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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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XIENCE Registry

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Application Number P070015 / PAS002
Current Plan Approved 07/02/2008
Study Name XIENCE Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description 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.
Sample Size 5000 patients, number of sites not listed
Data Collection 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.
Follow-up Visits and Length of Follow-up Clinical follow-up for this cohort will occur at 2, 3, 4, and 5 years.
Final Study Results
Interim Safety Information 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]).
Number of Patients 5,020
Number of Sites 161
Follow-up Rate 93%
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


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).

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.

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.
Label 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.

XIENCE Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/31/2008 12/24/2008 On Time
1 year report 07/02/2009 06/30/2009 Overdue/Received
18 month report 12/31/2009 12/22/2009 On Time
2 year report 07/02/2010 06/29/2010 On Time
3 year report 07/02/2011 07/01/2011 On Time
primary analysis report 01/17/2012 01/17/2012 On Time
4 year report 07/01/2012 07/02/2012 Overdue/Received
5 year report 07/01/2013 02/28/2013 On Time
6 year report-FINAL REPORT 07/01/2014 08/12/2013 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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