Abciximab reduced death, MI, and urgent target vessel revascularization in non-ST-segment elevation acute coronary syndromes.

M e t h o d s Design: Randomized placebo-controlled trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 2 [ISAR-REACT 2] trial). Allocation: {Concealed}†.* Blinding: Blinded {patients, clinicians, outcome assessors, data collectors, data analysts, and data safety and monitoring committee}†.* Follow-up period: 30 days. Setting: 7 clinical centers in Brazil, Germany, and the Netherlands. Patients: 2022 patients (mean age 66 y, 75% men) who had non–ST-segment elevation ACS (≥ 1 episode of angina in the previous 48 h and elevated troponin T level [> 0.03 μg/L], new ST-segment depression ≥ 0.1 mV or transient [< 20 min] elevation ≥ 0.1 mV, or new bundle-branch block), and significant angiographic lesions in a native coronary vessel or venous bypass graft amenable to and requiring PCI. Exclusion criteria included ST-segment elevation acute MI; hemodynamic instability; pericarditis; cancer with life expectancy < 1 year; increased risk for bleeding; oral anticoagulation with a coumarin derivative in the previous 7 days; receipt of glycoprotein (GP) IIb/IIIa inhibitor in the past 14 days; systolic blood pressure > 180 mm Hg; and hemoglobin level < 100 g/L, hematocrit < 34%, or platelet count < 100 000 cells/μL or > 600 000 cells/μL. Intervention: Abciximab (n = 1012) or placebo (n = 1010). The abciximab group received abciximab, 0.25 mg/kg of body weight bolus followed by 0.125 μg/kg per minute (maximum 10 μg/min) infusion for 12 hours, and heparin, 70 U/kg of body weight. The placebo group received placebo bolus and infusion for 12 hours, and heparin bolus, 140 U/kg. All patients received clopidogrel, 600 mg ≥ 2 hours before PCI, and aspirin, 500 mg. Outcomes: Composite endpoint of all-cause mortality, MI, or urgent target vessel revascularization (coronary artery bypass graft surgery or PCI) because of myocardial ischemia within 30 days. Secondary outcomes included individual events of the composite endpoint, and in-hospital major and minor bleeding. Patient follow-up: 100%.