EPIC

Platelets are believed to play a part in the ischemic complications of coronary angioplasty, such as abrupt closure of the coronary vessel during or soon after the procedure. Accordingly, we evaluated the effect of a chimeric monoclonal-antibody Fab fragment (c7E3) directed against the platelet glycoprotein IIb/IIIa receptor, in patients undergoing angioplasty who were at risk for ischemic complications. This receptor is the final common pathway for platelet aggregation.

Platelets are believed to play a part in the ischemic complications of coronary angioplasty, such as abrupt closure of the coronary vessel during or soon after the procedure. Accordingly, we evaluated the effect of a chimeric monoclonal-antibody Fab fragment (c7E3) directed against the platelet glycoprotein IIb/IIIa receptor, in patients undergoing angioplasty who were at risk for ischemic complications. This receptor is the final common pathway for platelet aggregation.In a prospective, randomized, double-blind trial, 2 099 patients treated at 56 centres received a bolus and an infusion of placebo, a bolus of c7E3 Fab and an infusion of placebo, or a bolus and an infusion of c7E3 Fab. They were scheduled to undergo coronary angioplasty or atherectomy in high-risk clinical situations involving severe unstable angina, evolving acute myocardial infarction, or high-risk coronary morphologic characteristics. The primary study endpoint consisted of any of the following: death, nonfatal myocardial infarction, unplanned surgical revascularization, unplanned repeat percutaneous procedure, unplanned implantation of a coronary stent, or insertion of an intraaortic balloon pump for refractory ischemia. The numbers of endpoint events werde tabulated for 30 days after randomization.As compared with placebo, the c7E3 Fab bolus and infusion resulted in a 35 %reduction in the rate of the primary endpoint (12.8 % vs. 8.3 %, p = 0.008), whereas a 10 % reduction was observed with the c7E3 Fab bolus alone (12.8 % vs. 11.5 %, p = 0.43). The reduction in the number of events with the c7E3 Fab bolus and infusion was consistent across the endpoints of unplanned revascularization procedures and nonfatal myocardial infarction. Bleeding episodes and transfusions were more frequent in the group given the c7E3 Fab bolus and infusion than in the other two groups.Ischemic complications of coronary angioplasty and atherectomy were reduced with a monoclonal antibody directed against the platelet IIb/IIIa glycoprotein receptor, although the risk of bleeding was increased. (Source: European Society of Cardiology: Acute Coronary Syndromes Trials)