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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the
TAXUS Liberte-Paclitaxel-Eluting Coronary Stent and prasugrel as part of a dual antiplatelet therapy drug regimen. This is a consecutively-enrolled study with follow-up through 5 years. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy.
tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter. The stent is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries > 2.25 mm to < 4.00 mm in diameter in lesions < 28 mm in length.
Sample Size
168 subjects, 100 sites
Data Collection
Data will be collected on the rate of cardiac death or myocardial infarction through 12
months. This will be compared with the cardiac death or myocardial infarction rates observed through 12 months in control arm of the TAXUS ATLAS Workhorse Clinical Trial and the ARRIVE 1 and 2 registries.
Followup Visits and Length of Followup
Patient follow up will occur at months 6, 12, 15, 18, 24, 30, 33, 36,
48 and 60 post index procedure, for all enrolled patients. Follow-up for months 15, 33, 36, 48 and 60 may be conducted via telephone. Follow-up for months 6, 12, 18, 24 and 30 must be conducted during a clinical visit for the purposes of study drug dispensing and accountability. The 18-month office visit is intended to serve the purposes of drug dispensing and accountability only.
Final Study Results
Actual Number of Patients Enrolled
261 TAXUS ATLAS patients, 75 DES control, 155 BMS control
Actual Number of Sites Enrolled
23
Patient Followup Rate
91.3% TAXUS ATLAS, 90.4% DES Control, 85.5% BMS Control. These percentages include patients who died
in both the numerator and denominator.
Final Safety Findings
MACE (cardiac death, MI, and TVR): The rate at 5 years was 26.3 in the
TAXUS ATLAS Group and 36.9% in the DES Control group and 44.4% in the BMS Control group.
Final Effectiveness Findings
TVR, TLR and TVF rates at 5 years were 20.1%, 13.4% and 25.6%, respectively, for
the TAXUS ATLAS Group. The rates for the DES Control Group were 30.8% (TVR), 23.1% (TLR) and 35.4% (TVF). The rates for the BMS Control Group were: 38.3% (TVR), 32.3% (TLR), and 42.9% (TVF).
Study Strengths and Weaknesses
The sponsor present a well designed study with a control group with good follow-up at 5 years.
Recommendations for Labeling Changes
Updated to include the long-term post-approval study data and findings.
