Interim Analysis of EVAPORATE

A discussion on the interim findings of the EVAPORATE trial studying the effects of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy.

Transcript

Deepak L. Bhatt, MD, MPH: Moving beyond the basic science to the next level of analysis, which is using imaging to gain insights in vivo and on what’s going on in human beings, I think the really seminal trial in that regard is EVAPORATE. We’ve got interim results that were presented by Dr Budoff as a late-breaking clinical trial at the American Heart Association [Scientific Sessions] in 2019. The results were met with great enthusiasm. I’d like to have Dr Budoff provide a recap of what those interim findings were from EVAPORATE.

Matthew J. Budoff, MD: Briefly, EVAPORATE was a mechanistic study to look at the effect of icosapent ethyl on atherosclerosis. We talked about some of the mechanisms. One of the purported mechanisms, or proposed mechanisms, is that it might lower atherosclerotic burden. So we did a randomized trial using the same entry criteria as REDUCE-IT: elevated triglycerides. This time they needed to have at least a 20% stenosis in a coronary artery. We did CT [computed tomography] angiography, so a noninvasive way of looking at the coronary anatomy. We randomized them to 4 g of icosapent ethyl or placebo and followed them for 18 months. We did a prespecified scan at 9 months, and those are the data we have to show. At 9 months, there was a 19% reduction in total noncalcified plaque and a 42% reduction in the rate of progression of total plaque when you compared icosapent ethyl to the placebo group. Both of those were statistically significant.

Our primary end point looked at low attenuation plaque, this type of vulnerable plaque that we think is important. There was a 21% reduction in the rate of progression of low attenuation plaque, but that was not significant and not significant enough to stop the trial.

We now have the 18-month data. It’s still embargoed, so I can’t share the final results with you. We did present our 9-month data at the American Heart Association meeting as a late-breaking clinical trial, and the data will be published. The manuscript is accepted to publish in Cardiovascular Research. It will be coming out fairly soon in publication.

Deepak L. Bhatt, MD, MPH: The interim results are very exciting. There will be many people eagerly awaiting the final results. This is probably 1 of the most anticipated trials out there right now.