Key result
CSL112 reduced MACE in post-AMI patients with elevated baseline neutrophil-lymphocyte ratio and LDL-C ≥100 mg/dL (P=0.029).
Why the study?
Does CSL112 reduce MACE in post-AMI patients, and is its efficacy modified by baseline neutrophil-lymphocyte ratio (NLR) and LDL-C?
RCT (n=18,219)
randomized
Does CSL112 reduce MACE in post-AMI patients, and is its efficacy modified by baseline neutrophil-lymphocyte ratio (NLR) and LDL-C?
Answers are grounded in this paper and cite their sources.
In an exploratory post hoc analysis, CSL112 was associated with a reduction in MACE among post-AMI patients who had both elevated systemic inflammation (NLR) and LDL-C ≥100 mg/dL.
BACKGROUND: The AEGIS-II (ApoA-I Event Reducing in Ischemic Syndromes-II; NCT03473223) trial evaluated CSL112, a human plasma-derived apolipoprotein A-I therapy, for reducing cardiovascular events after acute myocardial infarction (AMI). Given CSL112's potential anti-inflammatory properties, we conducted an exploratory post hoc analysis to determine if its efficacy is influenced by baseline neutrophil-lymphocyte ratio (NLR), a marker of systemic inflammation, and low-density lipoprotein cholesterol (LDL-C). OBJECTIVES: The purpose of this study was to investigate the association of baseline NLR and cardiovascular events and explore whether NLR and LDL-C modify CSL112's efficacy in post-AMI patients. METHODS: A total of 18,219 participants with AMI, multivessel coronary artery disease, and additional cardiovascular risk factors were randomized to 4 weekly infusions of 6 g CSL112 or placebo. The primary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]). Cox proportional hazards models evaluated risk by dichotomized baseline NLR (>median vs ≤median). Treatment interactions with NLR and LDL-C (≥100 vs <100 mg/dL) were assessed. CONCLUSIONS: Baseline elevated NLR predicts MACE in post-AMI patients, and CSL112 showed an associated reduction in MACE in patients with elevated NLR and LDL-C ≥100 mg/dL.
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Rikken et al. (2025) conducted an RCT in acute myocardial infarction (AMI) (n=18,219). CSL112 vs. placebo was evaluated on composite of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) (p=0.029). CSL112 reduced MACE in post-AMI patients with elevated baseline neutrophil-lymphocyte ratio and LDL-C ≥100 mg/dL (P=0.029).
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