Why the study?
Does rivaroxaban prevent venous thromboembolism in patients undergoing total knee and hip replacements compared to enoxaparin?
Does rivaroxaban prevent venous thromboembolism in patients undergoing total knee and hip replacements compared to enoxaparin?
Rivaroxaban is an effective and safe oral alternative to enoxaparin for VTE prophylaxis in major orthopedic surgery, offering the advantage of once-daily dosing without laboratory monitoring.
May support oral rivaroxaban for orthopedic VTE prophylaxis; leaves open need for updated RCTs before guideline changes.
Rivaroxaban is a novel oral direct factor Xa inhibitor. It is currently awaiting approval from the US Food and Drug Administration as a prophylaxis for venous thromboembolism in total knee and hip replacements. Based on phase II and III trials, rivaroxaban has been shown to be as efficacious, if not more, as traditional antithrombotic therapy with similar safety profiles. The Regulation of Coagulation in Major Orthopedic Surgery Reducing the Risk of Deep Vein Thrombosis and Pulmonary Embolism (RECORD) phase III trials have shown rivaroxaban 10 mg once daily to be superior to the low molecular weight heparin, enoxaparin, when used for prophylaxis of venous thromboembolism in orthopedic surgeries. Rivaroxaban has been shown to have tolerable adverse effects and a low potential for drug-drug or drug-food interactions. It has the major advantages of once daily oral dosing and no required laboratory monitoring, giving it the potential to replace current antithrombotics in the market today.
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Chen et al. (2009) studied this question.
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