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.
Editors
JACC: Asia Editor-in-Chief
Jian’an Wang, MD, PhD, FACC
CME Editor
Kenneth A. Ellenbogen, MD
Author
Kayo Yamamoto
Important Dates
Date of Release: June 3, 2025
Term of Approval/Date of CME/MOC Expiration: June 2, 2026