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Rivaroxaban (Xarelto): Treatment of Venous Thromboembolic Events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) and Prevention of Recurrent DVT and PE [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Aug.

Cover of Rivaroxaban (Xarelto)

Rivaroxaban (Xarelto): Treatment of Venous Thromboembolic Events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) and Prevention of Recurrent DVT and PE [Internet].

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5CONCLUSIONS

The review included two open-label RCTs, EINSTEIN DVT and EINSTEIN PE. The two trials compared the anticoagulation effects of rivaroxaban and enoxaparin/VKA for the treatment and recurrence prevention of DVT and or PE. Overall survival in the two trials showed similar incidence of all-cause mortality between the two study treatments. The EINSTEIN DVT trial showed that rivaroxaban was non-inferior to enoxaparin and a VKA for the treatment of DVT in patients without symptomatic PE. However, although rivaroxaban was found to be non-inferior to enoxaparin/VKA in the treatment and prevention of recurrent VTE based on the pre-specified NIM for EINSTEIN PE, there is uncertainty around the NIM used. CDR re-evaluation of the margin suggests a tighter and more conservative one than that used in EINSTEIN PE. Rivaroxaban appeared similar to enoxaparin/VKA with respect to clinically relevant harms such as bleeding and SAEs. The incidence of AEs did not differ significantly between treatment groups in either trial.

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Bookshelf ID: NBK344335

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