Largest pan-European study to determine whether an early comprehensive rhythm control strategy for the treatment of atrial fibrillation (AF) will benefit patients.
The first patient has been enrolled, in Hamburg, Germany, for the largest pan-European study to determine whether an early comprehensive rhythm control strategy for the treatment of atrial fibrillation (AF) will benefit patients. The European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) together with the German Competence Network on Atrial Fibrillation (AFNET) and industry partners have joined forces to conduct the EAST (Early comprehensive Atrial fibrillation Stroke prevention Trial) clinical trial. This investigator-initiated study seeks to determine whether an early, comprehensive, standardized rhythm control therapy can help prevent adverse cardiovascular outcomes associated with atrial fibrillation (AF), including stroke and death. More specifically, EAST study will evaluate whether an early and comprehensive rhythm control treatment of patients, with early onset AF leads to better patient outcomes than usual care alone. The sponsor of EAST is AFNET with EHRA as an equal scientific partner in the trial. The investigators plan to enroll more than 3000 patients from 200 centres in 11 European countries. Commenting on the need for the EAST study, Prof. Dr. Paulus Kirchhof, coordinating investigator of the trial said: “The trial is based on the observation that insufficient, non-structured and delayed therapy of the multiple factors that maintain AF and cause its complications has most likely contributed to the limited effectiveness of rhythm control interventions in past trials. This trial takes an important step forward to learn more about the value of rhythm control therapy to improve the lives of AF patients.” EAST Trial Background EAST is a prospective, parallel-group, randomized, open, blinded, end-point assessment trial. The multicentre study seeks to understand whether improved rhythm control therapy could prevent death and stroke. Specifically, whether an earlier initiation of rhythm control therapy, when included in a comprehensive AF management strategy, has the potential to maintain the heart’s rhythm more effectively, prevent AF-related complications, and disrupt the cycles that maintain AF and cause complications. Patients with recent-onset AF at risk for stroke or death are eligible for the trial. Participants will be randomized to either an “early, comprehensive, standardized” intervention to maintain sinus rhythm on top of usual care, or to “usual care” alone. Early intervention will include anti-arrhythmic drug therapy and/or pulmonary vein isolation (PVI) using catheter ablation as well as ECG monitoring of therapy. Usual care follows standardized therapy under the 2010 ESC guidelines for the treatment of AF. The primary outcome of EAST is the composite of cardiovascular death, stroke and heart failure or acute coronary syndrome (hospitalisation). There will be outpatient follow-up at 12, 24 and 36 months. -ends-
Background information: Atrial fibrillation: AF is a condition in which the upper chambers of the heart (atria) beat rapidly and erratically, affecting the heart’s ability to adequately pump blood to its lower chambers (ventricles) and subsequently to the rest of the body. Some of the complications caused by AF are increased risk of death or stroke, increased severity of stroke, increased hospitalisations, and reduced quality of life due to palpitations and other AF-related symptoms. The disease affects between one and two percent of the European population. AF can have an impact on the heart as early as a few weeks after onset, causing cycles of remodelling, dysfunction and additional triggers which lead to the progression of the disease. These cycles both maintain and perpetuate AF from the state of initial detection, to paroxysmal (AF that begins suddenly and ends spontaneously) to persistent (recurring episodes lasting more than seven days) to permanent (ongoing and long term). AFNET: The German Competence Network on Atrial Fibrillation (AFNET) is an interdisciplinary research network located in Germany. AFNET aims at improving care of patients with atrial fibrillation by promoting research, medical services and information in emerging diagnostic and therapeutic fields in atrial fibrillation. The network has been funded by the German Federal Ministry of Research and Education since 2003. http://www.kompetenznetz-vorhofflimmern.de EHRA: The European Heart Rhythm Association (EHRA) is an association specialising in electrophysiology and was created from the merger of two former Working Groups of the European Society of Cardiology on 'Cardiac Pacing' and on 'Arrhythmias’. Its goal is to serve as the leading organisation in the field of arrhythmias and electrophysiology in Europe, and to attract all physicians from Europe and beyond to foster the development of this area of expertise. http://www.escardio.org/EHRA About the European Society of Cardiology: The European Society of Cardiology (ESC) represents more than 70,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe. www.escardio.org EAST Website http://www.easttrial.org
1. Oxford University Press / Europace Journal Comprehensive risk reduction in patients with atrial fibrillation: emerging diagnostic and therapeutic options—a report from the 3rd Atrial Fibrillation Competence NETwork/European Heart Rhythm Association consensus conference Full text web version Full text PDF version 2. Sanofi and St Jude Medical have provided grants to support the conduct of the trial. Sanofi: www.sanofi.com St Jude Medical: www.sjm.com 3. ClinicalTrials.gov: NCT01288352 http://clinicaltrials.gov/ct2/show/NCT01288352?term=NCT01288352&rank=1 ISRCTN: ISRCTN04708680 http://www.controlled-trials.com/ISRCTN04708680/ISRCTN04708680
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