Patients who experience a ST-elevation myocardial infarction (STEMI) remain at considerable risk of further cardiovascular events, despite advances in interventions and standard therapies. Findings from the EARLY-STEMI trial were presented at the European Society of Cardiology (ESC) Congress 2025.
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have proven effective at lowering LDL-C and reducing major adverse cardiovascular events (MACE) in previous trials. However, most studies tested them in patients months or years after the acute coronary event. The EARLY-STEMI trial is the first to evaluate whether starting therapy within 48 hours of hospital admission could improve outcomes.
In this prospective, randomized, open-label trial, 147 patients with STEMI were assigned to receive either standard therapy alone or evolocumab plus standard therapy. Evolocumab was initiated within 48 hours following successful percutaneous coronary intervention.
At six months, LDL-C levels fell by 91% in the evolocumab group compared with 59% in the control group (p<0.001). Interim analysis also showed fewer MACE in the intervention group (1.4% vs 9.2%, p<0.037). Importantly, no safety signals or drug discontinuations were reported.
These results indicate that early PCSK9i therapy is both effective and safe in the acute phase of STEMI. Longer follow-ups are required to confirm durability of benefit and impact on long-term outcomes.