Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention - The ESPRIT trial: A randomized controlled trial

Context The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days. Objective To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment. Design Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000, Setting Ninety-two tertiary care centers in the United States and Canada. Participants A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation. Intervention Patients were randomly assigned to receive placebo or eptifibatide (two 180-mug/kg boluses 10 minutes apart and continuous infusion of 2.0 mug/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo. Main Outcome Measures Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups. Results By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P=.002), The composite of death, Mi, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI,0.60-0.93; P =.008), Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P=.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of the placebo group (HR, 0.91;95% CI, 0.68-1.22; P=.51). Conclusion Adjunctive eptifibatide therapy during coronary stent implantation provides benefit through 6-month follow-up.