EVAPORATE trial

• in the REDUCE-IT study, icosapent ethyl (IPE) added to statin therapy reduced initial CV events by 25% and total CV events by 30% (1)

The EVAPORATE study investigated the effects of IPE on coronary atherosclerosis progression

• study aimed to determine whether IPE 4 g/day will result in a greater change from baseline in plaque volume measured by serial multidetector computed tomography than placebo in statin-treated patients.

Methods and results:

• EVAPORATE is a randomized, double-blind, placebo-controlled trial
• patients had to have coronary atherosclerosis by coronary computed tomographic angiography (CCTA) (>=1 angiographic stenoses with >=20% narrowing), on stable statin therapy with low-density lipoprotein cholesterol levels 40-115 mg/dL, and persistently high triglyceride levels (135-499 mg/dL)
  
  
• patients underwent an interim scan at 9 months and were followed for an additional 9 months with CCTA at 0, 9, and 18 month
  • protocol-specified interim efficacy result have been published (2)
    • total of 80 patients were enrolled, with 67 completing the 9-month visit and having interpretable CCTA at baseline and at 9 months (age = 57 ± 6 years, male = 36, 63%)
    • 9-month interim analysis
      • no significant change in low attenuation plaque (LAP) between active and placebo groups (74% vs. 94%, P = 0.469
      • was slowing of total non-calcified plaque (sum of LAP, fibrofatty, and fibrous plaque) (35% vs. 43%, P = 0.010), total plaque (non-calcified + calcified plaque) (15% vs. 26%, P = 0.0004), fibrous plaque (17% vs. 40%, P = 0.011), and calcified plaque (-1% vs. 9%, P = 0.001), after adjustment by baseline plaque, age, sex, diabetes, baseline triglyceride levels, and statin use

Study authors suggest that:

• EVAPORATE is the first study using CCTA to evaluate the effects of IPE as an adjunct to statin therapy on atherosclerotic plaque characteristics in a high-risk CV population with persistently high triglyceride levels
• provides important mechanistic data in regards to the reduction in CV events in the REDUCE-IT clinical trial

Reference:

• Bhart DL et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.N Engl J Med. 2018 Nov 10.
• Budoff MJ et al. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: a prospective, placebo-controlled randomized trial (EVAPORATE): interim results. Cardiovasc Res. 2021 Mar 21;117(4):1070-1077. doi: 10.1093/cvr/cvaa184