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<p>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 &lt; 2, ARC-HBR &lt; 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 <i>p</i> &lt; 0.001) and in major bleeding events with higher novel bleeding risk scores (log-rank <i>p</i> &lt; 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&#xa0;year (0.72 vs. 0.66,<i> p</i> = 0.040) and 3&#xa0;years (0.66 vs. 0.61,<i> p</i> = 0.024). The novel bleeding risk score tended to have a higher AUC for predicting major bleeding events at 1&#xa0;year than modified J-HBR (0.77 vs. 0.69,<i> p</i> = 0.068) and ARC-HBR (0.77 vs. 0.67,<i> p</i> = 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.</p>

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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

  • 期刊论文

  • 发表日期：

    2025年11月23日

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  • Hirokazu Shimono,
  • Daisuke Kanda,
  • Akihiro Tokushige,
  • Nobuhiro Ito,
  • Yutaro Nomoto,
  • Hiroyuki Tabata,
  • Kenta Ohmure,
  • Takuro Kubozono,
  • Mitsuru Ohishi

摘要

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.