Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization
Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.
Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel eluting stents.
Coronary Heart Disease
Device: Sirolimus-eluting stent
Device: Paclitaxel-eluting stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization: SIRTAX Trial|
- Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
- Clinical: Ischemia-driven target lesion revascularization, target-vessel revascularization, and target-vessel failure (composite of cardiac death, myocardial infarction or ischemia-driven target-vessel revascularization)
- Angiographic: In-segment late luminal loss
|Study Start Date:||April 2003|
Design: Randomized controlled, observer-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents
Patients: 1012 patients undergoing percutaneous coronary intervention. The two groups had similar baseline clinical and angiographic characteristics.
|University Hospital Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Stephan Windecker, MD||Department of Cardiology, University Hospital Bern|
|Study Director:||Peter Juni, MD||Department of Social and Preventive Medicine, University of Bern|
|Study Chair:||Bernhard Meier, MD||Department of Cardiology, University Hospital Bern|