Patients with atrial fibrillation are at high risk of bleeding. How to prevent stroke?

For medical professionals to read and refer to clinical information only, long-term oral anticoagulants (OACs) are necessary measures to prevent stroke in patients with atrial fibrillation (AF)
.

But is very low-dose edoxaban (15 mg daily) safe and effective for stroke prevention in patients 80 to 90 years of age who are ineligible for standard-dose oral anticoagulants because of high bleeding risk? A study from JAMA Cardiology examined very low-dose edoxaban (15 mg) versus placebo in 3 age groups (80 to 84 years, 85 to 89 years old) and ≥90 years of age) in patients with atrial fibrillation
.

How is this research done? The study, conducted from August 5, 2016 to December 27, 2019, randomly recruited 984 patients with atrial fibrillation aged 80 years and older who were not considered candidates for standard-dose OACs from 164 hospitals in Japan.
Patients [Mean (SD) age: 80-84 year old age group, 82.
2 (1.
4) years old; 85-89 year old age group, 86.
8 (1.
4) years old; ≥90 year old age group, 92.
3 (2.
1) years old; 565 women (57.
4%)], randomized 1:1 to edoxaban or placebo
.

The main reasons why such patients cannot take standard doses of OACs are: low creatinine clearance (<30mL/min), low body weight (≤45kg), history of bleeding in vital organs, continuous use of non-steroidal anti-inflammatory drugs or concomitant use of antiplatelet drugs drug
.

The primary efficacy endpoint was a composite of stroke or systemic embolism
.

The primary safety endpoint was major bleeding as defined by the International Society of Thrombosis and Hemostasis
.

MAIN STUDY CONCLUSIONS The estimated (SE) event rate for stroke or systemic embolism increased with age in the placebo group; in the 80-84 year group (n=181), it was 3.
9% per patient per year ( 1.
2%); in the 85-89 age group (n=184), 7.
3% (1.
7%) per patient-year; in the ≥90-year-old age group (n=127), 10.
1% (2.
5%) per patient-year %)
.

The results of the edoxaban group showed that the incidence of stroke or systemic embolism continued to be reduced after treatment with no interaction with age (80-84 years, HR, 0.
41; 95% CI, 0.
13-1.
31; P=0.
13; 85-89 years, HR, 0.
42; 95%CI, 0.
17-0.
99; P=0.
05; ≥90 years, HR, 0.
23; 95%CI, 0.
08-0.
68; P=0.
008; P=0.
65 for interaction)
.

The number of major bleeding and major clinically relevant, non-major bleeding events was higher with edoxaban, but the difference did not reach statistical significance and there was no interaction with age
.

Across all age groups, there was no difference in all-cause mortality between the edoxaban and placebo groups
.

In conclusion, in Japanese AF patients 80 years and older who are not considered candidates for standard OACs, edoxaban 15 mg once daily was effective in all 3 age groups (including 90 years and older), It was consistently shown to be superior to placebo in preventing stroke or systemic embolism
.

Although the incidence of edoxaban-related bleeding was higher, it was not statistically significant
.

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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 Apr 13.
doi:10.
1001/jamacardio.
2022.
0480.
Epub ahead of print.
PMID:35416910.