EAST trial: Can early rhythm control therapy prevent complications in atrial fibrillation patients?
Today the 2000th patient has been enrolled in the EAST – AFNET 4 trial. The pan-European clinical trial “Early treatment of atrial fibrillation for stroke prevention trial (EAST)” conducted by the German Atrial Fibrillation Network (AFNET) in cooperation with the European Heart Rhythm Association (EHRA) aims to ascertain whether early rhythm control therapy benefits patients with atrial fibrillation.
Several million people in Europe, representing 1 to 2 percent of the population, suffer from atrial fibrillation. The arrhythmia can cause strokes and other severe complications and although in recent years the treatment options have been improved by new treatments (new medicines and other treatments), patients with atrial fibrillation still frequently end up in hospitals due to cardiovascular complications whilst also suffering increased risk of severe strokes and dying prematurely.
The Atrial Fibrillation Network has conducted the EAST – AFNET 4 trial to help determine the optimal therapy choice for this group of patients. Since 01.01.2015 the conduct of the trial is co-funded by the German Centre for Cardiovascular Research (DZHK). The trial investigates whether an early rhythm control therapy, additionally to anticoagulation treatment, prevents severe complications in patients with atrial fibrillation [1, 2] when compared to the usual care. More than 100 hospitals and practices in 11 European countries participate in the EAST trial. The study has enrolled 2000 of the 2745 patients expected to take part since its start in the summer of 2011.
EAST is an investigator initiated trial (IIT). The German Atrial Fibrillation Network (AFNET) has initiated the trial in cooperation with the European Heart Rhythm Association (EHRA) and bears the overall responsibility of the trial. The coordinating investigators are the four cardiologists Prof. Paulus Kirchhof, Birmingham, UK, and Münster, Germany, Prof. Günter Breithardt, Münster, Germany, Prof. Harry Crijns, Maastricht, The Netherlands, and Prof. John Camm, London, UK. Financial support for the conduct of the trial is provided by the German Centre for Cardiovascular Research (DZHK) and the German Heart Foundations as well as the companies Sanofi and St. Jude Medical.
“If the results of the EAST – AFNET 4 trial support our hypothesis that early rhythm control therapy can prevent complications, this will lead to an important change in the treatment of recent onset atrial fibrillation”, the principal investigator and coordinator Prof. Kirchhof predicts.
Controlled trials published to date failed to provide definitive evidence that rhythm control therapy has a true positive influence on the course of disease in the individual patient. Nevertheless, many cardiologists are convinced that the patients will benefit from preservation of sinus rhythm. Dr. Laurent Haegeli, Zurich, Switzerland, a member of the steering committee of the EAST trial, explains the differences between EAST and other rhythm control trials: “In previous trials rhythm control measures usually were applied very late, in patients who have had atrial fibrillation for a long time. However, if antiarrhythmic drugs or catheter ablation are used in an early stage while atrial fibrillation has not yet caused irreversible damage, we expect much bigger success. For this reason EAST enrolls only patients with recent onset atrial fibrillation (shorter than one year).” [3]
The study patients are randomized to receive either “early rhythm control therapy” or “usual care”. Usual care is consistent with the therapy recommended by the current guidelines of the European Society of Cardiology (ESC) consisting of anticoagulation, in order to lower the stroke risk, and rate control in order to protect the cardiac muscle. These measures do not stop atrial fibrillation itself.
In the early rhythm control therapy group all appropriate treatment options are used to stop atrial fibrillation as early as possible and to restore sinus rhythm and maintain it permanently. When appropriate these are used additionally to anticoagulation and rate control treatment. In this study group, the atrial fibrillations are terminated by cardioversion or by an antiarrhythmic drug as the first line of treatment. In case of recurrence, further treatment measures are initiated immediately to restore sinus rhythm, either by more efficient antiarrhythmic drugs, by an early catheter ablation, or by a combination of these two procedures.
The EAST trial is still open to new centers. Appropriately qualified physicians interested in participating need to contact the Atrial Fibrillation Network
info@kompetenznetz-vorhofflimmern.de
References
[1] Kirchhof P et al. Improving outcomes in patients with atrial fibrillation: Rationale and design of the Early treatment of Atrial fibrillation for Stroke prevention Trial. Am Heart J 2013; 166:442-8. doi:10.1016/j.ahj.2013.05.015
[2] Van Gelder I et al. Rationale and current perspective for early rhythm control therapy in atrial fibrillation. Europace 2011; 13:1517-25. doi:10.1093/europace/eur192.
[3] Haegeli L et al. The EAST study: redefining the role of rhythm control therapy in atrial fibrillation: EAST, the Early treatment of Atrial fibrillation for Stroke prevention Trial. Eur Heart J 2015; 36:255-6. doi: 10.1093/eurheartj/ehu476.
About AFNET
The Atrial Fibrillation Network association (AFNET) 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 and Europe. Its main objective is to conduct high quality investigator-initiated clinical trials and registries on a national and international level. 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).
Press contact
Angelika Leute PhD
Email: a.leute@t-online.de
Phone: +49 202 2623395
Weitere Informationen:
http://www.kompetenznetz-vorhofflimmern.de
http://www.kompetenznetz-vorhofflimmern.de/de/east-afnet-4-studie
http://www.easttrial.org
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