High Bleeding Risk and Clinical Outcomes in East Asian Patients Undergoing Percutaneous Coronary Intervention: the PENDULUM Registry.

AIMS We evaluated the validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria for East Asian patients undergoing contemporary percutaneous coronary intervention (PCI) from the PENDULUM registry. METHODS AND RESULTS This post hoc analysis included 6,267 Japanese patients undergoing PCI between December 2015 and June 2017 enrolled in PENDULUM. The primary endpoint was incidence of major bleeding at 12 months post-index PCI. In total, 3,185 (50.8%) and 3,082 (49.2%) patients were stratified to ARC-HBR and non-ARC-HBR groups, respectively and almost all patients had overlapping criteria. Incidence of major bleeding was 4.2% versus 1.4% in the ARC-HBR versus non-ARC-HBR (hazard ratio=3.00 [95% confidence interval, 2.11-4.27]; p<0.001). As the number of overlapping ARC-HBR criteria increased, incidence of major bleeding also increased. In contrast, incidence of major bleeding was 4.2% for one major criterion, 2.1% for two minor criteria. Multivariate analysis suggested severe CKD, anticoagulant use, acute coronary syndrome, low body weight and heart failure were independent predictors of major bleeding. CONCLUSIONS Half of the Japanese patients who underwent PCI in the PENDULUM registry met the ARC-HBR criteria, and many patients had overlapping criteria. ARC-HBR criteria are applicable to Japanese patients undergoing contemporary PCI.