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 study.
Study Population Description
The TAXUS Liberté Long Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel 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 >=2.75 mm to <=4. 00 mm in diameter in lesions <=34 mm in length.
Sample Size
84 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
150
Actual Number of Sites Enrolled
24
Patient Followup Rate
90.2%
Final Safety Findings
¿MACE: out-of-hospital MACE to 5 years was comparable for the groups (32.6% for the TAXUS®
ATLAS Group and 27.6% for the Control Group, P=0.3790).
¿Stent Thrombosis: Stent thrombosis rates were not statistically different for the TAXUS® ATLAS Group versus the Control Group (2.5% versus 0.9%, P=0.6220)
¿All Death: Rates through 5 years were comparable between the TAXUS® ATLAS Group and the Control Group (11.1% versus 10.9%, P=0.9465).
¿Non-cardiac Death: Rates through 5 years were not statistically different the TAXUS® ATLAS Group and the Control Group (7.0% versus 2.5%, P=0.1054).
Final Effectiveness Findings
¿MACE (cardiac death, MI, and TVR): The rate at 5 years was comparable between the
TAXUS® ATLAS Group and the Control Group (32.6% versus 30.7%, respectively).
¿Cardiac Death: Rates through 5 years were comparable for the TAXUS® ATLAS Group and the Control Group (4.5% versus 8.7%).
¿MI: Rates through 5 years were comparable for the TAXUS® ATLAS Group and the Control Group (7.6% versus 11.8%).
¿TVR: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (25.8% versus 20.5%).
¿TLR: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (18.9% versus 14.2%).
¿TVF: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (30.5% versus 28%.
*The study was not powered for these endpoints at 5 years
Study Strengths and Weaknesses
Sponsor had a high follow-up rate. The stent thrombosis rate was higher in the treatment
group. The study was not adequately powered to detect differences in stent thrombosis rates.
Recommendations for Labeling Changes
Yes, to update with the five year final study results.
