Primary and secondary safety endpoints from IMPACT II

Glycoprotein (GP) IIb-IIIa receptor inhibitors have recently emerged as potentially valuable new agents for the prevention of the acute ischemic complications of coronary angioplasty. The potent antiplatelet activity of these agents may not only reduce the rate of ischemic events but also increase bleeding risk. A rapidly reversible peptide inhibitor of the GP IIb- IIIa receptor, eptifibatide (INTEGRILIN), has been recently evaluated in the pivotal Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT II) phase III trial, which demonstrated a favorable adverse effects profile for this agent. Patients undergoing elective, urgent, or emergency percutaneous coronary intervention who were treated with eptifibatide were not at increased risk for major hemorrhage, thrombocytopenia, or the need for transfusions of red blood cells or platelets, compared with a placebo- treated group. The incidence of minor bleeding events in patients treated with eptifibatide was slightly increased. Additionally, administration of eptifibatide did not lead to the development of anti-eptifibatide antibodies. The lack of increased risk of major bleeding and other adverse effects, combined with encouraging efficacy results, indicates that treatment with eptifibatide may safely provide clinical benefit to all patients scheduled to undergo coronary angioplasty.