The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

DOI: 10.4244/EIJ-D-20-00052

1. Inselspital Universitatsspital Bern, Cardiology, Bern, Switzerland
2. Department of Cardiology, Bern University Hospital, Bern, Switzerland, Switzerland
3. Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.

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Aims: 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.

Methods and results: 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.

Conclusions: 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.

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