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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Safety and Efficacy of Bivalirudin Monotherapy in Patients With Diabetes Mellitus and Acute Coronary Syndromes

A Report From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial

Frederick Feit, MD, FACC^_*,_*, Steven V. Manoukian, MD, FACC, Ramin Ebrahimi, MD, FACC, Charles V. Pollack, MD, E. Magnus Ohman, MD, FACC^||, Michael J. Attubato, MD, FACC^_*, Roxana Mehran, MD, FACC^# and Gregg W. Stone, MD, FACC^#

^_* Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, New York
Emory University School of Medicine, Atlanta, Georgia
University of California and the Greater Los Angeles VA Center, Los Angeles, California
Pennsylvania Hospital, Philadelphia, Pennsylvania
^|| Duke University Medical Center, Durham, North Carolina
^# Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.

Manuscript received August 27, 2007; revised manuscript received November 5, 2007, accepted November 13, 2007.

^_* Reprint requests and correspondence: Dr. Frederick Feit, Cardiac Catheterization Laboratory, Room H576, Tisch Hospital, 550 First Avenue, New York, New York 10016. (Email: frederick.feit{at}med.nyu.edu).

Objectives: We sought to evaluate clinical outcomes of patients with diabetes mellitus in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, overall and by treatment arm.

Background: In the ACUITY trial, 13,819 patients with moderate- or high-risk acute coronary syndromes (ACS) were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Compared with heparin plus GPI, bivalirudin monotherapy resulted in similar protection from ischemic events with less major bleeding. Whether these results apply to patients with diabetes is unknown.

Methods: We evaluated the impact of diabetes on 30-day net adverse clinical outcomes (composite ischemia [death, myocardial infarction, or unplanned ischemic revascularization] or major bleeding), overall and by antithrombotic strategy.

Results: Diabetes was present in 3,852 randomized patients (27.9%). Compared with nondiabetic patients, diabetic patients had higher 30-day rates of net adverse clinical outcomes (12.9% vs. 10.6%; p < 0.001), composite ischemia (8.7% vs. 7.2%; p = 0.003), and major bleeding (5.7% vs. 4.2%; p < 0.001). Among diabetic patients, compared with heparin plus GPI, bivalirudin plus GPI resulted in similar rates of net adverse clinical outcomes (14.0% vs. 13.8%; p = 0.89), while bivalirudin monotherapy resulted in a similar rate of composite ischemia (7.9% vs. 8.9%; p = 0.39) and less major bleeding (3.7% vs. 7.1%; p < 0.001), yielding fewer net adverse clinical outcomes (10.9% vs. 13.8%; p = 0.02).

Conclusions: Diabetic patients with ACS managed invasively have higher rates of composite ischemia and major bleeding. Compared with treatment with heparin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding, resulting in a significant reduction in net adverse clinical outcomes.

Abbreviations and Acronyms   ACS = acute coronary syndromes   CABG = coronary artery bypass graft surgery   GPI = glycoprotein IIb/IIIa inhibitor   MI = myocardial infarction   PCI = percutaneous coronary intervention   TIMI = Thrombolysis In Myocardial Infarction

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