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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Use of Bivalirudin During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus

An Analysis From the Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 Trial

Hitinder S. Gurm, MD^_*, Ian J. Sarembock, MD, Dean J. Kereiakes, MD, John J. Young, MD, Robert A. Harrington, MD^||, Neal Kleiman, MD^||, Frederick Feit, MD^¶, Kathy Wolski, MPH^_*, John A. Bittl, MD^#, Robert Wilcox, MD^_**, Eric J. Topol, MD^_*, A. Michael Lincoff, MD^_*,_* for the REPLACE-2 Investigators

^_* Cleveland Clinic Foundation, Cleveland, Ohio
University of Virginia Health Systems, Charlottesville, Virginia
The Lindner Center and The Ohio Heart Health Center, Cincinnati, Ohio
Duke Clinical Research Institute, Durham, North Carolina
^|| Methodist-DeBakey Heart Center and Baylor College of Medicine, Houston, Texas
^¶ New York University School of Medicine, New York, New York
^# Oscala Heart Institute, Munroe Regional Medical Center, Oscala, Florida
^_** University Hospital Nottingham, Nottingham, United Kingdom

Manuscript received January 6, 2005; revised manuscript received February 17, 2005, accepted February 21, 2005.

^_* Reprint requests and correspondence: Dr. A. Michael Lincoff, Department of Cardiovascular Medicine, Desk F25, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195. (Email: lincofa{at}ccf.org).

OBJECTIVES: The objective of this study was to confirm that the efficacy and safety of percutaneous coronary intervention (PCI) in diabetic patients are not compromised by a bivalirudin-based antithrombotic strategy.

BACKGROUND: Previous studies have shown a survival benefit with use of platelet glycoprotein (GP) IIb/IIIa inhibitors in diabetic patients undergoing PCI. The Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed the non-inferiority of a strategy of bivalirudin with provisional GP IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. The relative efficacy of these two strategies in diabetic patients has not been studied.

METHODS: We evaluated the diabetic patients enrolled in the REPLACE-2 trial to assess the impact of these antithrombotic strategies on the short- and long-term outcome after PCI.

RESULTS: The REPLACE-2 trial enrolled 1,624 diabetic patients and 4,368 non-diabetic patients. Compared with non-diabetic patients, diabetic patients had similar short-term outcome but higher mortality at 1 year (3.06% vs. 1.85%, p = 0.004). There was no difference in short-term or long-term ischemic events among the diabetic patients randomized to the two arms. Specifically, the 1-year mortality rate was non-significantly lower in the bivalirudin arm, suggesting no differential survival impact of the two strategies (2.3% vs. 3.9%). There was less minor bleeding in the bivalirudin arm in diabetic patients (12.6% vs. 24.4%, p < 0.001), whereas no difference was seen in the incidence of major bleeding (3.0% vs. 3.3%, p = 0.69).

CONCLUSIONS: Compared with routine GP IIb/IIIa inhibition, the use of bivalirudin with provisional GP IIb/IIIa inhibitors in diabetic patients is associated with no differences in clinical outcomes at 30 days, a trend toward lesser mortality at 1 year, and a reduction in minor bleeding.

Abbreviations and Acronyms   GP = glycoprotein   PCI = percutaneous coronary intervention   REPLACE-2 = Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events trial

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