Issue: April 2014
February 18, 2014
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Ablation yielded lower recurrence rates than antiarrhythmic drugs in paroxysmal AF

Issue: April 2014
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In patients with paroxysmal atrial fibrillation who have not previously been treated with antiarrhythmic drugs, radiofrequency ablation yielded lower recurrence rates of atrial tachyarrhythmias at 2 years, according to findings from the RAAFT-2 study.

However, recurrences were common in both groups, and ablation was associated with a major complication in 9% of patients.

In the randomized, multicenter trial, the researchers evaluated 127 patients with paroxysmal AF aged 18 to 75 years. All patients had experienced recurrent AF episodes lasting longer than 30 seconds, with at least one episode verified by surface ECG within 6 months of randomization. Enrollment took place between 2006 and 2010.

The patients were randomly assigned at a 1:1 ratio to antiarrhythmic medication (n=61) or radiofrequency ablation (n=66). All patients were followed up at 1, 3, 6, 12 and 24 months after randomization. All participants received transtelephonic monitoring systems and were taught to report and record symptoms of possible AF episodes. They also were asked to submit biweekly recordings, regardless of symptom status.

The primary outcome was the time to the first AF, atrial flutter or recorded atrial tachyarrhythmia with duration of 30 seconds or longer. Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias, repeated AF episodes and quality-of-life assessments obtained through the EQ-5D tool.

Patients experienced the primary efficacy outcome in 72.1% of the antiarrhythmic arm and 54.5% of the ablation group (HR=0.56; 95% CI, 0.35-0.9). Asymptomatic AF occurred in 18% of cases in the antiarrhythmic group and 9% of the ablation group.

Recurrence of symptomatic AF, atrial flutter or atrial tachycardia occurred in 59% of the antiarrhythmic medication group and 47% of the ablation group (HR=0.56; 95% CI, 0.33-0.95). Significantly more patients in the antiarrhythmic group experienced a recurrence of symptomatic AF, excluding atrial flutter or tachyarrhythmias (57.4% vs. 40.9% in the ablation group; HR=0.52; 95% CI, 0.3-0.89). Stroke or death did not occur in either group, but four cases of cardiac tamponade occurred in the ablation group. After 1 year, 43% of patients in the antiarrhythmic drug group underwent ablation.

There was a moderate decrement in QOL at baseline in both groups compared with age-matched patients without AF, with an improvement in both groups at 1-year follow-up. The EQ-5D tariff score increased significantly from baseline in the ablation group (P=.03), but not in the antiarrhythmic drug group (P=.22).

“When offering ablation as a therapeutic option to patients with paroxysmal AF naive to antiarrhythmic drugs, the risks and benefits need to be discussed and treatment strategy individually recommended,” the researchers concluded.

Hugh Calkins, MD

Hugh Calkins

In an accompanying editorial, Hugh Calkins, MD, of Johns Hopkins Hospital, underscored the significance of these findings.

“The results of this study provide important additional evidence that catheter ablation should not be considered a ‘curative procedure’ for most patients with AF,” Calkins wrote. “… The current trial and other carefully performed studies make it clear that symptomatic and asymptomatic recurrences of AF are not uncommon following AF ablation, and that the efficacy of this procedure, even in optimal candidates, is modest.”

Disclosure: See the full study for a list of relevant financial disclosures.