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CLINICAL STUDY: INTERVENTIOANL CARDIOLOGY

Safety of concomitant therapy with eptifibatide and enoxaparin in patients undergoing percutaneous coronary intervention: Results of the coronary revascularization using integrilin and single bolus enoxaparin study

Deepak L. Bhatt, MD^*,*, Benjamin I. Lee, MD, FACC, Peter J. Casterella, MD, FACC,, Mark Pulsipher, MD, FACC,, Matthew Rogers, MD, FACC,^||, Marc Cohen, MD, FACC,^¶, Victor E. Corrigan, MD, FACC,^#, Thomas J. Ryan, Jr, MD, FACC^**, Jeffrey A. Breall, MD, PhD, FACC, Jeffrey W. Moses, MD, FACC, Gregory M. Eaton, MD, FACC, Mitchel A. Sklar, MD, FACC^|||| and A. Michael Lincoff, MD, FACC^*

^* Cleveland Clinic Foundation, Cleveland, Ohio, USA
Washington Hospital Center, Washington, DC, USA
Scripps Clinic, La Jolla, California, USA
Moses Cone Hospital, Greensboro, North Carolina, USA
^|| St. Luke’s Episcopal Hospital, Houston, Texas, USA
^¶ Hahnemann Hospital, Philadelphia, Pennsylvania, USA
^# St. Joseph’s Hospital of Atlanta, Atlanta, Georgia, USA
^** Maine Medical Center, Portland, Maine, USA
Krannert Institute of Cardiology, Indianapolis, Indiana, USA
Lenox Hill Heart and Vascular Institute of New York, New York, New York, USA
Mid Ohio Heart Clinic, Cardiovascular Disease Specialists, Mansfield, Ohio, USA
^|||| Medical City Dallas Hospital, Dallas, Texas, USA

Manuscript received June 10, 2002; revised manuscript received August 24, 2002, accepted September 6, 2002.

^* Reprint requests and correspondence: Dr. Deepak L. Bhatt, Cleveland Clinic Foundation, Department of Cardiovascular Medicine, Desk F25, 9500 Euclid Avenue, Cleveland, Ohio 44195, USA.
bhattd{at}ccf.org

OBJECTIVES: This study was designed to assess whether use of enoxaparin during percutaneous coronary intervention (PCI) increased bleeding compared with unfractionated heparin, in addition to background therapy with eptifibatide.

BACKGROUND: Data supporting the benefits of enoxaparin and the glycoprotein IIb/IIIa inhibitor eptifibatide evolved in parallel. Information on combining these two classes of medications is limited.

METHODS: A total of 261 patients undergoing elective or urgent PCI were randomized to either eptifibatide plus enoxaparin or eptifibatide plus unfractionated heparin.

RESULTS: The primary end point of the study, the bleeding index (change in hemoglobin corrected for blood transfusions), was 0.8 in the patients randomized to enoxaparin and 1.1 in patients randomized to unfractionated heparin (p = 0.15). The rate of vascular access site complications was 9.3% in the enoxaparin arm versus 9.8% in the unfractionated heparin arm (p = NS). The rate of bleeding complications was not significantly different between the two arms of the study, including in those patients who received vascular closure devices. The rate of angiographic complications was 6.3% in the enoxaparin group and 6.2% in the unfractionated heparin group (p = NS). Similarly, there were no significant differences in the composite of death, myocardial infarction, or urgent target vessel revascularization at 48 h or 30 days.

CONCLUSIONS: Compared with unfractionated heparin plus eptifibatide, the combination of enoxaparin plus eptifibatide is not associated with an excess of bleeding or vascular complications, including in those receiving closure devices. Despite no monitoring of anticoagulation activity with enoxaparin, there was no apparent increase in angiographic or clinical complications.

Abbreviations and Acronyms   ACT   activated clotting time   CK   creatine kinase   CRUISE   Coronary Revascularization Using Integrilin and Single bolus Enoxaparin trial   GP   glycoprotein   IV   intravenous   PCI   percutaneous coronary intervention   TIMI   Thrombolysis In Myocardial Infarction

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