The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.
Men aged 18-55 years and women aged 18-65 years;
CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);
LDL-C >3.4 mmol/L without regular statin therapy or LDL-C >1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
Prior use of PCSK9 inhibitors;
Prior history of hemorrhagic stroke;
Prior coronary artery bypass grafting or coronary intervention;