Transcript
Announcer:
Welcome to DataPulse from ACC 2026 on ReachMD. This activity, titled “Primary Care Takeaways From VESALIUS-CV: Evolocumab Efficacy in Patients Without Significant Atherosclerosis” is provided by Medcon International.
Dr. Morales:
Hello from the American College of Cardiology Scientific Sessions 2026 in New Orleans. I'm Dr. Javier Morales. I'm a practicing internist based out of Long Island, New York. And today I'll review data from the VESALIUS cardiovascular study, the evolocumab in patients without atherosclerosis study.
So I'll review from the primary care perspective, the findings from this study and the clinical implications that it may actually have for treatment of our patients that are at risk for cardiovascular disease, particularly with diabetes. So the question asked is do high-risk primary prevention patients without known significant atherosclerosis and with diabetes benefit from intensive lowering of their LDL cholesterol with a PCSK9 inhibitor?
So I'm going to review some data from a prespecified subgroup analysis of VESALIUS, and this included about 3,655 patients that were randomized to either evolocumab or placebo, and we looked at the outcomes that were encountered in this trial. And I'm happy to say that these data basically showed that the value of intensification of lipid-lowering therapy with a PCSK9 inhibitor, such as evolocumab, earlier in the disease process in a high-risk population without known significant atherosclerosis and with diabetes showed significant benefit.
So let's go over this trial design, because the VESALIUS study involved 12,257 stable patients at high risk for cardiovascular events, but without prior MI or stroke, and they were randomized to either receive evolocumab 140 mg subcutaneously every other week or a placebo as an injection every other week.
Now, we looked at 2 primary endpoints. The first one was the traditional 3-point MACE, which is cardiovascular death, nonfatal MI, and nonfatal stroke. But there was also a 4-point MACE that was explored as well, and this included the traditional 3-point MACE but also arterial revascularization.
So very early on in the study, we saw that there was a rapid reduction in the LDL cholesterol by over 40%, in fact, about the average LDL was a little bit above 40. Now what was very important is not only did that LDL go down significantly, but it stayed down. It remained low throughout the whole course of the study.
Now, when we looked at the traditional 3-point MACE, we saw that there was about a 25% reduction for the population in general. But let's take a look at the subset analysis. The subset analysis included patients with type 2 diabetes who maybe were not as high risk as the regular population in this clinical trial. When we looked at all-cause mortality, we saw that there was another significant reduction. And for cardiovascular death, it was about another 31% reduction.
So, in general, in our patients without established cardiovascular disease but maybe at high risk, we know that a medication like evolocumab would be significantly helpful in terms of reducing, well, the possibilities of having a major adverse cardiovascular event and reduction in having that first heart attack by about 36%. But what we do know is that in patients with type 2 diabetes, in the subset of this study, there was a reduction of 31% in 3-point MACE and 4-point MACE, which included revascularization.
Now remember, these are patients that we see every day, [patients with] type 2 diabetes, who may not be at such high risk. But as a primary care clinician, this resonates so importantly for me, because as a primary care clinician, we take ownership of the care of the patient. We manage their blood pressures; we manage their emotional disorders; we manage their lipids and their diabetes. And it's reassuring to know that the institution of such a therapy like evolocumab, particularly in our diabetic patients who may not be at risk, would have a significant impact in terms of their longevity and experiencing some sort of cardiovascular event.
So we own this. We have to do this. We're the ones that need to be aggressive and treat our patients to target sooner rather than later.
I'm Dr. Javier Morales, and I'm reporting from the American College of Cardiology conference in New Orleans. Thanks for listening.
Announcer:
Thank you for listening to this DataPulse from ACC 2026 on ReachMD. This activity is provided by Medcon International. Thank you for listening.