Safety and efficacy of eptifibatide vs placebo in patients receiving thrombolytic therapy with streptokinase for acute myocardial infarction - A phase II dose escalation, randomized, double-blind study

Aims Thrombolytic therapy restores coronary patency in patients with acute myocardial infarction, although normal perfusion (TIMI 3 flow) is not achie ved in all patients. In an attempt to improve TIMI 3 flow, a combination of full-dose streptokinase, aspirin and escalating dosages of a platelet glyc oprotein IIb/IIIa receptor blocker, eptifibatide, vs placebo were tested. Methods and Results A bolus of 180 mu g . kg(-1) of eptifibatide was admini stered in each group, followed by a 72 h continuous infusion of 0.75 (44 pa tients), 1.33 (n=45) and 2.00 mu g . kg(-1) . min(-1) (n=30); 62 patients r eceived placebo. Normal perfusion (TIMI 3 flow) at 90 min was observed in 3 1% of placebo patients compared to 46, 42 and 45% in the ascending eptifiba tide groups (44% for combined eptifibatide groups, P=0.07). Patency (TIMI 2 and 3 flow combined) increased from 61% (placebo) to 78% for the combined eptifibatide groups (P=0.02). Reocclusion was infrequent. No differences we re observed in TIMI flow grades among eptifibatide groups. Major and minor bleeding was increased and occurred mainly at the arterial puncture site. Conclusion A combination of full dose streptokinase with different eptifiba tide regimens enhanced coronary perfusion, but bleeding risk was excessive. Additional trials are needed with different dosage regimens to determine t he optimal combination of fibrinolytic agents and platelet glycoprotein IIb /IIIa receptor blockers. (Eur Heart J 2000; 21: 1530-1536) (C) 2000 The Eur opean Society of Cardiology.