Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction

Gibson, C. Michael; Duffy, Danielle; Korjian, Serge; Bahit, M. Cecilia; Chi, Gerald; Lincoff, A. Michael; Heise, Mark; Deckelbaum, Lawrence I.; Mears, Sojaita Jenny; Lopes, Renato D.; Trebacz, Jaroslaw; Bonaca, Marc; Tendera, Michal; Ridker, Paul M.; Aylward, Philip; et. al.

Abstract

--- - Background Cardiovascular events frequently recur after acute myocardial infarction, and low cholesterol efflux - a process mediated by apolipoprotein A1, which is the main protein in high-density lipoprotein - has been associated with an increased risk of cardiovascular events. CSL112 is human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity. Whether infusions of CSL112 can reduce the risk of recurrent cardiovascular events after acute myocardial infarction is unclear.Methods We conducted an international, double-blind, placebo-controlled trial involving patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors. Patients were randomly assigned to receive either four weekly infusions of 6 g of CSL112 or matching placebo, with the first infusion administered within 5 days after the first medical contact for the acute myocardial infarction. The primary end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes from randomization through 90 days of follow-up.Results A total of 18,219 patients were included in the trial (9112 in the CSL112 group and 9107 in the placebo group). There was no significant difference between the groups in the risk of a primary end-point event at 90 days of follow-up (439 patients [4.8%] in the CSL112 group vs. 472 patients [5.2%] in the placebo group; hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.05; P=0.24), at 180 days of follow-up (622 patients [6.9%] vs. 683 patients [7.6%]; hazard ratio, 0.91; 95% CI, 0.81 to 1.01), or at 365 days of follow-up (885 patients [9.8%] vs. 944 patients [10.5%]; hazard ratio, 0.93; 95% CI, 0.85 to 1.02). The percentage of patients with adverse events was similar in the two groups; a higher number of hypersensitivity events was reported in the CSL112 group.Conclusions Among patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors, four weekly infusions of CSL112 did not result in a lower risk of myocardial infarction, stroke, or death from cardiovascular causes than placebo through 90 days. (Funded by CSL Behring; AEGIS-II ClinicalTrials.gov number, NCT03473223.) - In patients with acute MI, multivessel coronary artery disease, and other cardiovascular risk factors, CSL112 did not reduce the risk of MI, stroke, or death from cardiovascular causes.

Más información

Título según WOS: ID WOS:001197648900001 Not found in local WOS DB
Título de la Revista: NEW ENGLAND JOURNAL OF MEDICINE
Volumen: 390
Número: 17
Editorial: MASSACHUSETTS MEDICAL SOC
Fecha de publicación: 2024
Página de inicio: 1560
Página final: 1571
DOI:

10.1056/NEJMoa2400969

Notas: ISI