Evolocumab before percutaneous coronary intervention for acute myocardial infarction: Design of the AMUNDSEN trial - 03/12/25
, Leonardo Bolognese, MD b, Stanislaw Bartus, MD c, Angel Cequier-Fillat, MD d, Holger Thiele, MD e, François Mach, MD f, J. Wouter Jukema, MD g, Emile Ferrari, MD-PhD h, Géraud Souteyrand, MD i, Claire Bouleti, MD-PhD j, Grégoire Range, MD k, Marco Chioccioli, MD b, Andréa Picchi, MD l, Laure Batias-Moreau, MD m, Giovanni Esposito, MD n, Nassim Braik, MD o, Nassim Redjimi, MD h, Benjamin Duband, MD i, Paul Guedeney, MD-PhD a, Michel Zeitouni, MD-PhD a, Karine Brochard, MS a, Johanne Silvain, MD-PhD a, Eric Vicaut, MD-PhD pon behalf of the AMUNDSEN investigators of the ACTION Study Group 1
ABSTRACT |
Rationale |
PCSK9 inhibitors are currently recommended as third-line therapy for post–myocardial infarction (MI) patients, added to high-dose statin, ezetimibe, and potentially bempedoic acid when the LDL-C target of <55 mg/dL is not achieved. These guideline-driven indications result in delayed initiation of PCSK9 inhibitors, potentially missing the opportunity for benefit during the acute phase. Recent studies have demonstrated that early PCSK9 inhibition promotes anti-inflammatory effects and plaque stabilization, suggesting a potential role early in MI management.
Methods |
The AMUNDSEN trial is a randomized, international, phase IV study using a PROBE (Prospective Randomized Open, Blinded Endpoint) design to evaluate the effects of early PCSK9 inhibition in high-risk acute MI patients undergoing percutaneous coronary intervention (PCI). A total of 2,166 patients were enrolled, including those with ST-elevation MI undergoing primary PCI and those with non–ST-elevation MI with an indication for PCI, all presenting with at least 1 high-risk clinical characteristic. Patients were randomized to receive either immediate evolocumab prior to PCI alongside standard care or standard care alone. The primary objective is to achieve both a ≥ 50% reduction in LDL-C from baseline and a target LDL-C < 55 mg/dL at 12 months. The main clinical objective is to assess the composite of all-cause death or unplanned hospitalization for a cardiovascular (CV) reason at 12 months.
Current status |
Enrollment and randomization are complete. Lipid and clinical follow-up are ongoing. Results from this study will clarify the lipid-lowering efficacy and clinical impact of early evolocumab initiation in the acute MI setting.
Conclusion |
The AMUNDSEN trial will provide critical insights into the potential benefits of early PCSK9 inhibition in high-risk MI patients undergoing PCI.
Clinical trial registration |
NCT (clinicaltrials.gov): 04951856 - EUCT number: 2024-518195-31-00.
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| AMUNDSEN: Acute myocardial infarction upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next 3 Days (NSTEMI), and randomized to subcutaneous evolocumab or normal strategies to reach guidelines LDL objectives |
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| NCT 04951856 - EUCT number: 2024-518195-31-00. |
Vol 292
Article 107295- février 2026 Retour au numéro
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