June 1, 2002Open Access

An evaluation of the strategy of maintenance of sinus rhythm by antiarrhythmic drug therapy after ablation and pacing therapy in patients with paroxysmal atrial fibrillation

Q: What is the clinical evidence from this study?

Study design: RCT. Population: severely symptomatic paroxysmal atrial fibrillation (n=137). Intervention: Antiarrhythmic drug therapy (amiodarone, propafenone, flecainide or sotalol) vs. No antiarrhythmic drug therapy. Primary outcome: Development of permanent atrial fibrillation (57% risk reduction, p=0.02).

Key Result

Antiarrhythmic drug therapy after AV junction ablation and pacing reduced the risk of developing permanent atrial fibrillation compared to no antiarrhythmic therapy (21% vs 37%, P=0.02).

Study Design

Type

RCT (n=137)

Randomization

randomized

Multicenter

Yes

Structured PICO

Does antiarrhythmic drug therapy reduce the development of permanent atrial fibrillation in patients with severely symptomatic paroxysmal atrial fibrillation after AV junction ablation and pacing?

Population

137 patients with severely symptomatic paroxysmal atrial fibrillation after successful atrioventricular junction ablation and pacing treatment

Intervention

Antiarrhythmic drug therapy (amiodarone, propafenone, flecainide, or sotalol) to restore and maintain sinus rhythm

Comparator

No antiarrhythmic drug therapy (allowing patients to remain in atrial fibrillation)

Outcome

Development of permanent atrial fibrillationhard clinical

While antiarrhythmic therapy reduces the risk of permanent atrial fibrillation after AV junction ablation and pacing, it does not improve quality of life and is associated with increased heart failure episodes and hospitalizations.

Main Result

Effect estimate: 57% risk reduction

Absolute Event Rate: 21% vs 37%

p-value: p=0.02

Abstract

AIMS: Permanent atrial fibrillation develops in many patients after ablation and pacing therapy. We compared a strategy that initially allowed patients to remain in atrial fibrillation with a strategy that initially attempted to restore and maintain sinus rhythm. METHODS AND RESULTS: In this multicentre randomized controlled trial, 68 patients affected by severely symptomatic paroxysmal atrial fibrillation were assigned, after successful atrioventricular junction ablation and pacing treatment, to antiarrhythmic drug therapy with amiodarone, propafenone, flecainide or sotalol and were compared with 69 patients assigned, after successful AV junction ablation and pacing treatment, to no antiarrhythmic drug therapy. The patients were followed-up for 12 to 24 months (mean 16+/-4). The drug arm patients had a 57% reduction in the risk of developing permanent atrial fibrillation (21% vs 37%, P=0.02). Evaluation after 12 months revealed similar quality of life scores and echocardiographic parameters in the two groups, but the drug arm patients had more episodes of heart failure and hospitalizations (P=0.05). The outcome was similar between the 40 patients who developed permanent atrial fibrillation and the 97 who did not. CONCLUSION: Conventional antiarrhythmic therapy reduces the risk of development of permanent atrial fibrillation after ablation and pacing therapy. The present data do not support the concept that the development of permanent atrial fibrillation is related to an adverse outcome when a perfect control of heart rate is obtained by ablation and pacing.