|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030025 S021/ PAS001 |
| Date Original Protocol Accepted |
09/24/2008
|
| Date Current Protocol Accepted |
09/24/2008
|
| Study Name |
5 year clinical outcomes
|
| Device Name |
TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM
|
| 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 Objectives |
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 |
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
|
| Key Study Endpoints |
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.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
1172 patients, 586 Control and 586 Taxus
|
| Actual Number of Sites Enrolled |
70 sites
|
| Patient Follow-up Rate |
83%
|
| Final 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).
|
| Study 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
|
| Recommendations for Labeling 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.
|
