OBSERVATIONAL STUDY TO COMPARE THE OUTCOMES OF APIXABAN PLUS ASPIRIN VERSUS DUAL ANTIPLATELET THERAPY AFTER REVASCULARIZATION IN CHRONIC LIMB THREATENING ISCHEMIA PATIENTS

Introduction: Patients with peripheral artery disease requiring lower extremity revascularization are at high risk of major adverse limb and cardiovascular events. Primary patency rate of above knee femoropopliteal reversed saphenous vein graft at 1 and 4 year is 99 and 69% and for below knee femoropopliteal reversed saphenous vein graft at 1 and 4 year is 98 and 77% respectively. Need for the Study: Antiplatelets and oral anticoagulants has been well recognized cardiac and cerebral protective effects and may also improve early graft patency. Considering the safety profile of apixaban3 over other newer oral anticoagulants and since only limited studies are available comparing the newer oral anticoagulant apixaban plus aspirin and dual antiplatelet therapy in Indian population, this study is proposed. Methods: The study population includes 306 patients with age 50 years or more males or females who have a documented PAD with CLTI undergoing limb revascularization either open surgery or endovascular or hybrid approach in Thanjavur medical college from May 2019 to June 2023. Postoperatively patients were discharged wth either apixaban plus aspirin therapy or dual antiplatelet therapy. Patients were excluded if they were clinically unstable, were at heightened bleeding risk. The primary outcome studied include major adverse limb events and major reintervention rate. The secondary outcomes studied include major adverse cardiovascular events, stroke, re- and cross-over intervention rates,major and non major bleeding for a period of 5 years.