STARS J-V

Studying Thrombosis After Replacement Surgery J-V (2010)

Condition

Prophylaxis for VTE after total hip arthroplas

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Objective

To evaluate the efficacy and safety of edoxaban compared with enoxaparin in Japanese patients undergoing elective total hip 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=303)
Control treatment: enoxaparin 20 mg (2000 IU) s.c. twice daily, initiated within 24–36 hours after surgery; edoxaban placebo (n=301)

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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

610 patients (20–84 years, mean age 62.8 years) undergoing elective unilateral total hip arthroplasty

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Results

Efficacy outcome: The primary efficacy outcome occurred in 6 of 255 (2.4%) patients receiving edoxaban and 17 of 248 (6.9%) patients receiving enoxaparin (relative risk reduction=65.7%). The thromboembolic events were all asymptomatic DVT. No symptomatic DVT or PE was observed in both treatment groups. There were no cases of intracranial hemorrhage or death in either treatment group
Safety outcome: The incidence of major and clinically relevant minor bleeding events was 2.6% (8/303) vs. 3.7% (11/301) in the edoxaban and enoxaparin groups, respectively. Major bleeding occurred in 0.7% of the edoxaban group and 2.0% of the enoxaparin group. Elevations ≥3x ULN of serum aminotransferase levels occurred in 2.6% of patients taking edoxaban compared with 10% of those taking enoxaparin

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Summary

Efficacy: Edoxaban was superior to enoxaparin in preventing VTE following 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, Fujita S, Tachibana S, Kawai Y, Koretsune Y, Yamashita T, Nakamura M. et al. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V trial. Poster presentation at the 52nd Annual Meeting of the American Society of Hematology, December 4–7 2010, Orlando, Florida
(2) ClinicalTrials.gov (NCT01181167)

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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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