November 14, 2018European Heart Journal
Clinical outcomes, edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial
Why the study?
Prior studies suggested that the risks of ischaemic stroke and bleeding in patients of Asian race with AF may be higher than that of non-Asians.
Does higher dose edoxaban reduce ischemic stroke and bleeding compared to warfarin in Asian versus non-Asian patients with atrial fibrillation?
Population
2909 Asian and 18 195 non-Asian AF patients in the ENGAGE AF-TIMI 48 trial
Comparison
Edoxaban vs warfarin across Asian vs non-Asian race
Design
Post-hoc/subgroup analysis of a randomized controlled trial
Authors
Discussion
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Implication
May favor edoxaban over warfarin to lower ICH in Asian AF patients; leaves open race-specific dosing needs in prospective trials.
Key Points
- This analysis aims to compare clinical outcomes, edoxaban concentration, and anti-factor Xa activity between Asian and non-Asian patients with atrial fibrillation.
- Analyzed data from the ENGAGE AF-TIMI 48 trial with 2909 Asian and 18195 non-Asian patients.
- Compared risks of thromboembolism and bleeding events between races treated with warfarin.
- Measured trough edoxaban concentration and anti-FXa activity.
- Adjusted risk of ischaemic stroke was similar between Asian and non-Asian patients (aHR=1.12, P=0.56).
- Asians had a higher risk of intracranial haemorrhage (ICH: aHR 1.71, P=0.03).
- Trough edoxaban concentration and anti-FXa activity were 20-25% lower in Asians; higher-dose edoxaban reduced ICH while maintaining stroke prevention efficacy.
Structured PICO
Does higher dose edoxaban reduce ischemic stroke and bleeding compared to warfarin in Asian versus non-Asian patients with atrial fibrillation?
P
Population
21,104 patients with atrial fibrillation (2,909 Asian and 18,195 non-Asian) from the ENGAGE AF-TIMI 48 trial
I
Intervention
Higher dose edoxaban
C
Comparator
Warfarin
O
Outcome
Ischaemic stroke and bleeding events (including intracranial haemorrhage)hard clinical
Higher dose edoxaban provides a favorable safety profile with reduced intracranial hemorrhage risk compared to warfarin in Asian patients with atrial fibrillation, potentially due to lower achieved trough concentrations and anti-FXa activity.
Cite This Study
Chao et al. (2018) studied this question.