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.

Results: Interim results of 77 patients who fulfil the inclusion criteria are analysed for publication.The primary outcome - major amputation above knee level occurred in 6.4% of apixaban /aspirin group and and 5.7% of aspirin/clopidogrel group and major re intervention occurred in 12.9% of apixaban /aspirin group and and 17.1% of aspirin/clopidogrel group . Secondary outcomes-major adverse cardiovascular events occurred in 5.5% of apixaban /aspirin group and and 4.8% of aspirin/clopidogrel group . Re and crossover intervention occurred in 6.4% of apixaban /aspirin group and and 8.5% of aspirin/clopidogrel group (p value of 0.5). non major bleeding occurred in 3.2% of apixaban /aspirin group and and 20% of aspirin/clopidogrel group (p value of 0.038).

Conclusion: From this study we found that - there is no significant difference with respect to MALE, MACE in CLTI patients undergoing Infra inguinal revascularization between Apixaban + Aspirin and Aspirin + Clopidogrel groups except for non major bleeding. With inclusion of all patients enrolled from 2019 till 2023 and after completion of 4 years follow up we try to overcome these limitations noted in this interim study.