Dual Pathway Inhibition Versus Dual Antiplatelet Therapy Following Isolated Tibial Balloon Angioplasty for Chronic Limb-Threatening Ischemia.

Abstract

Optimal antithrombotic therapy following infrapopliteal angioplasty for chronic limb-threatening ischemia (CLTI) remains uncertain. Dual pathway inhibition (DPI) with low-dose rivaroxaban plus aspirin has demonstrated benefit in broader peripheral arterial disease populations, including post lower extremity revascularization however evidence specific to isolated crural interventions is limited. Currently patients receive either DPI or DAPT based on surgeons' choice and this study will compare the outcomes of the 2 regimens from retrospective cohort analysis based on the hypothesis that DPI provides superior prevention of thromboembolic events post angioplasty. A retrospective cohort study was conducted including patients undergoing isolated tibial balloon angioplasty for CLTI between January 2022 and July 2024. Patients receiving dual antiplatelet therapy (DAPT; aspirin plus clopidogrel) were compared with those receiving DPI (rivaroxaban 2.5 mg twice daily plus aspirin) lifelong. Patients undergoing multilevel interventions, stenting, drug-coated balloon angioplasty, thrombolysis, or treatment for claudication were excluded. Primary outcomes included major limb amputation and all-cause mortality. Secondary outcomes included target lesion revascularization (TLR), acute limb ischemia (ALI), and bleeding complications. A total of 199 patients met the inclusion criteria, including 102 treated with DAPT and 97 treated with DPI. Baseline demographic and clinical characteristics were broadly comparable between groups. At 12 months, major limb amputation occurred in 27 patients (26.5%) receiving DAPT and 17 patients (17.5%) receiving DPI (p=0.04), corresponding to an absolute risk reduction of 9.0% and a number needed to treat of 11. TLR was required in 14 patients (13.7%) in the DAPT group and 5 patients (5.2%) in the DPI group (p=0.04), corresponding to an absolute risk reduction of 8.5% and a number needed to treat of 12. ALI occurred in 4 patients (3.9%) receiving DAPT and 1 patient (1.0%) receiving DPI (p=0.40). One-year mortality was similar between groups (3.9% vs 3.1%; p=0.79). No major bleeding events occurred in either group, while minor bleeding rates were low and comparable. Among patients undergoing isolated tibial angioplasty for CLTI, dual pathway inhibition with low-dose rivaroxaban plus aspirin was associated with reduced major limb amputation and target lesion revascularization compared with dual antiplatelet therapy, without an increase in major bleeding. Larger prospective studies are warranted to confirm these findings and define the optimal antithrombotic strategy following infrapopliteal intervention.