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

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 Ilb/Illa 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.