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An analysis of patient-operated ECGs from the EAST – AFNET 4 trial revealed: A low AF burden below 6% in the first year of early rhythm control therapy was associated with low cardiovascular event rates during the subsequent 4 years of follow-up. Patients with a higher AF burden on early rhythm control suffered more AF-related events. Today the findings were presented by AFNET board member Prof. Ulrich Schotten, Maastricht University, in a hotline session at the annual congress of the European Society of Cardiology (ESC) in Madrid (1,2).
Atrial fibrillation (AF) is a common arrhythmia leading to severe complications including stroke, heart failure and cardiovascular death. Currently AF is diagnosed by ECG, creating a lifelong, binary diagnosis based on presence of a single ECG showing AF. Recent data illustrated the shortcomings of this binary diagnosis and suggest that AF burden as a quantitative parameter, defined as the time spent in AF per monitored time, better reflects disease severity and modulates the risk of stroke and other cardiovascular events (3,4).
Prof. Schotten explained: “Intermittent monitoring using patient-operated ECGs or wearables enables estimates of AF burden that could refine the diagnosis and enable individualised therapy. If AF burden estimated by patient-operated ECGs were related to cardiovascular outcomes, this would invite their use for remote, digital patient management. To investigate this question, we analysed ECG data from the EAST – AFNET 4 trial.”
The EAST – AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention) trial demonstrated that early rhythm control – with antiarrhythmic drugs or atrial fibrillation ablation – delivered within one year after AF diagnosis improves outcomes compared to usual care (UC) over a 5-year follow-up time (5). A series of sub-analyses of the EAST – AFNET 4 data set verified the results for different sub-groups (6-17).
In the present analysis, AF burden was estimated using artificial-intelligence-based rhythm classification of patient-operated telemetric ECGs in patients randomised to early rhythm control in the EAST – AFNET 4 trial.
1,178 patients (70 years, 47% women, CHA2DS2-VA 2·8±1·2) transmitted 303,308 ECGs over 5.1 years. Median AF burden was 6% in the first year of follow-up. AF burden below the median was associated with low rates of cardiovascular death, stroke, or unplanned hospitalisation for heart failure or acute coronary syndrome. An AF burden above the median was associated with higher event rates, comparable to events with usual care.
Prof. Schotten concluded: “Our findings suggest that AF burden, estimated from patient-operated ECGs, is linked to AF-related events on rhythm control therapy. They call for further exploration of the role of AF burden and AF burden reduction for personalised rhythm-control therapy in patients with AF.”
References
(1) Zeemering S, Borof K, Schotten U, Obergassel J, Camm AJ, Crijns HJGM, Eckardt L, Fabritz L, Goette A, Habibi Z, Hermans BJM, Lemoine MD, Magnussen C, Metzner A, Rillig A, Schnabel RB, Suling A, Vardas P, Willems S, Zapf A, Kirchhof P. Atrial fibrillation burden on early rhythm-control and cardiovascular events in the EAST-AFNET 4 AF trial. Abstract ESC Congress 2025
(2) Zeemering S, Borof K, Schotten U, Obergassel J, Camm AJ, Crijns HJGM, Eckardt L, Fabritz L, Goette A, Habibi Z, Hermans BJM, Lemoine MD, Magnussen C, Metzner A, Rillig A, Schnabel RB, Suling A, Vardas P, Willems S, Zapf A, Kirchhof P. Estimated atrial fibrillation burden on early rhythm-control and cardiovascular events in the EAST-AFNET 4 trial. EClinicalMedicine. 2025 Sep 01. DOI:10.1016/j.eclinm.2025.103457
