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CLINICAL RESEARCH: ACUTE CORONARY SYNDROMES

A Risk Score to Predict Bleeding in Patients With Acute Coronary Syndromes

Roxana Mehran, MD^_*,_*, Stuart J. Pocock, PhD, Eugenia Nikolsky, MD, PhD^_*, Tim Clayton, MSc, George D. Dangas, MD^_*, Ajay J. Kirtane, MD^_*, Helen Parise, ScD^_*, Martin Fahy, MSc^_*, Steven V. Manoukian, MD, Frederick Feit, MD, Magnus E. Ohman, MD^||, Bernard Witzenbichler, MD^¶, Giulio Guagliumi, MD^#, Alexandra J. Lansky, MD^_* and Gregg W. Stone, MD^_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
London School of Hygiene and Tropical Medicine, London, United Kingdom
The Sarah Cannon Research Institute and The Hospital Corporation of America, Nashville, Tennessee
New York University School of Medicine, New York, New York
^|| Duke University, Durham, North Carolina
^¶ Charite Campus, Benjamin Franklin University Medicine Berlin, Berlin, Germany
^# Ospedali Riuniti de Bergamo, Bergamo, Italy

Manuscript received July 2, 2009; revised manuscript received September 16, 2009, accepted September 19, 2009.

^_* Reprint requests and correspondence: Dr. Roxana Mehran, Columbia University Medical Center, 161 Fort Washington Avenue, 5th Floor, New York, New York 10032 (Email: rmehran{at}crf.org).

Objectives: The aim of this study was to develop a practical risk score to predict the risk and implications of major bleeding in acute coronary syndromes (ACS).

Background: Hemorrhagic complications have been strongly linked with subsequent mortality in patients with ACS.

Methods: A total of 17,421 patients with ACS (including non–ST-segment elevation myocardial infarction [MI], ST-segment elevation MI, and biomarker negative ACS) were studied in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) and the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trials. An integer risk score for major bleeding within 30 days was developed from a multivariable logistic regression model.

Results: Non-coronary artery bypass graft surgery (CABG)-related major bleeding within 30 days occurred in 744 patients (7.3%) and had 6 independent baseline predictors (female sex, advanced age, elevated serum creatinine and white blood cell count, anemia, non–ST-segment elevation MI, or ST-segment elevation MI) and 1 treatment-related variable (use of heparin + a glycoprotein IIb/IIIa inhibitor rather than bivalirudin alone) (model c-statistic = 0.74). The integer risk score differentiated patients with a 30-day rate of non–CABG-related major bleeding ranging from 1% to over 40%. In a time-updated covariate-adjusted Cox proportional hazards regression model, major bleeding was an independent predictor of a 3.2-fold increase in mortality. The link to mortality risk was strongest for non–CABG-related Thrombolysis In Myocardial Infarction (TIMI)-defined major bleeding followed by non-TIMI major bleeding with or without blood transfusions, whereas isolated large hematomas and CABG-related bleeding were not significantly associated with subsequent mortality.

Conclusions: Patients with ACS have marked variation in their risk of major bleeding. A simple risk score based on 6 baseline measures plus anticoagulation regimen identifies patients at increased risk for non–CABG-related bleeding and subsequent 1-year mortality, for whom appropriate treatment strategies can be implemented.

Key Words: bleeding • mortality • myocardial infarction • risk score

Abbreviations and Acronyms   ACS = acute coronary syndromes   CABG = coronary artery bypass graft surgery   CI = confidence interval   GPI = glycoprotein IIb/IIIa inhibitor   HR = hazard ratio   MI = myocardial infarction   NSTEMI = non–ST-segment elevation myocardial infarction   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction   TIMI = Thrombolysis In Myocardial Infarction

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