable
  • BVS
  • Bioresorbable
  • Coronary Artery Disease
  • Coronary Artery Endothelial Responsiveness
  • Coronary artery restenosis
  • Coronary artery stenosis
  • Coronary scaffold
  • Coronary Stent
  • Drug eluting stents
  • Everolimus
  • Myocardial ischemia
  • Stent thrombosis
  • Stents
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 480 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject must be at least 18 years of age at the time of signing the informed consent form.
  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
  3. Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. Female subject of childbearing potential does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 14 days (≤14 days) prior to the index procedure per site standard test.
  6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  7. Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.

Exclusion criteria

Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure.
  2. Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

  3. Subject has a known allergic reaction, hypersensitivity or contraindication to:

    1. Aspirin; or
    2. All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or
    3. Heparin and bivalirudin.
  4. Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure.
  5. Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

  6. Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met:

    1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
    2. Subject likely to become hemodynamically unstable due to their arrhythmia.
    3. Subject has poor survival prognosis due to their arrhythmia.
  7. Subject has a known left ventricular ejection fraction (LVEF) \< 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
  8. Subject has received CABG at any time in the past.
  9. Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure.
  10. Subject requires future staged PCI either in target or non-target vessels.
  11. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  12. At the time of screening, the subject has a malignancy that is not in remission.
  13. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  14. Subject has previously received or is scheduled to receive radiotherapy to coronary artery (vascular brachytherapy), or chest/mediastinum.
  15. Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents).
  16. Subject has a platelet count \< 100,000 cells/mm3 or > 700,000 cells/mm3.
  17. Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  18. Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 or dialysis at the time of screening.
  19. Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions.
  20. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months or any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
  21. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial or brachial access can be used.
  22. Subject has life expectancy \< 2 years for any non-cardiac cause or cardiac cause.
  23. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  24. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint or protocol-required medications or invasive procedures.

Angiographic Inclusion Criteria

Assessment of angiographic eligibility is per visual assessment by an investigator both for qualitative and quantitative variables. On-line QCA is recommended to be used for appropriately sizing of the vessel. If on-line QCA cannot be used, visual estimation is required.

  1. One or two de novo target lesions:

    1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
    2. If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.
    3. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
  2. Target lesion must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
  3. Target lesion must have a Dmax (by on-line QCA) or reference vessel diameter (RVD) (by visual estimation) ≥ 2.50 mm and ≤ 3.75 mm (on-line QCA assessment is recommended).
  4. Target lesion must have a lesion length ≤ 24 mm based on either visual estimation or on-line QCA.

Angiographic Exclusion Criteria

All exclusion criteria apply to the target lesion(s) or target vessel(s). All exclusion criteria are based on visual estimation.

  1. Target lesion is located in left main.
  2. Aorto-ostial RCA target lesion (within 3 mm of the ostium).
  3. Target lesion located within 3 mm of the origin of the LAD or LCX.

  4. Lesion involving a bifurcation with a:

    1. Side branch ≥ 2 mm in diameter, or
    2. Side branch with diameter stenosis ≥ 50%, or
    3. Side branch requiring protection guide wire, or
    4. Side branch requiring pre-dilatation

  5. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE V, including:

    1. Extreme angulation (≥ 90°) proximal to or within the target lesion
    2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion
    3. Moderate or heavy calcification proximal to or within the target lesion
  6. Target lesion or target vessel involves a myocardial bridge.
  7. Target vessel contains thrombus as indicated in the angiographic images.
  8. Target vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE V would need to cross the stent to reach the target lesion.
  9. Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.

