Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients With Elevated Triglycerides on Statin Therapy - EVAPORATE

Contribution To Literature:

The EVAPORATE trial interim results suggest that icosapent ethyl 4 g/day does not reduce low attenuation plaque volume compared with placebo, but does reduce total plaque volume, as assessed by coronary CTA.

Description:

The goal of the trial was to assess the efficacy of icosapent ethyl in reducing plaque burden among patients with known angiographic coronary artery disease on statins.



Study Design

Eligible patients were randomized in a 1:1 fashion to either icosapent ethyl 4 g/day (n = 40) or placebo (n = 40).

  • Total number of enrollees: 80
  • Duration of follow-up: 9 months (interim)
  • Mean patient age: 57 years
  • Percentage female: 46%
  • Family history of coronary artery disease:30%

Inclusion criteria:

  • 30-85 years of age
  • Triglycerides: 135-499 mg/dl
  • Low-density lipoprotein cholesterol >40 mg/dl and ≤115 mg/dl (on statin)
  • ≥1 angiographic stenosis with ≥20% narrowing by computed tomography angiography (CTA)
  • No history of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months and no history of coronary artery bypass grafting

Principal Findings:

The primary outcome, % change in low attenuation plaque volume, for icosapent ethyl vs. placebo, was: 94% vs. 74% (p = 0.47).

Secondary outcomes for icosapent ethyl vs. placebo:

  • Change in fibrofatty plaque volume: 25% vs. 87% (p = 0.65)
  • Change in total plaque volume: 26% vs. 15% (p = 0.0004)

In a secondary analysis, plaque progression in the placebo arm of this trial (mineral oil placebo) was similar to that observed in the placebo arm of a nonmineral oil placebo from another cohort, GARLIC5.

Interpretation:

The results of this trial at 9 months indicate that icosapent ethyl 4 g/day does not reduce low attenuation plaque volume compared with placebo, but does reduce total plaque volume. This was assessed by coronary CTA. These are interim results; planned duration of follow-up is 18 months. These results may help explain the cardiovascular benefit noted with icosapent ethyl in the REDUCE-IT trial.

References:

Presented by Matthew J. Budoff at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 18, 2019.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Hypertriglyceridemia, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: AHA Annual Scientific Sessions, AHA19, Angiography, Atherosclerosis, Cholesterol, LDL, Coronary Angiography, Constriction, Pathologic, Coronary Artery Disease, Diagnostic Imaging, Dyslipidemias, Eicosapentaenoic Acid, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Mineral Oil, Plaque, Atherosclerotic, Primary Prevention, Triglycerides


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