What is the clinical evidence from this study?

Study design: Cohort. Population: Peripheral Arterial Disease (n=822). Intervention: ESC High Ischemic Risk (HIR) and High Bleeding Risk (HBR) criteria stratification vs. Patients without HIR or HBR. Primary outcome: Major adverse cardiovascular and limb events (MACLE) (p=0.005).

What does this research mean for the field?

The 2024 European Society of Cardiology high ischemic risk (HIR) and high bleeding risk (HBR) criteria successfully stratify ischemic and bleeding risks in real-world patients with peripheral arterial disease undergoing endovascular treatment. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

April 15, 2025Open Access

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

KYKayo YamamotoChiba University YSYuichi SaitoChiba University YOYuji OhnoJapanese Red Cross Narita Hospital

Key Result

The 2024 ESC high ischemic and bleeding risk criteria successfully stratified patients with peripheral arterial disease, with major adverse cardiovascular and limb events occurring in 16.4% of HIR(+)/HBR(+) patients compared to 0% in HIR(-)/HBR(-) patients.

Study Design

Type

Cohort (n=822)

Multicenter

Yes

Structured PICO

Does stratification by 2024 ESC high ischemic risk (HIR) and high bleeding risk (HBR) criteria predict major adverse cardiovascular and limb events and major bleeding in patients with PAD undergoing endovascular treatment?

Population

822 patients with lower extremity PAD undergoing endovascular treatment (EVT) for aortoiliac and femoropopliteal lesions, mean age 74.5, 73.6% male, in Japan.

Intervention

Stratification by 2024 ESC high ischemic risk (HIR) and high bleeding risk (HBR) criteria

Comparator

Comparison among three groups: HIR(-)/HBR(-), HIR(+)/HBR(-), and HIR(+)/HBR(+)

Outcome

Coprimary outcomes of major adverse cardiovascular and limb events (MACLE) (composite of cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation) and major bleeding events (BARC type 3 or 5)composite

The 2024 ESC high ischemic and high bleeding risk criteria successfully stratify the risk of major adverse cardiovascular and limb events and major bleeding in patients with PAD undergoing endovascular treatment.

Main Result

Absolute Event Rate: 16.4% vs 0%

p-value: p=0.005

Limitations

Retrospective study with a moderate sample size
Some criteria were slightly modified from the original definitions (e.g., active bleeding determined by gastrointestinal bleeding history)
Limited sample size prevented sub-analyses per EVT device used and site-level analysis
Exclusively included patients undergoing EVT for aortoiliac and femoropopliteal PAD, limiting generalizability to infrapopliteal lesions or non-Asian populations
Few patients received low-dose rivaroxaban, so the impact of antithrombotic regimens on outcomes was unknown
Details of MACLE, major bleeding events, and pharmacological treatment during follow-up were lacking

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: ), 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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