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Randomized Controlled Trial
. 2023 Mar 30;25(3):863-872.
doi: 10.1093/europace/euac253.

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

Prapa Kanagaratnam  1   2 , James McCready  3 , Muzahir Tayebjee  4 , Ewen Shepherd  5 , Thiagarajah Sasikaran  6 , Derick Todd  7 , Nicholas Johnson  6 , Andreas Kyriacou  8 , Sajad Hayat  9 , Neil A Hobson  10 , Ian Mann  1 , Richard Balasubramaniam  11 , Zachary Whinnett  1 , Mark Earley  12 , Sanjiv Petkar  13 , Rick Veasey  14 , Senthil Kirubakaran  15 , Clare Coyle  1 , Min-Young Kim  1 , Phang Boon Lim  2 , James O'Neill  4 , D Wyn Davies  2 , Nicholas S Peters  1 , Daphne Babalis  6 , Nicholas Linton  1 , Emanuela Falaschetti  6 , Mark Tanner  16 , Jaymin Shah  17 , Neil Poulter  6
Affiliations
Randomized Controlled Trial

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

Prapa Kanagaratnam et al. Europace. .

Abstract

Aims: 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.

Methods and results: 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).

Conclusion: 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.

Trial registration: Clinical Trials Registration: NCT02459574.

Keywords: Ablation; Anti-arrhythmic; Atrial fibrillation; Cryoablation; Radiofrequency ablation.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Screening, randomization, treatment, and follow-up. Consort diagram showing the patient numbers at each stage of the study. Patients referred to an arrhythmia specialist with a diagnosis of paroxysmal atrial fibrillation (AF) were screened. Enrolment was offered to those considered clinically suitable for any of the three treatment arms. Randomization took place once the treatment schedule was confirmed to be feasible irrespective of the assigned arm.
Figure 2
Figure 2
Ablation Versus Anti-arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent (AVATAR) protocol ablation vs. anti-arrhythmic drug therapy: primary endpoint analysis. Kaplan–Meier curves comparing AVATAR protocol ablation against drug therapy for the survival time to any hospital episode related to treatment for atrial arrhythmia. Number of remaining subjects at risk displayed at 50-day intervals. The hazard-ratio for achieving a hospital episode when comparing AVATAR protocol arm to drug therapy is 0.156 (95% CI, 0.097–0.250; P < 0.0001 by Cox regression). Comparing the survival distributions between the two groups, significantly fewer patients had reached the primary endpoint with 23 (21%) vs. 76 (74%) patients having events within the two arms, respectively (P < 0.0001 by log-rank test).
Figure 3
Figure 3
Cryo-balloon atrial fibrillation (AF) ablation vs. Ablation Versus Anti-arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent (AVATAR) protocol ablation: primary endpoint analysis. Kaplan–Meier curves comparing AVATAR protocol ablation against cryo-balloon AF ablation therapy for the survival time to any hospital episode related to treatment for atrial arrhythmia. Number of remaining subjects at risk displayed at 50-day intervals. The hazard ratio for achieving a hospital episode when comparing the AVATAR protocol arm against the conventional cryo-balloon ablation arm is HR 1.173 (95% CI, 0.639 to 2.154; P = 0.61 by Cox regression). No significant difference was found when comparing the survival distribution between the two groups with 23 (21%) vs. 19 (18%) patients having events within the two arms respectively (P = 0.61 by log-rank test).
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