Ablation versus anti-arrhythmic therapy for reducing all hospital episodes from recurrent atrial fibrillation: a prospective, randomized, multi-centre, open label trial.

There is rising healthcare utilization related to the increasing incidence and prevalence of atrial fibrillation (AF) worldwide. Simplifying therapy and reducing hospital episodes would be a valuable development. The efficacy of a streamlined AF ablation approach was compared to drug therapy and a conventional catheter ablation technique for symptom control in paroxysmal AF. We recruited 321 patients with symptomatic paroxysmal AF to a prospective randomized, multi-centre, open label trial at 13 UK hospitals. Patients were randomized 1:1:1 to cryo-balloon ablation without electrical mapping with patients discharged same day [Ablation Versus Anti-arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent (AVATAR) protocol]; optimization of drug therapy; or cryo-balloon ablation with confirmation of pulmonary vein isolation and overnight hospitalization. The primary endpoint was time to any hospital episode related to treatment for atrial arrhythmia. Secondary endpoints included complications of treatment and quality-of-life measures. The hazard ratio (HR) for a primary endpoint event occurring when comparing AVATAR protocol arm to drug therapy was 0.156 (95% CI, 0.097-0.250; P < 0.0001 by Cox regression). Twenty-three patients (21%) recorded an endpoint event in the AVATAR arm compared to 76 patients (74%) within the drug therapy arm. Comparing AVATAR and conventional ablation arms resulted in a non-significant HR of 1.173 (95% CI, 0.639-2.154; P = 0.61 by Cox regression) with 23 patients (21%) and 19 patients (18%), respectively, recording primary endpoint events (P = 0.61 by log-rank test). The AVATAR protocol was superior to drug therapy for avoiding hospital episodes related to AF treatment, but conventional cryoablation was not superior to the AVATAR protocol. This could have wide-ranging implications on how demand for AF symptom control is met. Clinical Trials Registration: NCT02459574.

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© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

Déclaration de conflit d'intérêts

Conflict of interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: aside from the funding acknowledgements, no other support from any organization for the submitted work; P.K. has received consulting fees and research grants from Biosense-Webster, Abbott-Medical, Medtronic, and Boston-Scientific; J.M.C. has received a research grant and speaker fees from Medtronic; M.T. has received research grants from Medtronic, Biosense-Webster and Abbott Medical, and other support from Daiichi Sankyo and Abbott Medical; D.T. has received a travel grant for conference attendance from Medtronic UK, a consultancy fee from Abbott UK, and fees for teaching on a course from Medtronic UK Ltd, Boston Scientific Ltd, and Abbott UK; Z.W. has received speaker fees from Medtronic in relation to cardiac pacing; D.W.D. has received personal fees from Medtronic as a Consultant for the Medtronic AF division; I.M. and C.C. have received BHF Clinical Research Training Fellowship grants; P.K. and N.L. have a patent for Ripple Mapping which is licensed to Biosense-Webster with royalties paid to Imperial College. No other competing interests are declared.