  10. Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

    1. Residual %DS is \< 40% (per visual estimation), ≤ 20% is strongly recommended.
    2. TIMI Grade-3 flow (per visual estimation).
    3. No angiographic complications (e.g. distal embolization, side branch closure).
    4. No dissections National Heart, Lung, and Blood Institute (NHLBI) grade D-F.
    5. No chest pain lasting > 5 minutes.
    6. No ST depression or elevation lasting > 5 minutes.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
480 participants (actual)

Study arms

  • Experimental
    Absorb BVS System

    Absorb BVS System: Subjects receiving Absorb BVS System

    Device: Absorb BVS System

  • Active comparator
    XIENCE V EECSS

    XIENCE V EECSS: Subjects receiving XIENCE V

    Device: XIENCE V EECSS

Interventions

  • DeviceXIENCE V EECSS

    Subjects receiving XIENCE V

  • DeviceAbsorb BVS System

    Subjects receiving Absorb BVS System

06

What researchers measure

Primary outcomes

  1. In-segment Late Loss (LL) - Per Subject Analysis

    In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

    Time frame: 1 year

  2. In-segment Late Loss (LL) - Per Lesion Analysis

    In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

    Time frame: 1 year

Secondary outcomes

  1. Acute Device Success

    Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

    Time frame: < or = 1 day

  2. Number of Participants With Acute Procedural Success

    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

    Time frame: At time of procedure up to 7 days in hospital

  3. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: ≤ 7 days post index procedure (In-hospital )

  4. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 0 to 37days

  5. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 0 to 208 days

  6. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 0 to 298 days

  7. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 1 year

  8. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 2 year

  9. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 3 years

  10. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Time frame: 4 years

  11. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

    Time frame: 5 years

  12. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: ≤ 7 days post index procedure (In-hospital )

  13. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 0 to 37 days

  14. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 0 to 208 days

  15. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 0 to 298 days

  16. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 1 year

  17. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 2 year

  18. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 3 years

  19. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 4 years

  20. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Time frame: 5 years

  21. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

  22. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 0 to 37 days

  23. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 0 to 208 days

  24. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 0 to 298 days

  25. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 1 year

  26. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 2 year

  27. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 3 years

  28. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 4 years

  29. Number of Participants With Target Lesion Revascularization (TLR)

    * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

    Time frame: 5 years

  30. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

  31. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 0 to 37 days

  32. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 0 to 208 days

  33. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 0 to 298 days

  34. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 1 year

  35. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 2 year

  36. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 3 years

  37. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 4 years

  38. Number of Participants With Target Vessel Revascularization (TVR)

    * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

    Time frame: 5 years

  39. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: ≤ 7 days post index procedure (In-hospital )

  40. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 0 to 37days

  41. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 0 to 208 days

  42. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 0 to 298 Days

  43. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 1 year

  44. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 2 year

  45. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 3 years

  46. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 4 years

  47. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Time frame: 5 years

  48. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: ≤ 7 days post index procedure (In-hospital )

  49. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 0 to 37 days

  50. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 0 to 208 days

  51. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 0 to 298 days

  52. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 1 year

  53. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 2 year

  54. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 3 years

  55. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 4 years

  56. Number of Death/All MI

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

    Time frame: 5 years

  57. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: ≤ 7 days post index procedure (In-hospital )

  58. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 0 to 37 days

  59. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 0 to 208 days

  60. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 0 to 298 days

  61. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 1 year

  62. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 2 year

  63. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 3 years

  64. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Time frame: 4 years

  65. Number of Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

    Time frame: 5 years

  66. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Time frame: ≤ 7 days post index procedure (In-hospital )

  67. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 0 to 37 days

  68. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 0 to 208 days

  69. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 0 to 298 days

  70. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 1 year

  71. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 2 year

  72. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 3 years

  73. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 4 years

  74. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Time frame: 5 years

  75. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: ≤ 7 days post index procedure (In-hospital )

  76. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 0 to 37 days

  77. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 0 to 208 days

  78. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 0 to 298 days

  79. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 1 year

  80. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 2 year

  81. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 3 years

  82. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 4 years

  83. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Time frame: 5 years

  84. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: ≤ 7 days post index procedure (In-hospital)

