Data from the Non-interventional EMIT-AF/VTE Study Shows Low Thromboembolic and Bleeding Event Rates in Unselected Elderly AF/VTE Patients on Oral, Once-daily LIXIANA®▼ Undergoing Diagnostic or Therapeutic Procedures

MUNICH, March 19, 2019 /PRNewswire/ --

• In 2019, the Edoxaban Clinical Research Programme will deliver new evidence on LIXIANA^®▼ (edoxaban) use in clinical practice. EMIT-AF/VTE is one of the first sets of data to be presented
• EMIT-AF/VTE is a large observational, multicentre, multinational study on edoxaban peri-procedural management and outcomes
• It is the first large prospective, non-interventional study to apply the European Heart Rhythm Association (EHRA) bleeding risk classification in edoxaban routine clinical practice¹
• In EMIT-AF/VTE, peri-procedure use of oral, once-daily edoxaban was associated with low incidence of bleeding and thromboembolic events, in elderly European Atrial Fibrillation (AF) and Venous Thromboembolism (VTE) patients

Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") announced today the results from EMIT-AF/VTE, a prospective, non-interventional study of oral, once-daily edoxaban (known by the brand name LIXIANA^®▼) in the peri-procedural management of AF, and VTE patients undergoing diagnostic and therapeutic procedures. The data from 1,155 patients across seven European countries showed that peri-procedural edoxaban management in routine clinical practice was associated with low bleeding incidence, even in procedures at high bleeding-risk as classified by EHRA, and with low rates of thromboembolic/ischemic complications.² The data were presented today during a late-breaker session at EHRA 2019, the annual congress of the European Heart Rhythm Association, in Lisbon, Portugal.

EMIT-AF/VTE is the first large observational, multicentre, multinational study on peri-procedural management and outcomes of edoxaban. It is the first large, single NOAC-prospective, non-interventional study to apply the EHRA peri-procedural bleeding risk classification, which was introduced in April 2018,¹ in a routine clinical practice setting.

Patients enrolled onto EMIT-AF/VTE were 62% male, elderly (mean age = 71.9 ± 10.4 years, 45% ≥ 75 years of age) and had multiple co-morbidities.² Of the participants, 294 (26%) had minor EHRA bleeding risk, 581 (50%) had low-risk, and 280 (24%) had high-risk. Additionally, 30% (345/1,155) of patients continued edoxaban treatment without any interruption during the peri-procedural period, whereas 73% (847/1,155) of patients were on edoxaban on the day after procedure with no post-procedural interruption.²

The primary safety outcome of major bleeding (MB), as defined by the International Society of Thrombosis and Haemostasis (ISTH), from five days before to 30 days after a procedure, occurred in 0.4% (5 of 1,155) of patients. Bleeding incidence was low, even in the 280 EHRA-classified high-risk procedures: with 0.7% (2 of 280) major bleedings and 1.4% (4 of 280) clinically relevant non-major bleedings (CRNMB).²

Commenting on the data, Paolo Colonna, MD, Professor of Cardiology at University Hospital and Policlinico of Bari, Italy, said, "Until now, there has been limited data available on the peri-procedural management of patients prescribed a NOAC, such as edoxaban, and the associated clinical outcomes. The low rates of bleeding and thromboembolic/ischemic complications associated with edoxaban in the EMIT-AF/VTE study provides insights of edoxaban use in unselected patients undergoing diagnostic or therapeutic procedures."

The secondary objective was to document the incidence of the composite of acute coronary syndrome (ACS), non-hemorrhagic stroke, transient ischemic attack (TIA), systemic embolism (SEE), deep vein thrombosis (DVT), pulmonary embolism (PE) and cardiovascular (CV) death.³ Thrombotic/ischemic events occurred in 0.6% (7 of 1,155) of patients.²

"The EMIT-AF/VTE study is part of the Edoxaban Clinical Research Programme that, in 2019, will deliver significant evidence to support the use of edoxaban in clinical practice, particularly for elderly patients. The results of this study further support Daiichi Sankyo Europe's long-term commitment to cardiovascular care", said Wolfgang Zierhut, MD, Executive Director Medical Affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe.

EMIT-AF/VTE is one of several studies included within the programme. More than 100,000 patients worldwide are expected to participate in studies, the goal of which is to generate new clinical and real-world data regarding the use of edoxaban in AF and VTE populations, thus, providing physicians and patients worldwide with greater treatment assurance.

About EMIT-AF/VTE
The observational study, conducted across seven European countries, includes data from 1,155 first diagnostic/therapeutic procedures in unselected edoxaban patients with AF and VTE. EMIT-AF/VTE is a multinational, multicentre, prospective observational, non-interventional study.⁴ The primary safety outcome was the incidence of major bleeding from five days before to 30 days post-procedure. Secondary objectives include efficacy outcomes as a composite of major cardiovascular events and collecting details on the types of diagnostic or therapeutic procedures.² 

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.⁵

AF is the most common type of heart rhythm disorder and is associated with substantial morbidity and mortality.⁶ More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.^7,8 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.⁷

About Venous Thromboembolism 
VTE is an umbrella term for two conditions, DVT and PE. 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.¹⁰ PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.¹¹

VTE is a major cause of morbidity and mortality.¹² There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial VTE event have recurrent VTE within three months.¹³ 

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 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 20 countries around the world.

About Edoxaban Clinical Research Programme

More than 10 studies, more than 100,000 patients worldwide
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our 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 the edoxaban clinical research programme which is comprised of more than 10 RCTs (randomised, controlled trials), registries and non-interventional studies, including completed, ongoing and future research. The goal is to generate new 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 DVT, 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)

In addition, global and regional registry studies will provide important real-world data about the use of edoxaban and other oral anticoagulants in everyday practice, and 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

Through our Clinical Research Programme, 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.

For more information, please visit: https://www.daiichisankyo.com/rd/pipeline/products/ecrp/index.html

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com.

Forward-looking statements
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.

References

1. Steffel, J. et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-1393.

2. Colonna, P. et al. Periprocedural edoxaban management in routine clinical practice is associated with low bleeding risk: outcomes from the prospective multicentre, multinational EMIT-AF/VTE study. Abstract presented at EHRA 2019.

3. Clinicaltrials.gov. Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE). Available at https://clinicaltrials.gov/ct2/show/NCT02950168. Last accessed February 2019.

4. Colonna P, et al. Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE)—Trial design. Clin Cardiol. 2018; 41:1123-1129. https://doi.org/10.1002/clc.23037

5. 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 February 2019.

6. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238–243.

7. 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.

8. Krijthe BP, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013;34(35):2746-2751.

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

10. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) — Blood Clot Forming in a Vein. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/ncbddd/dvt/facts.html. Last accessed February 2019.

11. Van Beek E, et al. Deep vein thrombosis and pulmonary embolism. New York: John Wiley & Sons, 2009. Print.

12. Cohen A, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost. 2007;98(4):756-764.

13. Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(23 suppl 1):I-22-30.

March 2019 Job Code: EDX/19/0093

Contact details
Lydia Worms (Europe) 
Daiichi Sankyo Europe GmbH 
Edoxaban Communications & Product PR Europe
+49-(89)7808751

SOURCE Daiichi Sankyo Company, Limited