Low-dose edoxaban prevents thrombotic events without major bleeding risk in very elderly
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In adults aged 80 years and older with atrial fibrillation, once-daily, low-dose edoxaban was superior to placebo for preventing stroke or systemic embolism and did not significantly increase major bleeding in the ELDERCARE-AF trial.
The annualized rate of stroke or systemic embolism, the primary efficacy endpoint, was 2.3% in patients assigned edoxaban (Savaysa, Daiichi Sankyo) 15 mg once daily vs. 6.7% in patients assigned placebo (HR = 0.34; 95% CI, 0.19-0.61; P < .001), according to data presented at the virtual European Society of Cardiology Congress.
The annualized rate of ISTH-defined major bleeding, the primary safety endpoint, was 3.3% in patients assigned edoxaban vs. 1.8% in patients assigned placebo, but not significantly different (HR = 1.87; 95% CI, 0.9-3.89; P = .09). Six of the major bleeding events were intracranial hemorrhages (two in the edoxaban group, four events in placebo group). However, risk for gastrointestinal bleeding was higher in the group assigned edoxaban (annualized rate, 2.3% in edoxaban group vs. 0.8% in placebo group; HR = 2.85; 95% CI, 1.03-7.88).
The researchers reported no difference in death from any cause (9.9% with edoxaban vs. 10.2% with placebo; HR = 0.97; 95% CI, 0.69-1.36).
“Edoxaban 15 mg may be an acceptable treatment option for stroke prevention in this high-risk population,” Ken Okumura, MD, PhD, of the division of cardiology at Saiseikai Kumamoto Hospital in Kumamoto, Japan, said during a presentation.
The randomized, placebo-controlled, event-driven ELDERCARE-AF trial enrolled 984 patients in Japan. The mean age was 86 years, 42% were men, mean CHADS2 score was 3.1, mean CHA2DS2-VASc score was 4.9 and mean HAS-BLED score was 2.3. Those enrolled were deemed ineligible for standard oral anticoagulation.
A study in this very elderly population is important because AF is challenging in this population due to concerns about bleeding, according to the researchers.
“Clinical guidelines recommend the use of direct oral anticoagulants for the prevention of stroke in patients with nonvalvular atrial fibrillation, including in elderly patients,” Okumura and colleagues wrote in NEJM. “The mean or median age of the patients enrolled in previous landmark clinical trials of direct oral anticoagulants was 70 to 73 years, which is 5 to 10 years younger than the average age in the general population with atrial fibrillation. Therefore, the findings in these major trials cannot be easily generalized to older patients, especially those who are 80 years of age or older.”
The trial was conducted in a Japanese population, so the researchers noted that the results may not be applicable in other populations.
Reference:
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Okumura K, et al. Late Breaking Clinical Science. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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