Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Trial

Marston, NA; Bohula, EA; Bhatia, AK; De Ferrari, GM; Leiter, LA; Nicolau, JC; Park, JG; Murphy, SA; Walsh, E; Liu, L; Verma, S; Sattar, N; Nicholls, SJ; Lopez-Sendon, J; Gouni-Berthold, I; Tokgozoglu, L; Blankstein, R; Cyrille, M; da Silva Lima, GP; Giugliano, RP; Sabatine, MS; VESALIUS-CV Investigators

doi:10.1001/jama.2026.3277

Prevention & lipids

Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Trial

JAMAPublished 28 Apr 2026Prespecified subgroup analysis of the VESALIUS-CV randomised controlled trial

Read the original article ↗PubMed

Cite

Authors' conclusion

In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event.

Study context

Population: Patients with diabetes without known significant atherosclerosis, no prior MI or stroke, LDL-C ≥90 mg/dLsubgroup of 12,257 enrolled
Participants: 3,655 patients

Comparison: Evolocumab vs placebo added to optimally tolerated statin therapy
Evolocumabn = 1,849
Placebon = 1,806reference
Primary endpoint: Dual primary end points: 3-P MACE (CHD death, MI or ischaemic stroke) and 4-P MACE (3-P MACE plus ischaemia-driven arterial revascularization)
Follow-up: Median 4.8 years

Methodological detailsdouble-blind, placebo-controlled, multicentre (774 sites, 33 countries), Enrolment June 2019 to last visit July 2025

Double-blind
Placebo-controlled
Multicentre (774 sites, 33 countries)
Enrolment June 2019 to last visit July 2025

Primary result

As reported in the abstract

3-P MACE and 4-P MACE · 5-year Kaplan-Meier estimates

Evolocumab

3-P major cardiovascular event (MACE): 83 (5.0%)
4-P MACE: 127 (7.6%)

Placebo

3-P MACE: 117 (7.1%)
4-P MACE: 178 (10.5%)

3-P major cardiovascular event (MACE)

Evolocumab83 (5.0%)

Placebo117 (7.1%)

4-P MACE

Evolocumab127 (7.6%)

Placebo178 (10.5%)

Evolocumab vs PlaceboHazard ratio (95% CI)P value

3-P MACE

0.69(0.52–0.91)

P = 0.009

4-P MACE

0.69(0.55–0.86)

P = 0.001

Evolocumab vs PlaceboBetween-group difference (95% CI)

3-P MACE

2.1%(0.4%–3.8%)

4-P MACE

2.9%(0.9%–4.9%)

Secondary outcomes

Outcome	Evolocumab	Placebo	← Lower risk with evolocumab ←→ Higher risk with evolocumab →	HR (95% CI)
All-cause mortality · 5-year Kaplan-Meier estimate	7.8%	10.1%	0.512	0.76 (0.61–0.95)
			0.512Hazard ratio (log scale)

LDL-C (lipid substudy) · 48 weeks

P < 0.001

Evolocumabmedian 52 mg/dL

Placebomedian 111 mg/dL

Original publication

Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Trial. JAMA. Published 28 April 2026. doi:10.1001/jama.2026.3277

Read the original article ↗

Summarised from the published abstract; every number is checked against it