New data from the VESALIUS-REAL study has uncovered alarming deficiencies in lipid management for high-risk cardiovascular patients in the United States, revealing a significant disconnect between available treatments and actual clinical practice.
The observational study, presented at the recent American College of Cardiology (ACC) meeting, analyzed data from over 278,000 high-risk patients between 2016 and 2022. The findings paint a concerning picture of cardiovascular care in the U.S., particularly in the critical period following major cardiac events.
Significant Care Gaps Identified
According to Dr. Leandro Boer, VP of U.S. General Medicines at Amgen, 70% of patients who experienced a myocardial infarction (MI) or stroke did not initiate any lipid-lowering therapy after the event. Even more concerning, 88% of these patients did not intensify their treatment over the following year.
"What we're seeing is really remarkable," Dr. Boer stated in an interview with Pharmaceutical Executive. "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."
These statistics are particularly troubling given the well-established link between LDL cholesterol management and reduced cardiovascular risk, as well as the availability of multiple effective treatment options.
Treatment Underutilization Despite Available Options
Despite the availability of proven therapies including statins, ezetimibe, and PCSK9 inhibitors, the study found that only 9.8% of high-risk patients were on high-intensity statins. This low utilization rate is especially surprising considering that many statins are now available as generics.
"We have so many available treatments to address this," Dr. Boer emphasized. "We've had statins since the 1990s, yet it feels like we're frozen in time. We're not seeing forward progress."
Barriers to Effective Care
The study identified several factors contributing to suboptimal care for cardiovascular patients, particularly those over 50 without prior cardiovascular events:
- Insurance gaps, particularly for patients in the "pre-Medicare" age range
- Poor risk perception of cardiovascular disease compared to other conditions like cancer
- Over-reliance on lifestyle interventions without appropriate pharmacological support
- Limited time with primary care providers
- Overly complex treatment guidelines that may impede clinical decision-making
A critical issue highlighted by Dr. Boer is the lack of accountability during transitions of care. "These patients aren't managed by just one specialty," he noted. "Typically, they start with their primary care physician. If they experience a cardiovascular event, they may transition to a cardiologist and then to cardiac rehab. After rehab, they return to primary care."
Addressing the Care Gap
In response to these findings, Amgen has announced an ambitious goal to cut the number of heart attacks and strokes in the U.S. in half by 2030. The company is pursuing this through multiple initiatives:
- Free LDL-C testing in collaboration with CVS MinuteClinics
- Community partnerships with organizations like the Association of Black Cardiologists and the Family Heart Foundation
- The LATTICE Consortium, focused on implementation science to reduce the time from discovery to practice
- An LDL-C Action Summit and partnerships with the National Lipid Association to raise awareness and improve communication
The VESALIUS-REAL findings may also influence future clinical guidelines by emphasizing treatment urgency, simplifying decision-making processes, and streamlining recommendations—particularly for primary care providers who manage the majority of these patients.
Improving Care Transitions
Dr. Boer emphasized that improving accountability across care transitions is essential. "Cardiologists should ensure that when patients transition back to primary care, the ongoing treatment is properly maintained, with clear education and documentation explaining why certain medications or therapies need to continue."
The study underscores that despite significant advances in cardiovascular medicine, implementation remains a critical challenge. Without addressing these systemic issues in care delivery, even the most effective treatments cannot reach their full potential to reduce cardiovascular morbidity and mortality.
"Ultimately, care needs to revolve around the patient, making sure there are no gaps where patients might miss out on proper treatment or follow-up," Dr. Boer concluded. "This collaboration between specialties is critical to delivering optimal care."
