STARS E-III

Studying Thrombosis After Replacement Surgery E-III (2010)

Condition

Prophylaxis for VTE after total knee arthroplasty

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Objective

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

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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)

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Endpoints

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

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Trial participants

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

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Results

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)

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Summary

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

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Reference

(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) ClinicalTrials.gov (NCT01181102)

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Corresponding author

Takeshi Fuji, MD, Department of Orthopedic Surgery, Osaka Koseinenkin Hospital, Osaka, Japan, e-mail: fuji-th@umin.ac.jp

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