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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070015 / PAS002 |
| Date Original Protocol Accepted |
07/02/2008
|
| Date Current Protocol Accepted |
07/02/2008
|
| Study Name |
XIENCE Registry
|
| Device Name |
XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study will 1) evaluate clinical outcomes in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use by various physicians with a range of coronary stenting experiences; 2) Evaluate patient compliance with adjunctive antiplatelet therapy and major bleeding complications;3) Determine clinical device and procedural success during commercial use; and 4) Evaluate patient health status using the Seattle Angina Questionnaire.
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| Study Population |
The XIENCE V Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery, lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.
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| Sample Size |
5000 patients, number of sites not listed
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| Key Study Endpoints |
The primary endpoints of the study are is stent thrombosis rates annually through 5 years as defined by Academic Research Consortium and the composite rate of cardiac death and any myocardial infarction at 1 year.
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| Follow-up Visits and Length of Follow-up |
Clinical follow-up for this cohort will occur at 2, 3, 4, and 5 years.
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| Interim or Final Data Summary |
| Interim Results |
The rate of definite and probable ST (ARC definition) through 194 days was 0.5% (27/4957). Based on the time window when those definite and probable ST events occurred, 2 patients (0.04%) were adjudicated with acute ST, 20 patients (0.4%) were adjudicated with subacute ST, and 5 patients (0.1%) were adjudicated with late ST.The composite rate of cardiac death and any MI (Q-wave [QMI] and non-Q-wave [NQMI]) and the composite rate of all death and any MI (QMI and NQMI), at the in-hospital, 21-day, 37-day, and 194-day post-procedure time points are provided. The event rates through 37 days were 2.5% (126/5016) for cardiac death and MI, and 2.5% (127/5016) for all death and MI. The event rates through 194 days were 3.7% (183/4983) for cardiac death and MI, and 3.9% (195/4983) for all death and MI, respectively. Through 194 days post-procedure, the composite cardiac death and MI rate were dominated by NQMI (2.5% [124/4983]).
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| Actual Number of Patients Enrolled |
5,020
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| Actual Number of Sites Enrolled |
161
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| Patient Follow-up Rate |
93%
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| Final Safety Findings |
The annual rate of ARC-defined definite and probable ST at 4 years for the first 1500 on-label and near on-label subjects from the long-term follow-up (LTF) cohort was 0.16% (2/1241, upper one-sided 95% CI
0.51%).
The 4-year cumulative ARC-defined definite and probable ST rates were 1.56% (64/4093, 95% CI [1.21%,
1.99%]) for the overall LTF cohort, 0.79% (10/1268, 95% CI [0.38%, 1.45%]) for the first 1500 on-label and near on-label population, and 1.91% (54/2825, 95% CI [1.44%, 2.49%]) for the remaining subjects in the LTF cohort.
The 1-year adjusted rate of cardiac death and any MI was 6.2% (166/2663) for the SPIRIT study arm, the
1-year event rate was 6.2% (55/881) for the XIENCE V USA test arm (non-inferiority p<0.01).
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| Final Effect Findings |
The cumulative rates of cardiac death and MI through 4 years were 14.9% (676/4530, 95% CI [13.90%,
15.99%] for the overall LFT cohort, 10.1% (139/1373, 95% CI [8.58%, 11.84%]) for the first 1500 on-label and near on-label subjects, and 17.0% (537/3157, 95% CI [15.71%, 18.37%]) for the remaining subjects
in the LFT cohort.
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| Study Strengths & Weaknesses |
The study had a low rate of attrition, thus minimizing selection bias. The study met its performance goals and had a large sample size.
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| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market cohort.
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