Bivalirudin: in patients with acute coronary syndromes : planned for urgent or early intervention.

Bivalirudin is a 20-amino acid synthetic polypeptide that directly inhibits both fibrin-bound and soluble thrombin. In a randomized, open-label, phase III study (ACUITY) in 13,819 patients with acute coronary syndromes (unstable angina or non-ST-segment elevation myocardial infarction) in whom urgent or early intervention was planned, both bivalirudin plus a glycoprotein (GP) IIb/IIIa inhibitor and bivalirudin alone were noninferior to heparin plus a GP IIb/IIIa inhibitor for the primary endpoint of composite ischaemia (myocardial infarction, unplanned revascularization or death from any cause) at 30 days. The primary endpoint of major bleeding not related to coronary artery bypass graft surgery had occurred in significantly fewer recipients of bivalirudin alone than of heparin plus a GP IIb/IIIa inhibitor after 30 days. Bivalirudin plus a GP IIb/IIIa inhibitor was noninferior to the heparin regimen with regard to this bleeding event. Bivalirudin alone was also associated with a significantly lower incidence of the primary net clinical outcome endpoint (composite ischaemia or major bleeding) after 30 days. Bivalirudin plus a GP IIb/IIIa inhibitor was noninferior to the heparin regimen with regard to this endpoint. The findings of ACUITY at 1 year indicate that both bivalirudin plus a GP IIb/IIIa inhibitor and bivalirudin alone were as effective as heparin plus a GP IIb/IIIa inhibitor with regard to the long-term incidence of composite ischaemia and all-cause mortality.