ELDERCARE-AF (subanalysis)
Trial question
What is the role of edoxaban in older adult patients with AF who were not considered candidates for standard-dose OACs?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 984
984 patients (565 female, 419 male).
Inclusion criteria: patients aged ≥ 80 years with AF who were not considered candidates for standard-dose OACs.
Key exclusion criteria: moderate to severe MS; mechanical heart valves.
Interventions
N=492 edoxaban (at a dose of 15 mg PO once daily).
N=492 placebo (matching placebo once daily).
Primary outcome
Stroke or systemic embolism in patients aged ≥ 90 years
2.4
10.1
10.1 % / p-y
7.6 % / p-y
5.0 % / p-y
2.5 % / p-y
0.0 % / p-y
Edoxaban
Placebo
Significant
decrease ▼
Significant decrease in stroke or systemic embolism in patients aged ≥ 90 years (2.4% / p-y vs. 10.1% / p-y; HR 0.23, 95% CI 0.08 to 0.68).
Secondary outcomes
Borderline significant decrease in stroke or systemic embolism in patients aged 85-89 years (2.8% / p-y vs. 7.3% / p-y; HR 0.42, 95% CI 0.17 to 0.99).
No significant difference in net clinical outcome in patients aged ≥ 90 years (19.6% / p-y vs. 22.1% / p-y; HR 0.88, 95% CI 0.54 to 1.42).
No significant difference in all-cause mortality in group aged 80-84 years (6.4% / p-y vs. 5% / p-y; HR 1.28, 95% CI 0.62 to 2.67).
Safety outcomes
No significant differences in major bleeding, major or clinically relevant nonmajor bleeding.
Significant difference in clinically relevant nonmajor bleeding in group aged 85-89 years (15.0% per patient-year vs. 7.4% per patient-year).
Conclusion
In patients aged ≥ 80 years with AF who were not considered candidates for standard-dose OACs, edoxaban was superior to placebo with respect to stroke or systemic embolism in patients aged ≥ 90 years.
Reference
Masaru Kuroda, Eiji Tamiya, Takahisa Nose et al. Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation: A Prespecified Subanalysis of the ELDERCARE-AF Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):583-590.
Open reference URL