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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Outcomes TAXUS ATLAS


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General
Application Number P060008 / PAS001
Current Plan Approved 10/10/2008
Study Name OSB Lead-Outcomes TAXUS ATLAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Follow-up Visits and Length of Follow-up Patient follow-up was planned annually for 5 years post-index procedure.
Final Study Results
Interim Safety Information The MACE (cardiac death, MI, and TVR) rate at 4 years post stent implantation was comparable between the TAXUS ATLAS Group and the Control Group (22.5% versus 23.8%, P=0.5015). There was no statistically significant difference in MI, cardiac death, TVR, TLR, stent thrombosis and death rates between the two groups. The principal safety and efficacy outcomes just noted in the interval from 3 to 4 years post stent implantation were comparable as well. Despite greater lesion complexity in the TAXUS ATLAS Group, the 4 year post implantation data presented by the sponsor demonstrate that the TAXUS Liberté stent is comparable to the TAXUS Express stent with respect to MACE (including individual MACE components cardiac death, MI, and TVR), TLR, and TVF. There are no new safety or effectiveness concerns raised by this data.
Number of Patients 867
Number of Sites 60
Follow-up Rate 91.7%
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.
Effect Findings See above
Strengths & Weaknesses Despite greater lesion complexity in the TAXUS ATLAS Group, the 5 year post implantation data presented by the sponsor demonstrate that the TAXUS Liberté stent is comparable to the TAXUS Express stent with respect to MACE (including individual MACE components cardiac death, MI, and TVR), TLR, and TVF.
Label Changes 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.


OSB Lead-Outcomes TAXUS ATLAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 10/10/2009 08/14/2009 On Time
2 year report 10/10/2010 05/05/2010 On Time
Final Report 10/10/2011 10/18/2010 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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