Outcomes of Factor Xa Inhibitor-based Regimens Versus Dual Antiplatelet Therapy in Managing Infrageniculate Critical Limb Ischemia Post Angioplasty

Abstract

Background: Critical limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease and is associated with high rates of limb loss and mortality. Although dual antiplatelet therapy (DAPT) is commonly used following infrageniculate endovascular revascularization, its effectiveness in maintaining vessel patency remains uncertain. Factor Xa inhibitor–based dual pathway inhibition may offer improved outcomes in this high-risk population.Patients and Methods: This multicenter retrospective cohort study included 145 patients with CLTI (Rutherford class 4–6) who underwent infrageniculate angioplasty between January 2022 and December 2023. Patients were stratified according to post-procedural antithrombotic therapy into three groups: apixaban plus aspirin (n = 37), rivaroxaban plus aspirin (n = 32), and DAPT with clopidogrel plus aspirin (n = 76). The primary outcome was primary patency rate at 12 months. Secondary outcomes included primary-assisted patency, clinical improvement based on Rutherford classification, limb-related outcomes, and safety endpoints including bleeding, hematoma, myocardial infarction, ischemic stroke, and cardiovascular death.Results: At 12 months, primary patency was significantly higher in the rivaroxaban (75%) and apixaban (72.9%) groups compared with the DAPT group (67.1%) (p < 0.001). Primary-assisted patency was also superior in the rivaroxaban (87.5%) and apixaban (83.7%) groups versus DAPT (78.9%) (p < 0.001). Clinical improvement was observed in 81% of patients receiving apixaban and 72% receiving rivaroxaban, compared with 9.2% in the DAPT group (p < 0.001). Rates of amputation, wound healing, and adverse safety outcomes did not differ significantly among groups.Conclusion: In patients with CLTI undergoing infrageniculate angioplasty, factor Xa inhibitor–based regimens combined with aspirin were associated with superior 12-month patency and greater clinical improvement compared with conventional DAPT, without an increased risk of adverse events. These findings support dual pathway inhibition as a promising antithrombotic strategy in this high-risk population.