Validation of Japanese Bleeding Risk Criteria in Patients After Percutaneous Coronary Intervention and Comparison With Contemporary Bleeding Risk Criteria

Background: The utility of the Japanese version of high bleeding risk (J-HBR) criteria compared with contemporary bleeding risk criteria, including Academic Research Consortium for High Bleeding Risk criteria, has not been fully investigated. Methods and Results: This study included patients who underwent percutaneous coronary intervention between 2010 and 2019. The J-HBR score was calculated by assigning 1 point for each major criterion and 0.5 points for each minor criterion in the J-HBR criteria. Among 1,643 patients, 1,143 (69.6%) met the J-HBR criteria. Accumulated major bleeding event rates at 1 year were higher among those who met the J-HBR criteria (4.8% vs. 0.6%; P<0.001). J-HBR criteria had higher sensitivity (94.8%) and lower specificity (31.4%) than contemporary bleeding risk criteria in predicting major bleeding. Bleeding events increased with increasing J-HBR score. The C statistic for the J-HBR score for predicting major bleeding at 1 year was 0.75 (95% confidence interval 0.69-0.81), and is comparable to that of other risk scores. In multivariate analysis, of the factors included in J-HBR criteria, chronic kidney disease, heart failure, and active malignancy were associated with major bleeding. Conclusions: J-HBR criteria identified patients at high bleeding risk with high sensitivity and low specificity. Bleeding risk was closely related to J-HBR score and its individual components. The discriminative ability of the J-HBR score was comparable to that of contemporary bleeding risk scores.