Novel Dosing Regimen of Eptifibatide in Planned Coronary Stent Implantation (ESPRIT): A Randomized, Placebo-Controlled Trial - ESPRIT 30 Day Results
Novel Dosing Regimen of Eptifibatide in Planned Coronary Stent Implantation (ESPRIT): A Randomized, Placebo-Controlled Trial.
To determine whether a novel, double-bolus dosing of the gpIIb/IIIa receptor blocker eptifibatide can improve outcomes of patients undergoing coronary stenting.
Patients Enrolled: 2064
A combined major adverse cardiac event endpoint (MACE) including death, MI and target lesion revascularization (TLR) at 12 months follow-up.
Patient with coronary artery disease scheduled to undergo stent implantation were randomized to placebo or to eptifibatide. Eptifibatide administration included two 180 mcg/kg boluses10 minutes apart followed by an infusion of 2 mcg/kg/min for 18–24 hours. A bailout blinded IIb/IIIa receptor was allowed by providing a bailout kit containing eptifibatide for patients randomized to placebo and placebo for patients randomized to eptifibatide. The primary end point was a composite of death, myocardial infarction, urgent target vessel revascularization and thrombotic bailout gpIIb/IIIa inhibitor therapy within 48 hours of randomization. The secondary end point was a composite of death, MI and urgent target vessel revascularization at 30 days.
The study was stopped prematurely for efficacy following recommendation of the safety committee after randomization of 1024 patients to placebo and 1040 patients to eptifibatide. The mortality rate was 0.2% in the placebo group and 0.1% in the eptifibatide group (p = 0.55), while the primary end point occurred in 10.5% of placebo treated patients and 6.4% of eptifibatide treated patients (risk ratio 0.63, 95% CI 0.47–0.84, p = 0.0015). This risk reduction was consistent across different components and combination of components of the primary end point (RR 0.65, CI 0.47–0.87 for death/MI/TVR; RR 0.60, CI 0.44–0.82 for death/MI; RR 0.67, CI 0.44–1.03 for large MI; RR 0.60, CI 0.44–0.83 for all MI; RR 0.5, C.I. 0.05–5,42 for death). At 30 days, there was a persistent reduction of the secondary end point from 10.5% to 6.8% (RR 0.65, 95% CI 0.49–0.87, p = 0.0034). Major bleeding was more frequent in the eptifibatide group when compared with placebo (1.3% vs. 0.4%, p = 0.027). No significant differences in the incidence of major bleeding were observed in the lowest tercile of activated clotting time (ACT<244 s, 0.6% major bleed in the eptifibatide group and 0.6% in the placebo group).
A double bolus of eptifibatide is safe and effective in reducing acute and 30 days adverse outcomes in patients undergoing stent implantation.
This study confirms the acute results of the EPISTENT trial, and it suggests that routine use of gpIIb/IIIa receptor blockers should become standard of care for patients undergoing stent implantation.
1. The ESPRIT Investigators. Lancet 2000;356:2037-4.
Keywords: Odds Ratio, Coronary Artery Disease, Myocardial Infarction, Platelet Aggregation Inhibitors, Peptides, Risk Reduction Behavior, Standard of Care, Stents, Platelet Glycoprotein GPIIb-IIIa Complex
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