Novel risk model for predicting incident atrial fibrillation in patients taking ω-3 fatty acid: sub-analysis of the STRENGTH randomized trial
Abstract
BACKGROUND: Fish oils are associated with higher risk of incident atrial fibrillation (AF) in randomized trials, risk factors for this remain unknown. We analyzed associated factors and developed a novel risk score for predicting AF in patients at elevated cardiovascular risk in this secondary analysis of the STRENGTH trial.
METHODS: The STRENGTH trial randomized 13,078 patients at high cardiovascular risk at 1:1 ratio to receive either ω-3 carboxylic acid (CA) or corn oil placebo at 675 centers during 10/30/2014-6/14/2017. Multivariable Cox proportional hazards regression was performed to develop a risk score to help identify new AF during follow-up in the ω-3 CA group without prior history of AF.
RESULTS: Amongst 6000 ω-3 CA group and 6012 placebo group patients without history of AF, 126 (2.1 %) and 75 (1.2 %) developed AF, respectively, during mean follow-up of 3.5 ± 0.8 years. In the ω-3 CA arm, older age, males, higher body mass index, history of heart failure, diabetes on insulin, and elevated high-sensitivity C-reactive protein were independently associated with incident AF during follow-up. A novel risk score based on these six parameters predicted incident AF with c-index 0.72 in the ω-3 CA group, and 0.73 when applied to the placebo group.
CONCLUSION: A novel risk score for predicting AF development in patients at elevated cardiovascular risk receiving ω-3 CA had moderate discriminative ability in both patients receiving ω-3 CA and placebo. Further research is…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 13,078 participants or records.
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