Coronary Heart Disease
Conditions
Keywords
Coronary Revascularization, Sirolimus-eluting stents, Paclitaxel-eluting stents
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.
Interventions
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Switzerland