Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study

Coronary artery disease (CAD) remains a leading cause of death worldwide, and while PCI has improved clinical outcomes, residual cardiovascular risk persists, especially in patients with lipid-rich plaques. Near-infrared spectroscopy combined with intravascular ultrasound (NIRS-IVUS) allows for the detection of lipid core burden, and high post-PCI LCBI values have been associated with worse prognosis.

This single-center, prospective, randomized pilot study (HANYANG-PICK) investigates the impact of a single dose of PCSK9 inhibitor administered immediately after PCI in patients with high post-PCI LCBI. The intervention group will receive the PCSK9 inhibitor, and the control group will undergo standard therapy. The primary endpoint is the incidence of major adverse cardiovascular events (MACE) at 12 months. The study is designed to inform the feasibility of a larger trial and to explore the potential of PCSK9 inhibitors for early plaque stabilization post-PCI.

Inclusion criteria

• Adults aged 19 years or older
• Patients diagnosed with coronary artery disease, including silent ischemia, stable angina, or acute coronary syndrome (unstable angina, NSTEMI, or STEMI)
• Underwent percutaneous coronary intervention (PCI) with NIRS-IVUS imaging
• Presence of target vessel post-PCI maxLCBI4mm ≥ 200
• Able and willing to provide written informed consent

Exclusion criteria

• Cardiogenic shock or hemodynamic instability within 24 hours prior to enrollment
• Expected life expectancy <1 year
• Participation in another investigational study that may interfere with the results
• Known contraindications to PCSK9 inhibitors or standard-of-care lipid-lowering therapy