In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
5000 patients, number of sites not listed
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.
Followup Visits and Length of Followup
Clinical follow-up for this cohort will occur at 2, 3, 4, and 5 years.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
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).
Final Effectiveness 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.
Study Strengths and 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.
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.