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Diagnostic Ability of the Japanese Version of the High Bleeding Risk Criteria in Patients With Lower Extremity
Tadahiro Matsumoto1, Yuichi Saito2, Yuji Ohno3
1Department of Cardiology, Chibaken Saiseikai Narashino Hospital.
Insights
The Japanese high bleeding risk (J-HBR) criteria effectively stratified risks in patients with lower extremity peripheral arterial disease (LEAD) undergoing endovascular treatment (EVT). While not differentiating bleeding risk, J-HBR predicted major adverse cardiovascular and limb events (MACLE) in LEAD patients.
Area of Science:
- Cardiovascular Medicine
- Vascular Surgery
- Interventional Cardiology
Background:
- The Japanese high bleeding risk (J-HBR) criteria were developed to identify patients at high bleeding risk (HBR) post-percutaneous coronary intervention.
- The utility of J-HBR criteria in patients with lower extremity peripheral arterial disease (LEAD) remains unestablished.
Purpose of the Study:
- To evaluate the diagnostic ability and risk stratification capability of the J-HBR criteria in patients with LEAD undergoing endovascular treatment (EVT).
Main Methods:
- A multicenter registry study involving 818 patients with LEAD undergoing EVT.
- Patients were categorized based on J-HBR criteria (≥2.0 points) versus lower scores (1.0-1.5 points), with LEAD itself considered a major criterion.
- Primary endpoints included major bleeding events and major adverse cardiovascular and limb events (MACLE).
Main Results:
- The majority of patients (83.5%) had LEAD with additional J-HBR criteria.
- No significant difference in major bleeding events was observed between groups.
- Patients with LEAD and additional J-HBR criteria exhibited a higher risk of MACLE (12.4% vs. 5.9%; P=0.03).
- Both major bleeding and MACLE risks increased progressively with more J-HBR criteria.
Conclusions:
- The J-HBR criteria demonstrated effectiveness in stratifying ischemic and bleeding risks among patients with LEAD undergoing EVT.
- This risk-prediction model shows potential utility for managing patients with LEAD.
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.
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