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Effects of N-3 Fatty Acid Supplements on Clinical Outcome After Myocardial Infarction in The Elderly: Results of the Omemi Trial

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Author Block: Are Annesoenn A Kalstad, Oslo Univ Hosp, Ullevaal, Oslo, Norway; Peder L Myhre, Akershus Univ Hosp, Lørenskog, Norway; Sjur Hansen Tveit, Akershus Univ Hosp, CRG, Lorenskog, Norway; Laake Kristian, Oslo Univ Hosp, Ullevaal, Oslo, Norway; Svein Solheim, Oslo Univ Hosp, Ulleval, Oslo, Norway; Arnljot Tveit, Vestre Viken Bærum Hosp, Gjettum, Norway; Erik B Schmidt, Aalborg Univ Hosp, Aalborg, Denmark; Pal Johan Smith, Akershus Univ Hosp, Lørenskog, Norway; Morten Fagerland, Oslo Univ Hosp, Ullevaal, Oslo, Norway; Dennis W Nilsen Sr., Stavenger Univ Hosp, Stavanger, Norway; Ingebjorg Seljeflot, Harald Arnesen, Oslo Univ Hosp, Ullevaal, Oslo, Norway
Disclosure Block: A.A.Kalstad: None. D.W.Nilsen: None. I.Seljeflot: None. H.Arnesen: None. P.L.Myhre: Speaker/Speaker's Bureau; Modest; Novartis. S.Tveit: None. L.Kristian: n/a. S.Solheim: None. A.Tveit: None. E.B.Schmidt: n/a. P.Smith: n/a. M.Fagerland: None.
Introduction High intake of marine n-3 polyunsaturated fatty acids (PUFA) has been associated with reduced risk of cardiovascular events, however, this has not been confirmed in patients with a recent myocardial infarction (MI). Elderly patients are at particularly increased cardiovascular risk after MI, but few trials address this group specifically. Omega-3 fatty acids hold the potential to reduce cardiovascular events, with limited adverse effects, in this vulnerable group. Hypothesis Supplementation with marine n-3 PUFAs reduces the risk of cardiovascular events and total mortality in elderly patients with a recent MI. Methods The OMega-3 fatty acids in Elderly with Myocardial Infarction (OMEMI) trial is a multi-center, randomized, placebo-controlled, double-blind clinical trial designed to determine the effect of adding 1.8 g marine n-3 PUFA (Pikasol®; 930 mg EPA and 660 mg DHA) to standard of care in patients aged 70-82 years old with a recent MI. Corn oils was used as placebo. The primary outcome was a composite of non-fatal MI, unscheduled revascularization, stroke, hospitalization for heart failure and all-cause death. The primary safety outcome was major bleeding (Bleeding Academic Research Consortium grade >= 2). Pre-defined follow-up time was 2 years. Fatty acids in serum phospholipids were measured at inclusion and end of study to assess compliance. Results Follow-up data for 1.014 patients were available for intention-to-treat analysis. Key baseline characteristics are given in Table. The primary endpoint occurred in 108 (21.4%) patients on n-3 PUFA vs 102 (20.0%) on placebo (HR 1.08 [95%CI 0.82-1.41], p=0.60) (Fig A). Consistent results were found for each component of the primary outcome, and across key clinical subgroups. Results in per-protocol analysis were similar. There were also no differences between the groups in total mortality (Fig B). Changes in EPA and DHA were +87% and +16% for n-3 PUFA vs -13% and -8% for placebo, indicating good overall treatment adherence. Conclusion Among elderly patients with a recent myocardial infarction, treatment with 1.8 g n-3 PUFAs daily for 2 years did not reduce the risk of clinical events.