CompletedNCT03355742Updated Mar 4, 2021Results posted

XIENCE 28 Global Study

An interventional study of XIENCE and DAPT in Bleeding Disorder, Stroke, Ischemic and Stroke Hemorrhagic, sponsored by Abbott Medical Devices. Completed at 52 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 963
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents

Read the detailed description

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting and have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continue with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 Global Study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT up to 12 months from the XIENCE V USA Study .

Conditions studied

Bleeding Disorder
Stroke, Ischemic
Stroke Hemorrhagic
Hematological Disease
Thrombocytopenia
Coagulation Disorder
Anemia
Renal Insufficiency
Coronary Artery Disease

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Keywords

XIENCE
High bleeding risk (HBR)
Dual antiplatelet therapy (DAPT)
Coronary Artery Disease
Drug eluting stent (DES)

In context

Hemostatic Disorders

515 studies on the registry are indexed under Hemostatic Disorders; 72 are open to participants now.

This study's enrollment of 963 is above the median of 52 across 261 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Browse Abbott Medical Devices studies →All Abbott studies →

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

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject is considered at HBR, defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:
1. Subjects ≥ 75 years of age.
2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.
3. History of major bleeding which required medical attention within 12 months of the index procedure.
4. History of stroke (ischemic or hemorrhagic).
5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count \<100,000/mm\^3, or any known coagulation disorder associated with increased bleeding risk).
7. Anemia with hemoglobin \< 11g/dl.
Subject must be at least 18 years of age.
Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.
Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

Angiographic Inclusion Criteria

Up to three target lesions with a maximum of two target lesions per epicardial vessel.
Note:
1. The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
2. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
Exclusive use of XIENCE family of stent systems during the index procedure.
Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of \<20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion criteria

Exclusion Criteria:

Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
Subject has a known left ventricular ejection fraction (LVEF) \<30%.
Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
Subject with a current medical condition with a life expectancy of less than 12 months.
Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

Target lesion is in a left main location.
Target lesion is located within an arterial or saphenous vein graft.
Target lesion is restenotic from a previous stent implantation.
Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
Target lesion is implanted with overlapping stents, whether planned or for bailout.

Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 963 participants (actual)

Study arms

Experimental
XIENCE
XIENCE + Short duration (1 month) of DAPT
Device: XIENCE · Drug: DAPT

Interventions

DeviceXIENCE
Subjects who received XIENCE family stent systems will be included.
DrugDAPT
1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Also known as: Dual antiplatelet therapy

What researchers measure

Primary outcomes

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium \[ARC\]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium \[BARC\] type 2-5)
Time frame: From 1 to 6 months

Secondary outcomes

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium \[ARC\]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium \[BARC\] type 2-5)
Time frame: From 6 to 12 months
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium \[ARC\]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium \[BARC\] type 2-5)
Time frame: From 1 to 12 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time frame: From 1 to 6 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time frame: From 6 to 12 months
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time frame: From 1 to 12 months
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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: From 1 to 6 months
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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: From 6 to 12 months
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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: From 1 to 12 months
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 1 to 6 months
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 6 to 12 months
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 1 to 12 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 1 to 6 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 6 to 12 months
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 1 to 12 months
Number of Participants With Composite of All Death or All MI (Modified ARC)
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 1 to 6 months
Number of Participants With Composite of All Death or All MI (Modified ARC)
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 6 to 12 months
Number of Participants With Composite of All Death or All MI (Modified ARC)
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Time frame: From 1 to 12 months
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. * Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. * Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. * Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. * Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time frame: From 1 to 6 months
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. * Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. * Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. * Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. * Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time frame: From 6 to 12 months
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. * Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. * Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. * Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. * Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time frame: From 1 to 12 months
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); * A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time frame: From 1 to 6 months
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); * A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time frame: From 6 to 12 months
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); * A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time frame: From 1 to 12 months
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); * A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time frame: From 1 to 6 months
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); * A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time frame: From 6 to 12 months
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); * A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time frame: From 1 to 12 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time frame: From 1 to 6 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time frame: From 6 to 12 months
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time frame: From 1 to 12 months
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time frame: From 1 to 6 months
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time frame: From 6 to 12 months
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time frame: From 1 to 12 months
Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time frame: From 1 to 6 months
Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time frame: From 6 to 12 months
Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time frame: From 1 to 12 months

Results

Posted Feb 8, 2021

Participant flow

A total of 963 subjects were enrolled across 52 sites globally, between 09 February, 2018 and 30 April, 2020. The last subject last visit was on 30 April, 2020 and the final data was extracted from the database on 01 July, 2020.

