• Arrhythmias
• Interventional Techniques & Devices
• Cardiology Clinical Trials

• Cardiology & Cardiovascular Medicine

Compared with antiarrhythmic drug therapy (ADT), catheter ablation (CA) is an effective treatment for paroxysmal atrial fibrillation (PAF) [Jaïs P et al. Circulation 2008]. Although CA is recommended as an indication for patients with PAF by current US and European guidelines [Camm A et al. Eur Heart J 2012; Fuster V et al. J Am Coll Cardiol 2011], its use by patients with persistent AF is unclear and even controversial. This is due in part to a paucity of data comparing the efficacy of the 2 therapies in patients with symptomatic, persistent AF.

Lluís Mont, MD, Universitat de Barcelona, Barcelona, Spain, reviewed data from the Study of Ablation Versus Antiarrhythmic Drugs in Persistent Atrial Fibrillation [SARA; Mont L et al. Eur Heart J 2014]. SARA was a multicenter trial conducted at 8 sites in Spain to compare the effectiveness of CA versus ADT among patients with symptomatic, persistent AF at 12 months of follow-up. Eligible patients were those with symptomatic, persistent AF (>7 days or ≤7 days requiring cardioversion) who were refractory to at least 1 class 1 or class 3 antiarrhythmic drug. Exclusion criteria are outlined in Table 1.

The study's primary outcome measure was any episode of atrial fibrillation (AF) or atrial flutter (AFL) lasting >24 hours or requiring cardioversion after a 3-month blanking period, the time during which recurrences of AF were not included in the data analysis. Secondary outcomes included negative recurrence of AF or AFL, need for cardioversion, arrhythmia-related hospitalizations, and quality-of-life measures. More than 75% of patients were men, with a mean age of 55 years, and patients were randomly assigned to receive either CA (n=98) or ADT (n=48). Patients were seen at 1, 3, 6, and 12 months and underwent 24-hour Holter monitoring at 3, 6, and 12 months.

Prof. Mont then reviewed the primary endpoint from both the intention-to-treat (ITT) and per protocol (PP) populations. In the ITT analysis, significantly more patients who underwent CA were free of the primary endpoint compared with the ADT group (70.4% vs 43.7%, p=0.002; absolute risk reduction, 26.6%; 95% CI, 10.0 to 43.3). In the PP analysis, CA was again significantly superior to ADT in reducing episodes of AF or AFL lasting >24 hours or requiring cardioversion (72.8% vs 43.8%, p<0.001). Compared with the ADT group, the CA group also showed higher probability of remaining free of sustained AF recurrence or AFL (p<0.001). There were significant differences favoring CA for negative recurrence of AF or AFL and the need for cardioversion, but not the other secondary outcomes.

No deaths or strokes occurred in either group. The incidence of adverse events in the CA group (ITT population) was 6.1% and included pericarditis (n=2), pericardial effusion (n=1), minor vascular complications (n=3), and pulmonary vein stenosis (n=1). In the ADT group, there were 2 adverse events: 1 episode of flecainide intoxication and 1 minor vascular access complication. Although not seen in this analysis, new data suggest that patients who underwent ablation experienced increased quality of life, not seen with patients treated with pharmacotherapy [Wynn GJ et al. Europace 2014].

Prof. Mont concluded that CA is superior to medical therapy as a strategy for maintenance of sinus rhythm in patients with persistent AF at 12-month follow-up. Longer follow-up will determine the durability of CA for persistent AF.

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