CompletedNCT01182428Updated Aug 7, 2012Results posted

XIENCE V: SPIRIT WOMEN Sub-study

A Phase 4 interventional study of XIENCE V®/ XIENCE PRIME™ and CYPHER SELECT in Coronary Artery Stenosis, Coronary Arteriosclerosis and Coronary Artery Disease, sponsored by Abbott Medical Devices. Completed at 25 sites in 15 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-07.

Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 455
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

Read the detailed description

SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years.

Conditions studied

Coronary Artery Stenosis
Coronary Arteriosclerosis
Coronary Artery Disease
Coronary Artery Restenosis
Total Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia

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Keywords

Stents
Angioplasty
Total coronary occlusions
Coronary restenosis
Stent thrombosis
Everolimus

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 455 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.

Who can participate

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

Eligibility criteria

General Inclusion Criteria:

Patient must be female.
Patient must be at least 18 years of age.
Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Patient must agree to undergo all protocol-required follow-up examinations.
Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic Inclusion Criteria:

Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
Target lesion greater than or equal to 28 mm in length by visual estimate.

General Exclusion Criteria:

Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 455 participants (actual)

Study arms

Experimental
XIENCE V® / XIENCE PRIME™
Device: XIENCE V®/ XIENCE PRIME™
Active comparator
CYPHER SELECT
Device: CYPHER SELECT

Interventions

DeviceXIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
DeviceCYPHER SELECT
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions

What researchers measure

Primary outcomes

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
Time frame: at 1 year
In-stent Late Loss (LL) (Main Secondary Endpoint)
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.
Time frame: at 270 days

Secondary outcomes

Clinical Device Success
Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
Time frame: Intra-operative
Clinical Procedure Success
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.
Time frame: Intra-operative
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: < 1 day (Acute)
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: 1 to 30 days (Sub-Acute)
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: 30 days to 1 year (Late)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: 30 days to 1 year (Late)
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
Time frame: at 30 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Time frame: at 240 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Time frame: at 1 year
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 30 days
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 30 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 1 year
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 30 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 240 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 1 year
In-segment Late Loss (LL)
LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
Time frame: at 270 days
In-stent Angiographic Binary Restenosis Rates
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Time frame: at 270 days
In-segment Angiographic Binary Restenosis Rates
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Time frame: at 270 days
In-stent Percent Diameter Stenosis
Time frame: at 270 days
In-segment Percent Diameter Stenosis
Time frame: at 270 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Time frame: at 30 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Time frame: at 240 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Time frame: at 1 year
Aneurysm
All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
Time frame: at 270 days
Thrombus
All subjects with thrombus of the target lesion up to the 270 day follow-up visit
Time frame: at 270 days
Persisting Dissection
All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit
Time frame: at 270 days

Results

Posted Jul 13, 2012

Participant flow

Patients were recruited between 30 Sept 2008 and 02 December 2009, from the general female interventional cardiology population who had been admitted for a PCI procedure.

Participant flow — Overall Study
Milestone	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Started	304	151
Completed	293	150
Not completed	11	1
Withdrew: Physician decision	1	0
Withdrew: Lost to follow-up	9	1
Withdrew: Withdrawal by subject	1	0

Outcome measures

PrimaryAdjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.

Time frame:: at 1 year
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	21.5 (16.94 to 26.65)	22 (15.65 to 29.49)

SecondaryClinical Device Success

Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.

Time frame:: Intra-operative
Reported as:: Number · Percentage of evaluated lesions

Clinical Device Success
Percentage of evaluated lesions	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Clinical Device Success	91.1 (87.99 to 93.63)	93.5 (89.14 to 96.49)

SecondaryClinical Procedure Success

Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.

Time frame:: Intra-operative
Reported as:: Number · Percentage of Participants

Clinical Procedure Success
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Clinical Procedure Success	85.2 (80.70 to 88.99)	84.1 (77.28 to 89.54)

SecondaryAdjudicated Stent Thrombosis (Definite, Probable)

Time frame:: < 1 day (Acute)
Reported as:: Number · Percentage of Participants

Adjudicated Stent Thrombosis (Definite, Probable)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Stent Thrombosis (Definite, Probable)	0.0 (0.0 to 1.21)	0.0 (0.0 to 2.41)

SecondaryAdjudicated Stent Thrombosis (Definite, Probable)

Time frame:: 1 to 30 days (Sub-Acute)
Reported as:: Number · Percentage of Participants

Adjudicated Stent Thrombosis (Definite, Probable)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Stent Thrombosis (Definite, Probable)	0.0 (0.0 to 1.21)	0.66 (0.02 to 3.63)

SecondaryAdjudicated Stent Thrombosis (Definite, Probable)

Time frame:: 30 days to 1 year (Late)
Reported as:: Number · Percentage of Participants

Adjudicated Stent Thrombosis (Definite, Probable)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Stent Thrombosis (Definite, Probable)	0.0 (0.0 to 1.28)	0.69 (0.02 to 3.81)

SecondaryAdjudicated Stent Thrombosis (Definite, Probable, Possible)

Time frame:: 30 days to 1 year (Late)
Reported as:: Number · Percentage of Participants

Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Stent Thrombosis (Definite, Probable, Possible)	0.35 (0.01 to 1.93)	1.39 (0.17 to 4.93)

SecondaryAdjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).

