Data from Phase 3b ENSURE-AF Study Investigating Once-Daily LIXIANA® (edoxaban)in Patients with Atrial Fibrillation Undergoing Cardioversion Among 13 Daiichi Sankyo Clinical Presentations at ESC Congress 2016 - Seite 3

Presentations
Clinical Events After Ilaria
Cavallari, MD, Sunday, August 28,
Interruption of
Anticoagulation Brigham and Women's 2:57-1:15 PM CET

in Patients With Atrial Hospital, Boston,
Location: Raphael -
Fibrillation: A
Subgroup Analysis Massachusetts, United The Hub

From the ENGAGE AF-TIMI 48 Trial States of America


A Novel Risk Prediction Score in Christina Fanola, MD,
Sunday, August 28,
Atrial Fibrillation for a Net Boston
Medical Center, 1:32-1:50 PM CET
Clinical Outcome from
the ENGAGE Brookline, Boston, Location: Galileo -

AF-TIMI 48 Randomized Clinical Massachusetts, United
The Hub
Trial States of
America


About ENSURE-AF

(EdoxabaN vs. warfarin in subjectS UndeRgoing
cardiovErsion of Atrial Fibrillation)

ENSURE-AF is a Prospective, R
andomized, Open-Label, Blinded Endpoint evaluation (PROBE),
parallel-group phase 3b study evaluating the efficacy and safety of
once-daily edoxaban versus enoxaparin/warfarin in patients with NVAF
undergoing electrical cardioversion. The primary efficacy endpoint
was the composite of stroke, systemic embolism, myocardial
infarction, and cardiovascular mortality. The primary safety endpoint
was the composite of major and clinically-relevant non-major
bleeding. A total of 2,199 NVAF patients undergoing electrical
cardioversion were enrolled at 239 clinical sites across North
America and Europe. Patients were randomized to receive edoxaban 60
mg (or a reduced dose of edoxaban 30 mg for specific patients with
renal impairment or low body weight or P-glycoprotein inhibitor use)
or enoxaparin/warfarin for 28-49 days.[1]

About the ENGAGE AF-TIMI 48 Study

The ENGAGE AF-TIMI 48 global phase 3 study investigated once-daily
edoxaban in comparison to warfarin in 21,105 patients with NVAF at
moderate-to-high risk of thromboembolic events. This represented the
largest and longest trial with a NOAC in patients with AF performed
to date, with a median follow-up of 2.8 years. Edoxaban demonstrated
non-inferiority for stroke or systemic embolism in comparison to
warfarin. For the principal safety endpoint, edoxaban was found to
significantly reduce major bleeding compared to warfarin.[2]

About PREFER in AF

The initial PREFER in AF registry enrolled 7,243 AF patients
across 461 centres in Austria, France, Germany, Italy, Spain,
Switzerland and the UK. The aim of this registry is to provide
information on the characteristics and management of patients with AF
with focus on prevention of thromboembolic events, specifically
stroke, together with other important patient-focused considerations