HMN 2025: How Anticoagulation offers no clear benefit in patients with device-detected atrial fibrillation

A Win Ratio analysis confirmed the primary result of the NOAH—AFNET 6 trial and did not find an advantage of anticoagulation with edoxaban over no anticoagulation in patients with device-detected atrial fibrillation. Clinical decisions should therefore be guided by individual factors. The findings were presented by Dr. Nina Becher, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany, in a hotline session at the annual congress of the European Society of Cardiology (ESC) in Madrid.

The paper is published in the journal European Heart Journal—Quality of Care and Clinical Outcomes.

Patients with device-detected atrial fibrillation (DDAF) have a lower risk of stroke than patients with ECG-diagnosed atrial fibrillation (AF) and comparable stroke risk factors. Which of the patients with DDAF need anticoagulation for stroke prevention is still an open question.

The primary analysis of NOAH—AFNET 6 (Non vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes), an investigator-initiated trial conducted by the AFNET, revealed: In patients with DDAF, anticoagulation slightly reduces the relatively low risk of stroke but also increases the risk of major bleeding. The trial was terminated early due to the expected increase in bleeding events in patients with DDAF while the stroke preventing effect was smaller than expected. The weak effects of anticoagulation were also found in several subgroups.

Dr. Becher explained: “Some of the events summarized in the combined study endpoint of NOAH—AFNET 6 have a higher impact on patients´ lives than others. Death is more severe than bleeding. Therefore we performed a win ratio analysis. This statistical method prioritizes events in a hierarchical order based on their clinical importance and thereby provides a nuanced assessment of the benefit of oral anticoagulation in patients with DDAF and stroke risk factors.”

The win ratio analysis included a total of 2,534 patients who participated in the NOAH—AFNET 6 trial. The components of the primary composite were used in the following hierarchical order: overall death, stroke, systemic embolism, myocardial infarction or pulmonary embolism, and major bleeding. In addition, win odds were also calculated as a measure that accounts for the number of undecided comparisons between anticoagulant and placebo.

Dr. Becher explained, “Sensitivity analysis also included different hierarchical orders, e.g. cardiovascular death replacing overall death, and added additional outcomes, e.g. quality of life.”

There are two main observations: Most patients with DDAF did not experience events throughout the follow-up. After integration of death, thrombotic events, and major bleeds with or without quality of life as an additional outcome, this analysis did not find an advantage of anticoagulation with edoxaban over no anticoagulation in patients with DDAF. Anticoagulation decisions must balance stroke prevention and increased risk of bleeding in patients with DDAF.

AFNET board chair Prof. Paulus Kirchhof, UKE, principal investigator of NOAH—AFNET 6, concluded, “The present analysis suggests that a treatment strategy consisting of no anticoagulation and an ECG every six months is acceptable in most patients with DDAF. Individual treatment decisions should include patient preferences. Further analyses may help to better define subpopulations of patients with DDAF in whom anticoagulation therapy is sufficiently effective to justify the increase in bleeding.”

Provided by
Kompetenznetz Vorhofflimmern e.V. (AFNET)

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