Association between the modified Japanese Version of High Bleeding Risk scores and clinical outcomes in Japanese patients with lower extremity artery disease undergoing endovascular treatment.

This study aimed to investigate the association between the modified Japanese Version of High Bleeding Risk (J-HBR) criteria and the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria with clinical outcomes in patients with lower extremity artery disease (LEAD) undergoing endovascular treatment (EVT). We enrolled 305 consecutive patients with LEAD who underwent EVT. Each modified J-HBR and ARC-HBR score was calculated by assigning 1 and 0.5 points to each major and minor criterion, respectively. Coronary artery disease was included as a major criterion in the modified J-HBR criteria, replacing peripheral vascular disease. The cut-off values for ARC-HBR and modified J-HBR scores were determined using the survival classification and regression tree (CART) model to predict all-cause mortality. A novel bleeding risk score associated with major bleeding events was developed from this dataset, with its cut-off determined by the CART model. The primary outcome was all-cause mortality; the secondary outcome was major bleeding events defined as Bleeding Academic Research Consortium type 3 or 5 following EVT. We also compared the discriminatory ability of the modified J-HBR, ARC-HBR, and novel bleeding risk scores. During a median follow-up of 1085 (435–1951) days, 116 patients died and 36 had major bleeding events. The CART model classified patients into low (modified J-HBR < 2, ARC-HBR < 1, novel bleeding risk 0), intermediate (modified J-HBR 2–2.5, ARC-HBR 1–1.5, novel bleeding risk 1), and high (modified J-HBR ≥ 3, ARC-HBR ≥ 2, novel bleeding risk ≥ 2) risk groups. Kaplan–Meier curves demonstrated a significant increase in mortality with higher modified J-HBR and ARC-HBR scores (log-rank p < 0.001) and in major bleeding events with higher novel bleeding risk scores (log-rank p < 0.001). Time-dependent receiver operating characteristic analysis for 1- and 3-year all-cause mortality showed modified J-HBR had a higher area under the curve (AUC) than ARC-HBR at 1 year (0.72 vs. 0.66, p = 0.040) and 3 years (0.66 vs. 0.61, p = 0.024). The novel bleeding risk score tended to have a higher AUC for predicting major bleeding events at 1 year than modified J-HBR (0.77 vs. 0.69, p = 0.068) and ARC-HBR (0.77 vs. 0.67, p = 0.067). The modified J-HBR and ARC-HBR scores effectively stratified the mortality risk, whereas the novel bleeding risk score effectively stratified bleeding risk in patients with LEAD undergoing EVT. The modified J-HBR score demonstrated superior discriminative ability in predicting mid- and long-term mortality compared to the ARC-HBR score.