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, 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.
Followup Visits and Length of Followup
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.
Final Study Results
Actual Number of Patients Enrolled
421
Actual Number of Sites Enrolled
37
Patient Followup 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 Effectiveness 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 and 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.
