Long-term treatment with a platelet glycoprotein-receptor antagonist afterpercutaneous coronary revascularization.

Background: When administered intravenously at the time of percutaneous cor onary revascularization, glycoprotein IIb/IIIa receptor antagonists decreas e the incidence of death and nonfatal myocardial infarction and the need fo r urgent revascularization. We hypothesized that long-term administration o f oral glycoprotein IIb/IIIa antagonists, which block the aggregation of pl atelets, might stabilize intravascular plaque and prevent additional ischem ic cardiac events. Methods: We conducted a prospective, double-blind trial in which 7232 patie nts were randomly assigned to receive 20 mg of oral xemilofiban or placebo 30 to 90 minutes before undergoing percutaneous coronary revascularization, with maintenance doses of 10 or 20 mg of xemilofiban or placebo administer ed three times daily for up to 182 days. There were two primary composite e nd points: one was death, nonfatal myocardial infarction, or urgent revascu larization at 182 days, and the other was death or nonfatal myocardial infa rction at 182 days. Results: Death, myocardial infarction, or urgent revascularization occurred within 182 days in 324 patients who received placebo (Kaplan-Meier cumulat ive event rate, 13.5 percent), 332 who received 10 mg of xemilofiban (13.9 percent, P=0.82 for the comparison with placebo), and 306 who received 20 m g of xemilofiban (12.7 percent, P=0.36 for the comparison with placebo). Th e incidence of death or myocardial infarction was also similar in all three groups. Clinically significant hemorrhagic complications and thrombocytope nia were infrequent. Conclusions: The administration of the glycoprotein IIb/IIIa antagonist xem ilofiban before percutaneous coronary revascularization and for up to six m onths thereafter does not significantly reduce the incidence of important c linical end points. (N Engl J Med 2000;342:1316-24.) (C) 2000, Massachusett s Medical Society.