June 28, 2016European Journal of Heart Failure
Efficacy and Safety of Edoxaban Compared with Warfarin in Patients with Atrial Fibrillation and Heart Failure: Insights from ENGAGE AF-TIMI 48
Key result
Edoxaban showed similar efficacy to warfarin for preventing stroke or systemic embolic events across heart failure severity groups (Pinteraction=0.97) with consistently lower major bleeding.
Why the study?
Does edoxaban reduce stroke or systemic embolic events compared to warfarin in patients with atrial fibrillation across the spectrum of heart failure severity?
Population
14,071 patients with atrial fibrillation, including 5,926 with no history of heart failure, 6,344 in NYHA…
Comparison
Edoxaban higher-dose regimen vs Well-controlled warfarin
Design
RCT, Randomized
Authors
Discussion
Loading...
Member takes
Implication
Edoxaban can be used across HF severity in AF; confirms consistent efficacy and lower bleeding versus warfarin in this RCT.
Study Design
Type
RCT (n=14,071)
Randomization
randomized
Multicenter
Yes
Structured PICO
Does edoxaban reduce stroke or systemic embolic events compared to warfarin in patients with atrial fibrillation across the spectrum of heart failure severity?
P
Population
14,071 patients with atrial fibrillation, including 5,926 (42%) with no history of heart failure, 6,344 (45%) in NYHA class I-II, and 1,801 (13%) in NYHA class III-IV
I
Intervention
Edoxaban higher-dose regimen (60 mg dose-reduced to 30 mg once daily)
C
Comparator
Well-controlled warfarin
O
Outcome
Stroke or systemic embolic events (SEE)hard clinical
Main Result
p-value: Pinteraction = 0.97
Edoxaban maintains its efficacy and safety benefits over warfarin in patients with atrial fibrillation regardless of the presence or severity of concomitant heart failure.
Cite This Study
Magnani et al. (2016) conducted an RCT in Atrial fibrillation and heart failure (n=14,071). Edoxaban vs. Warfarin was evaluated on Stroke or systemic embolic events (SEE) (p=Pinteraction = 0.97). Edoxaban showed similar efficacy to warfarin for preventing stroke or systemic embolic events across heart failure severity groups (Pinteraction=0.97) with consistently lower major bleeding.