Gaps in lipid management among high-risk patients without prior MI or stroke: the VESALIUS-REAL global study
Queenie ChanJaimini CeglaUlrich LaufsJan H. CornelGaetano M. De FerrariEmil HagströmHuei-Kai HuangJosé Lopez-MirandaSuna AvcilCorinne BrooksThomas CarsAdrienne Y L ChanChui ChMichael DuxburyEdward Chia-Cheng LaiDavid NeashamAndreas OchsJames O’KellyGabriel Paiva da Silva LimaNaomi ReimesSwati SakhujaShih‐Chieh ShaoJu-Young ShinM SibartieIlona VerburgMatthew J. BudoffKyung Woo ParkKenichi TsujitaKai Hang YiuNafeesa DhalwaniIan C. K. Wong
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Why the study?
Real-world evidence on lipid-lowering therapy use and LDL-C control in patients at high cardiovascular risk without prior MI or stroke remains limited.
Key Points
- To evaluate real-world lipid-lowering therapy utilization, treatment intensification, LDL-C monitoring, and LDL-C goal attainment in high cardiovascular risk patients without prior myocardial infarction or stroke.
- Conducted a retrospective observational study (VESALIUS-REAL) using a common protocol across 11 databases in North America, Europe, and Asia-Pacific between 2017 and 2022.
- Included 1,126,756 patients aged ≥ 50 years (51% female) with coronary artery disease, atherosclerotic cerebrovascular disease, peripheral artery disease, or high-risk diabetes alongside elevated lipids, but without prior myocardial infarction, stroke, or end-stage renal disease.
- At index, 60% of patients were not on lipid-lowering therapy, with statin monotherapy representing at least three quarters of therapy among treated patients.
Study Design
Type
Observational (n=1,126,756)
Multicenter
Yes
Structured PICO
P
Population
1,126,756 patients aged 50 years and older at high cardiovascular risk without prior myocardial infarction or stroke, followed for 1 year to assess real-world lipid management.
E
Exposure
Lipid-lowering therapy (LLT) use, initiation, intensification, and LDL-C monitoring
O
Outcome
LLT use at index, LLT initiation, LLT intensification, LDL-C testing, and achievement of local guideline-recommended LDL-C target within 1 year of follow-upsurrogate
Most high-risk patients without prior myocardial infarction or stroke are not optimally managed, with low rates of lipid-lowering therapy initiation, intensification, and LDL-C goal attainment globally.
Limitations
- Restricted to patients with elevated lipid levels, representing a subgroup of high-risk patients
- Routine data may not fully capture out-of-hospital care or over-the-counter medication use
- Information on treatment duration and adherence was not available
- LDL-C goal attainment analyses were conducted only among patients with available LDL-C measurements
- Access to and reimbursement for LLT varies across healthcare systems
- Observational nature of the study precludes assessing underlying reasons for treatment gaps
- Cohort restricted to patients with elevated LDL-C, which may not reflect lipid management patterns among all high-risk individuals
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“With the emerging data that we have now from the VESALIUS-CV outcome study showing that we can reduce events by an additional 25% if we need to add additional therapies, like evolocumab, to statins, we can really make a big impact in our clinical practice. But we have to start with LDL testing, we have to move to statin therapy, and then, if their LDL is still above target guidelines, we need to implement non-statin treatments to help us get this burden of risk down.”
LBLeandro BoerVP, US General Medicines, Amgen
“We found very startling findings in the US, which may not be different from the rest of the world, showing 70% of these patients are not starting any therapy for LDL reduction, which is the most modifiable risk factor. In 88% of patients, if they start on a medication, they don't have their medication intensified to the next level so they can achieve their goals.”
LBLeandro BoerVP, US General Medicines, Amgen
“What we're seeing is really remarkable. Seventy percent of patients who had a myocardial infarction or stroke did not initiate any lipid-lowering therapy after the event. Eighty-eight percent of those patients did not intensify their treatment over the following year. That, in itself, is quite significant. Another very concerning aspect is that, over a one-year follow-up after the event, 50% of patients never had an LDL test performed or ordered. Among those who did get tested, 82% didn't reach the guideline-recommended LDL goals.”
Implication
Undertreatment and low LDL-C attainment persist in high-risk patients; leaves open whether targeted implementation strategies can close these gaps.
Abstract
Background Real-world evidence on lipid-lowering therapy (LLT) use and low-density lipoprotein cholesterol (LDL-C) control in patients at high cardiovascular (CV) risk without prior myocardial infarction (MI) or stroke remains limited. We evaluated LLT use, treatment intensification, LDL-C monitoring, and LDL-C goal attainment across North America, Europe, and Asia-Pacific. Methods VESALIUS-REAL is a retrospective observational study using a common protocol across 11 databases between 2017 and 2022. Eligible patients (aged ≥ 50 years) had coronary artery disease, atherosclerotic cerebrovascular disease, peripheral artery disease, or high-risk diabetes, together with elevated lipids, and additional CV risk factors, but no history of MI or stroke or end-stage renal disease. The earliest date when all criteria were met was defined as the index date. LLT patterns and local guideline-recommended LDL-C goal achievement were summarised. Results Among 1,126,756 patients (51% female), 60% were not on LLT at index. Among patients with 1-year follow-up ( n = 830,516), 27% of untreated patients initiated LLT, and 9% of treated patients intensified therapy. Overall, 52% underwent LDL-C testing within 1 year. Among patients with LDL-C measurements during follow-up, 21% achieved their local guideline-recommended LDL-C goal with consistently low attainment in both sexes. Conclusions Most patients at high CV risk were not optimally managed, with low rates of LLT initiation, treatment intensification, LDL-C monitoring, and LDL-C goal attainment across 11 databases. These findings highlight a substantial unmet clinical need for improved guideline-based lipid management to prevent first major CV events in high-risk populations.
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Cite This Study
Chan et al. (2026) conducted an observational in High cardiovascular risk without prior MI or stroke (n=1,126,756). Lipid-lowering therapy management was evaluated on Lipid-lowering therapy use, initiation, intensification, LDL-C testing, and LDL-C goal attainment.
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