Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

University of Bern1,012 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,012

Conditions

Coronary Heart Disease

Interventions

Sirolimus-eluting stentDEVICE

Paclitaxel-eluting stentDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Bern

Bern, Switzerland

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

Data from ClinicalTrials.gov

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