Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial
Open accessAbstract
Aims: Despite the effects of statins in reducing cardiovascular events and slowing progression of coronary atherosclerosis, significant cardiovascular (CV) risk remains. Icosapent ethyl (IPE), a highly purified eicosapentaenoic acid ethyl ester, added to a statin was shown to reduce initial CV events by 25% and total CV events by 32% in the REDUCE-IT trial, with the mechanisms of benefit not yet fully explained. The EVAPORATE trial sought to determine whether IPE 4 g/day, as an adjunct to diet and statin therapy, would result in a greater change from baseline in plaque volume, measured by serial multidetector computed tomography (MDCT), than placebo in statin-treated patients. Methods and results: A total of 80 patients were enrolled in this randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis as documented by MDCT (one or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels. Patients 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 change in low-attenuation plaque (LAP) volume at 18 months between IPE and placebo groups. 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%) (P = 0.0061). 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 (P < 0.01 for all). When further adjusted for age, sex, diabetes status, hypertension, and baseline TG, plaque volume changes between groups remained significantly different, P < 0.01. Only dense calcium did not show a significant difference between groups in multivariable modelling (P = 0.053). Conclusions: Icosapent ethyl demonstrated significant regression of LAP volume on MDCT compared with placebo over 18 months. EVAPORATE provides important mechanistic data on plaque characteristics that may have relevance to the REDUCE-IT results and clinical use of IPE.
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The substantial risk reduction in REDUCE-IT is unlikely to be explained by the moderate 22% reduction in triglyceride levels, and mechanistic studies suggest direct effects of icosapent ethyl on coronary plaque regression.
“The substantial risk reduction in REDUCE-IT is unlikely to be explained by the moderate 22% reduction in triglyceride levels, and mechanistic studies suggest direct effects of icosapent ethyl on coronary plaque regression 34 .”
From Effects of n-3 Fatty Acid Supplements in Elderly Patients After Myocardial Infarction (2021) · cites this paper as [34]
The Introduction reports substantial cardiovascular event reductions in REDUCE-IT, and the Abstract Conclusions and Discussion describe EVAPORATE’s plaque-regression findings as a potential mechanism of benefit. Our copy does not report a 22% triglyceride reduction in REDUCE-IT or conclude that triglyceride lowering is unlikely to explain its risk reduction; the Introduction says the mechanism is not fully characterized. No page numbers are provided for these passages. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTriglyceride-lowering with icosapent ethyl may help stabilize high-risk plaque characteristics.
“EVAPORATE offered early mechanistic evidence suggesting that TG-lowering with icosapent ethyl may help stabilize high-risk plaque characteristics [36].”
From Targeting Triglycerides in Cardiovascular Disease Prevention: Evidence, Mechanisms, and Emerging Therapies (2026) · cites this paper as [36]
The Results report reduced low-attenuation plaque with icosapent ethyl, and the Discussion links that change to plaque stabilization. But the Discussion also says plaque progression slowed without a significant between-group difference in triglyceride changes, so EVAPORATE does not establish triglyceride lowering as the mechanism. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn EVAPORATE, among patients with ASCVD taking maximally tolerated statin therapy, 4 g/day of EPA vs. placebo led to a relative reduction of 17% in low attenuation plaque volume at 18 months.
“In EVAPORATE, among patients with ASCVD who were taking maximally tolerated statin therapy, 4 g/day of EPA vs. placebo led to a relative reduction of 17% in low attenuation plaque volume at 18 months [24].”
From Effect of omega-3 fatty acids on cardiovascular outcomes: A systematic review and meta-analysis (2021) · cites this paper as [24]
The Abstract (Methods and results; page unavailable) reports a 17% reduction in low-attenuation plaque volume with icosapent ethyl at 18 months, versus a 109% increase with placebo. Thus, 17% is the change within the treatment group, not a relative reduction versus placebo. The Methods (Study population; page unavailable) require stable statin therapy, not maximally tolerated statin therapy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the EVAPORATE trial, treatment with icosapent ethyl significantly reduced the progression of low-attenuation plaque volume compared to placebo.
“A prime example is the EVAPORATE (Effect of Vascepa on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides) trial, which utilized CCTA to show that treatment with icosapent ethyl significantly reduced the progression of low-attenuation plaque volume compared to placebo.”