Time frame:: at 30 days
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).	11.51 (8.15 to 15.65)	13.25 (8.28 to 19.71)

SecondaryAdjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.

Time frame:: at 240 days
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.	14.67 (10.86 to 19.18)	14.57 (9.36 to 21.22)

SecondaryAdjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.

Time frame:: at 1 year
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.	18.77 (14.47 to 23.72)	18.67 (12.78 to 25.84)

SecondaryAdjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

Time frame:: at 30 days
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	11.51 (8.15 to 15.65)	13.25 (8.28 to 19.71)

SecondaryAdjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

Time frame:: at 240 days
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	15.33 (11.45 to 19.92)	15.23 (9.91 to 21.97)

PrimaryIn-stent Late Loss (LL) (Main Secondary Endpoint)

In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.

Time frame:: at 270 days
Reported as:: Mean · millimeters

In-stent Late Loss (LL) (Main Secondary Endpoint)
millimeters	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
In-stent Late Loss (LL) (Main Secondary Endpoint)	0.20 ± 0.38	0.12 ± 0.36

SecondaryAdjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).

Time frame:: at 30 days
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).	12.17 (8.72 to 16.38)	13.91 (8.82 to 20.47)

SecondaryAdjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).

Time frame:: at 240 days
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).	18.0 (13.82 to 22.82)	17.88 (12.13 to 24.94)

SecondaryAdjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).

Time frame:: at 1 year
Reported as:: Number · Percentage of Participants

Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).	27.99 (22.92 to 33.5)	30 (22.8 to 38.01)

SecondaryAdjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Time frame:: at 30 days
Reported as:: Number · Percentage of Participants

Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).	11.51 (8.15 to 15.65)	13.25 (8.28 to 19.71)

SecondaryAdjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Time frame:: at 240 days
Reported as:: Number · Percentage of Participants

Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).	12.67 (9.12 to 16.97)	13.25 (8.28 to 19.71)

SecondaryAdjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Time frame:: at 1 year
Reported as:: Number · Percentage of Participants

Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).	13.99 (10.23 to 18.50)	15.33 (9.98 to 22.11)

SecondaryIn-segment Late Loss (LL)

LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up

Time frame:: at 270 days
Reported as:: Mean · millimeters

In-segment Late Loss (LL)
millimeters	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
In-segment Late Loss (LL)	0.10 ± 0.41	0.04 ± 0.37

SecondaryIn-stent Angiographic Binary Restenosis Rates

Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).

Time frame:: at 270 days
Reported as:: Number · Percentage of Target Lesions

In-stent Angiographic Binary Restenosis Rates
Percentage of Target Lesions	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
In-stent Angiographic Binary Restenosis Rates	3.2 (1.54 to 5.78)	0.7 (0.02 to 3.71)

SecondaryIn-segment Angiographic Binary Restenosis Rates

Time frame:: at 270 days
Reported as:: Number · Percentage of target lesions

In-segment Angiographic Binary Restenosis Rates
Percentage of target lesions	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
In-segment Angiographic Binary Restenosis Rates	4.3 (2.29 to 7.18)	2.1 (0.43 to 5.97)

SecondaryIn-stent Percent Diameter Stenosis

Time frame:: at 270 days
Reported as:: Mean · % diameter stenosis

In-stent Percent Diameter Stenosis
% diameter stenosis	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
In-stent Percent Diameter Stenosis	15.77 ± 14.19	13.62 ± 11.10

SecondaryIn-segment Percent Diameter Stenosis

Time frame:: at 270 days
Reported as:: Mean · % diameter stenosis

In-segment Percent Diameter Stenosis
% diameter stenosis	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
In-segment Percent Diameter Stenosis	22.26 ± 13.45	20.14 ± 12.63

SecondaryAdjudicated Revascularization (TLR/TVR/All Revascularizations)

Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations

Time frame:: at 30 days
Reported as:: Number · Percentage of Participants

Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	0.66 (0.08 to 2.36)	1.99 (0.41 to 5.7)

SecondaryAdjudicated Revascularization (TLR/TVR/All Revascularizations)

Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations

Time frame:: at 240 days
Reported as:: Number · Percentage of Participants

Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	8.0 (5.19 to 11.67)	5.96 (2.76 to 11.01)

SecondaryAdjudicated Revascularization (TLR/TVR/All Revascularizations)

Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations

Time frame:: at 1 year
Reported as:: Number · Percentage of Participants

Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Percentage of Participants	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	18.09 (13.85 to 22.98)	19.33 (13.35 to 26.57)

