Managing Unstable Angina in High-Risk Patients (Part II)

Author(s): 

Derek P. Chew, MBBS and David J. Moliterno, MD

Continued from previous page

PURSUIT. The PURSUIT trial was designed to evaluate eptifibatide as an adjunct to a broad spectrum of management strategies used to prevent death and MI in the 30 days following an urgent episode of UA or NQWMI. The 10,948 patients enrolled in PURSUIT experienced chest pain at rest (lasting >= 10 minutes) within the previous 24 hours and had one or more ECG or cardiac enzyme (CK-MB) test results confirming a diagnosis of UA or NQWMI.58

Patients were randomized to receive eptifibatide 180 µg/kg bolus plus 1.3 µg/kg/min infusion, eptifibatide 180 µg/kg bolus plus 2.0 µg/kg/min infusion, or placebo bolus plus infusion. The primary endpoint was death from any cause and nonfatal MI over the 30 days following initiation of drug therapy. Prospectively defined secondary endpoints included death or MI at 96 hours and 7 days; all-cause mortality within 30 days; first or recurrent MI within 30 days; and safety and efficacy in the subset of patients undergoing PTCA. Safety endpoints included bleeding complications, incidence of stroke and incidence of thrombocytopenia.58

Treatment with eptifibatide was associated with a statistically significant decrease in the composite primary endpoint at 30 days (15.7% placebo versus 14.2% eptifibatide; p = 0.04), and this benefit also was seen in the composite rates of death or MI at 96 hours (9.1% placebo versus 7.6% eptifibatide; p = 0.01) and 7 days (11.6% placebo versus 10.1% eptifibatide; p = 0.02).58

Major bleeding occurred in 10.6% and 9.1% of eptifibatide and placebo patients, respectively (p = 0.02), and approximately 80% of the major bleeding complications occurred in patients undergoing coronary artery bypass surgery. Minor bleeding occurred more frequently in eptifibatide versus placebo patients (12.9% versus 7.4%, respectively), but in most cases bleeding was mild and occurred at the femoral access site. Strokes occurred with similar frequency in the two study groups (0.7% eptifibatide versus 0.8% placebo), as did the incidence of thrombocytopenia (6.8% versus 6.7%, respectively). Intracranial bleeding was rare, occurring in less than 0.1% of patients in both study groups.58 In a sub-analysis of the 1,228 patients undergoing PCI within 72 hours of randomization in the PURSUIT trial, eptifibatide was associated with a 31% RR reduction in 30-day death or MI (11.6% eptifibatide versus 16.7% placebo; p = 0.01). Among patients undergoing PCI after 72 hours and before 30 days, a marginal difference in the 30-day rate of death or MI was observed (14.6% eptifibatide versus 15.6% placebo; p = 0.23). These data support the concept that benefit with glycoprotein IIb/IIIa inhibitors is of greater magnitude when associated with an early invasive approach.64



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