ThermoCool-AF TRIAL

Problem Paroxysmal AF
Format Multi-center open-label RCT
Treatment Catheter ablation
Control Maximum tolerable ADT
Population 167 patients
Inclusion criteria At least 3 symptomatic AF episodes (≥1 episode verified by electrocardiogram) within the 6 months before randomization
Not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker).
Exclusion criteria AF of more than 30 days in duration
Age younger than 18 years
An ejection fraction of less than 40%
Previous ablation for AF
Documented left atrial thrombus
Amiodarone therapy in the previous 6 months
New York Heart Association class III (marked limitation in activity due to symptoms) or IV (severe limitations)
Myocardial infarction within the previous 2 months
Coronary artery bypass graft procedure in the previous 6 months
Thromboembolic event in the previous 12 months
Severe pulmonary disease
A prior valvular cardiac surgical procedure
Presence of an implanted cardioverter-defibrillator
Contraindication to antiarrhythmic or anticoagulation medications
Life expectancy of less than 12 months
Left atrial size of at least 50 mm in the parasternal long axis view.
Follow-up 9 months
Primary endpoint Freedom from protocol-defined treatment failure, which included documented symptomatic paroxysmal AF during the effectiveness evaluation period
Patients in the ablation group with repeat ablation after day 80 after the initial ablation, absence of entrance block confirmed in all PVs at the end of the ablation procedure, or changes in specified drug regimen postblanking (including class I/III drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and atrioventricular nodal blocker) were also considered treatment failures, even if they remained free from symptomatic paroxysmal AF.
In the ADT group, an adverse event requiring discontinuation of the assigned drug was also considered a treatment failure.
Secondary endpoint(s) Nil
Details -
Brief summary: Ablation for PAF in ADT failure patients superior, but 1/3 failure at 9 mo
PAPER: Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
Date 27 Jan 2010
Journal JAMA. 2010 Jan 27;303(4):333-40.
Information At 9 months
-63% assigned to catheter ablation were free of atrial tachyarrhythmias.
-VS. 17% of those assigned to antiarrhythmic drug therapy

Ablation group had significantly greater improvement in quality of life.