| Title: |
Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI |
| Authors: |
Povsic, TJ; Korjian, S; Bahit, MC; Chi, G; Duffy, D; Alexander, JH; Vinereanu, D; Tricoci, P; Mears, SJ; Deckelbaum, LI; Bonaca, M; Ridker, PM; Goodman, SG; Cornel, JH; Lewis, BS; Parkhomenko, A; Lopes, RD; Aylward, P; Lincoff, AM; Heise, M; Sacks, F; Nicolau, JC; Merkely, B; Trebacz, J; Libby, P; Nicholls, SJ; Pocock, S; Bhatt, DL; Kastelein, J; Bode, C; Mahaffey, KW; Steg, PG; Tendera, M; Bainey, KR; Harrington, RA; Mehran, R; Duerschmied, D; Kingwell, BA; Gibson, CM |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2024 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0735-1097 |
| Relation: |
https://hdl.handle.net/11343/348950 |
| Availability: |
https://hdl.handle.net/11343/348950 |
| Rights: |
https://creativecommons.org/licenses/by-nc-nd/4.0 ; CC BY-NC-ND |
| Accession Number: |
edsbas.E7AE9509 |
| Database: |
BASE |