Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

BACKGROUND AND OBJECTIVES: Rapid reduction of low-density lipoprotein cholesterol (LDL-C) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) is critical but challenging. This study evaluated the efficacy and safety of early triple lipid-lowering therapy with evolocumab, a moderate-intensity statin, and ezetimibe in statin-naïve ACS patients. METHODS: The C-STAR trial (Effect of Early Initiation of Evolocumab on Lipid Profile Changes in Patients with ACS Undergoing PCI) was a single-center, randomized, open-label trial conducted from December 2022 to January 2025. A total of 108 statin-naïve ACS patients undergoing PCI were randomized to evolocumab (140 mg) plus rosuvastatin 5 mg and ezetimibe 10 mg (n=54) or rosuvastatin 5 mg and ezetimibe 10 mg alone (n=54). The primary endpoint was LDL-C level at 2 weeks; cognitive safety was assessed using the Everyday Cognition (ECog) tool. RESULTS: Baseline LDL-C levels were similar between the 2 groups. At 2 weeks, LDL-C levels were lower in the evolocumab group compared to the non-evolocumab group (31±16 mg/dL vs. 63±17 mg/dL; p<0.001), with a greater percentage reduction (-77.5% vs. -53.3%, p<0.001). Target achievement rates were also higher in the evolocumab group (84.6% vs. 26.9%, p<0.001). Comparable cognitive functions were observed using ECog questionnaire (23.9±3.4 vs. 24.5±5.5; p=0.493). CONCLUSIONS: Early initiation of evolocumab in combination therapy achieved greater LDL-C reduction and target achievement in ACS patients undergoing PCI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier:NCT05661552.