Clinical Endpoints Committee) within 30 days of randomization.
Compared to placebo, eptifibatide administered as a 180-mcg/kg bolus followed by a 2.0-mcg/kg/min infusion significantly (P=0.042) reduced the incidence of endpoint events (see Table 2). The reduction in the incidence of endpoint events in patients receiving eptifibatide was evident early during treatment, and this reduction was maintained through at least 30 days (see Figure 1). Table 2 also shows the incidence of the components of the primary endpoint, death (whether or not preceded by an MI) and new MI in surviving patients at 30 days.
Table 2 Clinical Events in the PURSUIT Study Death or MI Placebo
(n = 4739)
n Eptifibatide (180/2.0)
(n = 4722)
(%) P-value
3 days 359 (7.6%) 279 (5.9%) 0.001
7 days 552 (11.6%) 477 (10.1%) 0.016
30 days
Death or MI (primary endpoint) 745 (15.7%) 672 (14.2%) 0.042
Death 177 (3.7%) 165 (3.5%)
Nonfatal MI 568 (12.0%) 507 (10.7%)
Figure 1: Kaplan-Meier Plot of Time to Death or Myocardial Infarction Within 30 Days of Randomization
Treatment with eptifibatide prior to determination of patient management strategy reduced clinical events regardless of whether patients ultimately underwent diagnostic catheterization, revascularization (i.e., PCI or CABG surgery) or continued to receive medical management alone. Table 3 shows the incidence of death or MI within 72 hours.
Table 3 Clinical Events (Death or MI) in the PURSUIT Study Within 72 Hours of Randomization Placebo Eptifibatide 180/2.0
Overall patient population n=4739 n=4722
– At 72 hours 7.6% 5.9%
Patients undergoing early PCI n=631 n=619
– Pre-procedure (nonfatal MI only) 5.5% 1.8%
– At 72 hours 14.4% 9.0%
Patients not undergoing early PCI n=4108 n=4103
– At 72 hours 6.5% 5.4%
All of the effect of eptifibatide was established within 72 hours (during the period of drug infusion), regardless of management strategy. Moreover, for patients undergoing early PCI, a reduction in events was evident prior to the procedure.
An analysis of the results by sex suggests that women who would not routinely be expected to undergo percutaneous coronary intervention (PCI) receive less benefit from eptifibatide (95% confidence limits for relative risk of 0.94– 1.28) than do men (0.72– 0.90). This difference may be a true treatment difference, the effect of other differences in these subgroups, or a statistical anomaly. No differential outcomes were seen between male and female patients undergoing PCI (see results for ESPRIT).
Follow-up data were available through 165 days for 10,611 patients enrolled in the PURSUIT trial (96.9%of the initial enrollment). This follow-up included 4566 patients who received eptifibatide at the 180/2.0 dose. As reported by the investigators, the occurrence of death from any cause or new myocardial infarction for patients followed for at least 165 days was reduced from 13.6% with placebo to 12.1% with eptifibatide 180/2.0.
Percutaneous Coronary Intervention
IMPACT II (INTEGRILIN to Minimize Platelet Aggregation and Prevent Coronary Thrombosis II)
IMPACT II was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States in 4010 patients undergoing PCI. Major exclusion criteria included a history of bleeding diathesis, major surgery within 6 weeks of treatment, gastrointestinal bleeding |
