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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. (1,2)
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. (3-9)
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 prioritises 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: (1) overall death, (2) stroke, (3) systemic embolism, myocardial infarction or pulmonary embolism, and (4) 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 explicated: “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.”
References
(1) Becher N, Koellner G, Blomstrom-Lundqvist C, Camm AJ, Dan GA, Dichtl W, Goette A, De Groot JR, Mont L, Rohrer U, Schotten U, Toennis T, Vardas P, Zapf A, Kirchhof P. Effects of anticoagulation or placebo in patients with device-detected atrial fibrillation and multiple stroke risk factors: A win ratio and win odds analysis of the NOAH-AFNET 6 trial. Abstract ESC Congress 2025
(2) Becher N, Koellner G, Blomstrom-Lundqvist C, Camm AJ, Dan GA, Dichtl W, Goette A, De Groot JR, Mont L, Rohrer U, Schotten U, Toennis T, Vardas P, Zapf A, Kirchhof P. Effects of anticoagulation in patients with device-detected atrial fibrillation and multiple stroke risk factors: A Win Ratio analysis of the NOAH-AFNET 6 trial l. Eur Heart J Qual Care Clin Outcomes. 2025 Sep 01. DOI:10.1093/ehjqcco/qcaf087
(3) Kirchhof P, Toennis T, Goette A, et al. Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. N Engl J Med 2023; 389:1167-1179. DOI:10.1056/NEJMoa2303062.
(4) Toennis T, Bertaglia E, Brandes A, et al. The influence of Atrial High Rate Episodes on Stroke and Cardiovascular Death - An update. Europace. 2023 Jul 4;25(7). DOI:10.1093/europace/euad166.
(5) Becher N, Toennis T, Bertaglia E, et al. Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours. Eur Heart J. 2024 Mar 7;45(10):837-849. DOI:10.1093/eurheartj/ehad771
(6) Lip YH, Nikorowitsch J, Sehner S et al. Oral anticoagulation in device-detected atrial fibrillation: effects of age, sex, cardiovascular comorbidities, and kidney function on outcomes in the NOAH-AFNET 6 trial. Eur Heart J. 2024 April 9. DOI:10.1093/eurheartj/ehae225
(7) Diener HC, Becher N, Sehner S, Toennis T et al. Anticoagulation in patients with device-detected atrial fibrillation with and without a prior stroke or transient ischemic attack. The NOAH-AFNET 6 trial. J Am Heart Assoc. 2024 Sep 3;13(17):e036429. DOI:10.1161/JAHA.124.036429
(8) McIntyre WF, Benz AP, Becher N, et al. Direct Oral Anticoagulants for Stroke Prevention in Patients with Device-Detected Atrial Fibrillation: A Study-Level Meta-Analysis of the NOAH-AFNET 6 and ARTESiA Trials. Circulation. 2024 Mar 26;149(13):981-988. DOI:10.1161/CIRCULATIONAHA.123.067512
(9) Schnabel RB, Benezet-Mazuecos J, Becher N, McIntyre WF et al. Anticoagulation in patients with device-detected atrial fibrillation with and without concomitant vascular disease – A combined secondary analysis of the NOAH-AFNET 6 and ARTESiA trials. Eur Heart J. 2024 Dec 7;45(46):4902-4916. DOI:10.1093/eurheartj/ehae596
About the Atrial Fibrillation NETwork (AFNET)
The Atrial Fibrillation NETwork is an interdisciplinary research network comprising scientists and physicians from hospitals and practices dedicated to improving the management of atrial fibrillation through coordinated research in Germany, Europe, and worldwide. Its main objective is to conduct high quality investigator-initiated clinical trials and registries on a national and international level as well as translational research projects. The AFNET continues the long-term activities of the network which has been funded by the German Federal Ministry of Research and Education over a decade. Since January 2015, specific projects and infrastructures of the AFNET are funded by the German Centre for Cardiovascular Research (DZHK), and some projects by EU research grants. AFNET has long expertise in the management of atrial fibrillation, but also provides support for work in other fields informing cardiovascular care. The results of 20 years of clinical and translational research improved the lives of patients with cardiovascular diseases and influenced treatment guidelines.
Funding of the NOAH trial: AFNET, DZHK, Daiichi Sankyo
NOAH registration: NCT 02618577, ISRCTN 17309850
Press Contact
Angelika Leute, PhD
Phone: +49 202 2623395
a.leute@t-online.de
Becher N et al. Effects of anticoagulation in patients with device-detected atrial fibrillation and multiple stroke risk factors: A Win Ratio analysis of the NOAH-AFNET 6 trial l. Eur Heart J Qual Care Clin Outcomes. 2025 Sep 01. DOI:10.1093/ehjqcco/qcaf087
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