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Level of evidence A Data derived from multiple randomized clinical trials or meta-analyses Level of evidence B Data derived from a single randomized clinical trial or large non-randomized studies Level of evidence C Consensus of opinion of the experts and/ or small studies, retrospective studies, registries

MD; for the OMEGA Study GroupBackground-There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction. Methods and Results-OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (nϭ3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (Pϭ0.84); total mortality, 4.6% and 3.7% (Pϭ0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (Pϭ0.1); and revascularization in survivors, 27.6% and 29.1% (Pϭ0.34). Conclusions-Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids. Clinical Trial Registration-URL: http://www.clinicaltrials.gov.