  85. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 0 to 37 days

  86. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 0 to 208 days

  87. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 0 to 298 days

  88. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 1 year

  89. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 2 year

  90. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 3 years

  91. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 4 years

  92. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Time frame: 5 years

  93. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

    Time frame: ≤ 7 days post index procedure (In-hospital )

  94. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 0 to 37 days

  95. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 0 to 208 days

  96. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 0 to 298 days

  97. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 1 year

  98. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 2 year

  99. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 3 years

  100. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 4 years

  101. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Time frame: 5 years

  102. Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: < or = 1 day

  103. Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: >1 to 30 days

  104. Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 31 to 365 days

  105. Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 366 to 730 days

  106. Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 731 to 1095 days

  107. Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 366-1095 days

  108. Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 1096-1460 days

  109. Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 1461-1825 days

  110. Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 1096-1825 days

  111. Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

    Time frame: 0-1825 days

  112. In-Device Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    Time frame: 1 year

  113. In-Segment Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

    Time frame: 1 year

  114. Proximal Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    Time frame: 1 year

  115. Distal Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    Time frame: 1 year

  116. In-Segment Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Time frame: 1 year

  117. In-Device Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Time frame: 1 year

  118. Proximal Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Time frame: 1 year

  119. Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

    Time frame: 1 year

  120. Distal Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Time frame: 1 year

  121. Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

    Time frame: 1 year

  122. Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

    Time frame: 1 year

  123. In-Segment Late Loss (LL)

    In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).

    Time frame: 1 year

  124. Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

    Time frame: 1 year

  125. In-Device Late Loss (LL)

    In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).

    Time frame: 1 year

  126. Proximal Late Loss (LL)

    Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.

    Time frame: 1 year

  127. Distal Late Loss (LL)

    Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.

    Time frame: 1 year

07

Results

Posted Feb 14, 2018

Participant flow

The enrollment of the ABSORB China RCT began on July 31, 2013 \& completed on March 13, 2014 with the first subject randomized on 2 August 2013. A total of 480 subjects (Intent-to-treat (ITT) population) were randomized (Absorb BVS:241\&XIENCE:239) at 24 clinical sites in mainland China. Last subject completed the 5 year follow-up on March 7, 2019.

Participant flow — Overall Study
MilestoneAbsorb BVS SystemXIENCE V EECSS
Started227232
Completed221223
Not completed69
Withdrew: Lost to follow-up49
Withdrew: Withdrawal by subject20

Outcome measures

PrimaryIn-segment Late Loss (LL) - Per Subject Analysis

In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

Time frame:
1 year
Reported as:
Mean · Millimeter
In-segment Late Loss (LL) - Per Subject Analysis
MillimeterAbsorb BVS SystemXIENCE V EECSS
In-segment Late Loss (LL) - Per Subject Analysis0.19 ± 0.380.13 ± 0.38
PrimaryIn-segment Late Loss (LL) - Per Lesion Analysis

In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

Time frame:
1 year
Reported as:
Mean · Millimeter
In-segment Late Loss (LL) - Per Lesion Analysis
MillimeterAbsorb BVS SystemXIENCE V EECSS
In-segment Late Loss (LL) - Per Lesion Analysis0.19 ± 0.400.13 ± 0.37
SecondaryAcute Device Success

Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

Time frame:
< or = 1 day
Reported as:
Number · Percentage of target lesions
Acute Device Success
Percentage of target lesionsAbsorb BVS SystemXIENCE V EECSS
Acute Device Success98.099.6
SecondaryNumber of Participants With Acute Procedural Success

Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

Time frame:
At time of procedure up to 7 days in hospital
Reported as:
Count of participants · Participants
Number of Participants With Acute Procedural Success
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Acute Procedural Success230230
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)00
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
0 to 37days
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)00
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)03
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)04
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)04
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)15
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)25
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)47
SecondaryNumber of Death (Cardiac, Vascular, Non-cardiovascular)

