Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V

摘要

Background In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan. Methods This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30?mg once daily (n?=?307) or enoxaparin 2000?IU (equivalent to 20?mg) twice daily (n?=?303) for 11 to 14?days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding. Results The incidence of VTE, based on venography and clinical surveillance, was 2.4?% in the edoxaban group and 6.9?% in the enoxaparin group (P P?=?0.475). Conclusions Oral edoxaban 30?mg once daily was superior to subcutaneous enoxaparin 2000?IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding.