Arrhythmias & electrophysiology
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
Authors' conclusion
In this post hoc analysis of the ENGAGE AF-TIMI 48 randomized clinical trial, in patients 80 years and older with atrial fibrillation, major bleeding events were lower in patients randomized to receive edoxaban, 30 mg per day, compared with either edoxaban, 60 mg per day (in patients without dose-reduction criteria), or warfarin (irrespective of dose-reduction status), without an offsetting increase in ischemic events.
Study context
- Population
- Patients ≥80 years with AF
- Participants
- 2,966 patients
- Comparison
- Edoxaban 60 mg vs 30 mg; edoxaban 30 mg vs warfarin
- Primary endpoint
- Net clinical outcome of death, stroke or systemic embolism, and major bleeding, and each component
Methodological detailspost hoc, double-blind, parallel-design, global
- Post hoc
- Double-blind
- Parallel-design
- Global
Primary result
As reported in the abstract
Hazard ratio (95% CI)P value
Edoxaban 30 mg vs Warfarinprimary net clinical outcome; n = 2406 with or without dose-reduction criteria
0.78(0.68–0.91)
P = 0.001Edoxaban 30 mg vs Warfarinmajor bleeding
0.59(0.45–0.77)
P < 0.001Edoxaban 30 mg vs Warfarindeath
0.83(0.70–1.00)
P = 0.046Edoxaban 60 mg vs Edoxaban 30 mgmajor bleeding; n = 1138 without dose-reduction criteria
1.57(1.04–2.38)
P = 0.03Further findings
Endogenous factor Xa inhibition
- Comparable between younger patients on edoxaban 60 mg and older patients on edoxaban 30 mg
Safety
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| GI hemorrhage (no dose-reduction criteria)Edoxaban 60 mg vs Edoxaban 30 mg | 2.24 (1.29–3.90) | P = 0.004 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
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. Published 1 September 2024. doi:10.
Summarised from the published abstract; every number is checked against it