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Published on: February 28, 2012
Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized
Sheba Ahmed1, Michiel Rienstra, Harry J G M Crijns
1Department of Cardiology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands.
Insights
Episodic amiodarone treatment for atrial fibrillation did not differ in major adverse events but increased recurrence and mortality. Continuous treatment maintained sinus rhythm with fewer recurrences and lower mortality.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Amiodarone is effective for atrial fibrillation but associated with adverse events.
- Evaluating alternative amiodarone treatment strategies is crucial for patient safety.
- Recurrent symptomatic persistent atrial fibrillation poses significant health risks.
Purpose of the Study:
- To compare major adverse events between episodic and continuous amiodarone treatment for atrial fibrillation.
- To assess the efficacy of episodic versus continuous amiodarone in maintaining sinus rhythm.
- To evaluate the impact of amiodarone treatment strategies on mortality and hospitalizations.
Main Methods:
- A randomized trial involving 209 patients with recurrent symptomatic persistent atrial fibrillation.
- Patients received either episodic or continuous amiodarone treatment post-cardioversion.
- Primary endpoint: composite of amiodarone and heart disease-related major events; secondary endpoints: mortality and hospitalizations.
Main Results:
- No significant difference in the primary composite endpoint between episodic and continuous amiodarone groups.
- Episodic treatment led to significantly higher atrial fibrillation recurrence rates (80% vs 54%).
- Episodic treatment was associated with higher all-cause mortality and cardiovascular hospitalizations (53% vs 34%).
Conclusions:
- Episodic amiodarone did not reduce major adverse events compared to continuous treatment.
- Episodic amiodarone significantly increased atrial fibrillation recurrence.
- Continuous amiodarone treatment is associated with better outcomes regarding mortality and hospitalizations.
Context:
Amiodarone effectively suppresses atrial fibrillation but causes many adverse events.
Objective:
To compare major events in patients randomized to receive episodic amiodarone treatment with those who received continuous amiodarone treatment while still aiming to prevent atrial fibrillation.
Design, Setting, And Participants:
A randomized trial of 209 ambulatory patients with recurrent symptomatic persistent atrial fibrillation, conducted from December 2002 through March 2007 at 7 Dutch medical centers.
Intervention:
Patients were randomly assigned to receive either episodic or continuous amiodarone treatment after electrical cardioversion following amiodarone loading. Episodic amiodarone treatment was discontinued after a month of sinus rhythm and reinitiated if atrial fibrillation relapsed (1 month peri-electrical cardioversion). In the continuous treatment group amiodarone was maintained throughout.
Main Outcome Measures:
The primary end point was a composite of amiodarone and underlying heart disease-related major events. The secondary end points were all-cause mortality and cardiovascular hospitalizations.
Results:
After a median follow-up of 2.1 years (range, 0.4-2.5 years), 51 (48%) of those receiving episodic treatment vs 64 (62%) receiving continuous treatment had sinus rhythm (P = .05). There were 85 atrial fibrillation recurrences (80%) among the episodic treatment group vs 56 (54%) in the continuous treatment group (P < .001). No significant difference existed in the incidence of the primary composite end point between each group (37 [35%] episodic vs 34 [33%] continuous; incidence rate difference, 0.2; 95% confidence interval [CI], -10.2 to 10.6). However, there were nonstatistically significant differences in the incidence of amiodarone-related major events (20 [19%] episodic vs 25 [24%] continuous; incidence rate difference, -2.0; 95% CI, -8.7 to 4.6) and underlying heart disease-related major events (17 [16%] episodic vs 9 [9%] continuous; incidence rate difference, 3.6; 95% CI, -1.6 to 8.7). All-cause mortality and cardiovascular hospitalizations were higher among those receiving episodic treatment (56 [53%] vs 35 [34%], P = .02).
Conclusions:
In this study population, there was no difference in the composite of amiodarone and cardiac major adverse events between groups. However, patients receiving episodic treatment had a significantly increased rate of atrial fibrillation recurrence and a significantly higher rate of all-cause mortality and cardiovascular hospitalizations.
Trial Registration:
clinicaltrials.gov Identifier: NCT00392431.
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