Abstract 5582: Safety and Efficacy of Rivaroxaban in Prevention of Venous Thromboembolism in Patients Undergoing Elective Major Orthopedic Surgery: A Meta-Analysis of Randomized Controlled Trials
Background: Venous thromboembolism is a significant cause of morbidity and mortality after major orthopedic surgery. Recent clinical trials comparing enoxaparin with rivaroxaban, a novel oral factor Xa inhibitor for thromboprophylaxis were not adequately powered to detect differences in low frequency clinical outcomes. We evaluated the impact of rivaroxaban in prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) compared to enoxaparin in patients undergoing elective total knee replacement (TKR) or total hip replacement (THR).
Methods: Eight randomized trials (n=13398 patients) comparing rivaroxaban (10 mg/day) with enoxaparin therapy were included. Summary odds ratios for DVT, PE, deaths, major bleeding and cardiovascular events were calculated using random-effects models.
Results: Rivaroxaban therapy was associated with a significant reduction in DVT (Odds ratio [OR] 0.49, 95% CI 0.33 – 0.75, p = 0.001). There was no significant difference in the incidence of PE (OR 0.90, 95% CI 0.30 –2.77, p = 0.86), deaths (OR 0.66, 95% CI 0.27–1.65, p = 0.38) or cardiovascular events (OR 0.91, 95% CI 0.50 –1.65, p = 0.76) during follow up for rivaroxaban compared to enoxaparin in THR and TKR populations. Major bleeding (OR 1.56, 95% CI 0.86 –2.83, p = 0.15) was also not significantly different between the two regimens.
Conclusion: Rivaroxaban as a fixed once daily anticoagulant may be a more effective agent compared to enoxaparin for thromboprophylaxis in patients undergoing major orthopedic surgery.