Daiichi Sankyo Company, Limited, announced that the first patient has been enrolled into the ENVISAGE-TAVI AF study. The multinational, randomized 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), ischemic 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.

“ENVISAGE-TAVI AF is an 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 regimenfor 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. 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.

“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.

“ENVISAGE-TAVI AF will add to the growing body of evidence in the Edoxaban Clinical Research Program, 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.

EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation –Atrial Fibrillation (ENVISAGE-TAVI AF) is a prospective, randomized, 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.

Edoxaban is an oral, once-daily, direct factor Xa (pronounced “Ten A”) inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed in Japan, the US, South Korea, Hong Kong, Taiwan, Thailand, Switzerland, the UK, Germany, Ireland, the Netherlands, Italy, Spain, Belgium, Austria, Portugal, and other European countries.