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A-4 Trial

Atrial Fibrillation Ablation vs. Antiarrhythmic Drugs Trial. A-4 Trial. Presented at The Heart Rhythm Society Meeting May 2006 Presented by Dr. Pierre Jais. A-4 Trial: Background.

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A-4 Trial

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  1. Atrial Fibrillation Ablation vs. Antiarrhythmic Drugs Trial A-4 Trial Presented at The Heart Rhythm Society Meeting May 2006 Presented by Dr. Pierre Jais

  2. A-4 Trial: Background • The goal of this trial was to evaluate catheter ablation compared with antiarrhythmic drug therapy among patients with atrial fibrillation (AF). Presented at HRS 2006

  3. A-4 Trial: Study Design 112 patient with symptomatic AF > 6 months, ≥ 2 episodes of AF per month, documentation ≥1 episode of AF, resistant to ≥1 antiarrhythmic drugs from class l or lll Randomized. 16% female, mean age 51 years, mean follow-up 1 year Antiarrhythmic drug therapy with one of 6 medications n=59 Catheter Ablation n=53 • Primary Endpoint: Absence of AF for ≥ 3 minutes, either symptomatic or documented • Secondary Endpoint: Quality of life, AF burden, number of AF episodes on Holter, withdrawal of anticoagulant at 1 year After the primary endpoint was assessed at 3 months, patients could crossover from medical therapy to ablation, and would be counted as having met the endpoint. Presented at HRS 2006

  4. A-4 Trial : Principal Findings • At baseline, the average number of AF episodes per month was 20, lasting 9 hours. • Structural heart disease was present in 21% of patients. • In the ablation group, the mean procedure duration was 168 minutes, and an average of 1.8 procedures were performed. • In the medical therapy group, amiodarone was first used in 24 patients, 80% of whom failed therapy. • After month 3, 70% of patients crossed over to ablation therapy. Presented at HRS 2006

  5. A-4 Trial: Primary Endpoint Patients Free of Arrhythmic Recurrence at 1 Year p<0.05 • At one year, 75% of patients in the ablation group and 7% in the medical therapy group were free of arrhythmic recurrence (p<0.05) Presented at HRS 2006

  6. A-4 Trial: Secondary Endpoint Interruption of Oral Anticoagulation Therapy • Oral anticoagulation therapy was interrupted in 60% of the ablation group and 25% of the medical therapy group. • Among the quality of life parameters 6 of 8 were significantly improved in the ablation group. • Among all patients treated with ablation in the trial (n=90 patients and 155 procedures), including crossovers, there were 2 cases of tamponade. Presented at HRS 2006

  7. A-4 Trial: Limitations • One limitation of the trial was the short duration of AF needed to meet the primary endpoint, which was only 3 minutes. Presented at HRS 2006

  8. A-4 Trial: Summary • Among patients with atrial fibrillation, catheter ablation was associated with higher rates of absence of AF compared with antiarrhythmic drug therapy. • Additionally, it should be noted that patients in the trial had all previously failed antiarrhythmic drug therapy, and results may not be applicable to other AF patients who had not failed therapy or patients who are not symptomatic. Presented at HRS 2006

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