Progression of Atrial Fibrillation after Cryoablation or Drug Therapy.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
12 01 2023
12 01 2023
Historique:
pubmed:
8
11
2022
medline:
14
1
2023
entrez:
7
11
2022
Statut:
ppublish
Résumé
Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation. We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected. A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group. Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
Sections du résumé
BACKGROUND
Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation.
METHODS
We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected.
RESULTS
A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group.
CONCLUSIONS
Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
Identifiants
pubmed: 36342178
doi: 10.1056/NEJMoa2212540
doi:
Substances chimiques
Anti-Arrhythmia Agents
0
Banques de données
ClinicalTrials.gov
['NCT02825979']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
105-116Investigateurs
Jason Andrade
(J)
Jean Champagne
(J)
Marc W Deyell
(MW)
Vidal Essebag
(V)
Sandra Lauck
(S)
Carlos Morillo
(C)
John Sapp
(J)
Allan Skanes
(A)
George A Wells
(GA)
Atul Verma
(A)
Paul Novak
(P)
Larry Sterns
(L)
Richard Leather
(R)
Chris Lane
(C)
Markus Sikkel
(M)
Matthew Bennett
(M)
Nathaniel Hawkins
(N)
Marc Deyell
(M)
Andrew Krahn
(A)
Zackary Laksman
(Z)
John Yeung-Lai-Wah
(J)
Evan Lockwood
(E)
Randall Williams
(R)
Sajad Gulamhusein
(S)
Jacques Rizkallah
(J)
F Russell Quinn
(FR)
Stephen Wardell
(S)
Kelly Coverett
(K)
Carlo Stuglin
(C)
Peter Leong-Sit
(P)
Anthony Tang
(A)
Raymond Yee
(R)
Lorne Gula
(L)
Jason Roberts
(J)
Jaimie Manlucu
(J)
Umjeet Jolly
(U)
Clause Rinne
(C)
Guy Amit
(G)
Jorge Wong
(J)
Syam Divakara Menon
(SD)
Sebastian Ribas
(S)
Juan Acosta-Velez
(J)
Yaariv Khaykin
(Y)
Derek Yung
(D)
Bhavanesh Makanjee
(B)
Amir Janmohamed
(A)
Paul Angaran
(P)
Arnold Pinter
(A)
Iqwal Mangat
(I)
Victoria Korley
(V)
Kamran Ahmad
(K)
Girish Nair
(G)
David Birnie
(D)
Pablo Nery
(P)
Calum Redpath
(C)
Mehrdad Golian
(M)
Andres Klein
(A)
Isabelle Nault
(I)
Jean-Francois Sarrazin
(JF)
Francois Philippon
(F)
Gilles O'Hara
(G)
Franck Molin
(F)
Louis Blier
(L)
Benoit Plourde
(B)
Karine Roy
(K)
Christian Steinberg
(C)
Jacqueline Joza
(J)
Martin Bernier
(M)
Marcio Sturmer
(M)
Leila Laroussi
(L)
Jean-Francois Roux
(JF)
Mariano Badra-Verdu
(M)
Charles Dussault
(C)
Ratika Parkash
(R)
Amir AbdelWahab
(A)
Martin Gardner
(M)
Chris Gray
(C)
Ciorsti MacIntyre
(C)
Laurent Macle
(L)
Simon Kochhaeuser
(S)
Julia Cadrin-Tourigny
(J)
Chris Cheung
(C)
Jeff Healey
(J)
Corinne Pearce
(C)
Rose Pfeffer
(R)
Paul Dorian
(P)
Ben Glover
(B)
Lehana Thabane
(L)
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