October 30, 2019European Heart Journal - Cardiovascular Pharmacotherapy
Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial
Key result
The efficacy, safety, and net clinical outcomes of edoxaban versus warfarin in patients with atrial fibrillation were independent of the degree of comorbidity present (P-interaction > 0.10).
Why the study?
Little was known about the impact of non-cardiac comorbidities on the efficacy and safety profile of non-vitamin K antagonist oral anticoagulants in AF.
Does edoxaban improve net clinical outcomes compared to warfarin in patients with atrial fibrillation across different burdens of comorbidities?
Population
21 105 patients with AF
Comparison
Higher-dose edoxaban vs lower-dose edoxaban vs warfarin across Charlson Comorbidity Index categories
Design
Post hoc analysis of a randomized trial
Follow-up
Average of 2.8 years
Authors
Discussion
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Implication
Edoxaban's profile versus warfarin appears consistent across comorbidity burdens; supports broader applicability but leaves open dedicated validation in high-CCI patients.
Study Design
Type
RCT (n=21,105)
Randomization
randomized
Structured PICO
Does edoxaban improve net clinical outcomes compared to warfarin in patients with atrial fibrillation across different burdens of comorbidities?
P
Population
21,105 patients with atrial fibrillation followed for an average of 2.8 years to evaluate the impact of non-cardiac comorbidities on treatment outcomes.
I
Intervention
Edoxaban (higher-dose regimen or lower-dose regimen)
C
Comparator
Warfarin
O
Outcome
Primary net clinical outcome (composite of stroke/systemic embolism, major bleeding, or death)composite
Main Result
p-value: p=>0.10
The efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation are consistent regardless of the patient's burden of non-cardiac comorbidities.
Cite This Study
Nicolau et al. (2019) conducted an RCT in atrial fibrillation (n=21,105). Edoxaban vs. warfarin was evaluated on primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) (p=>0.10). The efficacy, safety, and net clinical outcomes of edoxaban versus warfarin in patients with atrial fibrillation were independent of the degree of comorbidity present (P-interaction > 0.10).