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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Safety and Efficacy of Switching From Either Unfractionated Heparin or Enoxaparin to Bivalirudin in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes Managed With an Invasive Strategy

Results From the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial

Harvey D. White, DSc, FACC^_*,_*, Derek P. Chew, MBBS, MPH, James W. Hoekstra, MD, Chadwick D. Miller, MD, Charles V. Pollack, Jr, MD, Frederick Feit, MD^||, A. Michael Lincoff, MD, FACC^¶, Michel Bertrand, MD, FACC^#, Stuart Pocock, PhD^_**, James Ware, PhD, E. Magnus Ohman, MD, FACC, Roxana Mehran, MD, FACC and Gregg W. Stone, MD, FACC^||||

^_* Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
Department of Cardiology, Flinders Medical Centre, Adelaide, Australia
Department of Emergency Medicine, Wake Forest University Health Sciences, Winston-Salem, North Carolina
Department of Emergency Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania
^|| New York University School of Medicine, New York, New York
^¶ Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio
^# Lille Heart Institute, Lille, France
^_** London School of Hygiene and Tropical Medicine, London, United Kingdom
Harvard School of Public Health, Boston, Massachusetts
Duke University Medical Center, Durham, North Carolina
Department of Medicine, Columbia University Medical Center, New York, New York
^|||| Cardiovascular Research Foundation, New York, New York.

Manuscript received September 12, 2007; revised manuscript received December 13, 2007, accepted December 17, 2007.

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

Objectives: The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to bivalirudin monotherapy.

Background: Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to bivalirudin monotherapy.

Methods: We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or bivalirudin monotherapy.

Results: Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to bivalirudin. Patients switching to bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p < 0.01), and improved net clinical outcomes (9.2% vs. 11.9%, p < 0.01) than those on consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy who were administered bivalirudin (n = 1,427) had similar rates of ischemia (6.2% vs. 5.5%, p = 0.47), less major bleeding (2.5% vs. 4.9%, p < 0.001), and similar net clinical outcomes (8.0% vs. 9.4%, p = 0.17) compared with naive patients administered UFH/ENOX plus a GP IIb/IIIa inhibitor (n = 1,462).

Conclusions: Switching from UFH/ENOX to bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.

Abbreviations and Acronyms   CABG = coronary artery bypass grafting   CI = confidence interval   ENOX = enoxaparin   GP = glycoprotein   MI = myocardial infarction   NSTE-ACS = non–ST-segment elevation acute coronary syndromes   PCI = percutaneous coronary intervention   RR = relative risk   UFH = unfractionated heparin

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