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A combined subgroup analysis of the similar trials NOAH – AFNET 6 (1) and ARTESiA (2) revealed: Patients with device-detected atrial fibrillation and concomitant vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from oral anticoagulation than those without vascular disease. The finding was presented by AFNET Steering Committee member Prof. Renate Schnabel, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany, at the annual congress of the European Society of Cardiology (ESC) in London on 02.09.2024 and published in the European Heart Journal (3).
Device-detected atrial fibrillation (DDAF) are short and typically rare episodes of atrial fibrillation (AF) detected by pacemakers, defibrillators, or implanted loop recorders. Device-detected atrial fibrillation is found in every fifth patient with a cardiac implanted electronic device (4). Device-detected atrial fibrillation can lead to stroke, but the stroke risk in patients with device-detected atrial fibrillation appears lower than the stroke risk in patients with ECG-documented atrial fibrillation (1%/year).
Two recent trials, NOAH – AFNET 6 and ARTESiA, assessed the benefit of anticoagulation in patients with DDAF and stroke risk factors, but without ECG-documented AF. In both trials, patients were randomized either to anticoagulation (edoxaban in NOAH – AFNET 6 and apixaban in ARTESiA) or no anticoagulation in order to compare efficacy and safety outcomes in both groups.
NOAH – AFNET 6 (Non vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes), an investigator-initiated trial conducted by the AFNET, was terminated early due to an expected increase in bleeding events in patients with device-detected atrial fibrillation while the stroke preventing effect was smaller than expected (1). The weak effects of anticoagulation are also found in several subgroups including patients with long episodes of device-detected AF (5), patients with a high comorbidity burden (6), and patients with prior stroke (7).
ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients with Device-Detected Sub-Clinical Atrial Fibrillation) confirmed the low rate of stroke in patients with DDAF and demonstrated a small stroke-reducing effect of anticoagulation (2). A meta-analysis of NOAH – AFNET 6 and ARTESiA confirmed an increase in bleeding and detected a small reduction in ischemic strokes with anticoagulation (8).
Prof. Schnabel, leading investigator of the combined NOAH – AFNET 6 / ARTESiA sub-analysis presented now at the ESC congress, explained the background of this research: “About half of patients with device-detected atrial fibrillation have concomitant vascular disease, i.e. prior stroke or transient ischemic attack (TIA), coronary or peripheral vascular disease. The main goal of our pre-specified subgroup analysis was to assess whether vascular disease affects the efficacy and safety of oral anticoagulation therapy in patients with DDAF. The NOAH – AFNET 6 results were validated in a pre-specified secondary analysis of ARTESiA and meta-analysed.”
About half of the study population of NOAH – AFNET 6 and ARTESiA (56% in NOAH – AFNET 6; 46% in ARTESiA) had concomitant vascular disease with an established indication for acetylsalicylic acid therapy. In these patients, stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred less often with than without anticoagulation (3.9% versus 5.0% per patient-year in NOAH – AFNET 6 and 3.2% versus 4.4% per patient-year in ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (2.7% per patient-year in NOAH – AFNET 6 and 2.3% per patient-year in ARTESiA in both groups). Meta-analysis found consistent results across both trials.
Anticoagulation increased major bleeding in a comparable fashion in patients with vascular disease (edoxaban 2.1% per patient-year; no anticoagulation 1.3% per patient-year; apixaban 1.7% per patient-year; no anticoagulation 1.1% per patient-year) and without vascular disease (edoxaban 2.2% per patient-year; no anticoagulation 0.6% per patient-year; apixaban 1.4% per patient-year; no anticoagulation 1.1% per patient-year).
AFNET board chair Prof. Paulus Kirchhof, UKE, principal investigator of the NOAH – AFNET 6 trial, concluded: “This combined NOAH – AFNET 6 and ARTESiA sub-analysis suggests different effects of anticoagulation in DDAF patients with and without concomitant vascular disease. In the high-risk subgroup of patient with DDAF and vascular disease, anticoagulation therapy appears to reduce thromboembolic events with a greater magnitude than in patients without vascular disease. These data can guide shared clinical decision making on anticoagulation therapy in patients with DDAF.”
References
(1) 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.
(2) Healey JS, Lopes RD, Granger CB et al. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med 2024; 390:107-117. DOI: 10.1056/NEJMoa2310234.
(3) Schnabel R 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, accepted. DOI: 10.1093/eurheartj/ehae596
(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. JAHA, in press.
(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. 2023. DOI: 10.1161/CIRCULATIONAHA.123.067512
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
Schnabel R 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, accepted.
DOI: 10.1093/eurheartj/ehae596
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