Cryoablation or drug therapy for initial treatment of atrial fibrillation

the EARLY-AF Investigators

doi:10.1056/NEJMoa2029980

Cryoablation or drug therapy for initial treatment of atrial fibrillation

the EARLY-AF Investigators

Medicine

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542 Citas (Scopus)

Resumen

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.

Idioma original	English
Páginas (desde-hasta)	305-315
Número de páginas	11
Publicación	New England Journal of Medicine
Volumen	384
N.º	4
DOI	https://doi.org/10.1056/NEJMoa2029980
Estado	Published - ene. 28 2021

Nota bibliográfica

Funding Information:
Dr. Andrade reports receiving grant support from Baylis Medical and lecture fees from Biosense Webster; Dr. Deyell, receiving grant support and honoraria from Biosense Webster and honoraria from Medtronic, Abbott, and Boston Scientific; Dr. Bennett, receiving grant support from Medtronic; Dr. Essebag, receiving honoraria from Biosense Webster, Abbott, and Medtron-ic; Dr. Roux, receiving lecture fees from Biosense Webster and Medtronic; Dr. Yung, receiving grant support and lecture fees from Pfizer, grant support from Abbott and Servier, and lecture fees from Bayer; Dr. Morillo, receiving grant support, advisory board fees, and steering committee fees from Medtronic and Abbott and advisory board fees from Novartis; Dr. Lockwood, receiving honoraria from Bayer and Pfizer–Bristol Myers Squibb; Dr. Amit, receiving honoraria from Johnson & Johnson and St. Jude Medical (Abbott); Dr. Angaran, receiving grant support from Servier Canada and Pfizer; Dr. Sapp, receiving honoraria from Medtronic and grant support and honoraria from Abbott and Biosense Webster; Dr. Macle, receiving grant support and honoraria from Biosense Webster and Pfizer–Bristol Myers Squibb; and Dr. Verma, receiving grant support, advisory board fees, and lecture fees from Bayer, Biosense Webster, and Medtronic, grant support from Biotronik, Bristol Myers Squibb, and Boehringer Ingelheim, consulting fees from Boston Scientific, MedLumics, and Thermedical, and lecture fees from Servier. No other potential conflict of interest relevant to this article was reported.

Funding Information:
Supported by a peer-reviewed grant (SRG-15-P15-001) from the Cardiac Arrhythmia Network of Canada, which is a Networks of Centres of Excellence program funded from a joint initiative of the Natural Sciences and Engineering Research Council, the Social Sciences and Humanities Research Council, the Canadian Institutes of Health Research, Industry Canada, and Health Canada; by unrestricted grants from Medtronic and Bay-lis Medical; and by in-kind support from Medtronic (implantable cardiac monitors) and the University of British Columbia.

Funding Information:
The trial was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada, unrestricted grants from Medtronic and Baylis Medical, and in-kind support from Medtronic and the University of British Columbia. The funders had no role in the trial design; the selection or monitoring of the participating centers; the selection or enrollment of the patients; the data collection, storage, or analysis; the interpretation of the data; the preparation of the manuscript; or the decision to submit the manuscript for publication.

Publisher Copyright:
Copyright © 2020 Massachusetts Medical Society.

ASJC Scopus Subject Areas

General Medicine

PubMed: MeSH publication types

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Acceder al documento

10.1056/NEJMoa2029980

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title = "Cryoablation or drug therapy for initial treatment of atrial fibrillation",

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 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.",

author = "{the EARLY-AF Investigators} and Andrade, {Jason G.} and Wells, {George A.} and Deyell, {Marc W.} and Matthew Bennett and Vidal Essebag and Jean Champagne and Roux, {Jean Francois} and Derek Yung and Allan Skanes and Yaariv Khaykin and Carlos Morillo and Umjeet Jolly and Paul Novak and Evan Lockwood and Guy Amit and Paul Angaran and John Sapp and Stephan Wardell and Sandra Lauck and Laurent Macle and Atul Verma",

note = "Funding Information: Dr. Andrade reports receiving grant support from Baylis Medical and lecture fees from Biosense Webster; Dr. Deyell, receiving grant support and honoraria from Biosense Webster and honoraria from Medtronic, Abbott, and Boston Scientific; Dr. Bennett, receiving grant support from Medtronic; Dr. Essebag, receiving honoraria from Biosense Webster, Abbott, and Medtron-ic; Dr. Roux, receiving lecture fees from Biosense Webster and Medtronic; Dr. Yung, receiving grant support and lecture fees from Pfizer, grant support from Abbott and Servier, and lecture fees from Bayer; Dr. Morillo, receiving grant support, advisory board fees, and steering committee fees from Medtronic and Abbott and advisory board fees from Novartis; Dr. Lockwood, receiving honoraria from Bayer and Pfizer–Bristol Myers Squibb; Dr. Amit, receiving honoraria from Johnson & Johnson and St. Jude Medical (Abbott); Dr. Angaran, receiving grant support from Servier Canada and Pfizer; Dr. Sapp, receiving honoraria from Medtronic and grant support and honoraria from Abbott and Biosense Webster; Dr. Macle, receiving grant support and honoraria from Biosense Webster and Pfizer–Bristol Myers Squibb; and Dr. Verma, receiving grant support, advisory board fees, and lecture fees from Bayer, Biosense Webster, and Medtronic, grant support from Biotronik, Bristol Myers Squibb, and Boehringer Ingelheim, consulting fees from Boston Scientific, MedLumics, and Thermedical, and lecture fees from Servier. No other potential conflict of interest relevant to this article was reported. Funding Information: Supported by a peer-reviewed grant (SRG-15-P15-001) from the Cardiac Arrhythmia Network of Canada, which is a Networks of Centres of Excellence program funded from a joint initiative of the Natural Sciences and Engineering Research Council, the Social Sciences and Humanities Research Council, the Canadian Institutes of Health Research, Industry Canada, and Health Canada; by unrestricted grants from Medtronic and Bay-lis Medical; and by in-kind support from Medtronic (implantable cardiac monitors) and the University of British Columbia. Funding Information: The trial was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada, unrestricted grants from Medtronic and Baylis Medical, and in-kind support from Medtronic and the University of British Columbia. The funders had no role in the trial design; the selection or monitoring of the participating centers; the selection or enrollment of the patients; the data collection, storage, or analysis; the interpretation of the data; the preparation of the manuscript; or the decision to submit the manuscript for publication. Publisher Copyright: Copyright {\textcopyright} 2020 Massachusetts Medical Society.",

