New Real-World Evidence in Patients with ASCVD and Elevated Lp(a)
Retrospective Multicenter Study Reports Lower Observed 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 described real-world cardiovascular and safety outcomes among U.S. patients with ASCVD and elevated Lp(a) who underwent lipoprotein apheresis using the LIPOSORBER® LA-15 System. Investigators at five U.S. clinical sites evaluated cardiovascular outcomes and safety over a two-year post-index 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.
The study inclusion criteria are not a substitute for the full FDA-cleared Indications for Use for the LIPOSORBER® LA-15 System. See the complete Indications for Use and Important Safety Information below.
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
Lower Observed MACE Incidence Rates Following LA Initiation
Investigators documented 41 MACE during the two-year pre-index period and 10 MACE during the two-year post-index period. Compared with the corresponding pre-index periods, the observed MACE incidence rate was:
- 3% lower during the first year after LA initiation
- 9% lower across the two-year post-index follow-up.
The observed differences remained consistent in sensitivity analyses excluding the first 30, 90, and 180 days after treatment initiation.
Interpretation: This was a retrospective pre/post comparison without a concurrent control group. The results show an association and do not establish that LA caused the observed difference in event rates.
Lower Observed MANCE Incidence Rates Following LA Initiation
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
Acute Pre- to Post-Apheresis Lipid Reductions
The study reported acute pre- to post-apheresis reductions in Lp(a) and LDL-C.
During the first year, mean pre- to post-apheresis session values changed from
- 0 to 37.7 mg/dL for Lp(a), a 70.3% acute reduction
- 8 to 28.2 mg/dL for LDL-C, a 71.2% acute reduction
Similar acute pre- to post-apheresis reductions were reported during the second year. These findings should not be interpreted as sustained between-session reductions or as evidence that the lipid changes caused the observed cardiovascular outcomes.
Reported Safety Outcomes
Adverse events were reported in 46.7% of patients. Reported events included nausea, vomiting, and angina or chest pain. No adverse events resulted in documented treatment interruption, and no deaths were reported during study follow-up.
Interpretation and Study Limitations: What They Mean for Clinical Practice
The study adds descriptive real-world evidence regarding patients with established ASCVD and elevated Lp(a) who underwent LA with the LIPOSORBER® LA-15 System. Important limitations include the retrospective design, small sample size, pre/post comparison, absence of a concurrent control group, and potential for confounding and incomplete chart documentation. Accordingly, the findings are hypothesis-generating and do not establish a causal relationship between LA and the observed event rates.
Looking Ahead
The authors reported acute reductions in Lp(a) and LDL-C together with lower observed MACE and MANCE incidence rates during the post-index period. Because the study was retrospective and lacked a concurrent control group, the findings are descriptive and hypothesis-generating and do not establish causality. Prospective controlled studies are needed to further evaluate the relationship between LA, lipid changes, and cardiovascular outcomes.
To read the full publication, please visit: 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
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