Evaluation of Rivaroxaban plus Aspirin versus Clopidogrel plus Aspirin in peripheral artery disease patients after Infrainguinal Endovascular Revascularization

Background: The best antithrombotic regimen following infrainguinal endovascular revascularization remains unknown. This study compared rivaroxaban with aspirin versus clopidogrel plus aspirin in patients with chronic limb-threatening ischemia. Methods: This prospective randomized clinical trial included 53 patients with Rutherford categories 4-6 who underwent technically and clinically successful infrainguinal endovascular revascularization. Computer-generated simple randomization allocated 24 patients to dual pathway therapy (DPT; rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily) and 29 patients to dual antiplatelet therapy (DAPT; clopidogrel 75 mg once daily plus aspirin 100 mg once daily). Both regimens were continued for 6 months. Patients were assessed at 1 : 6 months using the ankle-brachial index (ABI), Rutherford classification. Results: Baseline characteristics were comparable between groups. At 1 month, the mean ABI was higher in the DAPT group than in the DPT group (0.99±0.07 vs. 0.92±0.09; p=0.005), whereas no significant between-group differences were observed at 3 or 6 months. Major amputation occurred in 1 patient (4.2%) in the DPT group and 2 patients (6.9%) in the DAPT group (p=1.000). One cardiovascular death occurred in the DAPT group, while none occurred in the DPT group (p=1.000). No major bleeding occurred in either group. Clinically relevant non-major bleeding occurred in 2 patients (8.3%) in the DPT group and 1 patient (3.4%) in the DAPT group (p=0.866). Conclusion: Both regimens were associated with comparable short-term clinical and hemodynamic outcomes and no major bleeding events. DPT showed numerically fewer major amputations and cardiovascular deaths, but the differences were not statistically significant.