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| Turkish Society of Cardiology Young Cardiologists Bulletin Year: 7 Number: 1 / 2024 |
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Name of the Study: Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction AEGIS-2 Published in Congress: ACC 2024 Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2400969 Background: CSL112 is a human apolipoprotein A1 produced from plasma that improves cholesterol efflux. Poor cholesterol efflux, a mechanism mediated by apolipoprotein A1, has been linked to an increased risk of cardiovascular events. Objective:The trial's purpose was to evaluate the effect of CSL 112 (Apo -A1) therapy on incidence of cardiovascular death and recurrent MI. Methods:The study included 18,219 high-risk adult patients with type 1 MI who had multivessel coronary artery disease and signs of increased cardiovascular risk. They were randomized 1:1 to either a placebo (n=9,107) or four weekly 6 g infusions of CSL112 (n=9,112), with the first infusion given within five days of first medical contact for MI and the whole course completed within 30 days of randomization. Follow-up assessments were performed at screening, during each infusion session, on days 29, 60, and 90, and every 90 days until day 365. Results:The primary efficacy outcome of time to first occurrence of the composite of MI, stroke, or cardiovascular death randomization through 90 days, assessed in a time-to-first event analysis, was not statistically significantly reduced with CSL112 vs. placebo at 4.8% vs. 5.2% (hazard ratio [HR], 0.93; 95% CI, 0.81-1.05; p = 0.24). The two groups had similar percentages of patients experiencing adverse events; however, the CSL112 group reported more hypersensitivity reactions. Conclusion:Four weekly infusions of CSL112 did not reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients with acute myocardial infarction, multivessel coronary artery disease, and other cardiovascular risk factors over 90 days compared to placebo. Interpretations:The efficacy of LDL- or non-HDL-lowering treatments in reducing the frequency of events following myocardial infarction has already been established. However, it is becoming increasingly difficult to demonstrate additional benefit in populations where evidence-based, guideline-guided therapy are properly used. In this study, CSL112 did not provide additional benefit over optimal medical therapy in terms of reducing recurrent events in a high-risk group of patients with myocardial infarction.
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