ENSURE-AF

EFFICACY AND SAFETY IN NVAF PATIENTS UNDERGOING CARDIOVERSION IN ENSURE-AF TRIAL

Once-daily LIXIANA^® (edoxaban) was numerically lower in the primary efficacy endpoint^b vs. well-managed enoxaparin-warfarin in NVAF patients undergoing cardioversion, irrespective of a TEE^a-guided strategy.¹

PRIMARY ENDPOINT IN THE INTENTION-TO-TREAT POPULATION FOR THE OVERALL STUDY PERIOD

a Transoesophageal echocardiography.
b Composite endpoint of stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality.¹
c Cardioversion procedure was scheduled as early as two hours following the start of treatment when applying a TEE-guided approach.¹
d Includes patients taking LIXIANA^® 60 mg and those dose-reduced to 30 mg.
e Mean time-in-therapeutic range (TTR): 70.8% in total ENSURE-AF.¹
f Odds ratio.
g Confidence interval.

Once-daily LIXIANA^® was numerically similar and non-significant statistically in the primary safety endpoint^a vs. well-managed enoxaparin-warfarin in NVAF patients undergoing cardioversion.¹

SAFETY OUTCOMES AS ADJUDICATED BLEEDING EVENTS (SAFETY POPULATION, ON-TREATMENT PERIOD)

a Composite endpoint of major and clinically relevant non-major (CRNM) bleeding.¹
b Includes patients taking LIXIANA^® 60 mg and those dose-reduced to 30 mg.
c Mean time-in-therapeutic range (TTR): 70.8 % in total ENSURE-AF.¹
d Cardioversion procedure was scheduled as early as two hours following the start of treatment when applying a TEE-guided approach.¹

References:

Goette A, et al. Lancet. 2016; 388(10055): 1995–2003.

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