Author + information
- Received July 2, 2009
- Revision received September 16, 2009
- Accepted September 19, 2009
- Published online June 8, 2010.
- 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*
- ↵*Reprint requests and correspondence:
Dr. Roxana Mehran, Columbia University Medical Center, 161 Fort Washington Avenue, 5th Floor, New York, New York 10032
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.
The ACUITY trial was sponsored by The Medicines Company. The HORIZONS-AMI trial was sponsored by the Cardiovascular Research Foundation, with grant support from The Medicines Company and Boston Scientific. The sponsors did not provide financial support for this analysis. For full author disclosures, please see the end of this paper.
- Received July 2, 2009.
- Revision received September 16, 2009.
- Accepted September 19, 2009.
- American College of Cardiology Foundation