First Patient Enrolls in St. Jude Medical Study Investigating Atrial Fibrillation Treatment Options
August 2, 2011 — St. Jude Medical Inc. today announced the first patient was enrolled in the EAST (Early comprehensive Atrial fibrillation Stroke prevention Trial) clinical trial.
The investigator-initiated study seeks to determine whether an early, comprehensive, standardized intervention program can help prevent adverse cardiovascular outcomes associated with prolonged atrial fibrillation (AF), including stroke and death. More specifically, it will evaluate whether an early, comprehensive rhythm control treatment of patients with early onset AF produces better patient outcomes than usual care alone.
The clinical sponsor of EAST is AFNET (German Competence Network on Atrial Fibrillation). The European Heart Rhythm Association (EHRA) is an equal scientific partner in the trial. The planned enrollment is more than 3,000 patients from 200 centers in Europe, with locations in Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, and the United Kingdom.
In addition to EAST, St. Jude Medical also is a major supporter of the CABANA (Catheter Ablation versus Antiarrhythmic drug therapy for Atrial fibrillation) pivotal trial.
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-organizer of the EAST trial, we therefore highly appreciate the financial support from St. Jude Medical and Sanofi to make this important clinical research possible.”
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 hospitalizations, and reduced quality of life due to palpitations and other AF-related symptoms.
AF can have an impact on the heart as early as a few weeks after onset, causing cycles of remodeling, dysfunction and additional triggers that help progress 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).
EAST is a prospective, parallel group, randomized, open, and blinded endpoint assessment. The multicenter study seeks to understand whether improved rhythm control therapy could prevent death and stroke. More specifically, it seeks to understand 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. This could further help prevent AF-related complications and disrupt the cycles that maintain AF and cause complications.
Commenting on the need for the EAST study, Prof. Paulus Kirchhof, M.D., 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 by accounting for the cycles that initiate and maintain the disease and contribute to AF-related complications.”
Patients with recent onset AF at risk for stroke or death are eligible for trial enrollment. Participants will be randomized to either an “early, comprehensive, standardized” intervention to maintain sinus rhythm in addition to usual care, or to usual care alone. Early intervention will include anti-arrythmic 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.
For more information: www.sjm.com