Primary percutaneous coronary angioplasty with and without eptifibatide in ST-segment elevation myocardial infarction: a safety and efficacy study of integrilin-facilitated versus primary percutaneous coronary intervention in ST-segment elevation myocardial infarction (ASSIST).

BACKGROUND Primary percutaneous coronary intervention, if performed promptly, is the preferred strategy to restore flow to the infarct-related artery in patients with ST-segment elevation myocardial infarction. We sought to determine whether eptifibatide, a platelet glycoprotein IIb/IIIa inhibitor, given before catheterization would improve clinical outcomes in patients referred for primary percutaneous coronary intervention. METHODS AND RESULTS We randomly assigned a total of 400 patients with ST-segment elevation myocardial infarction referred for primary percutaneous coronary intervention to treatment initiated before cardiac catheterization, with either heparin plus eptifibatide (201 patients) or heparin alone (199 patients), in addition to oral aspirin (160 mg) and high-dose clopidogrel (600 mg). The primary end point was a composite of death from any cause, recurrent myocardial infarction, or recurrent severe ischemia during the first 30 days after randomization. At 30 days, the primary end point was reached by 13 patients (6.47%) assigned to heparin plus eptifibatide and by 11 patients (5.53%) assigned to heparin alone (relative risk, 1.18; 95% CI, 0.52 to 2.70; P=0.69). The rates of major or minor bleeding were higher in patients assigned to heparin plus eptifibatide than that in patients assigned to heparin alone (22.4% versus 14.6%; relative risk, 1.69; 95% CI, 1.01 to 2.83; P=0.04). CONCLUSIONS In patients pretreated with high-dose clopidogrel who were referred for primary PCI, treatment with heparin plus eptifibatide, when compared with heparin alone, did not improve clinical outcomes and was associated with more bleeding complications.