6/28/23, 9:52 PM ELDERCARE-AF (subanalysis) Pathway Feedback Search Clinical Topics Home Studies ELDERCARE AF (subanalysis) ELDERCARE AF (subanalysis) Disease Atrial fibrillation 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 N = 984 43.0% male 984 patients (565 female, 419 male) Inclusion criteria: adult patients, aged 80 years, with AF who were not considered candidates for standard-dose OACs Key exclusion criteria: moderate to severe mitral stenosis; 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 10.1 % / p-y 10.1 7 6 % / p y https://web.pathway.md/studies/recg1rQ5QrcVkFHIx 1/2 6/28/23, 9:52 PM 7.6 % / p-y ELDERCARE-AF (subanalysis) Pathway 5.0 % / p-y 2.5 % / p-y 2.4 Significant decrease 0.0 % / p-y Edoxaban Placebo 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 death from all causes 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 adult 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 https://web.pathway.md/studies/recg1rQ5QrcVkFHIx 2/2