Abstract 515: Coronary Atheroma Regression from Serial Infusions of Autologous Selectively Delipidated Preβ-HDL-enriched Plasma on Coronary Atheroma in Patients With Homozygous Familial Hypercholesterolemia in the HALO-FH Trial
Bibliographic record
Abstract
Background: Lipid-rich plaques are prone to rupture causing major adverse cardiac events (MACE). Selective delipidation of plasma via HDL Therapeutics PDS-2™ System converts a HDL to preβ-HDL, the most effective form of HDL for cholesterol removal from arterial plaques Objective: To determine the effect of 7 weekly serial infusions of autologous selectively delipidated preβ-HDL-enriched plasma on coronary atheroma, assessed by quantitative coronary computed tomography angiography (CCTA), in patients with homozygous familial hypercholesterolemia (HoFH). Methods: Open-label study of 6 subjects with HoFH at 3 centers. Inclusion criteria were subclinical atherosclerosis (≥20% luminal stenosis) on baseline CCTA, stable lipid-lowering therapy for ≥ 4 weeks prior, and meeting criteria for serial apheresis. All subjects received 7 weekly infusions of autologous selectively delipidated preβ-HDL-enriched plasma and baseline and final CCTA. The primary endpoint was the quantitative atheroma cross-sectional area for each plaque, and plaque composition. Plasma prior to and after each infusion was subjected to gel electrophoresis for preβ-HDL particle levels. Results: 16 coronary plaques were identified. The primary endpoint was met with a statistically significant 18% reduction in total atheroma cross-sectional area between baseline and follow-up (9.9±3.5 vs. 8.2±2.4 mm 2 ; P=0.023). This included a 20% reduction of noncalcified plaque (P=0.015), and reductions in the low-density (-38%; P=0.005) and necrotic core (-33%; P=0.007) components. The percentage of preβ-HDL particles levels increased significantly (p<0.001) by 65.92%. Conclusion: We observed coronary atheroma regression after 7 weekly serial infusions of autologous selectively delipidated preβ-HDL-enriched plasma in patients with HoFH. This was accompanied by an increase in preβ-HDL particles levels and a reduction in the low-density and necrotic core plaque portions (i.e. those associated with high-risk plaques prone to rupture and higher rates of MACE). Clinical Implications: Autologous selectively delipidated preβ-HDL-enriched plasma is the first of its kind treatment to rapidly reverse coronary atherosclerosis in patients with HoFH who are at increased risk for MACE.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".