Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization
- Conditions
- Coronary Heart Disease
- Registration Number
- NCT00297661
- Lead Sponsor
- University of Bern
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1012
Patients with either stable angina or an acute coronary syndrome were eligible to participate if they had at least one lesion with stenosis of at least 50 percent in a vessel with a reference diameter between 2.25 and 4.00 mm that was suitable for stent implantation.
Allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, sirolimus, or paclitaxel; participation in another coronary-device study; and terminal illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Hospital Bern
🇨🇭Bern, Switzerland