Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT-II. Integrilin to Minimise Platelet Aggregation and Coronary Thrombosis-II.
BACKGROUND: Platelet-mediated thrombosis has been implicated in the development of ischaemic complications of percutaneous coronary intervention. We investigated whether inhibition of the platelet glycoprotein IIb/IIIa integrin with eptifibatide (Integrilin) could prevent such complications. METHODS: We undertook a double-blind, placebo-controlled trial at 82 centres in the USA, enrolling 4010 patients undergoing elective, urgent, or emergency coronary intervention. Patients were assigned one of three treatments: placebo (n = 1328), a bolus of 135 micrograms/kg eptifibatide followed by an infusion of 0.5 microgram kg-1 min-1 for 20-24 h (n = 1349), or 135 micrograms/kg eptifibatide bolus with a 0.75 microgram kg-1 min-1 infusion (n = 1333). The coronary procedure was started within 10-60 min of the start of study treatment. The primary endpoint was the 30-day composite occurrence of death, myocardial infarction, unplanned surgical or repeat percutaneous revascularisation, or coronary stent implantation for abrupt closure (by intention to treat). The primary safety endpoint was major bleeding. FINDINGS: By 30 days, the composite endpoint had occurred in 151 (11.4%) patients in the placebo group compared with 124 (9.2%) in the 135/0.5 eptifibatide group (p = 0.063) and 132 (9.9%) in the eptifibatide 135/0.75 group (p = 0.22). By treatment-received analysis, the 135/0.5 regimen produced a significant reduction in the composite endpoint (11.6 vs 9.1%, p = 0.035), but the 135/0.75 regimen produced a less substantial reduction (11.6 vs 10.0%, p = 0.18). Eptifibatide treatment did not increase rates of major bleeding or transfusion. INTERPRETATION: In the 135/0.5 group, treatment with eptifibatide during coronary intervention reduced rates of early abrupt closure and ischaemic events at 30 days. Non-significant differences were seen with the 135/0.75 regimen. The doses studied thus appear to be at the low end of the efficacy-response curve. Further investigation to refine eptifibatide dosing during coronary intervention is warranted.
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