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. 2025 Jun;5(6):744-754.
doi: 10.1016/j.jacasi.2025.01.018. Epub 2025 Apr 15.

Validation of High Ischemic and Bleeding Risk Criteria of European Guidelines in Peripheral Arterial Disease

Kayo Yamamoto  1 , Yuichi Saito  2 , Yuji Ohno  3 , Norikiyo Oka  4 , Masayuki Takahara  5 , Sakuramaru Suzuki  6 , Raita Uchiyama  6 , Masahiro Suzuki  7 , Tadahiro Matsumoto  7 , Yo Iwata  4 , Yoshio Kobayashi  1
Affiliations

Validation of High Ischemic and Bleeding Risk Criteria of European Guidelines in Peripheral Arterial Disease

Kayo Yamamoto et al. JACC Asia. 2025 Jun.

Abstract

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.

Keywords: guidelines; peripheral arterial disease; risk stratification.

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Conflict of interest statement

Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
2024 ESC Guidelines HIR and HBR Criteria and Study Flow The European Society of Cardiology (ESC) proposed high ischemic risk (HIR) and high bleeding risk (HBR) criteria in 2024 for the ischemic and bleeding risk stratification in patients with peripheral arterial disease (PAD). According to the risk criteria, patients with PAD were divided into 4 groups. Patients with HBR and no HIR were excluded caused by the limited sample size. DM = diabetes; eGFR = estimated glomerular filtration rate; EVT = endovascular treatment; HF = heart failure; TIA = transient ischemic attack.
Central Illustration
Central Illustration
Clinical Outcomes According to Combinations of ESC-HIR and HBR Combinations of European Society of Cardiology (ESC) high ischemic risk (HIR) and high bleeding risk (HBR) criteria were significantly associated with major adverse cardiovascular and limb events (MACLE) and major bleeding events after endovascular treatment (EVT) in patients with peripheral arterial disease. Patients without HIR had a lower ischemic event risk than those with at least 1 ESC-HIR criteria. The risk of MACLE in patients with HIR was further stratified according to the ESC-HBR criteria. Patients with both HIR and HBR had a higher bleeding risk.
Figure 2
Figure 2
Clinical Outcomes According to the Number of HIR Criteria Ischemic and bleeding outcomes after EVT were evaluated. The number of HIR criteria was progressively associated with an increased major adverse cardiovascular and limb events (MACLE) risk, while it was not significantly related to the risk of major bleeding events. Abbeviations as in Figure 1.
Figure 3
Figure 3
Clinical Outcomes According to the Number of HBR Criteria Ischemic and bleeding outcomes after EVT were evaluated. The number of HBR criteria was significantly associated with increased risks of MACLE and major bleeding events in a stepwise manner. Abbreviations as in Figures 1 and 2.
Figure 4
Figure 4
Receiver-Operating Characteristic Curve Analysis for MACLE and Major Bleedings The receiver-operating characteristic curve analysis showed that the number of ESC-HIR predicted MACLE with moderate diagnostic ability. Similarly, the number of ESC-HBR criteria were predictive of major bleeding events after endovascular treatment. AUC = area under the curve; abbreviations as in Figures 1 and 2.
Figure 5
Figure 5
Prognostic Impact of Each Criterion of the ESC-HIR and HBR The rates of MACLE and major bleeding events were stratified by the individual ESC-HIR and HBR criteria. For ischemic risk stratification, the presence of CLTI and a history of previous revascularization were significantly associated with MACLE. For major bleeding events, renal impairment and active or clinically significant bleeding were particularly predictive. ACS = acute coronary syndrome; CLTI = critical limb-threatening ischemia; NA = not applicable; other abbreviations as in Figures 1 and 2.
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