Daiichi Sankyo Initiates ENVISAGE-TAVI AF Study Investigating Once-Daily LIXIANA® (edoxaban) in Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Implantation - Seite 2

"ENVISAGE-TAVI AF will add to the growing body of evidence in the
Edoxaban Clinical Research Programme, providing unique insights into
the potential benefit of edoxaban in atrial fibrillation patients
undergoing TAVI procedures, a high-risk population," said Hans J.
Lanz, MD, Executive Director, Global Medical Affairs, Daiichi Sankyo.

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About ENVISAGE-TAVI AF

EdoxabaN Versus standard of care and theIr effectS on clinical
outcomes in pAtients havinG undergonE Transcatheter Aortic Valve
Implantation - in Atrial Fibrillation (ENVISAGE-TAVI AF) is a
prospective, randomised, open-label, blinded endpoint evaluation,
parallel-group phase 3b study, evaluating the efficacy and safety of
once-daily edoxaban against a regimen of a vitamin K antagonist, with
or without antiplatelet therapy, in AF patients following successful
transcatheter aortic valve implantation (TAVI). The primary efficacy
endpoint is incidence of net adverse clinical events (NACE), i.e.,
the composite of all-cause death, MI, ischemic stroke, SEE, valve
thrombosis, and major bleeding (International Society on Thrombosis
and Haemostasis [ISTH] definition). The primary safety endpoint is
major bleeding (ISTH definition). Approximately 1,400 patients will
be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across
Europe, the United States and Canada. Edoxaban will be used with the
approved dosage regimen for stroke prevention in AF in each
country.[1]

For more information, please visit:
https://clinicaltrials.gov/ct2/show/NCT02943785.

About Atrial Fibrillation

AF is a condition where the heart beats irregularly and rapidly.
When this happens, blood can pool and thicken in the chambers of the
heart causing an increased risk of blood clots. These blood clots can
break off and travel through the blood stream to the brain (or
sometimes to another part of the body), where they have the potential
to cause a stroke.[6]

AF is the most common type of heart rhythm disorder, and is
associated with substantial morbidity and mortality.[7] An estimated
8.8 million Europeans suffered from AF in 2010, and this figure is
expected to at least double over the next 50 years.[8] Compared to
those without AF, people with the arrhythmia have a 3-5 times higher
risk of stroke.[9] One in five of all strokes are as a result of
AF.[5]

About Edoxaban

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten
A") inhibitor. Factor Xa is one of the key components responsible for