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Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation
Quick Takes
- At 12 months of follow-up, atrial tachyarrhythmia occurred in 43% of patients randomized to cryoablation and 68% of patients randomized to antiarrhythmic drugs (HR, 0.48; 95% CI, 0.35-0.66; p < 0.001).
- Serious adverse events occurred in 3.2% of patients who had ablation and in 4% of those who received antiarrhythmic drugs.
Study Questions:
What is the relative efficacy of one or more antiarrhythmic drugs versus catheter cryoablation in patients with paroxysmal atrial fibrillation and no prior therapy?
Methods:
A total of 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation were randomized to catheter cryoablation or antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary endpoint was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary endpoints included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.
Results:
At 12 months, atrial tachyarrhythmia occurred in 43% of patients who underwent ablation and in 68% of patients on antiarrhythmic drugs (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.35-0.66). Symptomatic atrial tachyarrhythmia recurred in 11% of the patients who underwent ablation and in 26% of those who received antiarrhythmic drugs (HR, 0.39; 95% CI, 0.22-0.68). The median percentage of time in atrial fibrillation was 0% with ablation and 0.13% with antiarrhythmic drugs. Serious adverse events occurred in 3.2% of patients who had ablation and in 4% of those who received antiarrhythmic drugs.
Conclusions:
Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy.
Perspective:
Prior studies showed that once a patient fails an antiarrhythmic agent, arrhythmia recurrence is less common and quality of life higher among patients who undergo ablation rather than another antiarrhythmic agent. This important study shows that early in the disease management, initial strategy of cryoballoon ablation is more effective than initial drug therapy, and remarkably the number needed to treat to observe the difference is 4. It is likely that these benefits would apply to radiofrequency ablation as well. Current American Heart Association/American College of Cardiology/Heart Rhythm Society and European Society of Cardiology guidelines recommend the use of antiarrhythmic drugs as initial therapy for the maintenance of sinus rhythm, and the current study may result in some modification of this recommendation. Admittedly, there is an upfront risk to ablation, but antiarrhythmic drug use is not benign either.
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: Ablation Techniques, Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Catheter Ablation, Cryosurgery, Disease Management, Quality of Life, Secondary Prevention, Tachycardia
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