Icosapent Ethyl helps achieve coronary plaque regression in CAD: EVAPORATE trial
USA: Treatment of coronary atherosclerosis patients with icosapent ethyl (IPE) helped to achieve significant regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT), according to results from the EVAPORATE trial. The findings were presented at the European Society of Cardiology (ESC) Congress 2020 and concurrently published in the European Heart Journal.
Despite treatment with statins for reducing cardiovascular events and slowing the progression of coronary atherosclerosis, there remains a significant cardiovascular risk. Icosapent ethyl (Vascepa) is a highly purified eicosapentaenoic acid ethyl ester which when added to a statin was shown to reduce CV events by 25% and total CV events by 32% in the REDUCE-IT trial. The mechanics of benefits were however not fully experienced.
The EVAPORATE trial by Matthew J Budoff, Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA, and colleagues sought to determine whether IPE 4 g/day given in addition to statin and diet, would result in a greater change from baseline in plaque volume, measured by serial MDCT, than placebo in statin-treated patients.
A total of 80 patients were enrolled in this randomized, double-blind, placebo-controlled trial. Conditions for inclusion -- the presence of coronary atherosclerosis as documented by MDCT (one or more angiographic stenoses with ≥20% narrowing), having persistently elevated triglyceride (TG) levels, and on statin therapy. They underwent an interim scan at 9 months and a final scan at 18 months with coronary computed tomographic angiography.
The pre-specified primary endpoint was changed in LAP volume at 18 months between IPE and placebo groups.
Key findings of the study include:
- Baseline demographics, vitals, and laboratory results were not significantly different between the IPE and placebo groups; the median TG level was 259.1 ± 78.1 mg/dL.
- There was a significant reduction in the primary endpoint as IPE reduced LAP plaque volume by 17%, while in the placebo group LAP plaque volume more than doubled (+109%).
- There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group.
- When further adjusted for age, sex, diabetes status, hypertension, and baseline TG, plaque volume changes between groups remained significantly different.
- Only dense calcium did not show a significant difference between groups in multivariable modelling.
"Icosapent ethyl demonstrated significant regression of LAP volume on MDCT than placebo over 18 months. The trial provides important mechanistic data on plaque characteristics that may have relevance to the REDUCE-IT results and clinical use of IPE," concluded the authors.
The study, "Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial," is published in the European Heart Journal.
