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02 August 2011

International Landmark EAST Study Investigates Treatment Options for Atrial Fibrillation‏

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 together with the German Competence Network on Atrial Fibrillation (AFNET) and industry partners1 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 (German Atrial Fibrillation Competence Network). EHRA (European Heart Rhythm Association) is 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 antiarrhythmic 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 (hospitalization). There will be outpatient follow-up at 12, 24 and 36 months.
Günter Breithardt (AFNET speaker), Angelo Auricchio, and Panos Vardas (current and past EHRA president) said in a joint statement today: “Investigator-initiated clinical research with a relevant impact requires good ideas, perseverance, a network of colleagues, but also financial resources. As sponsor and co-organiser of the EAST trial, we therefore highly appreciate the financial support from St. Jude Medical and Sanofi-Aventis to make this important clinical research possible.”

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