Early initiation of eicosapentaenoic acid and statin treatment is associated with better clinical outcomes than statin alone in patients with acute coronary syndromes: 1-year outcomes of a randomized controlled study

Background Early initiation of EPA treatment in combination with a statin within 24 h after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (MI) reduces inflammation and ventricular arrhythmia compared with statin monotherapy; however, the impact of early initiation of EPA treatment on cardiovascular events is unclear. We determined whether early eicosapentaenoic acid (EPA) treatment in patients with acute coronary syndrome (ACS) reduces adverse cardiovascular events. Methods This prospective, open-label, blind end point–randomized trial consisted of 241 patients with ACS. Patients were randomly assigned to receive pitavastatin (2 mg/day) with or without 1800 mg/day of EPA initiated within 24 h after PCI. The primary endpoint was defined as cardiovascular events occurring within 1 year, including death from a cardiovascular cause, nonfatal stroke, nonfatal MI and revascularization. Results The mean EPA/arachidonic acid ratio at follow-up was 0.40 in the control group and 1.15 in the EPA group. A primary endpoint event occurred in 11 patients (9.2%) in the EPA group and 24 patients (20.2%) in the control group (absolute risk reduction, 11.0%; hazard ratio, 0.42; 95% confidence interval, 0.21 to 0.87; P = 0.02). Notably, death from a cardiovascular cause at 1 year was significantly lower in the EPA group than in the control group (0.8% vs. 4.2%, P = 0.04). Conclusions Early initiation of treatment with EPA combined with statin after successful primary PCI reduced cardiovascular events after ACS. Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR); Registry Number, UMIN000016723; URL, http://www.umin.ac.jp/ctr/index-j.htm