Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial.

Abstract

OBJECTIVES:

The aim of this study was to evaluate the efficacy of polyunsaturated fatty acids (n-3 PUFA) for the prevention of recurrent atrial fibrillation (AF) in patients with normal sinus rhythm.

BACKGROUND:

Current pharmacological treatments to limit recurrent AF in patients with previous AF have limited efficacy and high rates of adverse events. Results of trials that tested the efficacy of n-3 PUFA provided heterogeneous results.

METHODS:

This was a prospective, randomized, double-blind, placebo-controlled, multicenter trial involving 586 outpatient participants with confirmed symptomatic paroxysmal AF that required cardioversion (n = 428), at least 2 episodes of AF in the 6 months before randomization (n = 55), or both (103). Patients were randomly allocated to n-3 PUFA (1 g/day) or placebo for 12 months. The primary endpoint was symptomatic recurrence of AF.

RESULTS:

There were no significant differences between patients allocated to placebo and those who received n-3 PUFA for the main outcome. At 12 months, 56 of 297 participants (18.9%) in the placebo group and 69 of 289 participants (24.0%) in the n-3 PUFA group had a recurrent symptomatic AF (hazard ratio: 1.28, 95% confidence interval: 0.90 to 1.83, p = 0.17). There was no difference between treatment with placebo and n-3 PUFA for any of the other pre-specified endpoints, including the composite of all-cause mortality, nonfatal stroke, nonfatal acute myocardial infarction, systemic embolism, heart failure development, or severe bleeding that occurred in 20 (6.7%) and 16 (5.5%) of patients randomized to placebo or n-3 PUFA, respectively (hazard ratio: 0.86, 95% confidence interval: 0.44 to 1.66, p = 0.65).

CONCLUSIONS:

Pharmacological supplementation with 1 g of n-3 PUFA for 1 year did not reduce recurrent AF. (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation [FORWARD]; NCT00597220).

• Authors: Alejandro Macchia, Hugo Grancelli, Sergio Varini, Daniel Nul, Nicolás Laffaye, Javier Mariani, Daniel Ferrante, Raúl Badra, Julio Figal, Silvina Ramos, Gianni Tognoni, Hernán C Doval, GESICA Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 61 Issue 4 Pg. 463-468 (Jan 29 2013) ISSN: 1558-3597 [Electronic] United States
• PMID: 23265344 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Arrhythmia Agents
• Fatty Acids, Omega-3

Topics

• Aged
• Anti-Arrhythmia Agents (administration & dosage)
• Atrial Fibrillation (diagnosis, mortality, physiopathology, therapy)
• Dietary Supplements
• Double-Blind Method
• Electric Countershock (methods)
• Electrocardiography
• Endpoint Determination (statistics & numerical data)
• Fatty Acids, Omega-3 (administration & dosage)
• Female
• Heart Function Tests (methods)
• Hospitalization (statistics & numerical data)
• Humans
• Male
• Middle Aged
• Secondary Prevention
• Stroke (epidemiology, etiology)
• Survival Rate
• Treatment Outcome