From Targeting Triglycerides in Cardiovascular Disease Prevention: Evidence, Mechanisms, and Emerging Therapies (2026) · cites this paper as [36]
The mechanistic validation was provided by the CHERRY and EVAPORATE trials.
“The mechanistic validation was provided by the CHERRY (combination therapy of eicosapentaenoic acid and pitavastatin vs. pitavastatin alone for coronary plaque regression evaluated by intravascular ultrasonography) [23] and EVAPORATE (The Effects of Vascepa on Improving Coronary Atherosclerosis in People with High Triglycerides Taking Statin Therapy) trials [24].”
From Effect of omega-3 fatty acids on cardiovascular outcomes: A systematic review and meta-analysis (2021) · cites this paper as [24]
Since low-density plaque is independently associated with MI, regression of plaque with EPA can reduce ASCVD events, supporting this meta-analysis.
“Since low-density plaque is independently associated with MI, these data indicate that regression of plaque with EPA can reduce ASCVD events, supporting this meta-analysis.”
From Effect of omega-3 fatty acids on cardiovascular outcomes: A systematic review and meta-analysis (2021) · cites this paper as [24]
In EVAPORATE, the IPE group showed significant differences in the primary endpoint of low-attenuation plaque as well as reductions in fibrous and fibrofatty plaque volumes without any significant differences in lipid levels between groups.
“The IPE group showed significant differences in the primary endpoint of low-attenuation plaque as well as reductions in fibrous and fibrofatty plaque volumes without any significant differences in lipid levels between groups.”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [26]
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Cites
Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia
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Self-citationEffects of Icosapent Ethyl on Total Ischemic Events
Bhatt, D. L., Steg, P. G., Miller, M., Brinton, E. A., Jacobson, T. A., Ketchum, S. B., Doyle, R. T., Juliano, R. A., Jiao, L., Granowitz, C., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.02.032 · Cited by 259 · see citing works
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Self-citationFan, W., Philip, S., Granowitz, C., Toth, P. P., & Wong, N. D. (2019) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2018.11.008 · Cited by 67 · see citing works
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“pitavastatin alone for coronary plaque regression evaluated by intravascular ultrasonography) [23] and EVAPORATE (The Effects of Vascepa on Improving Coronary Atherosclerosis in People with High Triglycerides Taking Statin Therapy) trials [24].”
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“We excluded those not reporting on cardiovascular outcomes [15 – 21] , those reporting on carotid artery parameters [22,23] , and those not involving IPE [8 – 10 , 24 ] .”
BackgroundTargeting triglycerides for cardiovascular risk reduction
Maiorca, C., Tramontano, D., Di Costanzo, A., & D’Erasmo, L. (2026) · Internal and Emergency Medicine · doi:10.1007/s11739-026-04383-1
- Authors
- Budoff, M. J., Bhatt, D. L., Kinninger, A., Lakshmanan, S., Muhlestein, J. B., Le, V. T., May, H. T., Shaikh, K., Shekar, C., Roy, S. K., Tayek, J., & Nelson, J. R.
- Affiliations
- The Lundquist Institute (US)
- Brigham and Women's Hospital (US)
- Intermountain Healthcare (US)
- California Cardiovascular Institute , Fresno, CA, USA
- Corresponding author
- Budoff, Matthew J
- ORCID
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-08-29
- Volume
- 41
- Issue
- 40
- Pages
- 3925-3932
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- PMC
- PMC7654934
- OpenAlex
- W3082332778
- Cited by
- 446
- References
- 5
- Citations by year
- 2026: 51 · 2025: 50 · 2024: 77 · 2023: 84 · 2022: 74 · 2021: 82 · 2020: 26 · 2018: 1
- FWCI
- 42.04
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- European Heart Journal (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc)
- Funders
- Amarin Pharma, Inc
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiac Imaging and Diagnostics
- Keywords
- icosapent ethyl, eicosapentaenoic acid ethyl ester, coronary artery disease, plaque regression, statin therapy, hypertriglyceridemia, coronary CT angiography, fibrofatty plaque, cardiovascular risk reduction, omega-3 fatty acids
- MeSH terms
- Aged, Coronary Artery Disease, Female, Humans, Male, Middle Aged, Triglycerides, Eicosapentaenoic Acid, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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