In elderly patients with a recent myocardial infarction (MI), 1.8 g of marine n-3 polyunsaturated fatty acids (PUFA) did not lower the incidence of cardiovascular (CV) events or all-cause death after 2 years of follow-up in the placebo-controlled OMEMI trial . The investigators could not rule out an increased risk of atrial fibrillation (AF).
Dr Are Kalstad (Oslo University Hospital, Norway) pointed out that elderly patients have a particularly increased CV risk after MI, even with secondary prevention; yet, this group is underrepresented in clinical trials. The hypothesis of the OMEMI trial (NCT01841944) was that supplementation with marine n-3 PUFA lowers the risk of CV events and total mortality in elderly patients with a recent MI during 2 years of follow-up. Participants were 70–82 years old and had an MI 2–8 weeks prior to inclusion. They were randomised to 1.8 g marine n-3 PUFA (Pikasol®: 930 mg EPA and 660 mg DHA) or placebo added to standard of care. The primary outcome was a composite of non-fatal MI, unscheduled revascularisation, stroke, hospitalisation for heart failure, or all-cause death. The primary safety outcome was major bleeding. The results were simultaneously published in Circulation .
Follow-up data for 1,014 patients were available for intention-to-treat analysis. Mean age was 74 years, and 29% were female. The primary endpoint occurred in 108 (21.4%) patients on n-3 PUFA and in 102 (20.0%) on placebo (HR 1.07; 95% CI 0.82–1.40; P=0.62). Consistent results were found for each component of the primary outcome and across key clinical subgroups. Findings were similar in a per-protocol analysis. There were 28 deaths in each group. There was no difference in risk of major bleeding: 54 (10.7%) and 56 (11.0%), respectively. An intention-to-treat analysis (n=759) of atrial fibrillation showed 28 (7.2%) and 15 (4.0%) new cases in the experimental and placebo group, respectively (HR 1.84; 95% CI 0.98–3.44; P=0.06). Self-reported adherence was good in both groups (87%), which was supported by changes in EPA and DHA.
- Kalstad AA, et al. Effects of N-3 Fatty Acid Supplements on Clinical Outcome After Myocardial Infarction in The Elderly: Results of the Omemi Trial. LBS.04, AHA Scientific Sessions 2020, 13–17 Nov.
- Kalstad AA, et al. Circulation. 2020 Nov 15. Doi: 10.1161/CIRCULATIONAHA.120.052209.
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