Studying Thrombosis After Replacement Surgery E-III (2010)


Prophylaxis for VTE after total knee arthroplasty

Close this section


To evaluate the efficacy and safety of edoxaban compared with enoxaparin in Japanese patients undergoing elective total knee replacement

Close this section

Trial design

Randomized, double-blind, double dummy phase III trial
Active treatment: edoxaban 30 mg once daily, initiated within 6–24 hours after surgery; enoxaparin placebo (n=360)
Control treatment: enoxaparin 20 mg (2000 IU) s.c. twice daily, initiated within 24–36 hours after surgery; edoxaban placebo (n=356)

Close this section


Primary efficacy endpoint: composite of symptomatic PE, symptomatic and asymptomatic DVT
Primary safety endpoints: composite of major bleeding and clinically relevant minor bleeding
Secondary safety endpoints: adverse events

Close this section

Trial participants

716 patients (20–84 years, mean age 72 years) undergoing elective unilateral total knee arthroplasty

Close this section


Efficacy outcome: There were no PE events observed in either treatment group. Symptomatic and asymptomatic DVT occurred in 22 of 299 (7.4%) of patients receiving edoxaban compared with 41 of 295 (13.9%) patients receiving enoxaparin (relative risk reduction 47%). No patient died and there were no cases of intracranial hemorrhage in either treatment group
Safety outcome: The incidences of major and clinically relevant minor bleeding were 6.2% with edoxaban vs. 3.7% with enoxaparin. The rate of liver function test abnormalities with edoxaban was lower than with enoxaparin (ALT or AST ≥3x ULN in 1.4% with edoxaban and 9.5% with enoxaparin)

Close this section


Efficacy: Edoxaban was superior to enoxaparin in preventing VTE in patients undergoing total hip arthroplasty
Safety: Incidence of major and clinically relevant minor bleeding was similar with edoxaban and enoxaparin

Close this section


(1) Fuji T, Wang CJ, Fujita S, Tachibana S, Kawai Y, Koretsune Y, Yamashita T, Nakamura M. Edoxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-III Trial. Oral presentation at the International Congress on Thrombosis 2010 (ICT), 6–9 July 2010, Milan, Italy
(2) (NCT01181102)

Close this section

Corresponding author

Takeshi Fuji, MD, Department of Orthopedic Surgery, Osaka Koseinenkin Hospital, Osaka, Japan, e-mail:

Close this section

Back To List

Recommend pageBack to top