Participant flow — Overall Study
Milestone	XIENCE
Started	963
Completed	864
Not completed	99
Withdrew: Lost to follow-up	4
Withdrew: Withdrawal by subject	29
Withdrew: Physician decision	6
Withdrew: Death	55
Withdrew: Administrative closure of the study, other status change reason, missed visit, protocol violation	5

Outcome measures

PrimaryNumber of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles

Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium \[ARC\]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium \[BARC\] type 2-5)

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Participants	XIENCE
Q1	2
Q2	5
Q3	10
Q4	15
Q5	40

SecondaryNumber of Participants With Composite of Net Adverse Clinical Endpoint (NACE)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Participants	XIENCE
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)	55

SecondaryNumber of Participants With Composite of Net Adverse Clinical Endpoint (NACE)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Participants	XIENCE
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)	121

SecondaryNumber of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Participants	XIENCE
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	4

SecondaryNumber of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Participants	XIENCE
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	0

SecondaryNumber of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Participants	XIENCE
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	4

SecondaryNumber of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Participants	XIENCE
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death	13

SecondaryNumber of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Participants	XIENCE
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death	30

SecondaryNumber of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Participants	XIENCE
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death	43

SecondaryNumber of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)

Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Participants	XIENCE
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)	16

SecondaryNumber of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Participants	XIENCE
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)	11

SecondaryNumber of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Participants	XIENCE
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)	27

SecondaryNumber of Participants With Composite of Cardiac Death or MI (Modified ARC)

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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Participants	XIENCE
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	22

SecondaryNumber of Participants With Composite of Cardiac Death or MI (Modified ARC)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Participants	XIENCE
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	23

SecondaryNumber of Participants With Composite of Cardiac Death or MI (Modified ARC)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Participants	XIENCE
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	45

SecondaryNumber of Participants With Composite of All Death or All MI (Modified ARC)

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of All Death or All MI (Modified ARC)
Participants	XIENCE
Number of Participants With Composite of All Death or All MI (Modified ARC)	29

SecondaryNumber of Participants With Composite of All Death or All MI (Modified ARC)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of All Death or All MI (Modified ARC)
Participants	XIENCE
Number of Participants With Composite of All Death or All MI (Modified ARC)	41

SecondaryNumber of Participants With Composite of All Death or All MI (Modified ARC)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Composite of All Death or All MI (Modified ARC)
Participants	XIENCE
Number of Participants With Composite of All Death or All MI (Modified ARC)	70

SecondaryNumber of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. * Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. * Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. * Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. * Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Participants	XIENCE
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke	3

SecondaryNumber of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Participants	XIENCE
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke	3

SecondaryNumber of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Participants	XIENCE
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke	6

SecondaryNumber of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)

TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); * A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Participants	XIENCE
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)	7

SecondaryNumber of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Participants	XIENCE
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)	3

SecondaryNumber of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Participants	XIENCE
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)	10

SecondaryNumber of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); * A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Participants	XIENCE
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)	5

SecondaryNumber of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Participants	XIENCE
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)	4

SecondaryNumber of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Participants	XIENCE
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)	9

SecondaryNumber of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Participants	XIENCE
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	21

SecondaryNumber of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Participants	XIENCE
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	21

SecondaryNumber of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Participants	XIENCE
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	42

SecondaryNumber of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Participants	XIENCE
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)	22

SecondaryNumber of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Participants	XIENCE
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)	22

SecondaryNumber of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Participants	XIENCE
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)	44

SecondaryNumber of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5

Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Time frame:: From 1 to 6 months
Reported as:: Count of participants · Participants

Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Participants	XIENCE
BARC Type 2-5	44
BARC Type 3-5	20

SecondaryNumber of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5

Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Time frame:: From 6 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Participants	XIENCE
BARC Type 2-5	19
BARC Type 3-5	7

SecondaryNumber of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5

Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Time frame:: From 1 to 12 months
Reported as:: Count of participants · Participants

Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Participants	XIENCE
BARC Type 2-5	61
BARC Type 3-5	27

Adverse events

Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
XIENCE	55/963 (5.7%)	374/963 (38.8%)	357/963 (37.1%)

Most frequent serious events

Showing 10 of 245

Most frequent serious events
Event	XIENCE
Angina PectorisCardiac disorders	55/963
HaemorrhageVascular disorders	54/963
Cardiac FailureCardiac disorders	30/963
Atrial FibrillationCardiac disorders	27/963
PneumoniaInfections and infestations	22/963
Myocardial InfarctionCardiac disorders	18/963
DeathGeneral disorders	15/963
Renal Failure AcuteRenal and urinary disorders	13/963
AnaemiaBlood and lymphatic system disorders	11/963
Urinary Tract InfectionInfections and infestations	10/963

Most frequent other events

Showing 10 of 223

Most frequent other events
Event	XIENCE
HaemorrhageVascular disorders	100/963
Angina PectorisCardiac disorders	54/963
DyspnoeaRespiratory, thoracic and mediastinal disorders	29/963
HypertensionVascular disorders	17/963
Atrial FibrillationCardiac disorders	15/963
Urinary Tract InfectionInfections and infestations	15/963
Oedema PeripheralGeneral disorders	9/963
DizzinessNervous system disorders	9/963
PalpitationsCardiac disorders	8/963
VertigoEar and labyrinth disorders	8/963

