ETNA-VTE is a non-interventional study on Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism (including deep vein thrombosis [DVT] and pulmonary embolism [PE]). It aimed to enrol a total of 4,500 venous thromboembolism (VTE) patients from sites across Europe, Japan, and East and Southeast Asia.1
The primary objective is the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE.1 The co-primary objective is to collect rates of real-world safety data on bleeding events, drug-related adverse events and mortality in VTE patients treated with edoxaban.1
About Venous Thromboembolism
VTE is an umbrella term for two conditions, DVT and PE.2 DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well. PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.2 The annual incidence of VTE in developed countries is estimated to be 1-3 per 1,000 adults.3,4 A prior incidence of a VTE is the most significant risk factor of a second occurrence.5
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 by Daiichi Sankyo and its partners in more than 30 countries and regions around the world.
More than 10 studies, more than 100,000 patients worldwide
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in AF and VTE designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000 patients worldwide are expected to participate in EDOSURE, which is comprised of more than 10 RCTs (randomised, controlled trials), registries and non-randomised clinical studies, including completed, ongoing and future research. Our goal is to generate new edoxaban clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.
The RCTs include:
- ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), in AF patients at moderate-to-high risk of thromboembolic events
- Hokusai VTE (Edoxaban in Venous Thromboembolism), in patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both
- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), in AF patients undergoing electrical cardioversion
- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in AF patients undergoing percutaneous coronary intervention
- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer), in patients with cancer and an acute VTE event
- ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan
- ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation)
- ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) – Atrial Fibrillation)
- STABLED Study (STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation) in Japan
- ENRICH-AF (EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation, an investigator initiated phase III study)
In addition, global and regional registry and non-randomised clinical studies provide important real-world and clinical data about the use of edoxaban and other oral anticoagulants in everyday practice; these include:
- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation)
- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism)
- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE)
- Prolongation PREFER in AF (PREvention oF thromboembolic events – European Registry) in patients with AF
- ANAFIE (All Nippon AF In Elderly) Registry in Japan
- Cancer-VTE Registry in Japan
- RYOUMA (Real world ablation therapY with anti-cOagUlants in Management of Atrial fibrillation) Registry in Japan
- KYU-RABLE (Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation) in Japan
- BPV-AF (Atrial Fibrillation with BioProsthetic valve) Registry in Japan
Through EDOSURE, we are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
1 De Caterina, R. et al. The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design. Clin Cardiol. 2019;42(12):1147-1154.
2 National Heart, Lunch, and Blood Institute. Venous Thromboembolism. Available: https://www.nhlbi.nih.gov/health-topics/venous-thromboembolism. Last accessed June 2020.
3 The Coalition to Prevent VTE. Available here
4 Braekkan, S. K. et al. Body height and risk of venous thromboembolism: The Tromsø Study. Am J Epidemiol. 2010;171:1109–15.
5 Zagaria, M. Venous Thrombosis: Pathogenesis and Potential for Embolism. US Pharm. 2009;34:22-24.