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MANTRA-PAF TRIAL |
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| Problem | Paroxysmal AF (first line) |
| Format | Multicenter, randomised trial |
| Treatment | Radiofrequency catheter ablation |
| Control | Class IC or class III antiarrhythmic agents |
| Population | 294 patients |
| Inclusion criteria | At least two episodes of symptomatic atrial fibrillation within the preceding 6 months but no episode of atrial fibrillation that was longer than 7 days (without spontaneous termination or cardioversion) |
| Exclusion criteria | Age of more than 70 years Previous or ongoing treatment with class IC or class III antiarrhythmic drugs Contraindication to both class IC and class III agents Previous ablation for atrial fibrillation Left atrial diameter of more than 50 mm Left ventricular ejection fraction of less than 40% Contraindication to oral anticoagulation therapy Moderate-to-severe mitral valve disease Severe heart failure (New York Heart Association functional class III to IV at the time of enrollment) Expected surgery for structural heart disease Secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism). |
| Follow-up | 24 months |
| Primary endpoint | Percentage of time in atrial fibrillation on 7 Holter-monitor recordings at 3, 6, 12, 18, and 24 months (Only episodes of atrial fibrillation longer than 1 minute were included in the analysis) |
| Secondary endpoint(s) | Freedom from any atrial fibrillation and freedom from symptomatic atrial fibrillation at 24 months of follow-up Cumulative and per-visit burden of symptomatic atrial fibrillation Time to first recurrence of atrial fibrillation after the blanking period Atrial flutter longer than 1 minute Quality of life was assessed at baseline and at 12 and 24 months with the use of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical-component summary score and mental-component summary score (both of which range from 0 to 100, with higher scores indicating greater well-being) |
| Details | . |
| Brief summary: | Ablation not superior to drugs 1st line for paroxysmal AF |
| PAPER: Radiofrequency Ablation as Initial Therapy in Paroxysmal Atrial Fibrillation | |
|---|---|
| Date | 25 Oct 2012 |
| Journal | N Engl J Med 2012; 367:1587-1595 |
| Information | In new PAF patients with no prior med treatment, ablation vs. drug therapy -No significant difference between treatment groups in the cumulative burden of atrial fibrillation (At 3, 6, 12, 18, and 24 months) -Trend emerging by 2 years --85% of free of AF in the ablation group vs.71% in the drug-therapy group N.B. 1) 36% of patients in the drug-therapy group had crossed over to receive ablation 2) Patiently highly selected (e.g. none > 70 y/o) 3) 3-month “blanking period” after ablation where attacks were not counted |