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

LAVAL, QC, May 2, 2017 /CNW Telbec/ - Servier Canada Inc. announced today that the first patient has been enrolled into the EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation – Atrial Fibrillation (ENVISAGE-TAVI AF). The ENVISAGE-TAVI AF study 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).1 The study is being performed by Daiichi Sankyo. with whom Servier Canada has a strategic agreement to commercialize Lixiana® (edoxaban) in Canada. The primary efficacy endpoint is incidence of net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction, ischemic stroke, systemic thromboembolism, 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 Canada, the United States and Europe.1 For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02943785

"Aortic stenosis is a severe and progressing condition that is more and more frequently being treated by TAVI. Patients undergoing TAVI often have concomitant AF which requires chronic oral anticoagulation treatment. This study will provide insight on the efficacy and safety of edoxaban and vitamin K antagonists after successful TAVI in non-valvular AF patients" said Jeffrey Weitz, MD, Professor of Medicine and Biochemistry at McMaster University and Executive Director of the Thrombosis and Atherosclerosis Research Institute in Hamilton, Ontario.

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.2 AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality.3 AF affects approximately 350 000 people in the Canada.4 Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.5 One in five of all strokes are as a result of AF.6

About LIXIANA® ® (edoxaban)
Lixiana® is an oral once daily, direct factor Xa inhibitor. Factor Xa is one of the key components responsible for blood clotting. AF, a heart rhythm disorder causing irregular rapid contractions of the upper chambers of the heart can lead to the formation of a clot. Venous thromboembolism (VTE), another condition in which blood clots form in deep veins of the leg and break off and travel to the lungs. Edoxaban was discovered and developed by Daiichi Sankyo Co., Ltd. On June 27, 2016, Daiichi Sankyo entered into a strategic agreement for Servier Canada to commercialize Lixiana in Canada.

Lixiana® was  approved in Canada in November 2016 under the brand name Lixiana® for the prevention of stroke and systemic embolic events (SEE) in patients with AF in whom anticoagulation is appropriate and for treatment of VTE (DVT, PE) and the prevention of recurrent DVT and PE.7 In addition, edoxaban is marketed under the brand name Lixiana® in Japan, South Korea, Hong Kong, Taiwan, Thailand, Switzerland, the U.K., Germany, Ireland, the Netherlands, Italy, Spain, Belgium, Austria, Portugal, and other European countries and under the brand name Savaysa® in the United States.

About Servier
Servier Canada was established in 1978 in Laval, Quebec and employs over 320 people across Canada.  Servier Canada is currently marketing medicines in Cardiology, Hematology and Diabetes, and will soon market oncology products indicated as treatment options in hematological malignancies. More information is available at www.servier.ca  


References

1.

Clinicaltrials.gov. Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF). Available at: https://clinicaltrials.gov/ct2/show/NCT02943785 . [Last accessed: March 2017].

2.

National Heart, Lung and Blood Institute – What is Atrial Fibrillation. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html . [Last accessed: March 2017].

3.

Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238–43.

4.

http://www.heartandstroke.ca/heart/conditions/atrial-fibrillation . [Last accessed: April 2017].

5.

Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824.

6.

Camm A, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369–2429.

7.

Servier Canada Inc. LIXIANA (edoxaban) Product Monograph. Laval, Quebec.November 2, 2016. 

 

®: Registered trademark of Daiichi Sankyo Co., Ltd. Used under license.

 

SOURCE Servier Canada Inc.

For further information: Servier CANADA Media Contact: Nadine Doucet, Servier Canada Inc., (450) 978-9700 Ext: 4225, nadine.doucet@servier.com

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