• J. Am. Coll. Cardiol. · Sep 2008

    Randomized Controlled Trial Clinical Trial

    Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention 1-year results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial.

    • Harvey D White, E Magnus Ohman, A Michael Lincoff, Michel E Bertrand, Antonio Colombo, Brent T McLaurin, David A Cox, Stuart J Pocock, James A Ware, Steven V Manoukian, Alexandra J Lansky, Roxana Mehran, Jeffrey W Moses, and Gregg W Stone.
    • Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. HarveyW@adhb.govt.nz
    • J. Am. Coll. Cardiol. 2008 Sep 2;52(10):807-14.

    ObjectivesThis study was designed to determine the impact of bivalirudin on 1-year outcomes in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).BackgroundThe ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated that in moderate- and high-risk ACS patients undergoing PCI, bivalirudin alone compared to unfractionated heparin (UFH) or enoxaparin plus a glycoprotein (GP) IIb/IIIa inhibitor resulted in less major bleeding and similar ischemic outcomes at 30 days. The impact of bivalirudin on 1-year outcomes in ACS patients undergoing PCI is unknown.MethodsIn the ACUITY trial, 13,819 patients were enrolled, and 7,789 (56.4%) patients had PCI. Composite ischemia (death, myocardial infarction, or unplanned revascularization) and mortality at 1 year were assessed.ResultsAmong patients undergoing PCI, 2,561, 2,609, and 2,619 were randomized to UFH or enoxaparin plus a GP IIb/IIIa inhibitor, bivalirudin plus a GP IIb/IIIa inhibitor, and bivalirudin monotherapy, respectively. At 1 year, there were no differences in composite ischemia (17.8% vs. 19.4% vs. 19.2%, p = NS) or mortality (3.2% vs. 3.3% vs. 3.1%, p = NS) among the 3 groups, respectively.ConclusionsBivalirudin compared with UFH or enoxaparin plus a GP IIb/IIIa inhibitor results in similar rates of composite ischemia and mortality at 1 year in moderate- and high-risk ACS patients undergoing PCI.

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