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Death (Cardiac, Vascular, Non-cardiovascular)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death (Cardiac, Vascular, Non-cardiovascular)67
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction12
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction23
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction24
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction24
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction34
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction55
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction65
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction76
SecondaryNumber of Participants With Myocardial Infarction

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Myocardial Infarction76
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)10
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)10
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)24
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)21
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)77
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)98
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)118
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)129
SecondaryNumber of Participants With Target Lesion Revascularization (TLR)

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Revascularization (TLR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Lesion Revascularization (TLR)129
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)10
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)10
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)21
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)21
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)912
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)1113
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)1413
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)1616
SecondaryNumber of Participants With Target Vessel Revascularization (TVR)

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With Target Vessel Revascularization (TVR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Target Vessel Revascularization (TVR)1616
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)10
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
0 to 37days
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)10
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)21
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
0 to 298 Days
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)22
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)1617
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)2120
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)2421
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)2726
SecondaryNumber of Participants With All Coronary Revascularization (PCI and CABG)

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With All Coronary Revascularization (PCI and CABG)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Coronary Revascularization (PCI and CABG)2826
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI12
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI23
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI26
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI26
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI36
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI68
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI88
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI1110
SecondaryNumber of Death/All MI

All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Death/All MI1310
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI12
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI23
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI24
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI24
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI34
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI65
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI75
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI96
SecondaryNumber of Cardiac Death/All MI

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Cardiac Death/All MI
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Cardiac Death/All MI106
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)12
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)23
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)37
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)38
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)1722
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)2226
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)2627
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)3134
SecondaryNumber of Participants With All Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With All Death/All MI/All Revascularization (DMR)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With All Death/All MI/All Revascularization (DMR)3434
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]12
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]22
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]34
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]35
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]79
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]910
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]1210
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]1512
SecondaryNumber of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]1612
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
≤ 7 days post index procedure (In-hospital)
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]12
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]23
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]35
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]35
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]813
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]1115
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]1415
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]1819
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]1919
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

Time frame:
≤ 7 days post index procedure (In-hospital )
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])12
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

Time frame:
0 to 37 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])23
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame:
0 to 208 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])35
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

Time frame:
0 to 298 days
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])35
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])79
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame:
2 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])1011
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame:
3 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])1311
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame:
4 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])1613
SecondaryNumber of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])1713
SecondaryNumber of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
< or = 1 day
Reported as:
Count of participants · Participants
Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable00
SecondaryNumber of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
>1 to 30 days
Reported as:
Count of participants · Participants
Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable10
SecondaryNumber of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
31 to 365 days
Reported as:
Count of participants · Participants
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable00
SecondaryNumber of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
366 to 730 days
Reported as:
Count of participants · Participants
Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite10
Probable00
SecondaryNumber of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
731 to 1095 days
Reported as:
Count of participants · Participants
Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable00
SecondaryNumber of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
366-1095 days
Reported as:
Count of participants · Participants
Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite10
Probable00
SecondaryNumber of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
1096-1460 days
Reported as:
Count of participants · Participants
Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable11
SecondaryNumber of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
1461-1825 days
Reported as:
Count of participants · Participants
Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable00
SecondaryNumber of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
1096-1825 days
Reported as:
Count of participants · Participants
Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite00
Probable11
SecondaryOver All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame:
0-1825 days
Reported as:
Count of participants · Participants
Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis
ParticipantsAbsorb BVS SystemXIENCE V EECSS
Definite10
Probable21
SecondaryIn-Device Minimum Lumen Diameter (MLD)

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

Time frame:
1 year
Reported as:
Mean · Millimeter
In-Device Minimum Lumen Diameter (MLD)
MillimeterAbsorb BVS SystemXIENCE V EECSS
In-Device Minimum Lumen Diameter (MLD)2.24 ± 0.482.50 ± 0.46
SecondaryIn-Segment Minimum Lumen Diameter (MLD)

