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▲ 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.
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