Applicability of the REDUCE-IT trial to the FAST-MI registry. Are the results of randomized trials relevant in routine clinical practice?

Abstract

The REDUCE-IT data revealed robust CVD reduction with a strategy comprising of high dose omega-3 icosapent ethyl. In order to evaluate the applicability of REDUCE-IT, we applied the inclusion and exclusion criteria in the French Registry on Acute ST- elevation and non-ST-elevation Myocardial Infarction (FAST-MI). We included patients over 45 years, who had detailed lipid values 11.1 months after hospitalization for MI. We compared the applicability of REDUCE-IT [TG between 150 and 500 mg/dl and an LDL-C between 40 and 100 mg/dl while treated with statin therapy] in the FAST-MI registry. 12.5% of the patients met the eligibility criteria for REDUCE-IT. The differences between the REDUCE-IT like and REDUCE-IT excluded samples were related to age, male gender, body mass index, current smoking, hypertension, and the percentage of diabetic patients. In the REDUCE-IT like sample, the mean values of total cholesterol, TG (median) and the HDL-C were respectively 159, 192, 43 and the LDL-C value was 72 mg/dl. The distribution of the statin regimens in the REDUCE-IT like sample was as follows: 65.3%, 32.4% and 2.3% had high, moderate and low intensity statin therapy. The distribution of TG categories in the REDUCE-IT like sample was as follows: 55.3% (150-199), 36.0% (200-299) and 8.7% (300-500 mg/dl). The subgroup with TGs greater than 200 mg/dl and HDL-C less than 35 mg/dl was 16.1% in the REDUCE-IT like group and 2.1% in the REDUCE-IT excluded group ( P < 0.001). The cardiovascular event rate (death, nonfatal MI, nonfatal stroke) was respectively 36.7 for the FAST-MI REDUCE-IT like group and 36.9 per 1000 persons-years (CVD death, nonfatal MI, nonfatal stroke) for the REDUCE-IT trial. If the results of REDUCE-IT are applied to patients hospitalized for a myocardial infarction in France, on top of statins, 12.5% of these patients could benefit from a strategy of high dose omega-3 icosapent ethyl.