VESALIUS-REAL Reveals Lipid Control Gaps in US with Leandro Boer, MD, PhD

Preliminary results from the VESALIUS-REAL study highlight a significant burden of cardiovascular risk in real-world settings, revealing gaps in lipid-lowering management among more than 277,000 individuals in the U.S. with elevated low-density lipoprotein cholesterol (LDL-C).

The analysis found that most high-risk patients aged ≥50 years with atherosclerotic cardiovascular disease (ASCVD)—including coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease (CeVD), or high-risk diabetes—who had no prior history of myocardial infarction or stroke were neither adequately tested for LDL-C nor treated with lipid-lowering therapy (LLT).

Among 277,808 patients, only 37.6% received statin therapy, while more than half (62.4%) had no background LLT. One year after the index date, 87.6% of patients had an LDL-C level above 70 mg/dL, yet only 22.4% intensified their treatment, and fewer than 2% initiated a nonstatin LLT.

In an interview at the American College of Cardiology (ACC) 2025 Annual Scientific Sessions, Leandro Boer, MD, PhD, vice president of general medicines at Amgen, discussed the study’s findings, emphasizing the urgent need for improved LDL-C management strategies to reduce cardiovascular risk in high-risk patient populations.

This transcript has been edited for clarity.

HCPLive: What do these results inform about the current state of cardiovascular disease risk management in US patients?

These results are part of a whole cohort of patients in the VESALIUS-REAL study, comprising 277,000 patients in the US, alongside 11 other countries. This just focuses on the presentation of the US data. Who are these patients? These patients are patients with a very high risk of cardiovascular events. They have CVD, but have never had a stroke or myocardial infarction before. We are focused on what happened with them once they are in that situation.

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. The level of patients not achieving this goal is high and that’s what we show in this poster.

HCPLive: When we consider this issue, do we see it more as a provider-driven issue, a patient adherence challenge, or a systemic health care obstacle?

It’s a systemic health care gap. I like to say there is no silver bullet for this problem, but we also should not be looking at the gap and say ‘it is what it is.’ Since I started practicing, I prescribed my first statin prescription more than 20 years ago. We haven’t seen much happening and have seen a lot of inertia. These results and outcomes in the US population are not acceptable.

I believe there is a problem that we need to tackle. We need to be together, hand in hand, with insurers; they need to do their part. The manufacturers need to do their part and the patient needs to do their part. And the HCP needs to do their part. I think it’s missing the element of empowerment of the patient and the HCP binary, we need to help them take control of their destiny and their treatments.

HCPLive: Despite the need for more intensive therapy, these data indicate <2% of patients initiated a nonstatin lipid-lowering therapy (LLT). What are the barriers that might be impacting the greater adoption of those agents?

In the US, we have some statistics. For example, one-third of the population does not have any insurance or is poorly insured. The second thing, a lot of cardiologists often come from cities, but 50% of counties in the country do not have a single cardiologist. We have a compounding effect of many things happening culminating with a patient not being intensified or therapy not achieving their goals. So, we have systemic barriers.

Even the possibility of a patient talking about their disease with their doctor, given the short duration of time, it often feels like patients spend more time asking questions with ChatGPT than their doctors. Is this the ideal thing? Maybe it’s an indication of how to use technology in the future, but we need to put the trust back in the relationship. Approximately three out of four patients in the US trust their primary care, so I think it’s an untapped opportunity.

We should not only focus on cardiology, we need to go to primary care, so they can also achieve their goals. This is not rocket science. We talk about lipids, the most modifiable risk factor. It’s accessible and really for everyone. It’s not complicated, so I think all primary care should have these goals and help their patients achieve those goals.

HCPLive: How can recent guideline recommendations from organizations like the ACC and the American Heart Association (AHA) help address this issue?

Every time they go with the guidelines in a simple way, they can make it clear that what they’re recommending can be translated into clinical practice. Even when the guideline is not clear, we have a gap of 17 years between what is published and actual clinical practice. That’s why we need implementation science that’s been around with the National Institutes of Health (NIH) for the last 20 years. They help, by not only being a beacon and source of knowledge, but also helping us be partners for implementation initiatives. What works best to have those patients achieve their goals?

HCPLive: Do you have any final thoughts on these treatment gaps in a high-risk population?

I would say just the importance of testing. In the country right now, we’re seeing dramatically low levels of testing. People are not testing for LDL, and when they do test, they don’t initiate the treatment. Something is going on there that we need to crack the code of, particularly what’s going on between the testing not being performed and why testing is not generating the urgency to do something.

It’s accessible to everyone and affordable, so why is someone not doing it? Testing is very important, because that’s the best way to put someone on a patient care pathway, so they can achieve their goals. The second thing is to continue mass education of both patients and also HCPs so they know the goal, know your number, and understand getting there is not so complicated.

Disclosures: Boer is an employee of Amgen.

References

Sakhuja S, Chan Q, Ochs A et al. Lipid Lowering Therapy Use in High-Risk ASCVD Patients Without Prior MI or Stroke - Preliminary Data from VESALIUS-Real, US. Presented at: American College of Cardiology (ACC.25) Annual Scientific Session. March 29 – 31, 2025. Chicago, Il.