(3) Linz D, Andrade JG, Arbelo E, Boriani G, Breithardt G, Camm AJ, Caso V, Nielsen JC, De Melis M, De Potter T, Dichtl W, Diederichsen SZ, Dobrev D, Doll N, Duncker D, Dworatzek E, Eckardt L, Eisert C, Fabritz L, Farkowski M, Filgueiras-Rama D, Goette A, Guasch E, Hack G, Hatem S, Haeusler KG, Healey JS, Heidbuechel H, Hijazi Z, Hofmeister LH, Hove-Madsen L, Huebner T, Kaab S, Kotecha D, Malaczynska-Rajpold K, Merino JL, Metzner A, Mont L, Ng GA, Oeff M, Parwani AS, Puererfellner H, Ravens U, Rienstra M, Sanders P, Scherr D, Schnabel R, Schotten U, Sohns C, Steinbeck G, Steven D, Toennis T, Tzeis S, van Gelder IC, van Leerdam RH, Vernooy K, Wadhwa M, Wakili R, Willems S, Witt H, Zeemering S, Kirchhof P. Longer and better lives for patients with atrial fibrillation: the 9th AFNET/EHRA consensus conference. Europace. 2024 Mar 30;26(4) DOI:10.1093/europace/euae070
(4) Becher N, Metzner A, Toennis T, Kirchhof P, Schnabel RB. Atrial fibrillation burden: a new outcome predictor and therapeutic target. Eur Heart J. 2024 Aug 16;45(31):2824-2838. DOI:10.1093/eurheartj/ehae373
(5) Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbüchel H, Hindricks G, Kautzner J, Kuck K-H, Mont L, Ng GA, Rekosz J, Schön N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G, for the EAST–AFNET 4 trial investigators. Early rhythm control therapy in patients with atrial fibrillation. N Engl J Med. 2020; 383:1305-1316. DOI:10.1056/NEJMoa2019422
(6) Metzner A, Suling A, Brandes A, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Elvan A, Goette A, Haegeli LM, Heidbuchel H, Kautzner J, Kuck KH, Mont L, Ng GA, Szumowski L, Themistoclakis S, van Gelder IC, Vardas P, Wegscheider K, Willems S, Kirchhof P. Anticoagulation, therapy of concomitant conditions, and early rhythm control therapy: a detailed analysis of treatment patterns in the EAST - AFNET 4 trial. EP Europace. 2022; 24:552–564. DOI:10.1093/europace/euab200
(7) Rillig A, Magnussen C, Ozga, Suling A, Brandes A, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Elvan A, Goette A, Gulizia M, Haegeli LM, Heidbuchel H, Kuck KH, Ng GA, Szumowski L, van Gelder IC, Wegscheider K, Kirchhof P. Early rhythm control therapy in patients with heart failure. Circulation. 2021;144(11):845-858. DOI:10.1161/CIRCULATIONAHA.121.056323
(8) Willems S, Borof K, Brandes A, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Gessler N, Goette A, Haegeli LM, Heidbuchel H, Kautzner J, Ng GA, Schnabel R, Suling A, Szumowski L, Themistoclakis S, Vardas P, van Gelder IC, Wegscheider K, Kirchhof P. Systematic, early rhythm control therapy equally improves outcomes in asymptomatic and symptomatic patients with atrial fibrillation: the EAST-AFNET 4 Trial. Eur Heart J. 2022; 43:1219-1230. DOI:10.1093/eurheartj/ehab593.
(9) Goette a, Borof K, Breithardt G, Camm AJ, Crijns H, Kuck KH, Wegscheider K, Kirchhof P, MD. Presenting Pattern of Atrial Fibrillation and Outcomes of Early Rhythm Control Therapy. J Am Coll Cardiol. 2022; 80:283-95. DOI:10.1016/j.jacc.2022.04.058
(10) Rillig A, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Goette A, Kuck KH, Metzner A, Vardas P, Vettorazzi E, Wegscheider K, Zapf A, Kirchhof P. Early rhythm control in patients with atrial fibrillation and high comorbidity burden. Circulation. 2022 Sep 13;146(11):836-847. DOI:10.1161/CIRCULATIONAHA.122.060274
(11) Jensen M, Suling A, Metzner A, Schnabel R, Borof K, Goette A, Haeusler KG, Zapf A, Wegscheider K, Fabritz L, Diener H-C, Thomalla G, Kirchhof P. Early rhythm-control therapy for atrial fibrillation in patients with a history of stroke: a subgroup analysis of the EAST- AFNET 4 trial. Lancet Neurol. 2023; 22: 45–54. DOI:10.1016/PIIS1474-4422(22)00436-7
(12) Eckardt L, Sehner S, Suling A, Borof K, Breithardt G, Crijns HJGM, Goette A, Wegscheider K, Zapf A, Camm AJ, Metzner A, Kirchhof P. Attaining sinus rhythm mediates improved outcome with early rhythm control therapy of atrial fibrillation: the EAST – AFNET 4 trial. Eur Heart J. 2022 Oct 21;43(40):4127-4144. DOI:10.1093/eurheartj/ehac471
(13) Van Gelder IC, Ekrami NK, Borof K, Fetsch T, Magnussen C, Mulder BA, Schnabel R, Wegscheider K, Rienstra M, Kirchhof P; EAST-AFNET 4 Trial Investigators. Sex Differences in Early Rhythm Control of Atrial Fibrillation in the EAST-AFNET 4 Trial. J Am Coll Cardiol. 2023 Feb 28;81(8):845-847. DOI:10.1016/j.jacc.2022.12.011.
