1. Patients with venous thromboembolism (VTE) treated with the oral factor Xa inhibitor apixaban experienced similar outcomes to patients treated with enoxaparin and warfarin.
2. Patients treated with apixaban experienced significantly fewer adverse bleeding events.
Evidence Rating Level: 1 (Excellent)
Study Rundown: This safety and efficacy study showed that in uncomplicated patients with VTE, apixaban appears to be a viable option for anticoagulation. Its oral availability and ease of dosing make it an attractive alternative to warfarin, as does its apparent lower risk of bleeding complication. However, the INR of the control group was within the therapeutic range only 61% of time, suggesting that tighter control of warfarin therapy may well produce just as impressive results. Additionally, apixaban is not reversible and requires a minimum of 24 hours to leave the system; therefore it would not be a viable option for patients who require anticoagulation but have risk factors for bleeds. Lastly, this study was funded by Pfizer and Bristol-Meyers Squibb and did not provide a cost-benefit analysis.
Relevant Reading: The AMPLIFY study
In-Depth [randomized controlled trial]: This study compared the efficacy and safety of abixaban with enoxaparin and warfarin for the treatment of venous thromboembolism. The authors enrolled 5395 patients with VTE (either DVT or PE) from 358 centers across multiple countries. 2691 patients were randomized to receive apixaban while 2704 were assigned to receive conventional therapy (enoxaparin and warfarin). The primary efficacy outcome was a composite of recurrent VTE or death from VTE. The primary safety outcome was a composite of major bleeding and clinically relevant nonmajor bleeding. 2.3% of patients receiving apixaban incurred the primary outcome, compared to 2.7% of patients receiving conventional therapy (relative risk 0.84, 95% CI 0.60 0 1.18). Additionally, 4.3% of patients in the apixaban group experienced clinical bleeds compared to 9.7% receiving conventional therapy.
By Akira Shishido, M.D. and Mitalee Patil
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