Transcript
Opening:
Welcome to DataPulse from ACC 2206 on ReachMD. This activity, titled “Value of Earlier Lipid-Lowering Therapy Intensification With Evolocumab in High-Risk Populations Without Known Significant ASCVD and With Diabetes: VESALIUS-CV Insights” is provided by Medcon International.
Dr. Giugliano:
Hello from ACC Scientific Sessions 2026 in New Orleans. My name is Dr. Robert Giugliano, and today I'll be reviewing data that were recently presented at the ACC meetings from the VESALIUS-CV trial study of evolocumab in patients without significant atherosclerosis.
This was a very interesting secondary, prespecified analysis from the main VESALIUS-CV trial that focused in on the 30% of patients enrolled in this study—it's approximately 4,000 patients—who had no prior MI, no prior stroke, but they had diabetes with no known significant atherosclerosis. And this is important because this is an even lower subgroup than has been studied widely with the PCSK9 inhibitors.
As you know, statins are approved and shown benefit across a broad spectrum of patients, including those with a recent ACS, those who have existing coronary vascular disease, and even those in primary prevention. But for the first time, we're reporting results from a clinical trial in patients with no significant atherosclerosis with the PCSK9 inhibitor.
The new and important findings were these patients had tremendous benefit from reducing the LDL from about 120-130 on average down to the 40s, and well below 55. Patients randomized to evolocumab had 30% to 40% reductions in cardiovascular events like coronary heart disease death, myocardial infarction, stroke, the need for arterial revascularizations, and, importantly, even reductions in mortality—32% reduction in coronary heart disease death and more than 20% reduction in all-cause mortality—with no offsetting safety signals.
So the clinical implications here are that we ought to be treating patients who have no prior MI or stroke more aggressively—even those without significant atherosclerosis who have diabetes—drive that LDL down well below 55.
I honestly wish the guidelines had waited another month for these results, but I'm sure we'll see these coming out in future iteration of practice guidelines. Thank you very much for your attention.
Closing:
Thank you for listening to this DataPulse from ACC 2206 on ReachMD. This activity is provided by Medcon International. Thank you for listening.