Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization: SIRTAX Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- University of Bern
- Enrollment
- 1012
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, sirolimus, or paclitaxel; participation in another coronary-device study; and terminal illness.
Outcomes
Primary Outcomes
Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
Secondary Outcomes
- 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