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 (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