Catheter ablation therapy has shown to be superior to medical therapy for maintenance of sinus rhythm in patients with persistent atrial fibrillation, according to results from the SARA study presented by Lluis Mont, Barcelona, Spain, at a late breaking trial session of the European Heart Rhythm Association (EHRA) Europace meeting (23–26 June, Athens, Greece).
While a number of previous studies have shown the superiority of catheter ablation over antiarrhythmic drug therapy for patients with paroxysmal atrial fibrillation, no previous studies have been undertaken specifically comparing ablation to drugs in patients with persistent atrial fibrillation. “Patients with persistent atrial fibrillation have in general been considered bad candidates for ablation, due to poor results, and the need for prolonged and aggressive procedures,” explained Mont, Atrial Fibrillation Unit, University of Barcelona, Spain and principal investigator of the SARA trial.
In the open parallel SARA (Study of ablation vs. antiarrhythmic drugs in persistent atrial fibrillation) trial, Mont and colleagues randomly assigned 146 patients with persistent atrial fibrillation 2:1 to catheter ablation (n=98) or antiarrhytmic drug therapy (n=48), between May 2009 and November 2011, in eight ablation centres in Spain. Medical therapy was administered according to current guidelines, with class III drugs, amiodarone being recommended for patients with structural heart disease and class Ic (flecainide) plus dilitiazem or beta blockers for patients without structural heart disease.
The inclusion criteria were that patients should have experienced symptomatic persistent atrial fibrillation (>7 days or 50mm anterioposterior diameters).
In an intention-to-treat analysis, the proportion of patients free of prolonged (>12 hours) atrial fibrillation at 12 months (the primary endpoint) was 70.4% in the catheter ablation group versus 43.7% in the antiarrhythmic drug therapy group (p=0.002), implying an absolute risk difference of 26.6% (95% CI: 10.0-43.3) and favouring the ablation group.
The proportion of patients who were free of any recurrence of atrial fibrillation or flutter (lasting >30 seconds) was 60.2% in the catheter ablation group compared to 29.2% in the antiarrhythmic drug therapy group (p<0.001).
“Our study shows that, if proper selection criteria are applied, ablation can achieve good results for patients with persistent atrial fibrillation,” said Mont. “It is likely to have an impact on guidelines and may contribute to an upgrade of ablation in persistent atrial fibrillation to category 1B.” Results would not apply to patients with very dilated atrium and long standing persistent atrial fibrillation.
Further studies, he added, are now needed to look at outcomes according to shape remodelling and levels of fibrosis. “This should help to further stratify patients and select good candidates for ablation,” he concluded.
Lucas Boersma, St Antonius Hospital, Nieuwegein, The Netherlands, discussed the outcomes of the SARA trial at EHRA. He said: “The impact of the trial is encouraging as it has been seen that the superiority of catheter ablation versus antiarrhythmic drug therapy is in line with other comparative trials in paroxysmal atrial fibrillation and long-standing persistent atrial fibrillation. Efficacy of catheter ablation for persistent atrial fibrillation is very similar to paroxysmal atrial fibrillation despite modest ablation strategy.”