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.
The objective of the Dual Antiplatlet Study is to evaluate
multiple durations of DAPT following DES
implantation to determine the optimal duration. The patients will be randomized to either their DAPT or placebo and followed from 12 months to 30 months post index procedure
Study Population Description
This device is indicated for improving luminal diameter for
the treatment of de novo lesions <
28 mm in length in native coronary arteries > 2.5 mm to < 4.0 mm in diameter. Study patients with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention with TAXUS Liberté stent placement and no contraindications to prolonged dual antiplatlet therapy are eligible to be enrolled in this study. Patients randomized to the control group will receive placebo.
Up to 4200 patients will be randomized for participation in
DAPT. The sample size is estimated
based on the expected follow-up rate.
No endpoints are specified for the descriptive analyses of
Overall: At three years: 85.8% (3579/4173) On-label: At three years: 86.3% (1370/1588)
Final Safety Findings
The primary endpoint (12-month Cardiac Death or myocardial infarction) was met as the difference of
-0.9%, with a 1-sided 95% upper confidence limit of -0.2%, was less (P<0.001) than the pre-specified non-inferiority margin of 1.6%.
The annualized stent thrombosis rate on on-label subjects met the pre-specified performance goal. It was 0.56% between 1 and 2 years (upper 1-sided 95% confidence limit (95% UCL):
0.82%) which was below the 1.0% performance goal (P=0.0025). Between 2 and 3 years, it was
0.51% (1-sided 95% UCL: 0.76%, p<0.001).
The secondary endpoint related to on-label subjects with diabetes also met its performance goal. The 12-month target vessel failure rate of 5.1% (1-sided 95% UCL 6.8%) was less (P<0.001) than the pre-specified non-inferiority performance goal of 12.6%.
Study Strengths and Weaknesses
This study provides longer term (3 years) safety and effectiveness results of the TAXUS Liberté
paclitaxel-eluting coronary stent system. This post-approval study contributed subjects to the Dual Antiplatelet Therapy (DAPT) trial, an industry/academic research organization/FDA collaboration with the Harvard Clinical Research Institute. This study supports the safety and effectiveness results of the premarket data on the TAXUS Liberté paclitaxel-eluting coronary stent system.
Recommendations for Labeling Changes
Labeling changes are not recommended since this device is no longer on the market.