Key result
Add-on inclisiran fails to reduce plaque lipid burden beyond standard lipid-lowering therapy in stable CAD.
Why the study?
Does add-on inclisiran therapy improve plaque lipid reduction and LDL-C levels in patients with stable coronary artery disease who do not reach LDL-C targets on standard statin/ezetimibe therapy?
Cohort (n=42)
Investigators blinded to clinical and angiographic findings for NIRS/IVUS analysis
No
Does add-on inclisiran therapy improve plaque lipid reduction and LDL-C levels in patients with stable coronary artery disease who do not reach LDL-C targets on standard statin/ezetimibe therapy?
Absolute Event Rate: -117.64% vs -141.88%
p-value: p=0.213
The addition of inclisiran to optimal statin/ezetimibe therapy significantly reduced LDL-C levels and yielded comparable plaque lipid stabilization (via maxLCBI4 mm reduction) to patients who had successfully reached LDL-C targets on statin/ezetimibe therapy alone.
May support comparable plaque stabilization with add-on inclisiran in statin non-responders; leaves open need for randomized outcome trials in stable CAD.
INTRODUCTION: Insufficient statin/ezetimibe effectiveness for low-density lipoprotein cholesterol (LDL-C) reduction is not uncommon. A novel gene-silencing medication inclisiran has been introduced. Near-infrared spectroscopy (NIRS) allows to assess the dynamics of plaque lipid content in the context of optimal lipid-lowering pharmacotherapy. The aim of this study was to evaluate the impact of optimal hypolipidaemic pharmacotherapy, including add-on inclisiran, on the plasma lipid profile and plaque lipid content. METHODS: This study enrolled patients with stable coronary artery disease, admitted for elective percutaneous coronary intervention (PCI). NIRS of the segment of interest was performed during index PCI and 15 months later. Patients having LDL-C >1.8 mmol/L after 4-6 weeks of maximum tolerated statin/ezetimibe therapy received add-on inclisiran. Lipid profile changes within 15 months were also evaluated. RESULTS: Among 42 included patients, 24 drug-resistant hypercholesterolaemia participants were assigned to inclisiran therapy. After 15 months, a significant LDL-C decrease of 26.42% was established (p = 0.006), with 12 participants reaching the LDL-C goal of <1.8 mmol/L. Average 15-month LDL-C reduction was 36.03%. NIRS data demonstrated a significant reduction in maximum lipid-core burden index within 4 mm (maxLCBI4 mm) in the inclisiran group (-117.64, p = 0.004) and statin/ezetimibe group (-141.88, p = 0.004), with no significant difference between the groups (p = 0.213). CONCLUSION: Results demonstrate an association between better LDL-C control and coronary plaque lipid burden reduction. Addition of inclisiran leads to remarkable LDL-C reduction in patients who have run out of statin and ezetimibe treatment options.
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Trušinskis et al. (2025) conducted a cohort in Stable coronary artery disease (n=42). Inclisiran vs. Statin and/or ezetimibe therapy (well-controlled LDL-C cohort) was evaluated on Maximum lipid-core burden index within 4 mm (maxLCBI4 mm) reduction at 15 months (p=0.213). In patients with stable coronary artery disease, add-on inclisiran reduced the maximum lipid-core burden index within 4 mm by 117.64, which was not significantly different from the 141.88 reduction in the well-controlled statin/ezetimibe group (p = 0.213).
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