Validation of Bleeding Risk Criteria (ARC-HBR) in Patients Undergoing Percutaneous Coronary Intervention and Comparison with Contemporary Bleeding Risk Scores.

The Academic Research Consortium for high bleeding risk (ARC-HBR) defined consensus-based criteria for patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). We aimed to validate the ARC-HBR criteria for the bleeding outcomes using a large cohort of patients undergoing PCI.Between 2009 and 2016, patients undergoing PCI were prospectively included in the Bern PCI Registry. Patients were considered to be at HBR if at least 1 major criterion or 2 minor criteria were met. The primary endpoint was Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year; ischemic outcomes were assessed using the device-oriented composite endpoints (DOCE) of cardiac death, target-vessel myocardial infarction, and target lesion revascularization. Among 12,121 patients, those at HBR (n=4,781, 39.4%) had an increased risk of BARC 3 or 5 bleeding (6.4% vs. 1.9%; P<0.001) and DOCE (12.5% vs. 6.1%; P<0.001) compared with those without HBR. The degree of risk and prognostic value was related to the risk factors composing the criteria. The ARC-HBR criteria had higher sensitivity than PRECISE-DAPT score and PARIS bleeding risk score (63.8%, 53.1%, 31.9%), but lower specificity (62.7%, 71.3%, 86.5%) for BARC 3 or 5 bleeding.Patients at HBR defined by the ARC-HBR criteria had a higher risk of BARC 3 or 5 bleeding as well as DOCE. The bleeding risk was related to its individual components. The ARC-HBR criteria was more sensitive to identify patients with future bleedings than other contemporary risk scores at the cost of specificity.