L'etude clinique du mois. Hokusai-VTE: edoxaban versus warfarine dans le traitement de la maladie thromboembolique veineuse symptomatique.

Currently venous thromboembolic disease (VTE), i.e. deep venous thrombosis and pulmonary embolism, remains a major cause of morbidity and mortality all around the world. The Hokusai-VTE study is a randomized, double-blind trial to evaluate whether initial heparin (5 days) followed by the oral Xa factor inhibitor edoxaban (60 mg once daily) may be an alternative to the standard therapy, i.e. heparin (5 days) followed by warfarin (INR of 2.0-3.0) for the prevention of recurrent thromboembolism in patients with acute symptomatic VTE. In patients with VTE, including pulmonary embolism with right ventricular dysfunction, treatment with heparin followed by oral edoxaban 60 mg once daily was non inferior to the standard treatment with respect to efficacy and superior with respect to bleeding (fewer fatal and intracranial bleeds, but no statistical significance regarding major bleeding). Reducing the dosage of edoxaban to 30 mg once daily is safe in case of renal impairment and low body weight.