year = "2021",

month = jan,

day = "28",

doi = "10.1056/NEJMoa2029980",

language = "English",

volume = "384",

pages = "305--315",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "4",

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TY - JOUR

T1 - Cryoablation or drug therapy for initial treatment of atrial fibrillation

AU - the EARLY-AF Investigators

AU - Andrade, Jason G.

AU - Wells, George A.

AU - Deyell, Marc W.

AU - Bennett, Matthew

AU - Essebag, Vidal

AU - Champagne, Jean

AU - Roux, Jean Francois

AU - Yung, Derek

AU - Skanes, Allan

AU - Khaykin, Yaariv

AU - Morillo, Carlos

AU - Jolly, Umjeet

AU - Novak, Paul

AU - Lockwood, Evan

AU - Amit, Guy

AU - Angaran, Paul

AU - Sapp, John

AU - Wardell, Stephan

AU - Lauck, Sandra

AU - Macle, Laurent

AU - Verma, Atul

N1 - Funding Information: Dr. Andrade reports receiving grant support from Baylis Medical and lecture fees from Biosense Webster; Dr. Deyell, receiving grant support and honoraria from Biosense Webster and honoraria from Medtronic, Abbott, and Boston Scientific; Dr. Bennett, receiving grant support from Medtronic; Dr. Essebag, receiving honoraria from Biosense Webster, Abbott, and Medtron-ic; Dr. Roux, receiving lecture fees from Biosense Webster and Medtronic; Dr. Yung, receiving grant support and lecture fees from Pfizer, grant support from Abbott and Servier, and lecture fees from Bayer; Dr. Morillo, receiving grant support, advisory board fees, and steering committee fees from Medtronic and Abbott and advisory board fees from Novartis; Dr. Lockwood, receiving honoraria from Bayer and Pfizer–Bristol Myers Squibb; Dr. Amit, receiving honoraria from Johnson & Johnson and St. Jude Medical (Abbott); Dr. Angaran, receiving grant support from Servier Canada and Pfizer; Dr. Sapp, receiving honoraria from Medtronic and grant support and honoraria from Abbott and Biosense Webster; Dr. Macle, receiving grant support and honoraria from Biosense Webster and Pfizer–Bristol Myers Squibb; and Dr. Verma, receiving grant support, advisory board fees, and lecture fees from Bayer, Biosense Webster, and Medtronic, grant support from Biotronik, Bristol Myers Squibb, and Boehringer Ingelheim, consulting fees from Boston Scientific, MedLumics, and Thermedical, and lecture fees from Servier. No other potential conflict of interest relevant to this article was reported. Funding Information: Supported by a peer-reviewed grant (SRG-15-P15-001) from the Cardiac Arrhythmia Network of Canada, which is a Networks of Centres of Excellence program funded from a joint initiative of the Natural Sciences and Engineering Research Council, the Social Sciences and Humanities Research Council, the Canadian Institutes of Health Research, Industry Canada, and Health Canada; by unrestricted grants from Medtronic and Bay-lis Medical; and by in-kind support from Medtronic (implantable cardiac monitors) and the University of British Columbia. Funding Information: The trial was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada, unrestricted grants from Medtronic and Baylis Medical, and in-kind support from Medtronic and the University of British Columbia. The funders had no role in the trial design; the selection or monitoring of the participating centers; the selection or enrollment of the patients; the data collection, storage, or analysis; the interpretation of the data; the preparation of the manuscript; or the decision to submit the manuscript for publication. Publisher Copyright: Copyright © 2020 Massachusetts Medical Society.

PY - 2021/1/28

Y1 - 2021/1/28

N2 - 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.

AB - 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.

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U2 - 10.1056/NEJMoa2029980

DO - 10.1056/NEJMoa2029980

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JO - New England Journal of Medicine

JF - New England Journal of Medicine

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Cryoablation or drug therapy for initial treatment of atrial fibrillation

Resumen

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ASJC Scopus Subject Areas

PubMed: MeSH publication types

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