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

Time frame:
1 year
Reported as:
Mean · Millimeter
In-Segment Minimum Lumen Diameter (MLD)
MillimeterAbsorb BVS SystemXIENCE V EECSS
In-Segment Minimum Lumen Diameter (MLD)2.11 ± 0.472.17 ± 0.49
SecondaryProximal Minimum Lumen Diameter (MLD)

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

Time frame:
1 year
Reported as:
Mean · Millimeter
Proximal Minimum Lumen Diameter (MLD)
MillimeterAbsorb BVS SystemXIENCE V EECSS
Proximal Minimum Lumen Diameter (MLD)2.64 ± 0.482.68 ± 0.56
SecondaryDistal Minimum Lumen Diameter (MLD)

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

Time frame:
1 year
Reported as:
Mean · Millimeter
Distal Minimum Lumen Diameter (MLD)
MillimeterAbsorb BVS SystemXIENCE V EECSS
Distal Minimum Lumen Diameter (MLD)2.39 ± 0.452.37 ± 0.50
SecondaryIn-Segment Percent Diameter Stenosis (%DS)

The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

Time frame:
1 year
Reported as:
Mean · Percent Diameter stenosis
In-Segment Percent Diameter Stenosis (%DS)
Percent Diameter stenosisAbsorb BVS SystemXIENCE V EECSS
In-Segment Percent Diameter Stenosis (%DS)24.02 ± 13.2322.96 ± 13.18
SecondaryIn-Device Percent Diameter Stenosis (%DS)

The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

Time frame:
1 year
Reported as:
Mean · Percent Diameter stenosis
In-Device Percent Diameter Stenosis (%DS)
Percent Diameter stenosisAbsorb BVS SystemXIENCE V EECSS
In-Device Percent Diameter Stenosis (%DS)19.16 ± 14.3611.15 ± 11.38
SecondaryProximal Percent Diameter Stenosis (%DS)

The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

Time frame:
1 year
Reported as:
Mean · Percent Diameter stenosis
Proximal Percent Diameter Stenosis (%DS)
Percent Diameter stenosisAbsorb BVS SystemXIENCE V EECSS
Proximal Percent Diameter Stenosis (%DS)11.09 ± 10.1312.12 ± 11.63
SecondaryPercentage of Participants With Proximal Angiographic Binary Restenosis (ABR)

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

Time frame:
1 year
Reported as:
Number · Percentage of participants
Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)
Percentage of participantsAbsorb BVS SystemXIENCE V EECSS
Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)1.01.5
SecondaryDistal Percent Diameter Stenosis (%DS)

The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

Time frame:
1 year
Reported as:
Mean · Percent Diameter stenosis
Distal Percent Diameter Stenosis (%DS)
Percent Diameter stenosisAbsorb BVS SystemXIENCE V EECSS
Distal Percent Diameter Stenosis (%DS)8.53 ± 8.158.14 ± 11.86
SecondaryPercentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

Time frame:
1 year
Reported as:
Number · percentage of participants
Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)
percentage of participantsAbsorb BVS SystemXIENCE V EECSS
Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)4.22.9
SecondaryPercentage of Participants With In-Device Angiographic Binary Restenosis (ABR)

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

Time frame:
1 year
Reported as:
Number · Percentage of participants
Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)
Percentage of participantsAbsorb BVS SystemXIENCE V EECSS
Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)3.31.0
SecondaryIn-Segment Late Loss (LL)

In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).

Time frame:
1 year
Reported as:
Mean · Millimeter
In-Segment Late Loss (LL)
MillimeterAbsorb BVS SystemXIENCE V EECSS
In-Segment Late Loss (LL)0.19 ± 0.400.13 ± 0.37
SecondaryPercentage of Participants With Distal Angiographic Binary Restenosis (ABR)

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

Time frame:
1 year
Reported as:
Number · Percentage of participants
Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)
Percentage of participantsAbsorb BVS SystemXIENCE V EECSS
Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)0.01.0
SecondaryIn-Device Late Loss (LL)

In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).

