Cumulative impact of procedural and anatomical factors on in-hospital bleeding complications in endovascular therapy for lower-extremity artery disease: A nationwide registry study in Japan

Background: Although bleeding is a common procedure-related adverse event following endovascular therapy (EVT), limited data exist regarding the procedural and anatomical factors associated with its complications in patients with lower-extremity artery disease (LEAD) undergoing EVT. Methods: Data were extracted from a nationwide Japanese EVT registry of 73,990 patients who underwent EVT for symptomatic LEAD between January 2021 and December 2022. The primary outcome measure was in-hospital bleeding complications, including access site bleeding, nonaccess site bleeding, and hemorrhagic stroke. Results: The mean age of the patients was 75 ± 9 years, and 69% were men. In-hospital bleeding complications were observed in 613 (0.8%) patients. Logistic regression analysis demonstrated significant associations between bleeding complications and the following procedural, anatomical, and pharmacological variables: emergent revascularization (odds ratio [OR]: 1.90, 95% CI: 1.29–2.79), multiple approach sites (OR: 2.46, 95% CI: 2.00–3.01), bilateral arterial calcification (OR: 1.46, 95% CI: 1.19–1.79), chronic occlusion (OR: 1.53, 95% CI: 1.28–1.83), dual antiplatelet therapy (OR: 1.70, 95% CI: 1.27–2.28), and oral anticoagulant (OR: 1.63, 95% CI: 1.31–2.03). The adjusted incidence of in-hospital bleeding was 0.59% (95% CI: 0.51–0.68%) in patients with one of the identified procedural and anatomical risk factors, 0.96% (95% CI: 0.82–1.13%) in patients with two factors, and 2.40% (95% CI: 1.88–3.05%) in patients with three or four factors. Conclusions: Procedural and anatomical factors as well as antithrombotic strategies were significantly associated with an increased risk of in-hospital bleeding in patients with LEAD who underwent EVT.