Baseline characteristics

Age, Continuous
Age, Continuous(years)	XIENCE
Mean	76.84 ± 7.73

Sex: Female, Male
Sex: Female, Male(Participants)	XIENCE
Female	320
Male	643

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	XIENCE
Hispanic or Latino	145
Not Hispanic or Latino	360
Unknown or Not Reported	458

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	XIENCE
American Indian or Alaska Native	0
Asian	124
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	381
More than one race	0
Unknown or Not Reported	458

Region of Enrollment
Region of Enrollment(participants)	XIENCE
Singapore	22
Hong Kong	48
United Kingdom	30
Portugal	8
Switzerland	37
Spain	89
Austria	3
Netherlands	49
Belgium	64
China	7
Taiwan	48
Italy	231
Germany	327

Prior Percutaneous Coronary Intervention (PCI)
Prior Percutaneous Coronary Intervention (PCI)(participants)	XIENCE
Number	276

History of Major Bleeding
History of Major Bleeding(participants)	XIENCE
Number	26

Study locations

52 sites

Kepler Universitätsklinikum GmbH
Linz, UPR AUS 4021, Austria
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst, Eflndrs 9300, Belgium
UZ Gent
Ghent, Flemish 42100, Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg 3600, Belgium
Jesse Ziekenhuis
Hasselt, Limburg 3500, Belgium
Beijing AnZhen Hospital
Beijing, Beijing Municipality 100029, China
The Second Hospital of Jilin University
Changchun, N China, China
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Bad-wur 79189, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, N. RHIN 45138, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela 55131, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony 4289, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Schlesw 23795, Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, 12200, Germany
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg, 20246, Germany
Prince of Wales Hospital
Hong Kong, Hong Ko, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Ko, Hong Kong
The University of Hong Kong (Queen Mary Hospital)
Hong Kong, HONG KO, Hong Kong
Clinica Mediterranea
Naples, Campani 80122, Italy
AOU Federico II - Università degli Studi di Napoli
Naples, Campani 80138, Italy
Az.Osp. Universitaria di Ferrara
Cona, Emi-rom 44124, Italy
AOU di Parma
Parma, Emi-rom 43126, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Rome, Lazio 00161, Italy
Policlinico Universitario A. Gemelli
Rome, Lazio 00168, Italy
Centro Cardiologico Monzino
Milan, Lombard 20138, Italy
Istituto Clinico Humanitas
Rozzano, Lombard 20089, Italy
Scheperziekenhuis
Emmen, Drenthe 7824 AA, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Friesld 8934 AD, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, ZUID 3318 AT, Netherlands
Hospital de Santa Cruz
Carnaxide, Lisbon District 2799-523, Portugal
Santa Maria Hospital
Lisbon, Lisbon District 1649-035, Portugal
National Heart Centre Singapore
Singapore, Central 169609, Singapore
Tan Tock Seng Hospital
Singapore, Central 308433, Singapore
HCU Virgen de la Victoria
Málaga, Andalu 29010, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabr 39008, Spain
Hospital del Mar
Barcelona, Catalon 08003, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalon 08036, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Cstleon 47005, Spain
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
Vigo, Pontev 36312, Spain
Hospital Universitario Doce de Octubre
Madrid, 28041, Spain
Kantonsspital Aarau
Aarau, Basel 5001, Switzerland
Center Inselspital Bern
Bern, 3010, Switzerland
Luzerner Kantonsspital
Lucerne, 6004, Switzerland
Chang Gung Memorial Hospital
Linkou District, Ntaiwan 333, Taiwan
National Taiwan University Hospital
Taipei, Ntaiwan 10002, Taiwan
Taipei Veterans General Hospital (VGH)
Taipei, Ntaiwan 11217, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Staiwan 83301, Taiwan
Freeman Hospital
Newcastle upon Tyne, NE ENGL NE7 7DN, United Kingdom
Craigavon Area Hospital
Portadown, Nirelnd BT63 5QQ, United Kingdom
Southampton University Hospital
Southampton, Soeast SO16 6YD, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Sowest BH7 7DW, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Sowest EX2 5DW, United Kingdom
University Hospital of Wales
Cardiff, Wales CF14 4XW, United Kingdom

References and documents

Publications

Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074. PubMed 34794687 ↗
Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6. PubMed 33031789 ↗

Study documents

Study protocol · Nov 13, 2018
Statistical analysis plan · Jun 19, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03355742
Lead sponsor: Abbott Medical Devices
Responsible party: Sponsor
First posted: Nov 28, 2017
Start date: Feb 9, 2018
Primary completion: Oct 24, 2019
Completion: Apr 30, 2020
Results posted: Feb 8, 2021
Last update: Mar 4, 2021

Study contacts

Marco Valgimigli, MD

principal investigator · Bern University Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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