Time frame:
1 year
Reported as:
Mean · Millimeter
In-Device Late Loss (LL)
MillimeterAbsorb BVS SystemXIENCE V EECSS
In-Device Late Loss (LL)0.24 ± 0.390.10 ± 0.32
SecondaryProximal Late Loss (LL)

Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.

Time frame:
1 year
Reported as:
Mean · Millimeter
Proximal Late Loss (LL)
MillimeterAbsorb BVS SystemXIENCE V EECSS
Proximal Late Loss (LL)0.19 ± 0.390.13 ± 0.42
SecondaryDistal Late Loss (LL)

Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.

Time frame:
1 year
Reported as:
Mean · Millimeter
Distal Late Loss (LL)
MillimeterAbsorb BVS SystemXIENCE V EECSS
Distal Late Loss (LL)0.08 ± 0.310.03 ± 0.33

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Absorb BVS System6/227 (2.6%)94/227 (41.4%)151/227 (66.5%)
XIENCE V EECSS7/232 (3%)81/232 (34.9%)135/232 (58.2%)
Most frequent serious events
Showing 10 of 94
Most frequent serious events
EventAbsorb BVS SystemXIENCE V EECSS
Angina unstableCardiac disorders15/22710/232
Angina pectorisCardiac disorders12/2275/232
Coronary artery diseaseCardiac disorders11/2274/232
Coronary artery restenosisInjury, poisoning and procedural complications9/22711/232
Coronary artery stenosisCardiac disorders10/2278/232
Chest discomfortGeneral disorders8/2275/232
Coronary artery dissectionCardiac disorders4/2275/232
Myocardial infarctionCardiac disorders4/2272/232
HypertensionVascular disorders4/2270/232
Non-cardiac chest painGeneral disorders3/2274/232
Most frequent other events
Showing 10 of 164
Most frequent other events
EventAbsorb BVS SystemXIENCE V EECSS
Troponin I increasedInvestigations25/22732/232
Angina pectorisCardiac disorders28/22716/232
Chest discomfortGeneral disorders25/22714/232
Angina unstableCardiac disorders16/22712/232
Coronary artery diseaseCardiac disorders12/2274/232
Non-cardiac chest painGeneral disorders8/22711/232
Coronary artery restenosisInjury, poisoning and procedural complications9/22711/232
Coronary artery stenosisCardiac disorders10/2278/232
Cardiac enzymes increasedInvestigations10/2279/232
Blood creatine phosphokinase MB increasedInvestigations7/2274/232

Baseline characteristics

Age, Continuous
Age, Continuous(years)Absorb BVS SystemXIENCE V EECSSTotal
Mean57.1 ± 11.457.7 ± 9.657.4 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Absorb BVS SystemXIENCE V EECSSTotal
Female6661127
Male161171332
Region of Enrollment
Region of Enrollment(Participants)Absorb BVS SystemXIENCE V EECSSTotal
China227232459
08

Study locations

1 site
  • Abbott Vascular
    Santa Clara, California 95054, United States
09

References and documents

Publications

  • Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101. PubMed 31561250 ↗
  • Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31. PubMed 29089314 ↗
  • Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27. PubMed 26825231 ↗
  • Gao R, Yang Y, Han Y, Huo Y, Chen J, Yu B, Su X, Li L, Kuo HC, Ying SW, Cheong WF, Zhang Y, Su X, Xu B, Popma JJ, Stone GW; ABSORB China Investigators. Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial. J Am Coll Cardiol. 2015 Dec 1;66(21):2298-2309. doi: 10.1016/j.jacc.2015.09.054. Epub 2015 Oct 12. PubMed 26471805 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01923740
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Aug 16, 2013
Start date
Jul 2013
Primary completion
May 2015
Completion
Mar 7, 2019
Results posted
Feb 14, 2018
Last update
Dec 4, 2019

Study contacts

Gao Runlin, MD, FACC
principal investigator · Fu Wai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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