Early Evolocumab Improves LDL-C Goal Attainment After MI

Starting evolocumab before percutaneous coronary intervention (PCI) substantially increased 1-year low-density lipoprotein cholesterol (LDL-C) goal attainment after high-risk acute myocardial infarction (MI), according to the phase 4 AMUNDSEN randomized clinical trial published in JAMA. The strategy did not improve clinical outcomes during the first year.

The prospective, open-label trial enrolled 2,161 adults at 48 sites in 6 countries. Participants had high-risk ST-segment elevation MI or non-ST-segment elevation MI and were assigned 1:1 to evolocumab 140 mg subcutaneously every 2 weeks for 1 year, beginning before PCI, plus standard care or to standard care alone. Clinical end points were adjudicated by a blinded committee.

At 12 months, the primary end point, an LDL-C level below 55 mg/dL and a reduction of at least 50% from baseline, occurred in 81.6% of evaluable patients receiving evolocumab and 39.6% receiving standard care. The adjusted odds ratio was 5.54 (95% CI, 4.50-6.82; P<.001). At 6 weeks, median LDL-C levels were 16mg/dL and 56mg/dL, respectively.

All-cause death or unplanned cardiovascular hospitalization occurred in 14.6% of the evolocumab group and 15.4% of the standard-care group, a nonsignificant difference (adjusted odds ratio, 0.94; 95% CI, 0.73-1.19; P=.59). Serious adverse-event incidence did not differ between groups. Investigators reported that the findings did not support a clinically meaningful acute pleiotropic effect from early proprotein convertase subtilisin-kexin type 9 inhibition.

The authors identified the open-label design and variation in background care across countries as limitations. They also cautioned that an apparent clinical benefit in a per-protocol analysis was susceptible to selection bias. The trial received an unrestricted grant from Amgen and support from the ACTION Study Group; the funders had no role in study conduct, analysis, or publication decisions.

Source: Bouleti C, Range G, Batias-Moreau L, et al. LDL cholesterol lowering with evolocumab before percutaneous coronary intervention for acute myocardial infarction: the AMUNDSEN randomized clinical trial. JAMA. Published online August 29, 2026. doi:10.1001/jama.2026.17302