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APAF Trial. Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Carlo Pappone. APAF Trial: Background. AF affects between 2 and 3 million people in the United States

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ablation for paroxysmal atrial fibrillation apaf trial

APAF Trial

Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial

Presented at

The American College of Cardiology

Scientific Session 2006

Presented by Dr. Carlo Pappone

apaf trial background
APAF Trial: Background
  • AF affects between 2 and 3 million people in the United States
  • Antiarrhythmic drugs have limited use in treating AF due to side effects and increased mortality
  • The present trial sought to investigate the treatment of paroxysmal atrial fibrillation using an alternative to pharmacologic treatment

Presented at ACC 2006

apaf trial study design
APAF Trial: Study Design

198 patients age 18-70 presenting with paroxysmal atrial fibrillation >6 months and qualifying atrial fibrillation burden >2 episodes per month/

Randomized.

33% female, mean age 56 years, mean follow-up 12 months

Circumferential pulmonary vein ablation (CPVA)

n=99

Antiarrhythmic medical therapy

n=99

with flecainide (n=33)

with sotalol (n=33)

with 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 8mm or a 3.5mm 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.

  • Primary Endpoint: Freedom from recurrent atrial arrhythmias
  • Secondary Endpoint: Monthly rhythm analysis; adverse events, left atrium remodeling

Presented at ACC 2006

apaf trial baseline data from 150 patients
APAF Trial: Baseline data from 150 patients

Atrial Fibrillation Episodes per Year at Time of Enrollment

p=0.05

  • Paroxysmal atrial fibrillation duration averaged 6 years at the time of enrollment
  • AF episodes per year were more common in the CPVA group at baseline (52 vs 30; p=0.05)
  • Baseline ejection fraction was 60%
  • History of hypertension was found in 56% of patients

number of AF episodes per year

Presented at ACC 2006

apaf trial primary endpoint at 9 months
APAF Trial: Primary Endpoint at 9 months

Freedom from recurrent AF and AT at 9 months (%)

p<0.001

  • At 9 months, a greater number of patients in the CPVA group were free from recurrent AF and AT (all CPVA patients in the absence of antiarrhythmic drug therapy) (87% vs 29%; p<0.001)

Presented at ACC 2006

apaf trial recurrent af
APAF Trial: Recurrent AF
  • Of the 8 patients who had recurrent AF in the CPVA group, repeat ablation procedure was performed in 3 patients, one of whom still had additional recurrent AF.
  • Of the 52 patients who had recurrent AF in the control group, 38 had CPVA performed, 4 of whom still had additional recurrent atrial fibrillation

Presented at ACC 2006

apaf trial secondary endpoints
APAF Trial: Secondary Endpoints
  • At 12 months, there was a significant decrease in left atrium diameter in patients randomized to CPVA (p<0.05), but no difference in patients randomized to the control group
  • Adverse events in the CPVA group included 1 TIA and 1 pericardial effusion

Presented at ACC 2006

taxus v isr trial limitations
TAXUS V ISR Trial: Limitations
  • This trial excluded many AF patients on the basis of age and disease progression: patients older than 70 and those with an enlarged atrium or low ejection fraction (<35%) were excluded from the APAF Trial. Future trials might look to include these patients who better represent the real-world AF population.
  • The current trial is too short to adequately assess and answer important safety concerns.

Presented at ACC 2006

taxus v isr trial summary
TAXUS V ISR Trial: Summary
  • 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 12 months
  • Medical management of AF can be difficult as it requires frequent monitoring. CPVA has been used as an alternative management strategy for AF 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 AF. CPVA was recently shown to be beneficial in maintaining sinus rhythm in the setting of chronic AF.
  • Full one-year data for the entire cohort of this trial are not yet available, although the 9-month data are very positive.

Presented at ACC 2006