OMega-3 fatty acids in Elderly with Myocardial Infarction - OMEMI

Nov 15, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Stein Erik Hagen Foundation for Clinical Heart Research and others
Date Presented:
11/15/2020
Date Published:
11/15/2020
Date Updated:
11/15/2020
Original Posted Date:
11/15/2020
References

Contribution To Literature:

The OMEMI trial failed to show that PUFA was superior to placebo at preventing adverse cardiovascular outcomes.

Description:

The goal of the trial was to evaluate n-3 polyunsaturated fatty acids (PUFAs) compared with placebo among elderly patients with recent myocardial infarction.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Double-blind
  • Stratification

Elderly patients with recent myocardial infarction were randomized to 1.8 g n-3 fatty acids (n = 513) versus placebo (n = 514). The study medication contained 930 g of eicosapentaenoic acid (EPA) and 660 g of docosahexaenoic acid (DHA).

  • Total number of enrollees: 1,027
  • Duration of follow-up: 24 months
  • Mean patient age: 74 years
  • Percentage female: 29.3%

Inclusion criteria:

  • Patients 70-82 years of age
  • Myocardial infarction 2-8 weeks prior to randomization

Exclusion criteria:

  • Intolerance to study medication
  • Limited life expectancy

Other salient features/characteristics:

  • In the PUFA group, serum EPA levels increased 87% and DHA increased 16%.
  • In the placebo group, serum EPA levels decreased -13% and DHA decreased -8%.

Principal Findings:

The primary outcome of all-cause death, nonfatal myocardial infarction, unscheduled revascularization (stent or bypass surgery), stroke, or hospitalization for heart failure at 24 months occurred in 21.0% of the PUFA group compared with 19.8% of the placebo group (p = 0.62). The treatment effect was the same in tested subgroups.

Secondary outcomes:

  • Atrial fibrillation: 7.2% of the PUFA group compared with 4.0% of the placebo group (p = 0.06)
  • Major bleeding: 10.7% of the PUFA group compared with 11.0% of the placebo group (p = 0.87)

Interpretation:

Among elderly patients with recent myocardial infarction, PUFA was not beneficial. Major adverse cardiovascular events were similar between treatment groups. There was a numerical increase in atrial fibrillation with PUFA. Major bleeding was similar between the groups.

This study contrasts with the REDUCE-IT trial, which found that icosapent ethyl was associated with a 25% reduction in cardiovascular events. Icosapent ethyl was associated with a 386% increase in serum EPA levels compared with placebo.

References:

Kalstad AA, Myhre PL, Laake K, et al., on behalf of the OMEMI Investigators. Effects of n-3 Fatty Acid Supplements in Elderly Patients After Myocardial Infarction: A Randomized Controlled Trial. Circulation 2020;Nov 15:[Epub ahead of print].

Presented by Dr. Are A. Kalstad at the American Heart Association Virtual Scientific Sessions, November 15, 2020.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Dyslipidemia, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Lipid Metabolism, Nonstatins, Acute Heart Failure, Interventions and ACS, Stable Ischemic Heart Disease

Keywords: AHA20, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Atrial Fibrillation, Docosahexaenoic Acids, Eicosapentaenoic Acid, Fatty Acids, Omega-3, Fatty Acids, Unsaturated, Geriatrics, Heart Failure, Hemorrhage, Myocardial Infarction, Myocardial Revascularization, Primary Prevention, Stents, Stroke


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