Evolocumab reduced major cardiovascular events in patients with high-risk diabetes, VESALIUS-CV analysis shows
Presenter: Lawrence A. Leiter, MD, FRCPC, University of Toronto, Toronto, Canada
Evolocumab reduces CV events in patients with high-risk diabetes: Results from VESALIUS-CV. Presented June 7, 2026.
In patients with high-risk diabetes and no prior myocardial infarction or stroke, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced the rate of major adverse cardiovascular events, according to a prespecified analysis of the VESALIUS-CV trial, presented at the American Diabetes Association 2026 Scientific Sessions.
Evolocumab lowered the combined risk of coronary heart disease death, myocardial infarction, or ischemic stroke by nearly one-third as compared with placebo, the results show.
The benefit held whether or not patients had qualifying atherosclerosis and regardless of their background use of statins or other cardioprotective agents, according to Lawrence A. Leiter, MD, FRCPC, and co-authors.
“We believe our study results support a single LDL-C target, much lower than currently recommended in our guidelines, for all high-risk individuals living with diabetes, whether they have known evidence of hardening of atherosclerosis or not,” Dr. Leiter said.
People living with diabetes carry a high risk of cardiovascular disease even without known cardiovascular disease, the authors noted. Accordingly, they sought to determine whether lowering low-density lipoprotein cholesterol (LDL-C) could prevent first cardiovascular events in this population.
VESALIUS-CV, a double-blind, randomized, placebo-controlled, multicenter trial, enrolled patients with LDL-C levels of 90 mg/dL or higher. Patients had either established atherosclerosis or high-risk diabetes, which was defined as microvascular disease, insulin use, or diabetes duration of 10 years or longer, but no prior myocardial infarction or stroke.
Patients were randomized to receive evolocumab 140 mg or matching placebo every 2 weeks, on top of optimized lipid-lowering therapy. The primary endpoints were a three-point composite of coronary heart disease death, myocardial infarction, or ischemic stroke, and a four-point composite that added ischemia-driven arterial revascularization.
The prespecified analysis focused on VESALIUS-CV patients with high-risk diabetes, including 6,002 out of 12,257 patients, or 49% of the overall trial population. Their median age was 66 years, 50% were women, 67% were taking a high-intensity statin, and 24% were taking a sodium-glucose cotransporter 2 (SGLT-2) inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist at baseline.
At 48 weeks, the median LDL-C level was 47 mg/dL in the evolocumab group and 109 mg/dL in the placebo group (P < .0001).
After a median follow-up of 4.6 years, the three-point composite endpoint had occurred in 29% fewer patients in the evolocumab group than in the placebo group (hazard ratio 0.71, 95% confidence interval 0.59–0.86, P = .0004), and the four-point composite had occurred in 21% fewer (hazard ratio 0.79, 95% confidence interval 0.69–0.91, P = .0013).
At the same time, 8.8% of patients in the evolocumab group had died of any cause, compared with 11.0% of those in the placebo group (hazard ratio 0.79, 95% confidence interval 0.67–0.93).
The benefit was consistent regardless of qualifying atherosclerosis, baseline LDL-C level, statin intensity, and SGLT-2 inhibitor or GLP-1 receptor agonist use (P for interaction > .05 for each), according to the authors.
Further analyses of the VESALIUS-CV trial are underway to better understand the clinical benefit across other subgroups, authors noted.
Disclosures
The VESALIUS-CV trial was funded by Amgen. Dr. Leiter reported disclosures related to Amgen Canada, among others. Full author disclosures were provided in the meeting abstract posted on the ADA Scientific Sessions website.
References
Leiter L, Marston N, De Ferrari G, et al. Evolocumab reduces CV events in patients with high-risk diabetes: Results from VESALIUS-CV. Abstract 1247-OR. Presented at: American Diabetes Association 86th Scientific Sessions; June 5-8, 2026; New Orleans, LA.
Leiter LA, Giugliano RP, Marston NA, et al. Evolocumab in patients with high-risk diabetes: results from the VESALIUS-CV trial. Diabetes Care 2026 Jun 7:dc260847. doi:10.2337/dc26-0847