Randomized Trial of Omega-3 Fatty Acids on Top of Modern Therapy After Acute Myocardial Infarction - OMEGA

Description:

The goal of the trial was to evaluate treatment with omega-3 fatty acids in addition to standard medical therapy compared with standard medical therapy alone in patients after acute myocardial infarction (MI).

Hypothesis:

Omega-3 fatty acids would be more effective in preventing sudden cardiac death, as compared with placebo in patients with acute MI treated with standard therapy.

Study Design

  • Blinded
  • Placebo Controlled
  • Randomized

Patients Enrolled: 3,851
Mean Follow Up: 1 year
Mean Patient Age: 64 years
Female: 26%

Patient Populations:

  • Patients within 3-14 days from NSTEMI or STEMI
  • Age at least 18 years

Exclusions:

  • Pregnant or nursing women
  • Hypersensitivity to study drugs
  • Already taking fish oil
  • Expected noncompliance

Primary Endpoints:

  • Sudden cardiac death

Secondary Endpoints:

  • All-cause mortality
  • Nonfatal MI
  • Stroke
  • Arrhythmic events
  • Revascularization

Drug/Procedures Used:

Patients who were 3-14 days after a non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) were randomized to omega-3 fatty acids and standard medical therapy (n = 1,940) versus standard medical therapy alone (n = 1,911). The test drug (omega) was a soft gelatin capsule containing 1 g omega-3 acid ethyl esters-90 (460 mg eicosapentaenoic acid, 380 mg docosahexaenoic acid).

Concomitant Medications:

Medications at the time of discharge were aspirin in 95%, clopidogrel in 88%, angiotensin-converting enzyme inhibitors in 83%, beta-blockers in 94%, and statins in 94%.

Principal Findings:

Overall, 3,851 patients were randomized. The mean age was 64 years, 26% were women, 66% had hypertension, 50% had hypercholesterolemia, 27% had diabetes, and 37% were smokers. Acute coronary syndrome was due to STEMI in 59% and NSTEMI in 41%. Coronary angiography was performed in 94% of patients, percutaneous coronary intervention in 78%, and thrombolysis in 8%.

At 1 year, the primary outcome, sudden cardiac death, occurred in 1.5% of the omega-3 group versus 1.5% of the control group (odds ratio [OR] 0.95, 95% confidence interval [CI] 0.56-1.60, p = 0.84).

Overall major adverse cardiac and cerebrovascular event (MACCE) rates were similar between the omega-3 and the control arms: 10.4% vs. 8.8%. For individual outcomes, all-cause mortality was 4.6% versus 3.7%, MI was 4.5% versus 4.1%, stroke was 1.4% versus 0.7%, revascularization was 27.7% versus 29.1%, and total arrhythmic events were 1.1% versus 0.7%, respectively, for omega-3 versus control. At follow-up, triglyceride levels were 121 versus 126 mg/dl, respectively.

Interpretation:

Among patients with recent NSTEMI or STEMI, treatment with omega-3 fatty acids did not appear to be of benefit. This treatment did not reduce the primary outcome, sudden cardiac death, or any of the individual cardiac outcomes. There was also no difference in triglyceride levels at follow-up.

These results are contradictory to those noted in the GISSI-Prevention trial, in which a 45% reduction in mortality was noted with omega-3, as compared with standard therapy in post-MI patients. However, in the GISSI-Prevention trial, medication use was open-label, and adjunctive medical therapy was poor (4.7% on cholesterol-lowering medications at discharge). Thus, based on these and other clinical data, the use of omega-3 fatty acids in addition to optimal medical therapy after an acute coronary syndrome cannot be endorsed.

References:

Rauch B, Schiele R, Schneider S, et al., on behalf of the OMEGA Study Group. OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. Circulation 2010;122:2152-2159.

Presented by Dr. Jochen Senges at ACC.09/i2, Orlando, FL, March 2009.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, SCD/Ventricular Arrhythmias, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Nonstatins, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging, Hypertension

Keywords: Odds Ratio, Myocardial Infarction, Stroke, Acute Coronary Syndrome, Follow-Up Studies, Gelatin, Hypercholesterolemia, Eicosapentaenoic Acid, Percutaneous Coronary Intervention, Coronary Angiography, Docosahexaenoic Acids, Fatty Acids, Omega-3, Esters, Confidence Intervals, Triglycerides, Hypertension, Death, Sudden, Cardiac, Diabetes Mellitus


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