Outcomes with Aspirin and Clopidogrel Versus Aspirin and Rivaroxaban in Infrainguinal Endovascular Revascularization for Critical Limb Ischemia

Background: The purpose of the study was to assess the benefits of dual antithrombotic therapy in the management of peripheral arterial disease in Indian population. Methods: We conducted a prospective review of patients on dual antithrombotic therapy who underwent infra-inguinal endovascular revascularisation at JIVAS for 18 months. Objectives: To study the outcomes with aspirin + clopidogrel (CA) versus aspirin + rivaroxaban (RA) after infrainguinal endovascular revascularization for critical limb ischemia. The main objective was to assess primary patency of vessel after endovascular revascularization. The secondary objectives were to study limb salvage, major adverse limb events (MALEs), major adverse cardiac events (MACEs), bleeding events (major and minor), and wound healing. Results: In the present study, a total of 104 patients underwent infrainguinal revascularization and fulfilled the inclusion criteria, of which 48 received RA and 56 received CA. The mean age was 49.8 years with no significant differences in the baseline demographics and comorbidities between the two groups. The primary objective of vessel patency was assessed measuring the ankle brachial index which was 0.91 in the RA group and 0.96 in the CA group and remained the same on follow-up till 6 months and mean trans cutaneous oxygen pressure of around 34 in both the groups. There was no significant difference in the incidence of MALE (2.1% in RA vs. 7.1% in CA; P = 0.2), MACE (6.3% in RA vs. 10.7% in CA; P = 0.4), wound healing (81% RA vs. 75% CA; P = 0.4), safety parameter of bleeding (6.3% RA vs. 3.6% CA), creatinine, and liver function tests (LFT) during the study period. Conclusion: Both the antithrombotic regimens can be considered safe and efficacious in the postoperative management of patients undergoing infrainguinal revascularization; with maintenance of primary patency, comparable wound healing, incidence of MALE and MACE, and safe with no bleeding; and no impairment in the serum creatinine and LFTs during follow-up.