1 / 9

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. AF affects between 2 and 3 million people in the United States

lotus
Download Presentation

Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. APAF Trial Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Carlo Pappone

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

More Related