A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively
      performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and
      efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been
      formally assessed in a randomized controlled trial.

      The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a
      randomized controlled trial.
    

Detailed description: 
      Antiarrhythmic drug therapy (ADT) is currently considered as first-line therapy in patients
      with paroxysmal atrial fibrillation (AF).1 However antiarrhythmic drugs are frequently
      ineffective and can have serious potential adverse effects, thus often offsetting any
      advantage offered by the maintenance of sinus rhythm (SR).2,3 Data from our and other
      laboratories suggest that pulmonary vein ablation techniques may be a curative alternative
      for AF, obviating the need for ADT and/or anticoagulation in many patients.4-8 However, only
      preliminary and frequently non-randomized data exists for an evidence-based evaluation of
      catheter ablation as compared to conventional antiarrhythmic drug therapyADT.4,8 Thus, we
      conducted a controlled randomized trial (the Ablation for Paroxysmal Atrial Fibrillation
      [APAF] trial) to determine the long-term efficacy of circumferential pulmonary vein ablation
      (CPVA) in patients with paroxysmal AF as compared with ADT with flecainide, sotalol or
      amiodarone.

      Methods: One hundred ninety-eight patients (age, 56±10 years) with PAF (duration, 6±5 years,
      mean AF episodes 3.4/month), were randomized to CPVA or to ADT with flecainide, sotalol or
      amiodarone. Ablation was randomly performed with the use of a standard or an irrigated tip
      catheter and with CARTO or NavX non fluoroscopic 3D systems guidance. Cardiac rhythm was
      assessed with daily transtelephonic transmissions over a 12 and 48 months follow-up.
      Crossovers to CPVA were allowed after 3 months of ADT.

      Results: By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% in the ADT group
      were free from recurrent atrial tachyarrhythmias ([AT] P<0.001); a repeat ablation was
      performed in 9% of patients in the CPVA group for recurrent AF (6%) or atrial tachycardia
      (3%). At 1 year, 93% and 35% of the CPVA and ADT groups were AT-free while at 4 years only
      72.7% patients assigned to RFA and 12.1% assigned to AADs reached the endpoint(p<0.001).Lower
      left ejection fraction, arterial hypertension and age independently predicted AF recurrences
      in the ADT group. CPVA was associated with a significant decrease in left atrial diameter
      (15±10%, P<0.01) and with fewer number of cardiovascular hospitalizations (p<0.01). Ablation
      with an irrigated tip catheter was more effective (P=0.03) with either the CARTO or NavX
      system (P=0.08). One transient ischemic attack and one pericardial effusion occurred in the
      CPVA group; side effects of ADT were reported in 23 patients.During the 4-year follow-up, 87
      initially AADs patients required cross over to RFA with a steeper rate at 1 year (42
      patients) and 19 of them progressed to persistent AF before switching. Considering repeat
      ablation and crossover, the overall success rate was 90% in RFA group and 80% in AAD group
      (p=0.0023, by log-rank test). New left AT developed in 9 patients requiring mapping and
      ablation in 7 patients. Quality of life was higher in the RFA group than in AAD group for all
      subscale scores (p<0.001) Conclusions: Compared to ADT, CPVA can safely and effectively cure
      PAF in many patients at one-year follow-up and this benefit is extended to 4 years.
    

Intervention name(s): Circumferential Pulmonary Vein Ablation; Antiarrhythmic Drug Therapy
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: symptomatic; paroxysmal; atrial fibrillation