Early Aggressive Invasive Intervention for Atrial Fibrillation - EARLY-AF

Jan 12, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Cardiac Arrhythmia Network of Canada
Date Presented:
11/07/2022
Date Published:
01/11/2023
Date Updated:
01/12/2023
Original Posted Date:
11/07/2022
References

Contribution To Literature:

The EARLY-AF trial showed that catheter ablation reduces the incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia compared with antiarrhythmic drug therapy.

Description:

The goal of the trial was to evaluate catheter cryoballoon ablation compared with antiarrhythmic drug therapy among patients with paroxysmal atrial fibrillation.

Study Design

  • Randomized
  • Parallel

Patients with paroxysmal atrial fibrillation were randomized to cryoballoon ablation (n = 154) vs. antiarrhythmic drug therapy (n = 149). All patients had an implantable loop recorder placed.

  • Total number of enrollees: 303
  • Duration of follow-up: 3 years
  • Mean patient age: 60 years
  • Percentage female: 31%

Inclusion criteria:

  • At least 18 years of age with symptomatic paroxysmal atrial fibrillation within the last 24 months

Exclusion criteria:

  • Use of a class I or class III antiarrhythmic drug

Principal Findings:

The co-primary outcome of persistent atrial fibrillation occurred in 1.9% of the ablation group vs. 7.4% of the antiarrhythmic drug group (p < 0.05).

The co-primary outcome of recurrent atrial tachyarrhythmia occurred in 56.5% in the ablation group vs. 77.2% in the antiarrhythmic drug group (p < 0.05).

Secondary outcomes:

  • Hospitalization: 5.2% in the ablation group vs. 16.8% in the antiarrhythmic drug group (p < 0.05)
  • Serious adverse events: 4.5% in the ablation group vs. 10.1% in the antiarrhythmic drug group (p = not significant)

Interpretation:

Among patients with paroxysmal atrial fibrillation, an initial strategy of catheter cryoballoon ablation was beneficial. Catheter cryoballoon ablation compared with antiarrhythmic drug therapy was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia. Catheter cryoballoon ablation was also associated with a reduction in hospitalization compared with antiarrhythmic drug therapy. Serious adverse events were similar between treatment groups.

References:

Highlighted text has been updated as of January 12, 2023.

Andrade JG, Deyell MW, Macle L, et al., on behalf of the EARLY-AF Investigators. Progression of Atrial Fibrillation After Cryoablation or Drug Therapy. N Engl J Med 2023;388:105-16.

Editorial: Sandhu RK, Albert CM. First-Line Catheter Ablation for Paroxysmal Atrial Fibrillation — Have We Reached the Tipping Point? N Engl J Med 2023;388:177-8.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Prevention, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias

Keywords: AHA Annual Scientific Sessions, AHA22, Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiology Interventions, Catheter Ablation, Cryosurgery, Secondary Prevention, Tachycardia


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