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AMUNDSEN: Evolocumab Immediately After MI Improves LDL-C Goal Achievement

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Despite failing to display a clinically significant reduction in all-cause death or hospitalization for cardiovascular events, the trial did highlight evolocumab’s LDL-C-lowering capacity.

Immediately beginning evolocumab treatment after a myocardial infarction (MI) substantially improves LDL-C goal achievement, but investigators did not record an early reduction in all-cause death or unplanned hospitalization versus standard-of-care.1

Presented at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, by Gilles Montalescot, MD, PhD, professor of cardiology at Pitié-Salpêtrière Hospital in Paris, France, these data reflect a potentially major method of optimizing lipid levels in a population that frequently never achieves the ideal LDL-C target despite cardiovascular disease.1

“Only around 1/3 of patients achieve LDL-C targets after an acute MI,” Montalescot said in a statement. “Patients are often discharged from hospital on a high-dose statin, then ezetimibe and possibly bempedoic acid may be added, but it can take months before treatment is intensified with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, if it ever occurs.”1

AMUNDSEN was a phase IV, multicenter, controlled, open-label randomized study, investigating evolocumab’s potential for superiority compared to standard of care in reducing LDL-C. Patients were eligible for inclusion if they had a diagnosis of STEMI or NSTEMI and were being treated with the maximally tolerated dose of a statin as part of the standard of care at randomization. Those with treatment for fibrinolysis or planned CABG, among other criteria, were excluded.2

The study’s primary endpoints were LDL-C reduction of ≥50% from baseline with a final LDL-C <1.4 mmol/L at 12 months’ follow-up and a composite endpoint of all-cause mortality or unplanned hospitalization for a cardiovascular reason. Secondary endpoints included LDL-C <40 mg/dL at 12 months and a composite of all-cause mortality, MI, stroke, and unplanned revascularization, among others.2

A total of 2,161 patients were enrolled in the trial, randomly assigned to receive either evolocumab before percutaneous coronary intervention alongside standard of care or standard of care alone. The patients in the control group received the therapeutic options available in their country, including the use of a PCSK9 inhibitor, according to 2019 guidelines from the ESC. All patients visited clinic at 6 weeks, 6 months, 9 months, and 12 months, with each visit including LDL-C assessments.1

Montalescot and colleagues found a substantial difference for the primary endpoint, with 82% of patients in the evolocumab group and 40% in the control group meeting the primary LDL-C endpoint at 12 months (P <.001). The patients who achieved the target in the evolocumab arm did so in 9 weeks, while the standard-of-care group took 19 weeks to reach the same target. There was no significant difference in clinical outcomes at 1 year – all-cause mortality and unplanned hospitalizations occurred in 14.6% of patients in the evolocumab arm versus 15.4% of the standard-of-care group.1

However, despite these results, the team also acknowledged that only 1 in 5 patients achieved their LDL-C goals the following year. This reflects the growing need for further LDL-C reduction therapies and methods by which patients can attain and maintain these goals over long periods of time.1

“Immediate in-hospital initiation of evolocumab substantially improved LDL-C goal attainment but even then, 1 in 5 patients failed to reach their target a year later,” Montalescot said in a statement. “Developing additional preventive strategies and delivering them early remains an imperative for high-risk patients.”1

References
  1. Montalescot G. AMUNDSEN: Evolocumab Before Percutaneous Coronary Intervention for Acute Myocardial Infarction. Presented at the European Society of Cardiology Congress 2026, Munich, Germany. August 28-31, 2026.
  2. Assistance Publique – Hôpitaux de Paris. Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI (AMUNDSEN). ClinicalTrials.gov Identifier: NCT04951856. Updated April 13, 2026. Accessed August 29, 2026. https://clinicaltrials.gov/study/NCT04951856

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