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

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.