Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial - APAF

Mar 12, 2006
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Date Presented:
01/01/2006
Date Published:
01/01/2011
Date Updated:
03/12/2006
Original Posted Date:
03/12/2006
References

Description:

The goal of the trial was to evaluate treatment with circumferential pulmonary vein ablation (CPVA) compared with conventional antiarrhythmic medical therapy among patients with paroxysmal atrial fibrillation.

Study Design

Patients Enrolled: 198
Mean Follow Up: 12 months
Mean Patient Age: Mean age 56 years
Female: 33

Patient Populations:

Paroxysmal atrial fibrillation >6 months; qualifying atrial fibrillation burden >2 episodes/month; age 18-70 years

Exclusions:

NYHA class III or IV; left atrium >65 mm; LV <35%; contraindication to anticoagulation or AAD therapy

Primary Endpoints:

Freedom from recurrent atrial arrhythmias

Secondary Endpoints:

Monthly rhythm analysis; adverse events; left atrium remodeling

Drug/Procedures Used:

Patients were randomized to CPVA (n=99) or to antiarrhythmic medical therapy (n=99) with flecainide (n=33), sotalol (n=33) or amiodarone (n=33). Following a 1 month run-in phase to uptitrate antiarrhythmic medical therapy in both arms, ablation was performed in patients randomized to CPVA to encircle all 4 PVs with 3 additional lines to prevent atrial tachycardias (ATs) using either a 8 mm or a 3.5 irrigated tip catheter and with the guide of CARTO or NavX system. Medical therapy was discontinued in the CPVA group. Crossovers were allowed after 3 months.

Principal Findings:

Data were available on 150 patients in the trial at the time of the presentation. Paroxysmal atrial fibrillation (AF) duration averaged 6 years at the time of enrollment, with 52 atrial fibrillation episodes per year in the CPVA group and 30 in the control group (p=0.05). Baseline ejection fraction was 60%, and 56% of patients had a history of hypertension.

At 9 months of follow-up, 87% of patients in the CPVA group and 29% in the medical therapy group were free from recurrent AF and AT (all CPVA patients in the absence of antiarrhythmic drug therapy, p<0.001). Of the 8 patients who had recurrent atrial fibrillation in the CPVA group, repeat ablation procedure was performed in 3 patients, one of whom still had additional recurrent atrial fibrillation. Of the 52 patients in the medical therapy group who had recurrent atrial fibrillation, 38 had CPVA performed, 4 of whom still had additional recurrent atrial fibrillation. There was a significant decrease in left atrium diameter at 12 months in patients randomized to CPVA (P<0.05) but no difference in the medical therapy group. Adverse events in the CPVA group included 1 TIA and 1 pericardial effusion.

Interpretation:

Among patients with paroxysmal atrial fibrillation, treatment with circumferential pulmonary vein ablation was associated with a reduction in recurrent AF and AT compared with conventional antiarrhythmic medical therapy at 9 months.

Medical management of atrial fibrillation can be difficult as it requires frequent monitoring. CPVA has been used as an alternative management strategy for atrial fibrillation but randomized data comparing the two therapies are limited. The present trial is one of the first randomized trials of CPVA in the setting of paroxysmal atrial fibrillation. CPVA was recently shown to be beneficial in maintaining sinus rhythm in the setting of chronic atrial fibrillation. Full one year data in the entire cohort for the present trial are not yet available, although the 9 month data were very positive.

References:

Presented by Dr. Carlo Pappone at the March 2006 ACC Annual Scientific Session, Atlanta, GA.

Pappone C, Vicedomini G, Augello G, et al. Radiofrequency catheter ablation and antiarrhythmic drug therapy: a prospective, randomized, 4-year follow-up trial: the APAF study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):808-14.

Keywords: Tachycardia, Supraventricular, Heart Atria, Pulmonary Veins, Sotalol, Flecainide, Hypertension, Pericardial Effusion


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