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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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5 year Clinical Outcomes

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Study Status Completed
Application Number P030025 S028/ PAS001
Date Current Protocol Accepted 09/24/2008
Study Name 5 year Clinical Outcomes
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical 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 prospective, randomized, controlled, multicenter, double-blind safety and efficacy study. Patients were randomized in a 1:1 ratio to receive either the TAXUS Express Slow-Release paclitaxel-eluting stent system or an uncoated Express control stent. Randomization included stratification by clinical site, target lesion length (<18 mm versus >18 mm), and the presence or absence of medically treated diabetes mellitus. The primary objective of this study was to further evaluate the safety and effectiveness of the TAXUS Express Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions.
Study Population Description The device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2. 25 to <=4. 00 mm in diameter in lesions <=28 mm in length, and within bare metal stent restenotic lesions >=2. 25 to <=3. 75 mm in diameter and <=28 mm in length.
Sample Size 1172 patients (86 in the TAXUS group and 586 in the Control group), 66 sites
Data Collection The primary endpoint is the rate of ischemia-driven target vessel revascularization at 9 months after the index procedure. The 5 year safety data will be reported for 1) Major Adverse Cardiac Events, 2) Myocardial infarction (Q-wave and non-Q-wave), 3) All-cause death and cardiac death, 4) Serious adverse events, and 5) Stent thrombosis.
Follow-up Visits and Length of Follow-up Patients will be follow for 5 years post procedure. A subset of patients will have a follow-up intravascular ultrasound at the 9-month follow-up evaluation.
Interim or Final Data Summary
Interim Safety Information The major cardiac eventrate at 4 years was significantly lower for TAXUS compared to Brachy (28.4% versus 41.6%; P=0.0054), a relative reduction of 31.7%. The decrease in the major cardiac event rate was largely driven by a significant reduction in target vessel revascularization in TAXUS patients (23.8%), as compared to Brachy patients (39.3%). Myocardial infarction rates through 4 years were comparable between the TAXUS (5.2%) and Brachy groups (9.3%). Cardiac death rates through 4 years were comparable between TAXUS (4.5%) and Brachy (3.4%).
Actual Number of Patients Enrolled 421
Actual Number of Sites Enrolled 37
Patient Follow-up Rate 86.3%
Final Safety Findings Through 5 years of follow-up, the safety profile of the TAXUS group demonstrated better MACE outcomes compared to Brachytherapy. The MACE benefit observed for TAXUS at 1 year persisted through 5 years and was driven predominantly by a significantly lower TVR rate. There were no significant differences in the individual rates of cardiac death, MI, and target vessel thrombosis between the TAXUS and Brachytherapy groups at 5 years. The rate of stent thrombosis remained low in the TAXUS group with no new events after 4 years.
Final Effect Findings Between 4 and 5 years, the rates of TVR (6.7% Brachytherapy, 5.5% TAXUS; P=0.6267) and TLR (5.5% Brachytherapy, 4.4% TAXUS; P=0.6296) were similar between treatment groups
Study Strengths & Weaknesses Sponsor demonstrated adequate follow-up out to 5 years. The results do not raise any safety concerns. The strength of the clinical evidence of the TAXUS V-ISR results is enhanced by the RCT design and relatively large sample size (421 patients with ISR from 37 centers).
Recommendations for Labeling Changes Updated labeling to include ISR 5 year study results.

5 year Clinical Outcomes Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
3 year data report 11/10/2008 11/10/2008 On Time
1 Year Report (4 year data) 06/25/2009 06/25/2009 On Time
Final Reportr 06/15/2010 06/15/2010 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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