Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.
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 <0.001). The absolute difference in the incidence of VTE was -4.5 % (95 % confidence interval [CI]: -8.6, -0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (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.
Department of Orthopaedic Surgery, Japan Community Healthcare Organization Osaka Hospital, 4-2-78, Fukushima, Fukushima-ku, Osaka 553-0003 Japan.
Takeshi
T
Fuji
Department of Orthopaedic Surgery, Takarazuka Daiichi Hospital, 19-5 Kogetsu-cho, Takarazuka, 665-0832 Japan.
Satoru
S
Fujita
International University of Health and Welfare, 8-10-16 Akasaka Minato-ku, Tokyo, 107-0002 Japan.
Yohko
Y
Kawai
Department of Clinical Cardiovascular Research, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507 Japan.
Mashio
M
Nakamura
Clinical Planning Department, Daiichi Sankyo Co. Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan.
Tetsuya
T
Kimura
Clinical Execution Department, Daiichi Sankyo Co. Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan.
Masayuki
M
Fukuzawa
Clinical Data & Biostatistics Department, Daiichi Sankyo Co. Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan.
Kenji
K
Abe
Department of Orthopaedic Surgery, Mishuku Hospital, 5-33-12 Shimomeguro, Meguro-ku, Tokyo, 153-0051 Japan.
Shintaro
S
Tachibana
Edoxaban; Enoxaparin; Factor Xa; Thromboprophylaxis; Total hip arthroplasty