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26 June 2013

SARA study shows ablation superior to drugs in persistent AF

Lluis Mont

“Our study shows that if proper selection criteria are applied ablation can achieve good results for patients with persistent AF. It’s likely to have an impact on guidelines and may contribute to an upgrade of ablation in persistent AF to category 1B,” said the principal investigator Lluis Mont, from the Atrial Fibrillation Unit, University of Barcelona, Spain.

While a number of studies have proven the superiority of catheter ablation (CA) over antiarrhythmic drug therapy (ADT) in paroxysmal AF, no previous studies have specifically compared ablation versus drugs in patients with persistent AF. “Patients with persistent AF have in general been considered bad candidates for ablation, due to poor results, and the need for prolonged and aggressive procedures,” said Mont.

In the open parallel Study of Ablation vs AntiaRrhythmic Drugs in Persistent Atrial Fibrillation (SARA) study between May 2009 and November 2011 Mont and colleagues, from eight ablation centres in Spain, randomly assigned a total of 146 patients with persistent AF 2:1 to CA (n=98) or ADT ( n=48). ADT was given according to current guidelines, with class III drugs (amiodarone) 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 AF (> seven days or
The study specifically excluded patients with long standing persistent AF (continuous for more than one year) since this represents ‘a bad scenario for ablation’, and also patients with extremely dilated atriums (>50mm anterioposterior diameters).

In an intention-to-treat analysis, the proportion of patients free of prolonged (>12 hours) AF at 12 months (the primary end-point) was 70.4% in the CA group versus 43.7% in the ADT group (p=0.002); implying an absolute risk difference of 26.6% (95% CI: 10.0-43.3) favouring ablation group.

Again in an intention-to treat analysis, the proportion of patients free of any recurrence of AF or flutter (lasting >30 seconds) was 60.2% in the CA group compared to 29.2% in the ADT group (p<0 .001="" added="" br="" centres="" found="" have="" influence="" mont="" no="" on="" place="" results.="" the="" to="" took="" treatments="" were="" where="">
“The take home message is that AF ablation in persistent AF has a reasonable success safety profile and can be offered to patients resistant to ADT, provided some specific selection criteria are applied, such as excluding patients with very dilated atrium and long-standing persistent AF,” said Mont.

One weakness, he added, was that the study only recruited patients from arrhythmia units. “Therefore they’re likely to represent a selected population resistant to ADT,” he said.

A challenge for increasing the number of ablation procedures taking place, he added, was likely to be the shortage of highly trained physicians. “But as happened years ago with coronary angioplasty, the demand is likely to increase the numbers of physicians and centres prepared to perform procedures,” he said.

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