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


White, HD; Ohman, EM; Lincoff, AM; Bertrand, ME; Colombo, A; McLaurin, BT; Cox, DA; Pocock, SJ; Ware, JA; Manoukian, SV; Lansky, AJ; Mehran, R; Moses, JW; Stone, GW; (2008) 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. Journal of the American College of Cardiology, 52 (10). pp. 807-814. ISSN 0735-1097 DOI: https://doi.org/10.1016/j.jacc.2008.05.036

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Abstract

Objectives This study was designed to determine the impact of bivalirudin on 1-year outcomes in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Background The 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. Methods In 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. Results Among 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. Conclusions Bivalirudin 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.

Item Type: Article
Keywords: Acute Coronary Syndrome, drug therapy, mortality, therapy, Adult, Aged, Aged, 80 and over, Angioplasty, Transluminal, Percutaneous Coronary, Anticoagulants, adverse effects, therapeutic use, Drug Therapy, Combination, Enoxaparin, adverse effects, therapeutic use, Female, Fibrinolytic Agents, adverse effects, therapeutic use, Heparin, adverse effects, therapeutic use, Hirudins, adverse effects, Humans, Male, Middle Aged, Peptide Fragments, adverse effects, therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex, antagonists & inhibitors, Recombinant Proteins, adverse effects, therapeutic use, Risk Factors, Time Factors
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
PubMed ID: 18755342
Web of Science ID: 258720200002
URI: http://researchonline.lshtm.ac.uk/id/eprint/6845

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