ARTS Trial Comparing Apixaban Versus No Anticoagulant in Adults Undergoing Abdominal, Gynecologic, or Urologic Surgery to Prevent Blood Clots and Bleeding

What this Trial Is About

Researchers are evaluating the use of a direct oral anticoagulant DOAC called apixaban compared to no anticoagulant in patients undergoing abdominal or pelvic surgery. This international, multicenter, randomized controlled trial focuses on patients with a moderate risk of venous thromboembolism VTE and bleeding where the benefits and harms of thromboprophylaxis are unclear. The study aims to clarify whether apixaban provides a net benefit or if avoiding anticoagulation is preferable in this population. The trial enrolls 5,436 patients who will be randomly assigned to receive either apixaban 2.5 mg orally twice daily for 28 days alongside standard mechanical prevention or no anticoagulant with standard mechanical prevention alone. Mechanical prophylaxis is provided as standard care in both groups. The study is open-label and compares the outcomes of using apixaban versus no anticoagulation after surgery. Participants will be monitored for 90 days to assess the incidence of VTE, including deep vein thrombosis and pulmonary embolism. Researchers will collect data on symptomatic events and major bleeding. Follow-up visits and assessments will track safety and effectiveness outcomes. The studys results will help guide decisions about thromboprophylaxis after abdominal and pelvic surgeries in patients at moderate risk.

Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial