LDL Cholesterol Lowering With Evolocumab Before Percutaneous Coronary Intervention for Acute Myocardial Infarction: The AMUNDSEN Randomized Clinical Trial.
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Montalescot Gilles, Ferrari Emile, Souteyrand Géraud, Bouleti Claire, Range Grégoire, Batias-Moreau Laure, Chioccioli Marco, Picchi Andrea, Dillinger Jean-Guillaume, Esposito Giovanni, Patti Giuseppe, Vincent Flavien, Braik Nassim, Ederhy Stéphane, Coste Pierre, Hannachi Sinda, Redjimi Nassim, Zeitouni Michel, Duband Benjamin, Fourrier Etienne, Guedeney Paul, Procopi Niki, Sabouret Pierre, Diallo Abdourahmane, Brochard Karine, Chamam Amel, Vignolles Nicolas, Kerneis Mathieu, Silvain Johanne, Jukema J Wouter, Mach François, Cequier-Fillat Angel, Thiele Holger, Bartus Stanislaw, Bolognese Leonardo, Vicaut Eric, AMUNDSEN Investigators of the ACTION Study Group
Аннотация
OBJECTIVE: To evaluate evolocumab as first-line therapy vs standard care in patients with high-risk acute MI undergoing percutaneous coronary intervention (PCI).
DESIGN, SETTING, AND PARTICIPANTS: This international, phase 4, prospective randomized, open, blinded end-point adjudication study was conducted at 48 sites in 6 countries. Adults with high-risk ST-elevation MI (STEMI; aged >55 years) or non-ST-elevation MI (NSTEMI) with 1 or more additional high-risk characteristics were enrolled beginning September 29, 2021, through May 22, 2025, with final follow-up on May 22, 2026.
INTERVENTIONS: Patients were randomized 1:1 to receive evolocumab 140 mg subcutaneously every 2 weeks for 1 year (first injection before PCI) in addition to standard care (n = 1087) or standard care alone (n = 1074). Standard care included high-intensity oral lipid-lowering therapy with the optional PCSK9 inhibitor use per guideline indication in the control group.
MAIN OUTCOMES AND MEASURES: The primary outcome was LDL-C less than 55 mg/dL and at least 50% reduction in LDL-C from baseline at 12 months. The main clinical end point was all-cause death or unplanned cardiovascular hospitalization at 12 months.
RESULTS: Among 2161 randomized patients (mean age, 67 years; 1703 males [79%]; 1261 [58%] with STEMI; 900 [42%] with NSTEMI), the primary outcome was achieved in 792 of 970 patients (82%) with evolocumab vs 370 of 934 (40%) with standard care (adjusted odds ratio, 5.54 [95% CI, 4.50-6.82]; P < .001). At 6 weeks, median LDL-C was 16 mg/dL with evolocumab vs 56 mg/dL with standard care. The main clinical end point occurred in 159 of 1087 patients (14.6%) with evolocumab vs 165 of 1074 (15.4%) with standard care (adjusted odds ratio, 0.94 [95% CI, 0.73-1.19]; P = .59).
CONCLUSIONS AND RELEVANCE: In patients with acute MI undergoing PCI, first-line evolocumab combined with high-intensity lipid-lowering therapy produced rapid and sustained LDL-C reduction, with more than 80% of patients reaching the guideline-recommended target at 1 year. However, no clinical benefit was detected during the first year of follow-up, arguing against clinically meaningful acute pleiotropic effects of PCSK9 inhibitors in addition to standard care.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04951856.