Very low-dose edoxaban may prevent stroke in older patients with atrial fibrillation: JAMA
Japan: A once-daily 15-mg dose of edoxaban may prevent stroke or systemic embolism in older Japanese patients with atrial fibrillation (AF) at high risk of bleeding, according to results of a subanalysis of the ELDERCARE–AF trial. The study appears in the journal JAMA Cardiology.
Long-term use of oral anticoagulants (OACs) prevents stroke in AF patients. The effectiveness of OACs in extremely older patients (ie, aged 80 years or older) with AF and at high risk of bleeding is not validated. Considering this, Masaru Kuroda, Department of Cardiology, Akashi Medical Center, Hyogo, Japan, and colleagues aimed to examine the effects of very low-dose edoxaban (15 mg) vs placebo across 3 age strata (80-84 years, 85-89 years, and ≥90 years) among AF patients who were a part of the Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE–AF) trial.
The prespecified subanalysis of a phase 3, randomized, double-blind, placebo-controlled trial was performed from August 5, 2016, to December 27, 2019. The study included AF patients aged 80 years or older who were not considered candidates for standard-dose OACs. Reasons these patients could not take standard-dose OACs included low creatinine clearance (<30 mL per minute), history of bleeding from critical organs, low body weight (≤45 kg), continuous use of nonsteroidal anti-inflammatory drugs, or concomitant use of antiplatelet drugs.
The composite of stroke or systemic embolism was the primary efficacy end point. The primary safety end point was International Society on Thrombosis and Hemostasis–defined major bleeding.
A total of 984 patients (mean age: age group 80-84 years, 82.2 years; age group 85-89 years, 86.8 years; age group ≥90 years, 92.3 years; 565 women) were included in this study.
The study led to the following findings:
- In the placebo group, estimated event rates for stroke or systemic embolism increased with age and were 3.9% per patient-year in the group aged 80 to 84 years (n = 181), 7.3% (1.7%) per patient-year in the group aged 85 to 89 years (n = 184), and 10.1% (2.5%) per patient-year in the group aged 90 years or older (n = 127).
- A 15-mg dose of edoxaban consistently decreased the event rates for stroke or systemic embolism with no interaction with age (80-84 years, hazard ratio [HR], 0.41, HR, 0.42, HR, 0.23).
- Major bleeding and major or clinically relevant nonmajor bleeding events were numerically higher with edoxaban, but the differences did not reach statistical significance, and there was no interaction with age.
- There was no difference in the event rate for all-cause death between the edoxaban and placebo groups in all age strata.
"Our findings revealed that a once-daily 15-mg dose of edoxaban among Japanese patients aged 80 years or older with AF who were not considered candidates for standard OACs, was superior to placebo in preventing stroke or systemic embolism consistently across all 3 age strata, including those aged 90 years or older, albeit with a higher but nonstatistically significant incidence of bleeding," the authors wrote in their study.
Reference:
Kuroda M, Tamiya E, Nose T, 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. Published online April 13, 2022. doi:10.1001/jamacardio.2022.0480
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