Effect of Vascepa (icosapent ethyl) on progression of coronary atherosclerosis in patients with elevated triglycerides (200–499 mg/dL) on statin therapy: Rationale and design of the EVAPORATE study

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  Figure 1. The potential effects of EPA on atherosclerosis. Atherosclerosis is a multistep process ranging from endothelial dysfunction to plaque development, progression, and rupture, leading to thrombus formation and cardiovascular events.2, 3 EPA has been reported to have beneficial effects on multiple atherosclerosis processes including endothelial function, oxidative stress, foam‐cell formation, inflammation/cytokines, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture.2 Abbreviations: CE, cholesteryl ester; EPA, eicosapentaenoic acid; HDL, high‐density lipoprotein; IFN, interferon; IL, interleukin; LDL, low‐density lipoprotein; MMP, matrix metalloproteinase; ox‐LDL, oxidized low‐density lipoprotein; SMC, smooth muscle cell; TG, triglycerides

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  Figure 2. EVAPORATE study design. At baseline and 9 months, assessments will include BP, height, weight, laboratory blood testing, physical examinations, MDCTA (to assess progression of low‐attenuation plaque volume), and safety evaluation. Safety will also be assessed at 3 months for all patients and at 15 months for patients continuing for a total of 18 months of treatment. *If a statistician and the Data Safety and Monitoring Board find that efficacy is not achieved at 9 months, patients will be followed for an additional 9 months to assess progression of low‐attenuation plaque volume by MDCTA. If a P value of ≤0.006 is achieved at 9 months, then the study will terminate because the efficacy boundary will have been achieved. Abbreviations: BP, blood pressure; EVAPORATE, Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy study; MDCTA, multi‐detector computed tomography angiography