Catheter Ablation vs. Antiarrhythmic Drug Treatment of Persistent Atrial Fibrillation: A Multicenter, Randomized, Controlled Trial (SARA Study)

Study Questions:

Is radiofrequency catheter ablation (RFCA) more effective than antiarrhythmic drug therapy (AADT) for preventing persistent atrial fibrillation (AF)?


In this multicenter trial, 146 patients (mean age 55 years) with persistent AF were randomly assigned to undergo RFCA (n = 98) or AADT (n = 48). RFCA consisted of wide-area pulmonary vein isolation plus linear ablation and/or ablation of complex atrial electrograms, at the operator’s discretion. A redo procedure was performed in 8% of patients in the RFCA arm. AADT was consistent with guidelines, but was not standardized. The most frequently used drug was amiodarone (46%). Follow-up was for 12 months, with a 24-hour Holter monitor at 6 and 12 months. The primary outcome was freedom from recurrent AF (or flutter) lasting >24 hours after a 3-month blanking period.


The primary outcome was achieved in a significantly larger proportion of patients in the RFCA arm (70.4%) than in the AADT arm (43.7%). Freedom from any episode of AF also was significantly more likely in the RFCA arm (60.2%) than in the AADT arm (29.2%).


The authors concluded that RFCA is superior to AADT for preventing recurrent AF in patients with persistent AF.


While freedom from AF is a legitimate study endpoint in a randomized trial, it is not necessarily the most clinically relevant endpoint. For example, a therapy that reduces the AF burden from 100% to 10% could be considered very acceptable by a patient despite failing to attain freedom from AF. Of note is that freedom from AF in both study arms probably was lower than reported, because of inadequate monitoring for asymptomatic episodes of AF during follow-up.

Clinical Topics: Arrhythmias and Clinical EP, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Novel Agents

Keywords: Bismuth, Dimercaprol, Catheter Ablation, Organometallic Compounds, Cost of Illness, Pregnancy, Atrial Flutter, Guaifenesin

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