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