title: 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: OBJECTIVE
  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.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina. Electronic address: macchia@negrisud.it.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Macchia
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Hugo
authors.initials: H
authors.lastname: Grancelli
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Sergio
authors.initials: S
authors.lastname: Varini
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Daniel
authors.initials: D
authors.lastname: Nul
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Nicolás
authors.initials: N
authors.lastname: Laffaye
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Javier
authors.initials: J
authors.lastname: Mariani
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ferrante
authors.affiliation: Hospital Privado de la Comunidad, Mar del Plata, Provincia de Buenos Aires, Argentina.
authors.forename: Raúl
authors.initials: R
authors.lastname: Badra
authors.affiliation: Fundación Favaloro, Buenos Aires, Argentina.
authors.forename: Julio
authors.initials: J
authors.lastname: Figal
authors.affiliation: Clínica Constituyentes, Morón, Provincia de Buenos Aires, Argentina.
authors.forename: Silvina
authors.initials: S
authors.lastname: Ramos
authors.affiliation: Fondazione Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Tognoni
authors.affiliation: Fundación GESICA (Grupo de Estudio de Investigación Clínica en Argentina), Buenos Aires, Argentina.
authors.forename: Hernán C
authors.initials: HC
authors.lastname: Doval
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy; D019587:Dietary Supplements; D004311:Double-Blind Method; D004554:Electric Countershock / Q000379:methods*; D004562:Electrocardiography; D023381:Endpoint Determination / Q000706:statistics & numerical data; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D006334:Heart Function Tests / Q000379:methods*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D055502:Secondary Prevention; D020521:Stroke / Q000453:epidemiology / Q000209:etiology*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D015525:Fatty Acids, Omega-3