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 Int egrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bo lus eptifibatide therapy in reducing ischemic complications of nonurgent co ronary stent implantation at 48 hours and at 30 days. Objective To determine whether the beneficial effects of eptifibatide persi st at 6 months after treatment. Design Follow-up study of a randomized, double-blind, placebo-controlled, c rossover-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 percut aneous coronary intervention with stent implantation. Intervention Patients were randomly assigned to receive placebo or eptifiba tide (two 180-mug/kg boluses 10 minutes apart and continuous infusion of 2. 0 mug/kg per minute), started immediately before stent implantation and con tinued 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 comp onents 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 pati ents (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 place bo group (HR, 0.56; 95% CI, 0.24-1.34; P=.19) and target vessel revasculari zation occurred in 8.6% of the eptifibatide group vs 9.4% of the placebo gr oup (HR, 0.91;95% CI, 0.68-1.22; P=.51). Conclusion Adjunctive eptifibatide therapy during coronary stent implantati on provides benefit through 6-month follow-up.