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Final EVAPORATE Results for Vascepa Raise Eyebrows

Final 18-month results of the EVAPORATE trial suggest icosapent ethyl (Vascepa) provides even greater slowing of coronary plaque progression when added to statins for patients with high triglyceride levels, but not all cardiologists are convinced.

The study was designed to explore a potential mechanism behind the cardiovascular event reduction in REDUCE-IT. Previously reported interim results showed that after 9 months, the pharmaceutical-grade omega-3 fatty acid formation significantly slowed the progression of several plaque types but not the primary endpoint of change in low-attenuation plaque volume on multidetector CT.

From baseline to 18-month follow-up, however, the primary endpoint was significantly reduced by 17% in the icosapent ethyl group, whereas low-attenuation plaque volumes increased by 109% in the placebo group (P = .0061).

Significant declines were also seen with icosapent ethyl 4 g/d vs the mineral oil placebo for all other plaque types except dense calcium after adjustment for age, sex, diabetes, hypertension, and triglyceride levels at baseline:

  • dense calcium: -1% vs 15% (P = .0531)
  • fibro-fatty: -34% vs 32% (P = .0002)
  • fibrous: -20% vs 1% (P = .0028)
  • noncalcified: -19% vs 9% (P = .0005)
  • total plaque: -9% vs 11% (= .0019)

The results parallel nicely with recent clinical data from REDUCE-IT REVASC, in which icosapent ethyl 4 g/d provided a very early benefit on first revascularization events that reached statistical significance after only 11 months (hazard ratio, 0.66), principal investigator Matthew Budoff, MD, director of cardiac CT at Harbor-UCLA Medical Center in Torrance, California, said during the virtual European Society of Cardiology Congress 2020.

The findings were also published simultaneously in the European Heart Journal and quickly prompted a flurry of comments on social media.

Some were supportive. Harvard University’s Christopher Cannon, MD, University of Pennsylvania lipidologist Dan Soffer, MD, and Intermountain Heart Institute researcher Viet Le, MPAS, PA, took to Twitter to praise Budoff and the final results of the mechanistic study. Soffer called the study “elegant,” while Cannon said the results provide “important mechanistic data on plaque character.”

Others were highly critical, including a poll questioning whether the article should be retracted or revised.

Ibrahim H. Tanboga, MD, PhD, a cardiology professor and biostatistician at Hisar Intercontinental Hospital in Istanbul, Turkey, questioned how the longitudinal change in low-attenuation plaque was possible clinically; his plot of the data showed these lesions getting worse in both arms before getting better in both arms.

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