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Validation of High Ischemic and Bleeding Risk Criteria of European Guidelines in Peripheral Arterial Disease
Kayo Yamamoto1, Yuichi Saito1, Yuji Ohno2
1Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Insights
The European Society of Cardiology (ESC) high ischemic risk (HIR) and high bleeding risk (HBR) criteria effectively stratified patient risk in peripheral arterial disease (PAD) endovascular treatments. These criteria accurately predicted major adverse cardiovascular and limb events and bleeding complications.
Area of Science:
- Vascular Surgery
- Cardiology
- Clinical Risk Stratification
Background:
- The 2024 European Society of Cardiology (ESC) guidelines introduced specific criteria for high ischemic risk (HIR) and high bleeding risk (HBR) in peripheral arterial disease (PAD).
- Validating these newly proposed risk criteria in real-world clinical practice is essential for their effective implementation.
Purpose of the Study:
- To validate the prognostic performance of the ESC-defined high ischemic risk (HIR) and high bleeding risk (HBR) criteria.
- To assess the ability of these criteria to stratify patients undergoing endovascular treatment for aortoiliac and femoropopliteal PAD.
Main Methods:
- A multicenter retrospective registry of 824 patients undergoing endovascular treatment for PAD between January 2019 and December 2022.
- Patients were categorized based on the presence or absence of ESC-HIR and ESC-HBR criteria.
- Outcomes evaluated included major adverse cardiovascular and limb events and major bleeding events.
Main Results:
- Of 822 evaluable patients, 7.5% were HIR(-)/HBR(-), 56.8% were HIR(+)/HBR(-), and 35.6% were HIR(+)/HBR(+).
- Major adverse cardiovascular and limb events occurred in 0%, 9.5%, and 16.4% of the groups, respectively (P=0.005).
- Major bleeding events occurred in 4.8%, 2.4%, and 6.8% of the groups, respectively (P=0.009).
Conclusions:
- The ESC-HIR and HBR criteria demonstrated significant ability to stratify ischemic and bleeding risks.
- These criteria are valuable tools for risk assessment in patients with PAD undergoing endovascular procedures.
Background:
The 2024 European Society of Cardiology (ESC) guidelines for peripheral arterial disease (PAD) propose the dedicated high ischemic risk (HIR) and high bleeding risk (HBR) criteria.
Objectives:
The purpose of this study was to validate the ESC-HIR and HBR criteria using real-world data.
Methods:
From January 2019 to December 2022, this multicenter retrospective registry included 824 patients undergoing endovascular treatment for aortoiliac and femoropopliteal PAD. The ESC-HIR criteria include previous amputation, critical limb-threatening ischemia, previous revascularization, high-risk comorbidities (heart failure, diabetes, polyvascular disease), and estimated glomerular filtration rate <60 mL/min/1.73 m2, while the ESC-HBR criteria include dialysis or renal impairment (estimated glomerular filtration rate <15 mL/min/1.73 m2), acute coronary syndrome <30 days, history of stroke or transient ischemic attack, and active or clinically significant bleeding. Although patients were initially divided into 4 groups according to the presence or absence of HIR and HBR, patients with HBR and no HIR were excluded caused by the small sample size (n = 2). Major adverse cardiovascular and limb events and bleedings were evaluated.
Results:
Of the 822 patients, 62 (7.5%), 467 (56.8%), and 293 (35.6%) were grouped in the HIR (-)/HBR (-), HIR (+)/HBR (-), and HIR (+)/HBR (+). During the median follow-up period of 726 days, major adverse cardiovascular and limb events occurred in 0%, 9.5%, and 16.4% among the 3 groups (P = 0.005). The incidence of major bleeding events was 4.8%, 2.4%, and 6.8%, respectively (P = 0.009).
Conclusions:
The ESC-HIR and HBR criteria successfully stratified ischemic and bleeding risks in patients with PAD undergoing endovascular treatment.
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