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

Aug 29, 2020
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Presenter/Author:
Matthew J. Budoff, MD, FACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Amarin Pharma
Date Presented:
08/29/2020
Date Published:
08/29/2020
Date Updated:
08/29/2020
Original Posted Date:
11/18/2019
References

Contribution To Literature:

The EVAPORATE trial showed that icosapent ethyl 4 g/day reduces low attenuation plaque volume at 18 months compared with placebo among patients with known CAD, as assessed by cardiac 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 (CAD) 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: 18 months 
  • Mean patient age: 57.4 years
  • Percentage female: 46%
  • Family history of CAD: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

Other salient features/characteristics:

  • Family history of coronary artery disease: 32%
  • Hispanic: 54%
  • Diabetes mellitus: 69%
  • Prior smoking: 43%

Principal Findings:

The primary outcome, change in low attenuation plaque volume, for icosapent ethyl vs. placebo, was -0.3 vs. 0.9 mm3 (p = 0.006).

Secondary outcomes for icosapent ethyl vs. placebo:

  • Change in total plaque volume: -9% vs. 11% (p = 0.002)
  • Change in total noncalcified plaque: -19% vs. 9% (p = 0.0005)
  • Change in fibrofatty plaque: -34% vs. 32% (p = 0.0002)
  • Change in triglycerides: -89.3 vs. -92.1 mg/dl (p = 0.91)

Interpretation:

The results of this trial indicate that icosapent ethyl  4 g/day reduces low attenuation plaque volume compared with placebo at 18 months, as measured by cardiac CTA. In addition, there was a reduction in total plaque volume and other plaque parameters as well. In the setting of a small sample size, there was no difference in triglyceride levels. These results may help explain the cardiovascular benefit noted with icosapent ethyl  in the REDUCE-IT trial.

References:

Budoff MJ, Bhatt DL, Kinninger A, et al. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial. Eur Heart J 2020;Aug 29:[Epub ahead of print].

Presented by Dr. Matthew J. Budoff at the European Society of Cardiology Virtual Congress, August 29, 2020.

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: ESC Congress, ESC20, 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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