Abstract 3080: Effectiveness of Eicosapentanoic Acid for Preventing Coronary Artery Disease: Secondary Prevention Strata
Introduction: The Japan EPA (eicosapentanoic acid) Lipid Intervention Study (JELIS) was a prospective randomized open-label blinded endpoint trial that examined the effects of EPA on hypercholesterolemia and in preventing coronary artery disease (CAD). We conducted a post hoc subgroup analysis of this trial to determine whether EPA is effective for secondary prevention of CAD.
Methods: We analyzed data from JELIS, a randomized trial of EPA + statin (EPA group; n=1,823) versus statin only (control group; n=1,841) in 3,664 patients with established CAD and total cholesterol level of at least 250 mg/dL (7.1 mmol/L). We excluded the patients with unstable angina, myocardial infarction within the last 6 months, angioplasty/ stenting within the last 6 months. The primary endpoint was major coronary events (MCE: sudden cardiac death, fatal and nonfatal myocardial infarction (MI), unstable angina pectoris including hospitalization for ischemic episodes, and events of angioplasty/stenting or coronary artery bypass grafting). Study analyses were performed in the intention-to-treat population.
Results: Patients were followed for an average of 4.6 years with 93% follow-up rate. There was no significant difference of serum lipid profiles among two groups during the study period. The incidence of MCE in EPA group (8.7%) was significantly lower than that in control group (10.7%, adjusted hazard ratio=0.77, P=0.017, NNT=49). In subgroup of 1,050 patients with prior MI, the incidence of MCE in EPA group (15.0%) was also significantly lower than that in control group (20.1%, adjusted hazard ratio=0.73, P=0.033, NNT=19). In EPA group, 62% of subjects achieved to EPA/arachidonic acid (AA) ratio of 1.0 or above, in comparison to only 10% in the control group. The incidence of cardiac death or MI was significantly lower (P=0.038) in the patients group showing a high EPA/AA ratio.
Conclusion: EPA appears effective for secondary prevention of CAD, especially in individuals with prior MI, which effect might be independent from serum cholesterol levels. A high plasma EPA/AA ratio significantly contributed to the prevention of cardiac death and re-attack of MI. These results indicate that EPA should be additive to a conventional treatment for the secondary prevention of CAD.