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.
target vessel failure (TVF) rate, myocardial infarction [ MI (Q-wave and non¿Q-wave)] rate, cardiac death rate, non-cardiac death rate, all death rate, cardiac death or MI rate, all death or MI rate, all death/MI/TVR rate, and stent thrombosis rate (definite or probable by ARC definitions)
Followup Visits and Length of Followup
18-Month, and 2, 3, 4, 5-Year Follow-Up
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
86.7% at 5years
Final Safety Findings
The 12 month primary effectiveness was met. For ITT patients, the 12 month TLF
rate was 3.1% (3/96)
with upper 1-sided upper confidence bound 7.88% which is significantly less than the performance goal (PG) of 19.4% (p<0.001), and for per protocol patients the 12-month TLF rate was 3.2% (3/95) with 1- sided upper confidence bound of 7.96%, significantly less than the PG, 19.4% (P<0.001).
Final Effectiveness Findings
The main safety and effectiveness endpoint rates through 5 years in the Platinum LL sub-study
are: Target lesion revascularization (TLR) 7.5%, target lesion failure (TLF) 13.6%, target vessel revascularization (TVR) 11.6%, target vessel failure (TVF) 17.7%, myocardial infarction (Q and non-Q wave) 1.3%, cardiac death 8.6%, Non cardiac death 2.2%, all death 10.6%, all death or MI 11.7%, All death, MI, TVR 20.7% and Academic Research Consortium (ARC)-defined Stent Thrombosis 1%.
Study Strengths and Weaknesses
The Long lesion study met the primary endpoint and provided long term data. However the
sample size was small and subgroup analyses were not conducted.
Recommendations for Labeling Changes
Labeling change is recommended to reflect the long term data from the post-approval study. The
labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.
OSB Lead-Continued F/U of Premarket Cohort