Key result
n-3 PUFA fails to reduce recurrent symptomatic AF compared to placebo.
Why the study?
Current pharmacological treatments to limit recurrent AF have limited efficacy and high adverse event rates, and previous trials of n-3 PUFA yielded heterogeneous results.
Does n-3 PUFA 1 g/day prevent symptomatic recurrence of AF in outpatients with confirmed symptomatic paroxysmal AF?
RCT (n=586)
double-blind
randomized
Yes
Does n-3 PUFA 1 g/day prevent symptomatic recurrence of AF in outpatients with confirmed symptomatic paroxysmal AF?
Effect estimate: HR 1.28 (95% CI 0.90-1.83)
Absolute Event Rate: 24% vs 18.9%
p-value: p=0.17
Pharmacological supplementation with 1 g/day of n-3 PUFA for 1 year does not reduce recurrent symptomatic atrial fibrillation in patients with paroxysmal AF.
n-3 PUFA 1 g/day does not prevent recurrent AF; challenges prior observational signals and reinforces null RCT evidence.
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).
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Macchia et al. (2012) conducted an RCT in symptomatic paroxysmal atrial fibrillation (n=586). n-3 PUFA vs. placebo was evaluated on symptomatic recurrence of AF (HR 1.28, 95% CI 0.90-1.83, p=0.17). Supplementation with n-3 PUFA (1 g/day) did not reduce recurrent symptomatic atrial fibrillation compared to placebo (24.0% vs 18.9%; HR 1.28; 95% CI 0.90-1.83; p=0.17).
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