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CLINICAL RESEARCH: COAGULATION

A Comparison of the Clinical Impact of Bleeding Measured by Two Different Classifications Among Patients With Acute Coronary Syndromes

Sunil V. Rao, MD^_*,_*, Kristi O’Grady, MS^_*, Karen S. Pieper, MS^_*, Christopher B. Granger, MD, FACC^_*, L. Kristin Newby, MD, MHS, FACC^_*, Kenneth W. Mahaffey, MD, FACC^_*, David J. Moliterno, MD, FACC, A. Michael Lincoff, MD, FACC, Paul W. Armstrong, MD, FACC, Frans Van de Werf, MD, FACC^||, Robert M. Califf, MD, FACC^_* and Robert A. Harrington, MD, FACC^_*

^_* Duke Clinical Research Institute, Durham, North Carolina
University of Kentucky, Lexington, Kentucky
Cleveland Clinic Foundation, Cleveland, Ohio
University of Alberta, Edmonton, Alberta, Canada
^|| Universitaire Ziekenhuizen Leuven, Leuven, Belgium.

Manuscript received February 17, 2005; revised manuscript received August 26, 2005, accepted September 9, 2005.

^_* Reprint requests and correspondence: Dr. Sunil V. Rao, The Duke Clinical Research Institute, P.O. Box 17969, Durham, North Carolina 27715. (Email: sunil.rao{at}duke.edu).

OBJECTIVES: The goal of this study was to determine the association between Thrombolysis In Myocardial Infarction (TIMI) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding and clinical outcomes.

BACKGROUND: There are limited data on the relative utility of either scale at predicting clinical outcomes in patients with non–ST-segment elevation acute coronary syndromes (ACS).

METHODS: Pooled data from two randomized trials of patients with ACS (n = 15,454) were analyzed to determine the association between TIMI and GUSTO bleeding and 30-day and 6-month death/myocardial infarction (MI) using Cox proportional hazards modeling that included bleeding as a time-dependent covariate.

RESULTS: There was a stepwise increase in the adjusted hazard of 30-day death/MI with worsening GUSTO bleeding (hazard ratio [95% confidence interval], GUSTO mild 1.20 [1.05 to 1.37]; moderate 3.28 [2.88 to 3.73]; severe 5.57 [4.33 to 7.17]), and an increased risk with all three levels of TIMI bleeding (TIMI minimal 1.84 [1.63 to 2.08]; TIMI minor 1.64 [1.31 to 2.04]; major 1.45 [1.23 to 1.70]). When both bleeding scales were included in the same model, the risk with GUSTO bleeding persisted; however, the association between TIMI bleeding and outcome was no longer significant.

CONCLUSIONS: Both scales identify ACS patients with bleeding complications at risk for adverse outcomes. In a model that included both definitions, the risk with GUSTO bleeding persisted while the risk with TIMI bleeding did not. This suggests that bleeding assessed with clinical criteria is more important than that assessed by laboratory criteria in terms of outcomes. Future clinical trials should consider using a combination of the GUSTO bleeding scale and the need for transfusion to assess bleeding complications.

Abbreviations and Acronyms   ACS = acute coronary syndrome   CABG = coronary artery bypass grafting   GUSTO = Global Use of Strategies to Open Occluded Coronary Arteries   MI = myocardial infarction   PARAGON = Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network trial   PURSUIT = Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy trial   TIMI = Thrombolysis In Myocardial Infarction

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