Key result
Additional J-HBR criteria linked to ~2-fold higher MACLE risk after endovascular treatment for LEAD.
Why the study?
The Japanese version of the high bleeding risk criteria was proposed for patients after PCI, but its diagnostic ability in patients with lower extremity peripheral arterial disease remains unclear.
Does the Japanese version of the high bleeding risk (J-HBR) criteria predict major bleeding and major adverse cardiovascular and limb events in patients with lower extremity peripheral arterial disease undergoing endovascular treatment?
Observational (n=818)
Yes
Does the Japanese version of the high bleeding risk (J-HBR) criteria predict major bleeding and major adverse cardiovascular and limb events in patients with lower extremity peripheral arterial disease undergoing endovascular treatment?
The Japanese version of the high bleeding risk (J-HBR) criteria successfully stratifies ischemic and bleeding risks in patients with lower extremity peripheral arterial disease undergoing endovascular treatment.
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J-HBR criteria may aid risk stratification in LEAD-EVT patients; leaves open whether prospective validation changes management.
BACKGROUND: The Japanese version of the high bleeding risk (J-HBR) criteria was proposed to identify Japanese patients at HBR after percutaneous coronary intervention. However, the diagnostic ability of the J-HBR in patients with lower extremity peripheral arterial disease (LEAD) remains unclear. METHODS AND RESULTS: This multicenter registry included 818 LEAD patients undergoing endovascular treatment (EVT). Based on J-HBR major (1 point) and minor (0.5 points) criteria, patients were grouped into LEAD with (≥2.0 points) and without (1.0-1.5 points) additional J-HBR. LEAD itself is a major criterion. The primary endpoint was major bleeding events and major adverse cardiovascular and limb events (MACLE), a composite of cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation. Of the 818 patients in the study, 683 (83.5%) had LEAD with additional J-HBR. During the median follow-up period of 729 days, the risk of major bleeding events did not differ significantly between the 2 groups, although the risk of MACLE was higher in the LEAD with than without additional J-HBR group (12.4% vs. 5.9%; P=0.03). The probability of major bleeding and MACLE increased progressively with an increase in the number of J-HBR major and minor criteria. CONCLUSIONS: Among patients with LEAD undergoing EVT, the J-HBR criteria successfully stratified ischemic and bleeding risks. This risk-predicting model may be useful in patients with LEAD.
Matsumoto et al. (2026) conducted an observational in Lower extremity peripheral arterial disease (LEAD) (n=818). Additional Japanese high bleeding risk (J-HBR) criteria (≥2.0 points) vs. No additional J-HBR criteria (1.0-1.5 points) was evaluated on Major adverse cardiovascular and limb events (MACLE) (p=0.03). In patients with lower extremity arterial disease undergoing endovascular treatment, the presence of additional Japanese high bleeding risk criteria was associated with a higher risk of MACLE (12.4% vs. 5.9%).
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