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 Therape

Munich (ots/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

ots Originaltext: Daiichi Sankyo Europe GmbH
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