New Real-World Evidence Highlights Cardiovascular Outcomes with Lipoprotein Apheresis in Patients with Established ASCVD and Elevated Lp(a)
Real-World Study Reports Lower Cardiovascular Event Rates Following Lipoprotein Apheresis Initiation
Elevated lipoprotein(a), or Lp(a), is increasingly recognized as an important and genetically driven contributor to atherosclerotic cardiovascular disease (ASCVD). For patients with established ASCVD and persistently elevated Lp(a), treatment options have historically been limited.
A newly published retrospective, multicenter chart review in the American Journal of Preventive Cardiology examined real-world outcomes associated with lipoprotein apheresis (LA) using the LIPOSORBER® LA-15 System in U.S. patients with ASCVD and elevated Lp(a). Investigators from leading cardiovascular centers across the country evaluated both cardiovascular outcomes and safety over a two-year follow-up period.
Study Overview
The study analyzed medical records from 60 patients treated at five U.S. clinical sites between 2012 and 2025. All patients had established ASCVD, elevated Lp(a) levels greater than 60 mg/dL, were receiving maximally tolerated lipid-lowering therapy, and underwent treatment with the LIPOSORBER® LA-15 System.
Researchers compared cardiovascular events occurring before initiation of lipoprotein apheresis with events occurring after treatment began, evaluating:
- Major adverse cardiac events (MACE)
- Major adverse non-cardiac events (MANCE)
- Lipid changes, including Lp(a) and LDL-C reduction
- Safety and tolerability outcomes
Key Findings
Significant Reduction in Major Cardiovascular Events
During the two years before lipoprotein apheresis initiation, investigators documented 41 major adverse cardiac events. Following treatment initiation, that number decreased to 10 events.
The incidence rate of MACE declined by:
- 75.3% during the first year of treatment
- 72.9% across the full two-year follow-up period compared with the two years before treatment initiation
These reductions remained consistent in sensitivity analyses that excluded the first 30, 90, and 180 days after treatment initiation, supporting the robustness of the findings.
Reduction in Non-Cardiac Vascular Events
Researchers also observed a substantial decline in major adverse non-cardiac events, including conditions such as deep vein thrombosis and pulmonary embolism.
Compared with the two years before treatment:
- MANCE incidence rates declined by 95%
- No MANCE events were observed during the first year after treatment initiation
Robust Lipid Lowering
Consistent with the established mechanism of lipoprotein apheresis, treatment produced substantial acute reductions in both Lp(a) and LDL cholesterol levels.
During the first year of therapy:
- Mean Lp(a) levels decreased from 127.0 mg/dL to 37.7 mg/dL, representing a 70.3% reduction
- Mean LDL-C levels decreased from 97.8 mg/dL to 28.2 mg/dL, representing a 71.2% reduction
Similar reductions were maintained during the second year of follow-up.
Safety Profile
Lipoprotein apheresis was generally well tolerated in this patient population. While adverse events were reported, most were manageable and consisted primarily of nausea, vomiting, and angina or chest pain. Importantly:
- No deaths were reported
- No adverse events resulted in documented treatment interruption
What These Findings Mean for Clinical Practice
Lp(a) remains a significant residual cardiovascular risk factor for many patients despite aggressive LDL-C lowering strategies. As awareness and routine measurement of Lp(a) continue to increase, clinicians are identifying more patients whose cardiovascular risk may be driven in part by elevated Lp(a).
This real-world analysis provides additional real-world evidence on outcomes associated with lipoprotein apheresis in appropriately selected high-risk patients with ASCVD and elevated Lp(a). While the authors note important limitations, including the retrospective design and lack of a control group, the magnitude of event reduction observed over two years is noteworthy and aligns with findings from previous observational studies.
Looking Ahead
The authors conclude that reductions in Lp(a) and LDL-C levels were associated with lower observed rates of cardiovascular and non-cardiovascular events over two years of treatment. They emphasize that these findings should be viewed as descriptive, real-world evidence and as hypothesis-generating rather than definitive proof of causality. Future prospective studies will help further clarify the relationship between Lp(a) lowering and cardiovascular outcomes.
To read the full publication, please visit: https://www.sciencedirect.com/science/article/pii/S2666667726003715?fr=RR-2&ref=pdf_download&rr=a39780e399cada48
Reference:
Moriarty PM, Fernandez AB, Saucier SJ, Babirak SP, Bajaj A, Saxon D. Real-world cardiovascular and safety outcomes associated with lipoprotein apheresis using the LIPOSORBER® LA-15 system in patients with atherosclerotic cardiovascular disease having elevated lipoprotein(a): A retrospective chart review study in the US. American Journal of Preventive Cardiology. Published online August 22, 2026.
For LIPOSORBER Indications for Use and other safety information, please visit: https://liposorber.com/liposorber-safety-info