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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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5 year clinical outcomes


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General
Application Number P030025 S021/ PAS001
Current Plan Approved 09/24/2008
Study Name 5 year clinical outcomes
General Study Protocol Parameters
Study Design Randomized Clinical Trial
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 was 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 <4.0mm in diameter in lesions < 28mm in length.
Sample Size 1108 patients, 70 sites
Data Collection Primary endpoint for this study is the rate of ischemia-driven target vessel revascularization at 9 months after the index procedure.
Follow-up Visits and Length of Follow-up All patients were followed at 30 days, were to completed a 9-month follow-up evaluation, which included angiographic assessmen and followed annually through 5 years post index procedure.
Final Study Results
Interim Safety Information Study completed, see final results.
Number of Patients 1172 patients, 586 Control and 586 Taxus
Number of Sites 70 sites
Follow-up Rate 83%
Safety Findings At the 5 year endpoint of the study, the TAXUS treatment group exhibited a statistically significant excess of MI compared to the Control treatment group (5.6% in Control vs. 9.3% in TAXUS). In addition, the "Cardiac death and MI" rates across time though 5 years were statistically significantly different for the TAXUS group (13.5%) relative to the Control group (8.6%). The overall MACE rates (cardiac death, myocardial infarction [MI], and TVR rate) over time through 5 years were comparable between the TAXUS (30.6%) and Control groups (33.6%). The Cardiac death rates over time through 5 years were not statistically significantly different between the TAXUS (5.3%) and Control groups (3.6%). The per protocol stent thrombosis rates were similar between the two groups through 5 years (1.9% for TAXUS vs. 0.7% for Control). From 4 to 5 years, there were no ST events per protocol in either treatment group. The rates for all death through 5 years were comparable in the TAXUS (10.2%) and Control groups (8.5%). The serious adverse events rates through 5 years were comparable between the TAXUS and Control groups (71.1% in TAXUS vs. 73.4% in Control).
Strengths & Weaknesses Strengths: Five year clinical follow-up was completed in 83.1% of all patients enrolled and eligible for follow-up (871/1048). Weaknesses: The main area of concern is the higher MI rate in the TAXUS versus the control group
Label Changes The high rates of MI and cardiac death or MI at five years in TAXUS patients compared to BMS patients with a visually assessed RVD > 2.5 mm and lesion length >26 mm with > 2 planned stents are notable. The sponsor has been asked to include this data in the label.


5 year clinical outcomes Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/24/2009 12/23/2008 On Time
2 year report 09/24/2010 10/30/2009 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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