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A Comparison of Edoxaban and Warfarin for Symptomatic VTE

September 1, 2013

A Comparison of Edoxaban and Warfarin for Symptomatic VTE

  1. Frederick A. Masoudi, MD, MSPH, FACC, FAHA

In a noninferiority trial, edoxaban had similar efficacy, with lower rates of bleeding.

  1. Frederick A. Masoudi, MD, MSPH, FACC, FAHA

Although warfarin remains the standard therapy for venous thromboembolism (VTE), recent studies have identified other effective agents, including direct thrombin inhibitors (dabigatran) and factor Xa inhibitors (rivaroxaban and apixaban). This manufacturer-sponsored, double-blind, noninferiority trial assessed the efficacy and safety of another factor Xa inhibitor, edoxaban, for patients with symptomatic deep venous thrombosis, pulmonary embolism, or both.

A total of 8240 patients (mean age, 56; 57% men, 60% with deep venous thromboembolism only and 40% with pulmonary embolism) were randomized to receive either warfarin adjusted to an INR of 2.0 to 3.0 or edoxaban (60 mg orally once daily, or 30 mg daily for those with creatinine clearance of 30–50 mL/min) in addition to initial heparin therapy. Among the exclusion criteria were severely reduced renal function (creatinine clearance <30 mL/min) or the need for antiplatelet therapy. Therapy was continued for 3 to 12 months at the discretion of the treating physician. The time in therapeutic range in the warfarin group was 63.5%.

At 1 year, the primary efficacy endpoint of adjudicated recurrent VTE occurred in 3.2% of patients receiving edoxaban and 3.5% of those receiving warfarin (hazard ratio, 0.89; P for noninferiority, <0.001). This endpoint occurred significantly less often with edoxaban therapy in the subgroup of patients with pulmonary embolus and evidence of right ventricular dysfunction. The safety endpoint of major or clinically relevant non-major bleeding occurred significantly less often with edoxaban therapy than with warfarin (8.5% vs. 10.3% of patients; HR=0.81, P for superiority, 0.004), driven primarily by differences in non-major bleeding. Other adverse events were similar between the two therapies.

Comment

This study — which included patients with venous thromboembolic disease over a wide range of severity, and involved comparatively long-term follow up and a physician-driven length of therapy — found that, in conjunction with initial heparin therapy, the oral factor Xa inhibitor edoxaban is similar to warfarin in preventing recurrent thrombotic events, with lower rates of bleeding events. However, edoxaban is not yet FDA approved, and its cost compared with warfarin or rivaroxaban remains to be seen.

  • Disclosures for Frederick A. Masoudi, MD, MSPH, FACC, FAHA at time of publication Royalties Darling, Milligan, Smith & Lesch Grant / research support Agency for Healthcare Research and Quality; American College of Cardiology; Patient-Centered Outcomes Research Institute Editorial boards Circulation: Cardiovascular Quality and Outcomes Leadership positions in professional societies American College of Cardiology (Senior Medical Officer, National Cardiovascular Data Registries); American Heart Association (Vice Chair, Council on Quality of Care and Outcomes Research)

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Yuri Shubik, prof. Physician, Cardiology

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