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- Title
Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial.
- Authors
Ahmed S; Rienstra M; Crijns HJ; Links TP; Wiesfeld AC; Hillege HL; Bosker HA; Lok DJ; Van Veldhuisen DJ; Van Gelder IC; CONVERT Investigators; Ahmed, Sheba; Rienstra, Michiel; Crijns, Harry J G M; Links, Thera P; Wiesfeld, Ans C P; Hillege, Hans L; Bosker, Hans A; Lok, Dirk J A; Van Veldhuisen, Dirk J
- Abstract
<bold>Context: </bold>Amiodarone effectively suppresses atrial fibrillation but causes many adverse events.<bold>Objective: </bold>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.<bold>Design, Setting, and Participants: </bold>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.<bold>Intervention: </bold>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.<bold>Main Outcome Measures: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT00392431.
- Publication
JAMA: Journal of the American Medical Association, 2008, Vol 300, Issue 15, p1784
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.300.15.1784