In a new study conducted by Shintaro Akashi and colleagues, it was found that older individuals with atrial fibrillation (AF) who took low-dose edoxaban (15 mg) had a lower risk of stroke or systemic embolism than those who took a placebo. The findings of this study were published in the Journal of American Medical Association.
Atrial fibrillation is more prevalent in elderly and debilitated people and rises with age. Data on the effectiveness of oral anticoagulants (OACs) in extremely old individuals with AF who are ineligible for traditional anticoagulant therapy, however, are scarce. In order to evaluate extremely low dosage edoxaban (15 mg daily) with placebo across frailty status, including each of the 5 frailty assessment criteria, among AF patients participating in the ELDERCARE-AF trial, this study was carried out.
This is a cohort analysis using data from ELDERCARE-AF, a double-blind, multicenter, randomized, placebo-controlled phase 3 investigation of Japanese patients with AF 80 years of age or older who were ineligible for OACs at dosages allowed for stroke prevention due to their significant bleeding risks. Edoxaban or a placebo was randomly given to eligible patients (1:1). The last patient was followed up on December 27, 2019, and the study ran from August 5, 2016, to November 5, 2019. The period of data analysis lasted from February 2021 to February 2022. Major bleeding served as the key safety endpoint while the composite of stroke or systemic embolism served as the primary effectiveness endpoint.
The key highlights of this study were:
1. 984 patients in all were randomly assigned to receive therapy, and 944 of those patients were counted in the study.
2. The estimated incident rates (SE) for stroke or systemic embolism in the placebo group were 7.1% (1.6%) for the frail group and 6.1% (1.3%) for the non-frail group per patient-year.
3. Edoxaban had no interactions with frailty status or frailty assessment parameters but was linked to decreased stroke or systemic embolism event rates.
4. There was no heterogeneity with regard to frailty status, but major bleeding and major or clinically significant nonmajor bleeding episodes were numerically greater in the edoxaban group than in the placebo group.
5. There was no relationship between the frailty state of the participants in the edoxaban and placebo groups, despite the fact that both all-cause death and net clinical composite result happened more frequently in the frail group than in the nonfrail group.
In conclusion, regardless of frailty status, once-daily 15-mg edoxaban was linked to a lower incidence of stroke or systemic embolism among Japanese patients with AF 80 years of age or older who were ineligible for regular OACs and may be a feasible therapy choice for these individuals.
Reference:
Akashi, S., Oguri, M., Ikeno, E., Manita, M., Taura, J., Watanabe, S., Hayashi, T., Akao, M., Okumura, K., Akishita, M., & Yamashita, T. (2022). Outcomes and Safety of Very-Low-Dose Edoxaban in Frail Patients With Atrial Fibrillation in the ELDERCARE-AF Randomized Clinical Trial. In JAMA Network Open (Vol. 5, Issue 8, p. e2228500). https://doi.org/10.1001/jamanetworkopen.2022.28500
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