Jason G Andrade1, George A Wells1, Marc W Deyell1, Matthew Bennett1, Vidal Essebag1, Jean Champagne1, Jean-Francois Roux1, Derek Yung1, Allan Skanes1, Yaariv Khaykin1, Carlos Morillo1, Umjeet Jolly1, Paul Novak1, Evan Lockwood1, Guy Amit1, Paul Angaran1, John Sapp1, Stephan Wardell1, Sandra Lauck1, Laurent Macle1, Atul Verma1. 1. From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.
Abstract
BACKGROUND: Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm. METHODS: We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergocatheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life. RESULTS: At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs. CONCLUSIONS: Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
RCT Entities:
BACKGROUND: Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm. METHODS: We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life. RESULTS: At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs. CONCLUSIONS: Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
Authors: Federico Cecchini; Giacomo Mugnai; Saverio Iacopino; Juan Pablo Abugattas; Bert Adriaenssens; Maysam Al-Housari; Alexandre Almorad; Gezim Bala; Antonio Bisignani; Carlo de Asmundis; Yves De Greef; Riccardo Maj; Thiago G Osòrio; Luigi Pannone; Bruno Schwagten; Juan Sieira; Antonio Sorgente; Erwin Stroker; Michael Wolf; Gian-Battista Chierchia Journal: J Interv Card Electrophysiol Date: 2022-07-22 Impact factor: 1.759
Authors: Malte Kuniss; Nikola Pavlovic; Vedran Velagic; Jean Sylvain Hermida; Stewart Healey; Giuseppe Arena; Nicolas Badenco; Christian Meyer; Jian Chen; Saverio Iacopino; Frédéric Anselme; Douglas L Packer; Heinz-Friedrich Pitschner; Carlo de Asmundis; Stephan Willems; Fabio Di Piazza; Daniel Becker; Gian-Battista Chierchia Journal: Europace Date: 2021-07-18 Impact factor: 5.214