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European Heart Journal Advance Access originally published online on June 15, 2007
European Heart Journal 2007 28(16):1936-1945; doi:10.1093/eurheartj/ehm194
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Development and validation of a prognostic risk score for major bleeding in patients undergoing percutaneous coronary intervention via the femoral approach

Eugenia Nikolsky1, Roxana Mehran1, George Dangas1, Martin Fahy1, Yingbo Na1, Stuart J. Pocock2, A. Michael Lincoff3 and Gregg W. Stone1,*

1 Cardiovascular Research Foundation, Columbia University Medical Center, Herbert Irving Pavilion, 5th Floor, 161 Fort Washington Avenue, New York, NY 10032, USA
2 London School of Hygiene and Tropical Medicine, London, UK
3 Cleveland Clinic Foundation, Cleveland, OH, USA

Received 16 September 2006; revised 5 April 2007; accepted 26 April 2007; online publish-ahead-of-print 15 June 2007.

* Corresponding author. Tel: +1 212 851 9304; fax: +1 212 851 9396. E-mail address: gs2184{at}columbia.edu

See page 1917 for the editorial comment on this article (doi:10.1093/eurheartj/ehm265)

Aims: Major bleeding after percutaneous coronary intervention (PCI) is an independent risk factor for early and late mortality. We developed and validated a risk score predictive of major bleeding after PCI using the femoral approach.

Methods and results: Baseline clinical and procedural variables from two contemporary, multicentre, randomized PCI trials were used for risk score development (the REPLACE-2 trial, n = 6002) and validation (the REPLACE-1 trial, n = 1056). On the basis of the odds ratio, independent risk factors were assigned a weighted integer, the sum of which comprised a total risk score. Seven variables were identified as independent correlates of major bleeding (age >55 years, female gender, estimated glomerular filtration rate <60 mL/min/1.73 m2, pre-existing anaemia, administration of low-molecular-weight heparin within 48 h pre-PCI, use of glycoprotein IIb/IIIa inhibitors, and intraaortic balloon pump use). In the development set, the risk of major bleeding varied from 1.0% in patients without risk factors to 5.4% in high-risk patients. The discriminatory power of this risk model was confirmed in the validation data set (area under the receiver operating curve = 0.62).

Conclusion: A simple risk score of baseline clinical and procedural variables is useful to predict the incidence of major peri-procedural bleeding after contemporary PCI using the femoral approach.

Key Words: Major bleeding • Angioplasty • Risk score


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