(14) Gottschalk S, Kany S, König H-H, Crijns HJGM, Vardas P, Camm AJ, Wegscheider K, Metzner A, Rillig A, Kirchhof P, Dams J. Cost- effectiveness of early rhythm-control versus usual care in atrial fibrillation care: an analysis based on the German subsample of the EAST-AFNET 4 trial. EP Europace. 2023 May 19;25(5). DOI:10.1093/europace/euad051
(15) Kany S, Al-Taie C, Roselli C, Pirruccello JP, Borof K, Reinbold C, Suling A, Krause L, Reissmann B, Schnabel R, Zeller T, Zapf A, Wegscheider K, Fabritz L, Ellinor PT, Kirchhof P. Association of genetic risk and outcomes in patients with early rhythm control therapy in atrial fibrillation: results from the EAST-AFNET4 study. Cardiovasc Res. 2023 Aug 7;119(9):1799-1810. DOI:10.1093/cvr/cvad027
(16) Fabritz L, Chua W, Cardoso VR, Al-Taie C, Borof K, Suling A, Krause L, Kany S, Magnussen C, Wegscheider K, Breithardt G, Crijns HJGM, Camm AJ, Gkoutos G, Ellinor PT, Goette A, Schotten U, Wienhues-Thelen U-H, Zeller T, Schnabel RB, Zapf A, Kirchhof P. Blood-based cardiometabolic phenotypes in atrial fibrillation and their associated risk: EAST-AFNET 4 biomolecule study. Cardiovasc Res. 2024. DOI:10.1093/cvr/cvae067
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Funding: AFNET, BMBF, DZHK, EHRA, Deutsche Herzstiftung, Abbott, Sanofi
About the EAST – AFNET 4 trial
EAST – AFNET 4 is an investigator-initiated trial (IIT) that compared two different treatment strategies in atrial fibrillation. The EAST – AFNET 4 trial tested whether an early, comprehensive rhythm control therapy can prevent adverse cardiovascular outcomes in patients with atrial fibrillation (AF) compared to usual care.
A total of 2789 patients with early AF (diagnosed less than a year ago) and at least two cardiovascular conditions (approximating a CHA₂DS₂-VASc score >=2) were enrolled by 135 sites in 11 countries during 2011 to 2016. Patients were randomized 1:1 to early rhythm control therapy or usual care, stratified by sites. Patients in both groups received guideline-recommended treatment for underlying cardiovascular conditions, anticoagulation, and rate control.
All patients in the early rhythm control group received antiarrhythmic drugs or catheter ablation after randomization (chosen by the local study teams). Rhythm control therapy was escalated with AF ablation and/or antiarrhythmic drugs when recurrent AF was documented clinically or by ECG, including monitoring with patient-operated ECG devices.
Patients in the usual care group were initially managed with rate control. Rhythm control therapy was only used to improve atrial fibrillation-related symptoms despite optimal rate control, following current guidelines.
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.
Press Contact
Angelika Leute, PhD
Phone: +49 202 2623395
a.leute@t-online.de
Zeemering S et al. Estimated atrial fibrillation burden on early rhythm-control and cardiovascular events in the EAST-AFNET 4 trial. EClinicalMedicine. 2025 Sep 01. DOI:10.1016/j.eclinm.2025.103457
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