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 - Seite 2

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