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APAF TRIAL |
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| Problem | Paroxysmal AF |
| Format | Single-center RCT |
| Treatment | AF ablation (CPVA) |
| Control | Maximum tolerable ADT |
| Population | 198 patients |
| Inclusion criteria | One hundred ninety-eight patients (age, 56 10 years) with PAF of 6 5 years’ duration (mean AF episodes 3.4/month) who had failed ADT Age 18 or 70 yrs Creatinine concentration 1.5 mg/dl AF history 6 months AF burden 2 episodes/month in the last 6 months* *The AF burden was quantiï¬Åed before enrolment by review of patient charts. |
| Exclusion criteria | AF secondary to transient or correctable abnormality Intra-atrial thrombus, tumor precluding catheter insertion LA diameter 65 mm Left ventricular ejection fraction 35% HF symptoms NYHA functional class II Prior ADT therapy with amiodarone, flecainide, and sotalol Contraindication to beta-blocking therapy Patients with rheumatic mitral valve disease Unstable angina or acute or prior myocardial infarction (6 months) Wolff-Parkinson-White syndrome Renal or hepatic failure Implanted device (pacemaker or cardioverter-deï¬Åbrillator) Need for antiarrhythmic therapy for arrhythmias other than AF Contraindication to ADT†or anticoagulation with warfarin History of a cerebrovascular accident Prior attempt at catheter or surgical ablation for AF †Thyroid dysfunction, interstitial lung disease with DLCO 70% of predicted or severe asthma, QT interval exceeding 400 ms, symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker is implanted, or evidence of stressinduced myocardial ischemia. ADT antiarrhythmic drug therapy; AF atrial ï¬Åbrillation; DLCO diffusion capacity of the lung for carbon monoxide; HF heart failure; LA left atrial; NYHA New York Heart Association. |
| Follow-up | 12 months |
| Primary endpoint | Freedom from documented recurrent AT during a 12-month follow-up in patients who underwent CPVA and in those receiving ADT. The end point was reached with the ï¬Årst episode of AT, and cases with a second ADT or repeat ablation procedure were considered failures. Recurrence of AT was deï¬Åned as AT that lasted at least 30 s |
| Secondary endpoint(s) | Nil |
| Details | - |
| Brief summary: | PAF patients who failed ADT did well with RF ablation at 1 year |
| PAPER: A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. | |
|---|---|
| Date | 5 Dec 2006 |
| Journal | J Am Coll Cardiol. 2006 Dec 5;48(11):2340-7. |
| Information | Those not having had recurrent atrial tachycardia -86% assigned to ablation free of atrial tachycardias -vs. 22% assigned to medical Rx (P<0.001) Hospitalisations for CV disease less frequent in ablation group. |