Anil Nigam1, Mario Talajic2, Denis Roy2, Stanley Nattel2, Jean Lambert3, Anna Nozza3, Peter Jones4, Vanu R Ramprasath4, Gilles O'Hara5, Stephen Kopecky6, James M Brophy7, Jean-Claude Tardif2. 1. Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal Heart Institute Research Center, Montreal, Quebec, Canada. Electronic address: anil.nigam@icm-mhi.org. 2. Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal Heart Institute Research Center, Montreal, Quebec, Canada. 3. Coordinating Center and Université de Montréal, Montreal, Quebec, Canada. 4. Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg, Manitoba, Canada. 5. Department of Cardiology, Quebec Heart and Lung Institute, Quebec, Quebec, Canada. 6. Division of Cardiology, Mayo Clinic, Rochester, Minnesota. 7. McGill University Health Centre, Montreal, Quebec.
Abstract
BACKGROUND: Recent trials of fish oil for the prevention of atrial fibrillation (AF) recurrence have provided mixed results. Notable uncertainties in the existing evidence base include the roles of high-dose fish oil, inflammation, and oxidative stress in patients with paroxysmal or persistent AF not receiving conventional antiarrhythmic (AA) therapy. OBJECTIVES: The aim of this study was to evaluate the influence of high-dose fish oil on AF recurrence, inflammation, and oxidative stress parameters. METHODS: We performed a double-blind, randomized, placebo-controlled, parallel-arm study in 337 patients with symptomatic paroxysmal or persistent AF within 6 months of enrollment. Patients were randomized to fish oil (4 g/day) or placebo and followed, on average, for 271 ± 129 days. RESULTS: The primary endpoint was time to first symptomatic or asymptomatic AF recurrence lasting >30 s. Secondary endpoints were high-sensitivity C-reactive protein (hs-CRP) and myeloperoxidase (MPO). The primary endpoint occurred in 64.1% of patients in the fish oil arm and 63.2% of patients in the placebo arm (hazard ratio: 1.10; 95% confidence interval: 0.84 to 1.45; p = 0.48). hs-CRP and MPO were within normal limits at baseline and decreased to a similar degree at 6 months (Δhs-CRP, 11% vs. -11%; ΔMPO, -5% vs. -9% for fish oil vs. placebo, respectively; p value for interaction = NS). CONCLUSIONS: High-dose fish oil does not reduce AF recurrence in patients with a history of AF not receiving conventional AA therapy. Furthermore, fish oil does not reduce inflammation or oxidative stress markers in this population, which may explain its lack of efficacy. (Multi-center Study to Evaluate the Effect of N-3 Fatty Acids [OMEGA-3] on Arrhythmia Recurrence in Atrial Fibrillation [AFFORD]; NCT01235130).
RCT Entities:
BACKGROUND: Recent trials of fish oil for the prevention of atrial fibrillation (AF) recurrence have provided mixed results. Notable uncertainties in the existing evidence base include the roles of high-dose fish oil, inflammation, and oxidative stress in patients with paroxysmal or persistent AF not receiving conventional antiarrhythmic (AA) therapy. OBJECTIVES: The aim of this study was to evaluate the influence of high-dose fish oil on AF recurrence, inflammation, and oxidative stress parameters. METHODS: We performed a double-blind, randomized, placebo-controlled, parallel-arm study in 337 patients with symptomatic paroxysmal or persistent AF within 6 months of enrollment. Patients were randomized to fish oil (4 g/day) or placebo and followed, on average, for 271 ± 129 days. RESULTS: The primary endpoint was time to first symptomatic or asymptomatic AF recurrence lasting >30 s. Secondary endpoints were high-sensitivity C-reactive protein (hs-CRP) and myeloperoxidase (MPO). The primary endpoint occurred in 64.1% of patients in the fish oil arm and 63.2% of patients in the placebo arm (hazard ratio: 1.10; 95% confidence interval: 0.84 to 1.45; p = 0.48). hs-CRP and MPO were within normal limits at baseline and decreased to a similar degree at 6 months (Δhs-CRP, 11% vs. -11%; ΔMPO, -5% vs. -9% for fish oil vs. placebo, respectively; p value for interaction = NS). CONCLUSIONS: High-dose fish oil does not reduce AF recurrence in patients with a history of AF not receiving conventional AA therapy. Furthermore, fish oil does not reduce inflammation or oxidative stress markers in this population, which may explain its lack of efficacy. (Multi-center Study to Evaluate the Effect of N-3 Fatty Acids [OMEGA-3] on Arrhythmia Recurrence in Atrial Fibrillation [AFFORD]; NCT01235130).
Authors: Bulent Gorenek; Antonio Pelliccia; Emelia J Benjamin; Giuseppe Boriani; Harry J Crijns; Richard I Fogel; Isabelle C Van Gelder; Martin Halle; Gulmira Kudaiberdieva; Deirdre A Lane; Torben Bjerregaard Larsen; Gregory Y H Lip; Maja-Lisa Løchen; Francisco Marin; Josef Niebauer; Prashanthan Sanders; Lale Tokgozoglu; Marc A Vos; David R Van Wagoner; Laurent Fauchier; Irina Savelieva; Andreas Goette; Stefan Agewall; Chern-En Chiang; Márcio Figueiredo; Martin Stiles; Timm Dickfeld; Kristen Patton; Massimo Piepoli; Ugo Corra; Pedro Manuel Marques-Vidal; Pompilio Faggiano; Jean-Paul Schmid; Ana Abreu Journal: Eur J Prev Cardiol Date: 2016-11-04 Impact factor: 7.804
Authors: Bulent Gorenek; Antonio Pelliccia; Emelia J Benjamin; Giuseppe Boriani; Harry J Crijns; Richard I Fogel; Isabelle C Van Gelder; Martin Halle; Gulmira Kudaiberdieva; Deirdre A Lane; Torben Bjerregaard Larsen; Gregory Y H Lip; Maja-Lisa Løchen; Francisco Marín; Josef Niebauer; Prashanthan Sanders; Lale Tokgozoglu; Marc A Vos; David R Van Wagoner; Laurent Fauchier; Irina Savelieva; Andreas Goette; Stefan Agewall; Chern-En Chiang; Márcio Figueiredo; Martin Stiles; Timm Dickfeld; Kristen Patton; Massimo Piepoli; Ugo Corra; Pedro Manuel Marques-Vidal; Pompilio Faggiano; Jean-Paul Schmid; Ana Abreu Journal: Europace Date: 2017-02-01 Impact factor: 5.214
Authors: David S Siscovick; Thomas A Barringer; Amanda M Fretts; Jason H Y Wu; Alice H Lichtenstein; Rebecca B Costello; Penny M Kris-Etherton; Terry A Jacobson; Mary B Engler; Heather M Alger; Lawrence J Appel; Dariush Mozaffarian Journal: Circulation Date: 2017-03-13 Impact factor: 29.690