ENGAGE AF-TIMI 48 (post-hoc analysis, edoxaban 60 mg vs. 30 mg)
Trial question
What is the role of edoxaban in elderly patients with AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 1138
1138 patients (411 female, 727 male)
Inclusion criteria: elderly patients aged ≥ 80 years with AF who were receiving edoxaban without dose-reduction criteria
Key exclusion criteria: estimated CrCl < 30 mL/min; moderate or severe MS; mechanical heart valve; high risk of bleeding; use of dual antiplatelet therapy; AF due to a reversible disorder
Interventions
N=560 high-dose edoxaban (at a dose of 60 mg daily)
N=578 low-dose edoxaban (at a dose of 30 mg daily)
Primary outcome
Stroke or systemic embolism
1.93
2.26
2.3 %
1.7 %
1.1 %
0.6 %
0.0 %
High-dose
edoxaban
Low-dose
edoxaban
No significant
difference ↔
No significant difference in stroke or systemic embolism (1.93% vs. 2.26%; HR 0.83, 95% CI 0.5 to 1.36)
Secondary outcomes
No significant difference in death, stroke, systemic embolism, and major bleeding (10.65% vs. 9.47%; HR 1.11, 95% CI 0.88 to 1.4)
No significant difference in death from all causes (5.35% vs. 5.37%; HR 0.98, 95% CI 0.72 to 1.34)
No significant difference in ischemic stroke (1.51% vs. 1.72%; HR 0.84, 95% CI 0.48 to 1.49)
Safety outcomes
Significant differences in major bleeding (4.84% vs. 3.08%), major gastrointestinal bleeding (3.28% vs. 1.49%).
Conclusion
In elderly patients aged ≥ 80 years with AF who were receiving edoxaban without dose-reduction criteria, high-dose edoxaban was not superior to low-dose edoxaban with respect to stroke or systemic embolism.
Reference
André Zimerman, Eugene Braunwald, Jan Steffel et al. Dose Reduction of Edoxaban in Patients 80 Years and Older With Atrial Fibrillation: Post Hoc Analysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2024 Jul 10:e241793. Online ahead of print.
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