SecondaryAneurysm

All subjects with aneurysm of the target lesion up to the 270 day follow-up visit

Time frame:: at 270 days
Reported as:: Number · % of target lesions with aneurysm

Aneurysm
% of target lesions with aneurysm	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Aneurysm	0.0 (0.0 to 1.15)	0.0 (0.0 to 2.41)

SecondaryThrombus

All subjects with thrombus of the target lesion up to the 270 day follow-up visit

Time frame:: at 270 days
Reported as:: Number · Percentage of evaluated lesions

Thrombus
Percentage of evaluated lesions	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Thrombus	0.3 (0.01 to 1.74)	1.3 (0.16 to 4.70)

SecondaryPersisting Dissection

All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit

Time frame:: at 270 days
Reported as:: Number · Percentage of evaluated lesions

Persisting Dissection
Percentage of evaluated lesions	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Persisting Dissection	0.0 (0.0 to 1.2)	0.0 (0.0 to 2.51)

Adverse events

Collected over 1 year. Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
XIENCE V® / XIENCE PRIME®	—	120/304 (39.5%)	39/297 (13.1%)
CYPHER® SELECT	—	61/151 (40.4%)	11/149 (7.4%)

Most frequent serious events

Showing 10 of 122

Most frequent serious events
Event	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Angina pectorisCardiac disorders	38/297	8/149
Coronary artery stenosisCardiac disorders	5/297	6/149
In-stent coronary artery restenosisInjury, poisoning and procedural complications	5/297	6/149
Angina unstableCardiac disorders	8/297	2/149
AnaemiaBlood and lymphatic system disorders	1/297	4/149
Cardiac enzymes increasedInvestigations	2/297	4/149
Myocardial infarctionCardiac disorders	5/297	3/149
Non-cardiac chest painGeneral disorders	1/297	3/149
Catheter site haematomaGeneral disorders	5/297	1/149
Percutaneous coronary interventionSurgical and medical procedures	5/297	2/149

Most frequent other events

Most frequent other events
Event	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT
Cardiac enzymes increasedInvestigations	18/297	11/149
Angina pectorisCardiac disorders	21/297	4/149

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT	Total
<=18 years	0	0	0
Between 18 and 65 years	105	42	147
>=65 years	199	109	308

Age Continuous
Age Continuous(years)	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT	Total
Mean	68.37 ± 10.14	69.85 ± 10.54	68.86 ± 10.29

Sex: Female, Male
Sex: Female, Male(Participants)	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT	Total
Female	304	151	455
Male	0	0	0

Region of Enrollment
Region of Enrollment(participants)	XIENCE V® / XIENCE PRIME®	CYPHER® SELECT	Total
Spain	24	13	37
Austria	3	3	6
Switzerland	43	25	68
Italy	62	31	93
France	24	17	41
Hungary	41	12	53
Argentina	11	6	17
Belgium	6	4	10
Brazil	5	1	6
Poland	12	3	15
Denmark	16	5	21
Germany	26	13	39
Latvia	16	11	27
Netherlands	8	2	10
Norway	7	5	12

Study locations

25 sites

Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, 1181, Argentina
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, 1428, Argentina
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Wien, 1090, Austria
Heilig Hart Ziekenhuis Roeselare
Roeselare, 8800, Belgium
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Sao Paulo, 04012-180, Brazil
Rigshospitalet
Copenhagen, Denmark
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
Massy, 91300, France
Kardiologische Klinik Herz- und Diabeteszentrum
Bad Oeynhausen, 32545, Germany
Segebergerkliniken
Bad Segeberg, 23795, Germany
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
Dresden, 01307, Germany
Semmelweis University, Department of Cardiovascular Surgery
Budapest, Hungary
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
Milano, 20149, Italy
Centro Cardiologico Monzino
Milan, 20138, Italy
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
Modena, 41100, Italy
Ospedale Cisanello
Pisa, 56127, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Latvian Center of Cardiology, P. Stradina University Hospital
Riga, 1002, Latvia
AMC
Amsterdam, 1105, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3430, Netherlands
Haukeland university hospital
Bergen, 5021, Norway
Institute of Cardiology
Warsaw, 04-628, Poland
Hospital General de Alicante
Alicante, 3010, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916, Spain
Inselspital Bern, Kardiologie
Bern, 3010, Switzerland
Cardiocentro Ticino
Lugano, 6900, Switzerland

References and documents

Publications

Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439. PubMed 19072483 ↗
Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017. PubMed 28796809 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01182428
Lead sponsor: Abbott Medical Devices
Responsible party: Sponsor
First posted: Aug 16, 2010
Start date: Sep 2008
Primary completion: Feb 2011
Completion: Jul 2011
Results posted: Jul 13, 2012
Last update: Aug 7, 2012

Study contacts

Marie-Claude Morice

principal investigator · Institut Cardiovasculaire Paris Sud (ICPS), Paris, France

Stephan Windecker

principal investigator · University Hospital Bern, Bern, Switzerland

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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