Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation

Abstract Aims Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy...

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Published inEuropace (London, England) Vol. 23; no. 7; pp. 1033 - 1041
Main Authors Kuniss, Malte, Pavlovic, Nikola, Velagic, Vedran, Hermida, Jean Sylvain, Healey, Stewart, Arena, Giuseppe, Badenco, Nicolas, Meyer, Christian, Chen, Jian, Iacopino, Saverio, Anselme, Frédéric, Packer, Douglas L., Pitschner, Heinz-Friedrich, Asmundis, Carlo de, Willems, Stephan, Di Piazza, Fabio, Becker, Daniel, Chierchia, Gian-Battista
Format Journal Article
LanguageEnglish
Published England Oxford University Press 18.07.2021
Oxford University Press (OUP)
Subjects
Cardiology and cardiovascular system
Clinical Research
Human health and pathology
Life Sciences
Pharmaceutical sciences
Pharmacology
Surgery
First-line treatment
Randomized study
Antiarrhythmic drug
Cryoballoon
Catheter ablation
Atrial fibrillation
Online AccessGet full text
ISSN1099-5129
1532-2092
1532-2092
DOI10.1093/europace/euab029

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Abstract Abstract Aims Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). Methods and results A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). Conclusions Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy. Graphical Abstract
AbstractList Aims: Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF).Methods and results: A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001).Conclusions: Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.
Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.
Abstract Aims Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). Methods and results A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). Conclusions Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy. Graphical Abstract
Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF).AIMSTreatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF).A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001).METHODS AND RESULTSA total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001).Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.CONCLUSIONSCryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.
Author Pavlovic, Nikola
Becker, Daniel
Iacopino, Saverio
Packer, Douglas L.
Hermida, Jean Sylvain
Kuniss, Malte
Healey, Stewart
Meyer, Christian
Chen, Jian
Asmundis, Carlo de
Chierchia, Gian-Battista
Anselme, Frédéric
Pitschner, Heinz-Friedrich
Di Piazza, Fabio
Arena, Giuseppe
Velagic, Vedran
Badenco, Nicolas
Willems, Stephan
AuthorAffiliation 14 University Heart Center, Hamburg, Asklepios Klinik St. Georg , Hamburg, Germany
9 Haukeland University Hospital, University of Bergen , Bergen, Norway
8 University Heart Center, Hamburg, Cardiac Neuro- and Electrophysiology Research Consortium, EVK Düsseldorf , Düsseldorf, Germany
6 Ospedale Apuane , Massa Carrara, Italy
4 Centre Hospitalier Universitaire d'Amiens-Picardie , Amiens, France
15 Medtronic, Core Clinical Solutions, Study and Scientific Solutions , Rome, Italy
10 Maria Cecilia Hospital, GVM Care&Research , Cotignola, Italy
12 Mayo Clinic Hospital—St. Mary’s Campus , Rochester, MN, USA
3 University Hospital Centre Zagreb , Zagreb, Croatia
5 Monash Health , Clayton, Australia
7 AP-HP Sorbonne Université, ICAN Institute, Hopital Pitié-Salpétrière , Paris, France
2 Sestre Milosrdnice University Hospital Centre , Zagreb, Croatia
11 CHU de Rouen , Rouen, France
16 Medtronic , Meerbusch, Germany
1 Kerckhoff Heart Center , Benekestrasse 2-8 , 61231 Bad Nauheim, Germany
13 Heart Rhythm Manageme
AuthorAffiliation_xml – name: 1 Kerckhoff Heart Center , Benekestrasse 2-8 , 61231 Bad Nauheim, Germany
– name: 10 Maria Cecilia Hospital, GVM Care&Research , Cotignola, Italy
– name: 12 Mayo Clinic Hospital—St. Mary’s Campus , Rochester, MN, USA
– name: 16 Medtronic , Meerbusch, Germany
– name: 13 Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel , Brussels, Belgium
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  surname: Kuniss
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  organization: Kerckhoff Heart Center, Benekestrasse 2-8, 61231 Bad Nauheim, Germany
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  organization: University Hospital Centre Zagreb, Zagreb, Croatia
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  orcidid: 0000-0003-0217-3960
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  surname: Chen
  fullname: Chen, Jian
  organization: Haukeland University Hospital, University of Bergen, Bergen, Norway
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  surname: Anselme
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  organization: Medtronic, Meerbusch, Germany
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  surname: Chierchia
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  organization: Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel, Brussels, Belgium
BackLink https://www.ncbi.nlm.nih.gov/pubmed/33728429$$D View this record in MEDLINE/PubMed
https://hal.sorbonne-universite.fr/hal-03346324$$DView record in HAL
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Keywords First-line treatment
Randomized study
Antiarrhythmic drug
Cryoballoon
Catheter ablation
Atrial fibrillation
Language English
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Snippet Abstract Aims Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before...
Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing...
Aims: Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before...
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SubjectTerms Cardiology and cardiovascular system
Clinical Research
Human health and pathology
Life Sciences
Pharmaceutical sciences
Pharmacology
Surgery
Title Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation
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