Design and rationale of the multicenter randomized clinical trial (REVERSE): Efficacy and safety of rivaroxaban in the early postoperative period for patients with bioprosthetic valve replacement or valve repair.

Background: Rivaroxaban, a Non-vitamin K oral anticoagulant (NOAC), is extensively employed for patients at heightened risk of thrombosis, including those with non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). However, to date, there is a lack of robust clinical data to explore the efficacy and safety of rivaroxaban in thromboprophylaxis during the early postoperative period (<6 months) in patients following surgical bioprosthetic valve (BPV).

Methods: The REVERSE trial is a prospective, multicenter, non-inferior, randomized controlled trial enrolling a planned 250 patients in China. Patients are randomly assigned 1:1 to receive rivaroxaban (20 mg once daily) or dose-adjusted warfarin (target international normalized ratio 2.0-3.0) for 6 months. The primary outcome is defined as the composite of all-cause death, major cardiovascular events, or major bleeding. The safety outcome is all bleeding events defined by the International Society on Thrombosis and Haemostasis (ISTH).

Conclusions: The REVERSE trial stands as the inaugural multicenter study dedicated to evaluating the efficacy and safety of rivaroxaban for early postoperative anticoagulation in BPV surgery patients. Its findings are anticipated to contribute pivotal evidence regarding the clinical advantages of NOACs.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT06476301.