Edoxaban for the treatment of pediatric venous thromboembolism: phase 3 randomized controlled trial

Mihir Bhatt, M.D., M.Sc.
McMaster Children's Hospital, McMaster University
Hamilton, ON, Canada

Standard treatments for pediatric venous thromboembolism (VTE) include low-molecular-weight heparins and vitamin K antagonists, but data on direct oral anticoagulants (DOACs) remain limited. In this presentation, Mihir Bhatt shares results from a phase 3 randomized trial evaluating edoxaban in children with VTE. The study enrolled 286 participants and assessed noninferiority of edoxaban compared to standard of care (SOC) with respect to a composite efficacy outcome. While the predefined noninferiority margin was not statistically met, the efficacy and safety profiles of edoxaban were numerically comparable to SOC.