Physicians' Academy for Cardiovascular Education

First-line therapy of cryoballoon ablation reduces AF recurrence

Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation

Literature - Andrade JG, Wells GA, Deyell MW et al. - N Engl J Med. 2021; 384:305-315, doi:10.1056/NEJMoa2029980

Introduction and methods

Current guidelines recommend antiarrhythmic drugs as first therapy for maintaining sinus rhythm in patients with symptomatic atrial fibrillation (AF) [1-3]. But efficacy of these drugs is to some extent limited with some observed side effects [4-7]. Catheter ablation resulted in improved maintenance of sinus rhythm and increase quality of life compared to antiarrhythmic drugs in patients in whom drugs did not work [8-10]. Trials evaluating early catheter ablation (with radiofrequency energy) have been inconclusive [11-13].

This trial examined the effect of initial rhythm control by catheter cryoballoon ablation compared to antiarrhythmic drugs on recurrence of atrial tachyarrhythmia, assessed by an implantable continuous rhythm monitor in patient with symptomatic untreated atrial fibrillation. The Early Aggressive Invasive Intervention for Atrial Fibrillation (EARLY-AF) trial was an investigator-initiated, multicenter, open-label, randomized trial conducted in Canada. 303 Adults with symptomatic atrial fibrillation detected on electrocardiography were enrolled. Those with a history of regular use of a class I or III antiarrhythmic drug were excluded. After enrollment, all patients underwent insertion of an implantable cardiac monitor. Catheter ablation consisted of pulmonary-vein isolation with use of a cryoballoon. The procedural end point was bidirectional conduction block of all pulmonary veins after a 20-min observation period. Follow-up was 1 year. Primary end point was first recurrence of any atrial tachyarrhythmia (AF, atrial flutter or atrial tachycardia) lasting 30 sec or longer between day 91 and 365. Secondary end points were first recurrence of symptomatic atrial tachyarrhythmia between day 91 and 365, the arrhythmia burden (% of time in AF), quality of life (assessed by disease-specific Atrial Fibrillation Effect on Quality-of-Life survey [AFEQT]), health care utilization, serious adverse events.

Main results


Initial strategy of cryoablation resulted in significantly less arrhythmia compared to an initial strategy of antiarrhythmic drug therapy in patients with symptomatic, paroxysmal AF. Also burden of arrhythmia was lower in those who underwent cryoablation compared to those receiving antiarrhythmic drugs.


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