STARS E3
Trial question
What is the role of edoxaban for thromboprophylaxis in patients who underwent total knee arthroplasty?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
80.0% female
20.0% male
N = 594
594 patients (474 female, 120 male).
Inclusion criteria: patients who underwent total knee arthroplasty.
Key exclusion criteria: increased risk of bleeding; high risk for thromboembolism; body weight < 40 kg; severe renal impairment (CrCl < 30 mL/min); hepatic dysfunction; or pregnant or lactating women.
Interventions
N=299 edoxaban (30 mg once daily PO beginning 6 to 24 hours postsurgery for 11 to 14 days).
N=295 enoxaparin (2,000 IU (equivalent to 20 mg) SC BID beginning 24 to 36 hours postsurgery for 11 to 14 days).
Primary outcome
Symptomatic pulmonary embolism and symptomatic and asymptomatic deep venous thrombosis
7.4%
13.9%
13.9 %
10.4 %
7.0 %
3.5 %
0.0 %
Edoxaban
Enoxaparin
Significant
decrease ▼
NNT = 15
Significant decrease in symptomatic PE and symptomatic and asymptomatic DVT (7.4% vs. 13.9%; RR 0.53, 95% CI 0.9 to 0.96).
Safety outcomes
No significant differences in serious adverse events, major bleeding events (1.1% vs. 0.3%, p=0.373) and major or CRNM bleeding (6.2% vs. 3.7%, p=0.129).
Conclusion
In patients who underwent total knee arthroplasty, edoxaban was superior to enoxaparin with respect to symptomatic PE and symptomatic and asymptomatic DVT.
Reference
Fuji T, Wang CJ, Fujita S et al. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thromb Res. 2014 Dec;134(6):1198-204.
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