Prescribing Information

The phase 3 VESALIUS-CV study demonstrated that addition of evolocumab to optimized lipid lowering therapy significantly reduced major adverse cardiovascular events (MACE) in high-risk patients without prior myocardial infarction (MI) or stroke.

CV Outcomes

CV_Outcomes_3point_MACE

*P-value based on the log-rank test stratified by the randomization stratification factors. Hazard ratio and 95% CI were estimated from the Cox model stratified by the randomization stratification factors.2
CHD, coronary heart disease; IDR, ischemia-driven arterial revascularization; MI, myocardial infarction; MACE, major adverse cardiovascular event.

CV_Outcomes_4point_MACE

*P-value based on the log-rank test stratified by the randomization stratification factors. Hazard ratio and 95% CI were estimated from the Cox model stratified by the randomization stratification factors.2
CHD, coronary heart disease; IDR, ischemia-driven arterial revascularization; MI, myocardial infarction; MACE, major adverse cardiovascular event.

CV_Outcomes_End_Points

*CHD death was not statistically significant, therefore, subsequent secondary endpoints were not formally tested and should be interpreted as exploratory.
CHD, coronary heart disease; CV, cardiovascular; IDR, ischemia-driven arterial revascularization; MI, myocardial infarction; NA, not applicable.

1. Bohula E, et al. Oral presentation presented at: American Heart Association; November 7-10, 2025; New Orleans, LA. download slides

2. Bohula E, et al. N Engl J Med. 2025; In Press. view publication

 
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LDL-C lowering

Lipid sub-study included 2,014 patients with central lab testing
LDL-C_Lowering

*As assessed by least-squares means
IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol.
Bohula E, et al. N Engl J Med. 2025; In Press.

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Safety

pho

Bohula E, et al. N Engl J Med. 2025; In Press.

Study Design

Phase 3 Trial Schema
Randomized, double-blind, placebo-controlled, global trial evaluating the effect of evolocumab on major cardiovascular events in patients at high cardiovascular risk without a previous myocardial infarction (MI) or stroke1
Randomized, double-blind, placebo-controlled, global trial evaluating evolocumab in high-risk patients

*Optimized lipid-lowering treatment defined as maximally tolerated statin plus or minus ezetimibe.2 †Or, non-HDL-C ≥ 120 mg/dL, or ApoB ≥ 80 mg/dL.2
CV, cardiovascular; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; Q2W, every 2 weeks; SC, subcutaneous.
1. Bohula E, et al. N Engl J Med. 2025; In Press. 2. Bohula E, et al. Am Heart J. 2024; 269:179-190.

Study Endpoints Overview
Two primary endpoints
  • 3-point MACE: Time to first occurrence of CHD death, MI, or ischemic stroke
  • 4-point MACE: Time to first occurrence of CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization (IDR)*
Secondary endpoints

Time for first occurence of:

  • MI, ischemic stroke, or IDR*
  • CHD death, MI, or IDR*
  • CV death, MI, or ischemic stroke
  • CHD death or MI
  • Individual endpoints of MI, IDR, CHD death, CV death, all-cause death, and ischemic stroke

Exploratory-endpoint
  • Change in LDL-C from baseline

Safety endpoints
  • Treatment-emergent serious AEs and those that led to treatment discontinuation

*IDR was defined as revascularization of any vascular bed (including coronary, cerebrovascular, or peripheral) in the presence of ischemia of the relevant end-organ.
AE, adverse event; CHD, coronary heart disease; CV, cardiovascular; MACE, major adverse cardiovascular event; MI, myocardial infarction.
Bohula E, et al. N Engl J Med. 2025; In Press.

Eligibility
Patients with a prior MI or stroke were excluded. Patients were eligible for inclusion if the following four criteria were met:
Key exclusion criteria: myocardial infarction (MI) or stroke

*CAD included CAC score ≥ 100, history of coronary revascularization with multivessel coronary disease, or significant coronary disease without prior revascularization. †High-risk DM included diabetes duration ≥ 10 years, known microvascular disease defined by diabetic nephropathy or treated retinopathy, or chronic daily insulin treatment. ‡Defined by ≥1 of the following criteria: Limb artery with ≥ 50% stenosis, history of abdominal aorta treatment(percutaneous or surgical) due to atherosclerotic disease, or ankle brachial index <0.85. §Defined by ≥ 1 of the following criteria: Prior transient ischemic stroke with ≥ 50% carotid stenosis, internal or external carotid artery stenosis of ≥ 70%, or ≥ 2 of ≥ 50% stenoses, or prior internal or external carotid artery revascularization. **Based on the most recent value in the 3 months prior to screening, reflecting ≥ 2 weeks of stable, optimized background lipid-lowering therapy. ††More information can be found in Bohula, NEJM, 2025. ApoB, apolipoprotein B; CAC, coronary artery calcium; CAD, coronary artery disease; CeVD, cerebrovascular disease; DM, diabetes mellitus; eGFR, estimated glomerular filtration rate; HDL-C, high-density lipoprotein cholesterol; hsCRP, high-sensitivity C-reactive protein; LDL‑C, low-density lipoprotein cholesterol; Lp(a), lipoprotein(a); MI, myocardial infarction; PAD, peripheral artery disease.
Bohula E, et al. N Engl J Med. 2025; In Press.

Publications & Resources

VESALIUS-CV Primary Results Manuscript

Bohula E, et al. Evolocumab in patients without previous myocardial infarction or stroke. N Engl J Med. 2025; In Press.

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VESALIUS-CV Oral Presentation at AHA

Bohula E, et al. The effect of eVolocumab in patiEntS at high cArdiovascuLar rIsk withoUt prior myocardial infarction or Stroke: primary results of the VESALIUS-CV study. Oral presentation presented at: American Heart Association; November 7-10, 2025; New Orleans, LA.

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VESALIUS-REAL Global Observational Preliminary Results

Chan Q, et al. Lipid management in high cardiovascular risk patients without prior myocardial infarction or stroke: Preliminary data from the VESALIUS-REAL global burden study. Oral presentation at the European Society of Cardiology; August 29-September 1,2025; Madrid, Spain/Virtual meeting.

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VESALIUS-REAL Global Observational Preliminary Results From the United States

Chan, Q et al. Lipid-lowering therapy use in high-risk ASCVD patients without prior MI or stroke – preliminary data from VESALIUS-REAL, US. Poster presented at the American College of Cardiology Annual Meeting; March 29–31, 2025; Chicago, IL, US.

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REASSURE Study

Wong, ND, et al. Assessment of risk reduction of recurrent cardiovascular events in patients with ASCVD and diabetes. Oral Presentation at ObesityWeek; November 4-7 2025; Atlanta, GA.

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