TY - JOUR
T1 - Cryoballoon ablation vs. antiarrhythmic drugs
T2 - First-line therapy for patients with paroxysmal atrial fibrillation
AU - Kuniss, Malte
AU - Pavlovic, Nikola
AU - Velagic, Vedran
AU - Hermida, Jean Sylvain
AU - Healey, Stewart
AU - Arena, Giuseppe
AU - Badenco, Nicolas
AU - Meyer, Christian
AU - Chen, Jian
AU - Iacopino, Saverio
AU - Anselme, Frédéric
AU - Packer, Douglas L.
AU - Pitschner, Heinz Friedrich
AU - Asmundis, Carlo De
AU - Willems, Stephan
AU - Di Piazza, Fabio
AU - Becker, Daniel
AU - Chierchia, Gian Battista
N1 - Publisher Copyright:
© 2021 The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - 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.
AB - 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.
KW - Antiarrhythmic drug
KW - Atrial fibrillation
KW - Catheter ablation
KW - Cryoballoon
KW - First-line treatment
KW - Randomized study
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U2 - 10.1093/europace/euab029
DO - 10.1093/europace/euab029
M3 - Article
C2 - 33728429
AN - SCOPUS:85108598338
SN - 1099-5129
VL - 23
SP - 1033
EP - 1041
JO - Europace
JF - Europace
IS - 7
ER -