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Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation (RAAFT-2): A Randomized Trial
Study Questions:
What is the efficacy of radiofrequency ablation as compared with antiarrhythmic drugs (standard therapy) in treating patients with paroxysmal atrial fibrillation (AF) as a first-line therapy?
Methods:
This was a randomized clinical trial involving 127 treatment-naïve patients with paroxysmal AF who were randomized at 16 centers in Europe and North America to received either antiarrhythmic therapy or ablation. The first patient was enrolled on July 27, 2006; the last patient, January 29, 2010. The last follow-up was February 16, 2012. Sixty-one patients in the antiarrhythmic drug group and 66 in the radiofrequency ablation group were followed up for 24 months. The time to the first documented atrial tachyarrhythmia of more than 30 seconds (symptomatic or asymptomatic AF, atrial flutter, or atrial tachycardia), detected by either scheduled or unscheduled electrocardiogram, Holter, transtelephonic monitor, or rhythm strip, was the primary outcome. Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias and quality-of-life measures assessed by the EQ-5D tool.
Results:
Forty-four patients (72.1%) in the antiarrhythmic group and 36 patients (54.5%) in the ablation group experienced the primary efficacy outcome (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.35-0.90; p = 0.02). For the secondary outcomes, 59% in the drug group and 47% in the ablation group experienced the first recurrence of symptomatic AF, atrial flutter, atrial tachycardia (HR, 0.56; 95% CI, 0.33-0.95; p = 0.03). No deaths or strokes were reported in either group; four cases of cardiac tamponade were reported in the ablation group. In the standard treatment group, 26 patients (43%) underwent ablation after 1 year. Quality of life was moderately impaired at baseline in both groups and improved at the 1-year follow-up. However, improvement was not significantly different among groups.
Conclusions:
The authors concluded that among patients with paroxysmal AF without previous antiarrhythmic drug treatment, radiofrequency ablation compared with antiarrhythmic drugs resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years.
Perspective:
The randomized clinical trial investigators report that among patients with paroxysmal AF without previous antiarrhythmic drug treatment, radiofrequency ablation resulted in a significantly lower rate of recurrent atrial tachyarrhythmias at 2 years. Ablation also significantly reduced the frequency of repeated episodes of AF. However, recurrence of AF was documented in almost half of the patients after 2 years. The study sample was small and the treatment effect, although significant, may be clinically modest, and the risks of ablation were not negligible. It seems reasonable that when offering ablation as a therapeutic option to patients with paroxysmal AF naïve to antiarrhythmic drugs, the risks and benefits should be discussed thoroughly and treatment strategy should be individualized.
Keywords: North America, Follow-Up Studies, Heart Atria, Europe, Electrocardiography, Tachycardia, Quality of Life, Catheter Ablation, Atrial Flutter, Cardiac Tamponade
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