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.

The arithmetic test was associated with a significantly higher heart rate for CLS than for AS, showing a greater sensitivity of CLS-based rate adaptation to mental stress. Performance during physical stress was comparable. Patients preferred CLS.

Clinical performance of CLS was very satisfactory in the large cohort studied.

The TmSC-based management concept was well accepted and appreciated by the majority of physicians and patients. It may be helpful in gaining symptomatic information on top of automatic HM data and in supporting smaller clinics in the follow-up of their device patients.

No abstract