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Effect of reconstituted human apolipoprotein A-I on recurrent ischemic events in survivors of acute MI

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 evalu...

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Main Authors: Povsic, Thomas J. (Author) , Korjian, Serge (Author) , Bahit, M. Cecilia (Author) , Chi, Gerald (Author) , Duffy, Danielle (Author) , Alexander, John H. (Author) , Vinereanu, Dragos (Author) , Tricoci, Pierluigi (Author) , Mears, Sojaita Jenny (Author) , Deckelbaum, Lawrence I. (Author) , Bonaca, Marc (Author) , Ridker, Paul M. (Author) , Goodman, Shaun G. (Author) , Cornel, Jan H. (Author) , Lewis, Basil S. (Author) , Parkhomenko, Alexander (Author) , Lopes, Renato D. (Author) , Aylward, Philip (Author) , Lincoff, A. Michael (Author) , Heise, Mark (Author) , Sacks, Frank (Author) , Nicolau, Jose C. (Author) , Merkely, Bela (Author) , Trebacz, Jaroslaw (Author) , Libby, Peter (Author) , Nicholls, Stephen J. (Author) , Pocock, Stuart (Author) , Bhatt, Deepak L. (Author) , Kastelein, John (Author) , Bode, Christoph (Author) , Mahaffey, Kenneth W. (Author) , Steg, P. Gabriel (Author) , Tendera, Michal (Author) , Bainey, Kevin R. (Author) , Harrington, Robert A. (Author) , Mehran, Roxana (Author) , Dürschmied, Daniel (Author) , Kingwell, Bronwyn A. (Author) , Gibson, C. Michael (Author)
Format: Article (Journal)
Language:English
Published: 4 June 2024
In: Journal of the American College of Cardiology
Year: 2024, Volume: 83, Issue: 22, Pages: 2163-2174
ISSN:1558-3597
DOI:10.1016/j.jacc.2024.03.396
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.jacc.2024.03.396
Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0735109724067020
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Author Notes:Thomas J. Povsic, MD, PHD, Serge Korjian, MD, M. Cecilia Bahit, MD, Gerald Chi, MD, Danielle Duffy, MD, John H. Alexander, MD, MHS, Dragos Vinereanu, MD, Pierluigi Tricoci, MD, P HD, MHS, Sojaita Jenny Mears, MS, Lawrence I. Deckelbaum, MD, Marc Bonaca, MD, MPH, Paul M. Ridker, MD, Shaun G. Goodman, MD, MSC ,Jan H. Cornel, MD, Basil S. Lewis, MD, Alexander Parkhomenko, MD, Renato D. Lopes, MD, PHD, Philip Aylward, BM, BCH, PHD, A. Michael Lincoff, MD, Mark Heise, PHD, Frank Sacks, MD, Jose C. Nicolau, MD, P HD, Bela Merkely, MD, Jaroslaw Trebacz, MD, Peter Libby, MD, Stephen J. Nicholls, MBBS, PHD, Stuart Pocock, PH D, Deepak L. Bhatt, MD, MPH, MBA, John Kastelein, MD, Christoph Bode, MD, Kenneth W. Mahaffey, MD, P. Gabriel Steg, MD, Michal Tendera, MD, Kevin R. Bainey, MD, MSC, Robert A. Harrington, MD, Roxana Mehran, MD, Daniel Duerschmied, MD, Bronwyn A. Kingwell, PHD, C. Michael Gibson, MS, MD, the AEGIS-II Committees and Investigators

MARC

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245 1 0 |a Effect of reconstituted human apolipoprotein A-I on recurrent ischemic events in survivors of acute MI  |c Thomas J. Povsic, MD, PHD, Serge Korjian, MD, M. Cecilia Bahit, MD, Gerald Chi, MD, Danielle Duffy, MD, John H. Alexander, MD, MHS, Dragos Vinereanu, MD, Pierluigi Tricoci, MD, P HD, MHS, Sojaita Jenny Mears, MS, Lawrence I. Deckelbaum, MD, Marc Bonaca, MD, MPH, Paul M. Ridker, MD, Shaun G. Goodman, MD, MSC ,Jan H. Cornel, MD, Basil S. Lewis, MD, Alexander Parkhomenko, MD, Renato D. Lopes, MD, PHD, Philip Aylward, BM, BCH, PHD, A. Michael Lincoff, MD, Mark Heise, PHD, Frank Sacks, MD, Jose C. Nicolau, MD, P HD, Bela Merkely, MD, Jaroslaw Trebacz, MD, Peter Libby, MD, Stephen J. Nicholls, MBBS, PHD, Stuart Pocock, PH D, Deepak L. Bhatt, MD, MPH, MBA, John Kastelein, MD, Christoph Bode, MD, Kenneth W. Mahaffey, MD, P. Gabriel Steg, MD, Michal Tendera, MD, Kevin R. Bainey, MD, MSC, Robert A. Harrington, MD, Roxana Mehran, MD, Daniel Duerschmied, MD, Bronwyn A. Kingwell, PHD, C. Michael Gibson, MS, MD, the AEGIS-II Committees and Investigators 
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520 |a 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. 
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650 4 |a apoA-I 
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650 4 |a myocardial infarction 
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