Evolocumab in Patients with High-Risk Diabetes: Results from the VESALIUS-CV trial

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Objective This pre-specified analysis of VESALIUS-CV evaluated the efficacy of the PCSK9i evolocumab for preventing first CV events in patients with high-risk diabetes. Research Design and Methods VESALIUS-CV randomized patients with high-risk diabetes (microvascular disease, insulin use, or duration ³10 years) or qualifying atherosclerosis, but no prior myocardial infarction (MI) or stroke, and low-density lipoprotein cholesterol (LDL-C) ≥90 mg/dL, to evolocumab 140 mg or matching placebo every 2 weeks. The dual primary endpoints were a composite of coronary heart disease death, MI or ischemic stroke (3P-MACE) and 3-P MACE plus ischemia-driven arterial revascularization (4P-MACE). Results Of the 6002 patients with high-risk diabetes, 67% were on a high-intensity statin and 24% on an SGLT2i or a GLP-1RA at baseline. The median LDL-C at 48-weeks was 47 mg/dL and 109 mg/dL in the evolocumab and placebo arms, respectively (P<0.0001). After a median follow-up of 4.6 years, evolocumab decreased 3P-MACE and 4P-MACE rates by 29% (HR 0.71; 95% CI 0.59─0.86, P=0.0004) and 21% (HR 0.79; 95% CI 0.69─0.91, P=0.0013), respectively. These findings were consistent regardless of the presence or absence of qualifying atherosclerosis, baseline LDL-C, statin intensity, and SGLT2i or GLP-1RA use (Pint >0.05 for each). The 5-year Kaplan Meier rates of all-cause death were 9.5% vs. 11.7% in the evolocumab vs. placebo arms (HR 0.79; 95% CI 0.67─0.93). Conclusions Evolocumab reduced the risk of CV events in patients with high-risk diabetes, regardless of the presence or absence of qualifying atherosclerosis and background use of other cardioprotective agents.

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