Key result
Low-dose edoxaban reduced stroke or systemic embolism compared to placebo in elderly AF patients across body weights (≤45 kg: HR 0.36; >45 kg: HR 0.31), though major bleeding was numerically higher.
Why the study?
Whether the benefits of low-dose edoxaban in elderly patients with nonvalvular AF ineligible for standard oral anticoagulants applied to those with extremely low body weight was unclear.
Does edoxaban 15 mg once daily reduce stroke or systemic embolism in very elderly patients with atrial fibrillation and extremely low body weight who are ineligible for standard oral anticoagulants?
RCT (n=984)
double-blind
randomized
Yes
Does edoxaban 15 mg once daily reduce stroke or systemic embolism in very elderly patients with atrial fibrillation and extremely low body weight who are ineligible for standard oral anticoagulants?
Effect estimate: HR 0.36 (≤45 kg); HR 0.31 (>45 kg) (95% CI 0.16-0.80 (≤45 kg); 0.13-0.73 (>45 kg))
p-value: p=interaction P=0.82
Low-dose edoxaban (15 mg daily) effectively reduces stroke and systemic embolism without a statistically significant interaction for major bleeding in very elderly AF patients with extremely low body weight (≤45 kg).
Low-dose edoxaban reduces stroke risk consistently in extremely low-weight elderly AF patients; extends ELDERCARE-AF to this high-bleeding-risk subgroup.
Background The ELDERCARE‐AF trial showed that low‐dose edoxaban benefits elderly patients with nonvalvular atrial fibrillation considered ineligible for standard oral anticoagulants due to high bleeding risk, but whether this applied to patients with extremely low body weight was unclear. Methods and Results This was a prespecified subanalysis by body weight (≤45, >45 kg) of the phase 3, multicenter, randomized, double‐blind, placebo‐controlled, event‐driven ELDERCARE‐AF trial, which compared low‐dose edoxaban (15 mg once daily) with placebo in Japanese patients considered ineligible for oral anticoagulants at the recommended therapeutic strength or the approved doses. The primary efficacy and safety end points were stroke or systemic embolism and major bleeding (International Society on Thrombosis and Hemostasis definition), respectively. The ≤45‐kg weight group included 374/984 patients (38.0%), and the >45‐kg group included 610/984 patients (62.0%). The stroke or systemic embolism rate was lower with edoxaban than placebo in both weight groups (≤45 kg: hazard ratio [HR], 0.36 [95% CI, 0.16–0.80]; >45 kg: HR, 0.31 [95% CI, 0.13–0.73]; interaction P =0.82). Major bleeding incidence was numerically higher with edoxaban than placebo (≤45 kg: HR, 3.05 [95% CI, 0.84–11.11]; >45 kg: HR, 1.40 [95% CI, 0.56–3.48), with no interaction with body weight (interaction P =0.33). All‐cause mortality was higher in the ≤45‐kg group, with no significant difference between treatment groups. Conclusions The benefit of edoxaban 15 mg was consistent in elderly patients with atrial fibrillation and extremely low body weight, though clinicians must remain vigilant about the risk of major bleeding, especially gastrointestinal bleeding. Registration Information ClinicalTrials.gov . Identifier: NCT02801669.
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Akao et al. (2024) conducted an RCT in nonvalvular atrial fibrillation (n=984). Low-dose edoxaban vs. Placebo was evaluated on stroke or systemic embolism (HR 0.36 (≤45 kg); HR 0.31 (>45 kg), 95% CI 0.16-0.80 (≤45 kg); 0.13-0.73 (>45 kg), p=interaction P=0.82). Low-dose edoxaban reduced stroke or systemic embolism compared to placebo in elderly AF patients across body weights (≤45 kg: HR 0.36; >45 kg: HR 0.31), though major bleeding was numerically higher.
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