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 multicenter, single-arm trial to evaluate the safety and efficacy of the TAXUS
Liberte
stent m the treatment of de novo coronary artery lesions compared with the TAXUS
Express Paclitaxel-Eluting Coronary Stent System (case-matched historical control data were derived from the TAXUS IV and TAXUS V de novo studies). Treatment was done in an open label fashion.
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. The FDA approved the TAXUS ATLAS study to increase the enrollment to 872 patients at 63 investigational sites in order to complete the enrollment of the subgroup analysis. The study was originally required to enroll 100 patients in the large diameter vessel subgroup. The FDA approved the minimum enrollment of 70 patients in the large diameter vessel subgroup. The control data comes from case-matched historical control data that were derived from the TAXUS IV and TAXUS V de novo studies.
Sample Size
822 patients, 60 sites
Data Collection
The primary endpoint of the study was ischemia-driven target vessel revascularization at 9-month follow-up. The
study was considered complete (with regard to the primary endpoint) after all patients enrolled completed the 9-month follow-up. Angiographic follow-up at 9 months was to be completed in a subset of 500 patients inclusive of an intravascular ultrasound analysis in 350 patients at qualified sites participating in the IVUS substudy.
Followup Visits and Length of Followup
Patient follow-up was planned annually for 5 years post-index procedure.
Final Study Results
Actual Number of Patients Enrolled
867
Actual Number of Sites Enrolled
60
Patient Followup Rate
91.7%
Final Safety Findings
The MACE (cardiac death, MI, and TVR) rate at 5 years post stent implantation was
comparable between the TAXUS ATLAS Group and the Control Group (26.2% versus 27.1%, P=0.7026). There was no statistically significant difference in MI, cardiac death, TVR, TLR, overall stent thrombosis and death rates between the two groups. The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0% in the control group. This, with a 5-year stent thrombosis rate of 2.3% in the TAXUS ATLAS group and 2% in the control group.
Final Effectiveness Findings
See above
Study Strengths and Weaknesses
Despite greater lesion complexity in the TAXUS ATLAS Group, the 5 year post implantation data
The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0%
in the control group. This, with a 5-year stent thrombosis rate of 2.3% in the TAXUS ATLAS group and 2% in the control group is higher than would be expected and was updated in a labeling change.
