Venous Thromboembolism in Patients Receiving Rivaroxaban Plus Aspirin or Standard Treatment after Lower Limb Revascularization-Rationale and Design of the RESOLUTION Trial.

BACKGROUND: Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, is a major cause of perioperative morbidity and mortality, particularly in patients undergoing lower limb revascularization (LLR) for peripheral arterial disease. Despite the known risk, evidence supporting optimal postoperative VTE prophylaxis in this population remains limited. This study aims to evaluate the efficacy and safety of rivaroxaban combined with aspirin in reducing VTE incidence after LLR.

STUDY DESIGN: This prospective, randomized, open-label, controlled trial will enroll 100 patients undergoing LLR, randomized 1:1 to receive either the standard dual antiplatelet therapy for 3 months followed by aspirin (control) or rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily (intervention). The primary outcome is the incidence of VTE within 30 days postoperatively, assessed through routine lower limb venous ultrasound, regardless of symptoms. Secondary outcomes include sociodemographic characterization, bleeding complications, and hospital readmission or reoperation due to bleeding. VTE and bleeding risks will be stratified using the Caprini and IMPROVE Bleeding Risk Scores. The trial is registered at www.

CLINICALTRIALS: gov (NCT06873321).

SUMMARY: This trial will provide high-quality evidence regarding the efficacy and safety of rivaroxaban plus aspirin for postoperative VTE prophylaxis after LLR. If successful, the findings may support rivaroxaban as an effective strategy for extended prophylaxis, enhancing postoperative outcomes while maintaining an acceptable safety profile.