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ThermoCool-AF TRIAL |
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|---|---|
| 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 | |
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| 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. |