Results of the pivotal studies: The Hokusai-VTE trial

The association of parenteral rapid-onset anticoagulants with oral anticoagulants has become the standard of treatment for venous thromboembolism. Vitamin K antagonists, the most widely used oral anticoagulants, should be administered for at least 3 months or, in some patients, indefinitely. Although this approach is highly effective, it suffers from well known practical limitations. In order to overcome these limitations, a number of studies have assessed the role of novel oral anticoagulant drugs also in this setting. These studies compared standard treatment of venous thromboembolism with the newer compounds that were either administered as a stand alone therapy from the first day or started after an initial course of parenteral therapy. Novel oral anticoagulant drugs have consistently been shown to be as effective as the standard of treatment, and were associated with significantly fewer bleeding events regardless of the study design. The Hokusai-VTE study, the last of these trials to be published, was a randomized controlled trial comparing in more than 8000 patients edoxaban with warfarin in a double blind fashion after an initial course of parenteral treatment with enoxaparin or unfractionated heparin, administered for at least 5 days. We hereby present and discuss the design, the study population, and the results of the Hokusai-VTE trial.