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CLINICAL RESEARCH: CLINICAL TRIAL

Correlates of Bleeding Events Among Moderate- to High-Risk Patients Undergoing Percutaneous Coronary Intervention and Treated With Eptifibatide

Observations From the PROTECT–TIMI-30 Trial

Ajay J. Kirtane, MD, SM^_*, Gregory Piazza, MD^_*, Sabina A. Murphy, MPH, Daniela Budiu, MD, David A. Morrow, MD, MPH, FACC, David J. Cohen, MD, MSc^_*,1, Eric Peterson, MD, MPH, FACC^,2, Nasser Lakkis, MD, FACC, Howard C. Herrmann, MD, FACC^||,3, Theresa M. Palabrica, MD^¶,4, C. Michael Gibson, MS, MD, FACC^_*,,5,_* for the TIMI Study Group

^_* Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center
Cardiovascular Division, Department of Medicine, Brigham & Women’s Hospital, Harvard Medical School, Boston, Massachusetts
Duke Clinical Research Institute, Durham, North Carolina
Ben Taub General Hospital, Houston, Texas
^|| University of Pennsylvania Medical Center, Philadelphia, Pennsylvania
^¶ Millennium Pharmaceuticals, Cambridge, Massachusetts

Manuscript received May 29, 2005; revised manuscript received September 1, 2005, accepted September 8, 2005.

^_* Reprint requests and correspondence: Dr. C. Michael Gibson, 350 Longwood Avenue, First Floor, Boston, Massachusetts 02115. (Email: mgibson{at}timi.org).

OBJECTIVES: We aimed to identify correlates of Thrombolysis In Mycocardial Infarction (TIMI) major/minor bleeding among eptifibatide-treated patients undergoing percutaneous coronary intervention (PCI).

BACKGROUND: Evaluation of bleeding predictors among patients treated with glycoprotein IIb/IIIa receptor inhibition might aid in the identification of targets to reduce bleeding risk.

METHODS: Data were analyzed from 567 moderate- to high-risk PCI patients with non–ST-segment elevation acute coronary syndrome (NSTEACS) treated with eptifibatide/reduced-dose unfractionated heparin or eptifibatide/reduced-dose enoxaparin enrolled in the Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents–Thrombolysis In Myocardial Infarction-30 (PROTECT–TIMI-30).

RESULTS: The incidence of significant bleeding was 3.2% with a median time to event of 7.0 h after the first eptifibatide bolus. Increased age was the only independent correlate of bleeding events. Among patients with reduced creatinine clearance (CrCl), lack of adjustment of the maintenance infusion for CrCl 50 ml/min occurred frequently (15 of 33 patients, or 45%) and was associated with a high rate of bleeding (20%). The association of CrCl with bleeding appeared to be largely mediated by the incorporation of age in the estimation of CrCl. Patient gender, Cr, weight, and the peak activated clotting time were not associated with bleeding.

CONCLUSIONS: Among NSTEACS PCI patients treated with eptifibatide, increased age was a significant correlate of bleeding events and appeared to explain the association between low CrCl and bleeding. The more widespread use of CrCl or other estimates of renal function over Cr may lead to more appropriate dose adjustments of eptifibatide.

Abbreviations and Acronyms   ACS = acute coronary syndrome   ACT = activated clotting time   Cr = creatinine   CrCl = creatinine clearance   GFR = glomerular filtration rate   GPIIb/IIIa = glycoprotein IIb/IIIa receptor   NSTEACS = non–ST-segment elevation acute coronary syndrome   PCI = percutaneous coronary intervention   UFH = unfractionated heparin

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