In Brief | Neurology | Cardiovascular Disease
NOAH AFNET 6 trial shows no significant reduction in second stroke risk in patients treated with anticoagulant edoxaban
Time to read: 01: 50
Time to listen: 03: 57
Originally Published: 17 May 2024
Sourced: European Heart Journal
Type of article: In Brief
MedED Catalogue Reference: MGIB007
Category: Gerontology & Healthy Ageing
Cross Reference: Cardiovascular, Neurology
Keywords: Stroke, CVS, cognitive impairment
Apixaban significantly reduced stroke and embolism in the ARTESiA trial, but stroke reduction in NOAH-AFNET 6 was marginal, highlighting the need for improved stroke risk markers in low AF burden patients.
Originally published in European Heart Journal, 7 March 2024 .This summary does not represent the original research, nor is it intended to replace the original research. Access the full Disclaimer Information
A sub-analysis of the NOAH-AFNET 6 trial has shown that patients who were treated with oral anticoagulation edoxaban showed no significant reduction in the risk of a second stroke. At the same time, the study showed that the treatment may quadruple the risk of major bleeding when compared to patients who receive no anticoagulation therapy.
The results of the study were presented at the Heart Rhythm Society (HRS) 2024 annual meeting, held in Boston, Massachusetts, earlier this year (May 2024).
The sub-analysis involved 253 patients from the larger NOAH-AFNET 6 trial population, which included 2536 patients.
Patients had a history of stroke or transient ischemic attack and device-detected atrial fibrillation and were randomized into either the edoxaban or no anticoagulation group. Of note, 53.9% of the no-anticoagulation group were taking aspirin at trial enrolment.
The following was reported:
- The primary composite outcome of stroke, systemic embolism, and cardiovascular death was similar between the edoxaban and no-anticoagulation group: 5.7% per patient-year for fourteen of the 122 patients treated with edoxaban versus 6.3% per patient-year for sixteen of the 131 patients with no-anticoagulation.
- Recurrent stroke rates were also comparable between the two groups (four of 122 patients [3.3%] vs. six of 131 patients [4.6%]; 1.6% vs. 2.3% per patient-year), with edoxaban showing no significant impact on stroke rates or other cardiovascular outcomes.
- Major bleeding rates were significantly higher in the edoxaban group, with eight out of ten major bleeds occurring in patients randomized to edoxaban
The conference also presented a comparative analysis of the ARTESiA trial, which evaluated apixaban versus aspirin in patients with subclinical AF. Patients in the ARTESiA trial were all on aspirin prior to being randomised into the no-anticoagulation group, in comparison with NOAH-AFNET 6, in which approximately half were on aspirin at the time of randomisation.
While patients in the ARTESiA trial showed a significant reduction in stroke and systemic embolism with apixaban, the stroke reduction in NOAH-AFNET 6 trial was marginal, reflecting a need for better markers to evaluate stroke risk in patients with low AF burden.
These findings suggest that a more nuanced approach to anticoagulation in stroke patients is required, one which emphasises the need for individualized risk assessment to balance stroke prevention and bleeding risk.
Access the trial information
NOAH-AFNET 6
Becher N, Toennis T, Bertaglia E, et al. Anticoagulation with edoxaban in patients with long atrial high-rate episodes ≥24 h. Eur Heart J. 2024;45(10):837-849. doi:10.1093/eurheartj/ehad771
ARTESiA
Healey JS, Lopes RD, Granger CB, et al. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med. 2024;390(2):107-117. doi:10.1056/NEJMoa2310234
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