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CLINICAL RESEARCH: 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, DSc, FACC^_*,_*, E. Magnus Ohman, MD, FACC, A. Michael Lincoff, MD, FACC, Michel E. Bertrand, MD, FACC, Antonio Colombo, MD, FACC^||, Brent T. McLaurin, MD, FACC^¶, David A. Cox, MD, FACC^#, Stuart J. Pocock, PhD^_**, James A. Ware, PhD, Steven V. Manoukian, MD, FACC, Alexandra J. Lansky, MD, FACC, Roxana Mehran, MD, FACC, Jeffrey W. Moses, MD, FACC and Gregg W. Stone, MD, FACC

^_* Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
Duke University Medical Center, Durham, North Carolina
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio
Lille Heart Institute, Lille, France
^|| EMO Centro Cuore Columbus, San Raffaele Scientific Institute, Milan, Italy
^¶ University of South Carolina School of Medicine, Columbia, South Carolina
^# Mid Carolina Cardiology, Charlotte and Durham, North Carolina
^_** London School of Hygiene and Tropical Medicine, London, United Kingdom
Harvard School of Public Health, Boston, Massachusetts
Sarah Cannon Research Institute and Centennial Heart Center, Nashville, Tennessee
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York

Manuscript received December 12, 2007; revised manuscript received May 21, 2008, accepted May 27, 2008.

^_* Reprint requests and correspondence: Prof. Harvey D. White, Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92024, Auckland 1030, New Zealand (Email: HarveyW{at}adhb.govt.nz).

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.

Key Words: bivalirudin • unfractionated heparin • enoxaparin

Abbreviations and Acronyms   ACS = acute coronary syndrome   CABG = coronary artery bypass graft   CI = confidence interval   GP = glycoprotein   HR = hazard ratio   IV = intravenous   LMWH = low-molecular-weight heparin   MI = myocardial infarction   NSTE-ACS = non–ST-segment elevation acute coronary syndromes   PCI = percutaneous coronary intervention   TIMI = Thrombolysis In Myocardial Infarction   UFH = unfractionated heparin

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