Daiichi Sankyo initiates ENVISAGE-TAVI AF study to investigate once-daily edoxaban in atrial fibrillation undergoing TAVI

George Dangas

The ENVISAGE-TAVI AF is the first study to evaluate the effects of a novel oral anticoagulant on clinical outcomes exclusively in atrial fibrillation patients following successful transcatheter aortic valve implantation (TAVI). A press release reports that the study edoxaban (Lixiana) adds to the growing Edoxaban Clinical Research Programme (ECRP) evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings.

The multinational, randomised phase 3b study will evaluate a treatment regimen based on the Daiichi Sankyo’s oral, once-daily direct factor Xa-inhibitor edoxaban against a vitamin K antagonist based regimen, with or without antiplatelet therapy, in patients with atrial fibrillation following successful TAVI. It will investigate the incidence of net adverse clinical events (NACE), including the composite of all-cause death, myocardial infarction, ischaemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition). Approximately 1,400 patients will be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across Europe, the USA and Canada.

George Dangas (Mount Sinai School of Medicine, New York, USA), co-principal study investigator, says: “ENVISAGE-TAVI AF is a very important study because it will provide the first clinical evidence comparing the safety and efficacy of an edoxaban-based versus a VKA-based regimen in non-valvular AF patients with indication for chronic oral anticoagulation after successful TAVI in a sufficiently powered study. In this study, edoxaban will be used with the approved dosage regimen for stroke prevention in atrial fibrillation.”