Daiichi Sankyo Initiates ENVISAGE-TAVI AF Study Investigating Once-Daily LIXIANA® (edoxaban) in Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Implantation

Munich (ots/PRNewswire) -

- 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
- Study adds to the growing Edoxaban Clinical Research Programme
(ECRP) evaluating its use in a broad range of cardiovascular
conditions, patient types and clinical settings

Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") today
announced that the first patient has been enrolled into the
ENVISAGE-TAVI AF study. The multinational, randomised phase 3b study
will evaluate a treatment regimen based on the company's oral,
once-daily direct factor Xa-inhibitor edoxaban (known by the brand
name LIXIANA® outside the US and SAVAYSA® in the US) against a
vitamin K antagonist based regimen, with or without antiplatelet
therapy, in patients with atrial fibrillation (AF) following
successful transcatheter aortic valve implantation (TAVI). The study
will investigate the incidence of net adverse clinical events (NACE),
including the composite of all-cause death, myocardial infarction
(MI), ischaemic stroke, systemic thromboembolism (SEE), 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 United States and Canada.[1]

"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," said George Dangas, MD, PhD,
Professor of Medicine, Mount Sinai School of Medicine and
co-principal study investigator.

Transcatheter aortic valve implantation (TAVI) has become an
increasingly frequent procedure to treat aortic stenosis.[2] Aortic
stenosis is a progressing disease, and may turn into a life
threatening condition.[3] In patients undergoing a TAVI procedure, AF
is a frequent comorbidity which requires chronic oral anticoagulation
therapy.[4],[5]

"At present, ENVISAGE-TAVI AF is the only study of patients
undergoing TAVI designed to compare exclusively non-valvular AF
patients on a novel oral anticoagulant regimen against a VKA-based
regimen," said Nicolas M. van Mieghem, MD, PhD, Erasmus University of
Rotterdam and co-principal investigator.