Learning new practical tools for deciding which anti coagulation treatment to use in AF patients, in the Israeli Association of Family Physicians conference in Eilat.
N Engl
J Med
Edoxaban versus Warfarin for the Treatment
of Symptomatic Venous Thromboembolism
Author(s): The Hokusai-VTE Investigators
Treatments discussed: edoxaban, heparin,warfarin
Background Whether the oral factor Xa inhibitor edoxaban can
be an alternative to warfarin in patients with venous thromboembolism is
unclear. Methods In a randomized, double-blind, noninferiority study, we
randomly assigned patients with acute venous thromboembolism, who had
initially received heparin, to receive edoxaban at a dose of 60 mg once
daily, or 30 mg once daily (e.g., in the case of patients with creatinine
clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to
receive warfarin. Patients received the study drug for 3 to 12 months. The
primary efficacy outcome was recurrent symptomatic venous thromboembolism.
The principal safety outcome was major or clinically relevant nonmajor
bleeding. Results A total of 4921 patients presented with deep-vein
thrombosis, and 3319 with a pulmonary embolism. Among patients receiving
warfarin, the time in the therapeutic range was 63.5%.
Edoxaban was
noninferior to warfarin with respect to the primary efficacy outcome, which
occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in
the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval
[CI], 0.70 to 1.13; P<0.001 for noninferiority). The safety outcome
occurred in 349 patients (8.5%) in the edoxaban group and 423 patients
(10.3%) in the warfarin group (hazard ratio, 0.81; 95% CI, 0.71 to 0.94;
P=0.004 for superiority). The rates of other adverse events were similar in
the two groups. A total of 938 patients with pulmonary embolism had right
ventricular dysfunction, as assessed by measurement of N-terminal pro-brain
natriuretic peptide levels; the rate of recurrent venous thromboembolism in
this subgroup was 3.3% in the edoxaban group and 6.2% in the warfarin group
(hazard ratio, 0.52; 95% CI, 0.28 to 0.98).
Conclusions : Edoxaban
administered once daily after initial treatment with heparin was
noninferior to high-quality standard therapy and caused significantly less
bleeding in a broad spectrum of patients with venous thromboembolism,
including those with severe pulmonary embolism. (Funded by Daiichi-Sankyo;
Hokusai-VTE ClinicalTrials.gov number, NCT00986154 .).
PubMed abstract