The largest pan-European study to determine whether an early comprehensive rhythm control strategy will be beneficial in patients with atrial fibrillation has recruited its first patient.
Investigators for the early comprehensive atrial fibrillation stroke prevention trial (EAST) have recruited the first of what they hope will be more than 3000 patients, from 200 centres in 11 European countries. The aim of the pan-European study is to investigate whether an early standardised, rhythm control therapy can help to prevent patients with atrial fibrillation from having adverse cardiovascular outcomes, such as stroke. The primary outcome, therefore, is a composite of cardiovascular death, stroke, heart failure, or acute coronary syndrome (hospitalisation).
Patients will be randomised to receive early intervention which will include antiarrhythmic drug therapy and/or pulmonary vein isolation using catheter ablation as well as electrocardiogram (ECG) monitoring of therapy or usual care as outlined in the 2010 European Society of Cardiology (ESC) guidelines for atrial fibrillation. Patients will be followed up at 12, 24, and 36 months.
The rationale for the study, according to Paulus Kirchhof, coordinating investigator of the study, is the observation that “insufficient, non-structured, and delayed therapy of the multiple factors that maintain atrial fibrillation and cause its complications has most likely contributed to the limited effectiveness of rhythm control interventions in the past.” He added that the trial was “an important step forward” in learning more about the value of rhythm control therapy to improve lives of patients with atrial fibrillation.
The German competence network on atrial fibrillation (AFNET) is the clinical sponsor of the trial, and European Heart Rhythm Association (EHRA) is an equal scientific partner. St Jude Medical and Sanofi are providing financial support. In a joint statement, Gunter Breithardt (on behalf of AFNET), Angelo Auricchio and Panos E Vardas (current and past president of EHRA, respectively) said: “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 to make this important clinical research possible.”