6/29/23, 11:45 PM STARS E3 Pathway Feedback Search Clinical Topics Home Studies STARS E3 STARS E3 Disease Knee osteoarthritis 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 79.5% female N = 716 20.5% male 716 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=360 edoxaban (30 mg once daily PO beginning 6 to 24 hours postsurgery for 11 to 14 days) N=356 enoxaparin (2,000 IU (equivalent to 20 mg) SC BID beginning 24 to 36 hours postsurgery for 11 to 14 days) https://web.pathway.md/studies/recoRCFyuUcypm7p5 1/2 6/29/23, 11:45 PM STARS E3 Pathway Primary outcome Symptomatic pulmonary embolism and symptomatic and asymptomatic deep venous thrombosis 13.9 % 13.9 10.4 % 7.4 7.0 % Significant decrease 3.5 % NNT = 15 0.0 % Edoxaban Enoxaparin 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. Open reference URL https://web.pathway.md/studies/recoRCFyuUcypm7p5 2/2