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

Eur Heart J. 2007 Aug;28(16):1936-45. doi: 10.1093/eurheartj/ehm194. Epub 2007 Jun 15.


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 m(2), 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Anemia / complications
  • Angioplasty, Balloon, Coronary / adverse effects*
  • Anticoagulants / adverse effects
  • Body Weight
  • Female
  • Humans
  • Male
  • Middle Aged
  • Postoperative Hemorrhage / etiology*
  • Prognosis
  • Renal Insufficiency / complications
  • Risk Assessment
  • Risk Factors
  • Sex Factors
  • Whole Blood Coagulation Time


  • Anticoagulants