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The ESPRIT Trial: A Randomized Controlled Trial

J. Conor O'Shea, MD; Gail E. Hafley, MS; Sally Greenberg, PhD; Vic Hasselblad, PhD; Todd J. Lorenz, MD; Michael M. Kitt, MD; John Strony, MD; James E. Tcheng, MD; for the ESPRIT Investigators

JAMA. 2001;285:2468-2473.

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-µg/kg boluses 10 minutes apart and continuous infusion of 2.0 µg/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.

Author Affiliations: Duke Clinical Research Institute, Durham, NC (Drs O'Shea, Hasselblad, and Tcheng and Ms Hafley); COR Therapeutics Inc, South San Francisco, Calif (Drs Greenberg, Lorenz, and Kitt); and Schering-Plough Research Institute, Kenilworth, NJ (Dr Strony).

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