Abstract: Background: An accurate tool with good discrimination for bleeding would be useful to clinicians for improved management of all their patients. Bleeding risk models have been published but not externally validated in independent clinical dataset. We chose the NCDR PCI score to validate within a large, multi-site community datasets. The aim of the study was to determine the diagnostic utility of this bleeding risk score tool.

Methods: This is a large-scale retrospective analysis utilizing American College of Cardiology data from a 37-hospital health system. The central repository of PCI procedures between 6-1-2009 and 6-30-2012 was utilized to validate the NCDR PCI bleeding risk score (BRS) among 4693 patients. The primary endpoint was major bleeding. Discriminant analysis calculating the receiver operating characteristic curve was performed.

Results:There were 143 (3.0%) major bleeds. Mean bleeding risk score was 14.7 (range 3 – 42). Incidence of bleeding by risk category: low (0.5%), intermediate (1.7%), and high risk (7.6%). Patients given heparin had 113 (3.7%) major bleeds and those given bivalirudin had 30 (2.1%) major bleeds. Tool accuracy was poor to fair (AUC 0.78 heparin, 0.65 bivalirudin). Overall accuracy was 0.71 (CI: 0.66-0.76). Accuracy did not improve when confined to just the intermediate risk group (AUC 0.58; CI: 0.55-0.67).

Conclusion:Bleeding risk tools have low predictive value. Adjustment for anticoagulation use resulted in poor discrimination because bivalirudin differentially biases outcomes toward no bleeding. The current state of bleeding risk tools provides little support for diagnostic utility in regards to major bleeding and therefore have limited clinical applicability.

Keywords: Major bleeding, bleeding risk model, anticoagulant, percutaneous coronary intervention, cardiovascular.