Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.
J Am Coll Cardiol
; 83(22): 2163-2174, 2024 Jun 04.
Article
em En
| MEDLINE
| ID: mdl-38588930
ABSTRACT
BACKGROUND:
The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI.OBJECTIVES:
This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI.METHODS:
The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo.RESULTS:
The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR 0.84; 95% CI 0.7-1.0; P = 0.056 at day 90; HR 0.86; 95% CI 0.74-0.99; P = 0.048 at day 180; and HR 0.89; 95% CI 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR 0.92; 95% CI 0.80-1.05 at day 90, HR 0.89; 95% CI 0.79-0.996 at day 180, HR 0.91; 95% CI 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis).CONCLUSIONS:
Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis-related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Apolipoproteína A-I
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Infarto do Miocárdio
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article