tients were male. The study enrolled 90% Caucasian, 5% African American, 2% Hispanic, and 1% Asian patients. Patients received a wide variety of stents. Patients were randomized either to placebo or eptifibatide administered as an intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/min, and a second bolus of 180 mcg/kg administered 10 minutes later (180/2.0/180). Eptifibatide infusion was continued for 18 to 24 hours after PCI or until hospital discharge, whichever came first. Each patient received at least 1 dose of aspirin (162–325 mg) and 60 U/kg of heparin as a bolus (not to exceed 6000 U) if not already receiving a heparin infusion. Additional boluses of heparin (10–40 U/kg) could be administered in order to reach a target ACT between 200 and 300 seconds.
The primary endpoint of the ESPRIT study was the composite of death, MI, urgent target vessel revascularization (UTVR), and "bailout" to open-label eptifibatide due to a thrombotic complication of PCI (TBO) (e.g., visible thrombus, "no reflow," or abrupt closure) at 48 hours. MI, UTVR, and TBO were eva luated by a blinded Clinical Events Committee.
As shown in Table 5, the incidence of the primary endpoint and selected secondary endpoints was significantly reduced in patients who received eptifibatide. A treatment benefit in patients who received eptifibatide was seen by 48 hours and at the end of the 30-day observation period.
Table 5 Clinical Events in the ESPRIT Study Placebo
(n=1024) Eptifibatide 180/2.0/180
(n=1040) Relative Risk
(95% CI) P-value
Death, MI, Urgent Target Vessel Revascularization, or Thrombotic "Bailout"
48 hours (primary endpoint) 108 (10.5%) 69 (6.6%) 0.629 (0.471, 0.840) 0.0015
30 days 120 (11.7%) 78 (7.5%) 0.640 (0.488, 0.840) 0.0011
Death, MI, or Urgent Target Vessel Revascularization
48 hours 95 (9.3%) 62 (6.0%) 0.643 (0.472, 0.875) 0.0045
30 days (key secondary endpoint) 107 (10.4%) 71 (6.8%) 0.653 (0.490, 0.871) 0.0034
Death or MI
48 hours 94 (9.2%) 57 (5.5%) 0.597 (0.435, 0.820) 0.0013
30 days 104 (10.2%) 66 (6.3%) 0.625 ( 0.465, 0.840) 0.0016
The need for thrombotic "bailout" was significantly reduced with eptifibatide at 48 hours (2.1% for placebo, 1.0% for eptifibatide; P=0.029). Consistent with previous studies of GP IIb/IIIa inhibitors, most of the benefit achieved acutely with eptifibatide was in the reduction of MI. Eptifibatide reduced the occurrence of MI at 48 hours from 9.0% for placebo to 5.4% (P=0.0015) and maintained that effect with significance at 30 days.
There was no treatment difference with respect to sex in ESPRIT. Eptifibatide reduced the incidence of the primary endpoint in both men (95% confidence limits for relative risk: 0.54, 1.07) and women (0.24, 0.72) at 48 hours.
Follow-up (12-month) mortality data were available for 2024 patients (1017 on eptifibatide) enrolled in the ESPRIT trial (98.1% of the initial enrollment). Twelve-month clinical event data were available for 1964 patients (988 on eptifibatide), representing 95.2% of the initial enrollment. As shown in Table 6, the treatment effect of eptifibatide seen at 48 hours and 30 days appeared preserved at 6 months and 1 year. Most of the benefit was in reduction of MI.
Table 6 Clinical Events at 6 Months and 1 Year in the ESPRIT Study Placebo
(n=1024) Eptifibat |
