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

• Published in: EP Europace
• 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
• Other Authors: Kerckhoff-Klinik, University Hospital Sestre Milosrdnice, University Hospital Centre Zagreb, Partenaires INRAE, CHU Amiens-Picardie, Monash Health and Hudson Institute, Institut de cardiologie CHU Pitié-Salpêtrière, CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition CHU Pitié Salpêtrière (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University Heart Center Hamburg, Haukeland University Hospital, University of Bergen (UiB), Maria Cecilia Hospital, CHU Rouen, Normandie Université (NU), Mayo Clinic, Vrije Universiteit Brussel Bruxelles (VUB), Medtronic SNT, Medtronic
• Format: Article in Journal/Newspaper
• Language: English
• Published: HAL CCSD 2021
• Subjects: Antiarrhythmic drug; Catheter ablation; Atrial fibrillation; Cryoballoon; First-line treatment; Randomized study; [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system; [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery; [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology; Arctic; Human health
• Online Access: https://hal.sorbonne-universite.fr/hal-03346324; https://hal.sorbonne-universite.fr/hal-03346324/document; https://hal.sorbonne-universite.fr/hal-03346324/file/euab029.pdf; https://doi.org/10.1093/europace/euab029

International audience 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.