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Background <p>Fibroblast activation plays a key role in plaque instability and coronary artery disease (CAD) progression. In-stent restenosis (ISR) remains a major complication after percutaneous coronary intervention (PCI), increasing the risk of major adverse cardiovascular events (MACEs). This study primarily aimed to investigate whether coronary [¹⁸F]AlF-NOTA-FAPI-04 uptake is associated with major adverse cardiovascular events (MACEs) in symptomatic post-PCI patients, and secondarily to explore its ability to differentiate ISR from in-stent non-restenosis (ISnR) and to evaluate longitudinal changes under lipid-lowering therapy.</p> Methods <p>In this prospective single-centre observational cohort study, we enrolled symptomatic CAD patients with a history of PCI A total of 76 symptomatic CAD patients (30 with acute coronary syndrome [ACS] and 46 with stable coronary syndrome [SCS]) underwent FAPI PET/CT imaging. Twenty-two non-CVD individuals served as controls. Coronary SUV<sub>max</sub> and TBR were measured. The primary endpoint was the occurrence of MACEs, while the secondary endpoint was changes in FAPI uptake on follow-up PET/CT. The effects of Lipid-lowering therapy(LLT) on coronary FAPI uptake were also evaluated.</p> Results <p>FAPI uptake was significantly higher in ACS (SUV<sub>max</sub>: 4.06 ± 1.81, TBR: 4.51 ± 2.20) than in SCS (SUV<sub>max</sub>: 2.47 ± 1.82, TBR: 2.89 ± 2.23, <i>P</i> &lt; 0.05). ISR plaques exhibited markedly elevated FAPI uptake (SUV<sub>max</sub>: 4.06 ± 1.91, TBR: 4.69 ± 2.25) compared to ISnR plaques (SUV<sub>max</sub>: 1.69 ± 0.72, TBR: 1.88 ± 0.91, <i>P</i> &lt; 0.0001). Exploratory analyses suggested a trend toward higher MACE risk with elevated uptake, but survival differences were not significant.</p> Conclusion <p>FAPI PET/CT enables non-invasive assessment of fibroblast-driven plaque activity, particularly in ISR, and identifies high-risk coronary plaques linked to MACEs. While LLT did not significantly modify fibroblast activity in the short term, further studies are needed to explore its long-term effects on plaque stability. (FAPI-PLAQUE Study, NCT06280287).</p> Graphical abstract <p></p>

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FAPI PET/CT in post-PCI coronary disease: in-stent restenosis characterization, MACE association, and limited short-term modulation by lipid-lowering therapy: FAPI athero trial

  • 期刊论文

  • 发表日期：

    2026年6月3日

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  • Ximin Shi,
  • Liang Wang,
  • Haiqiong Zhang,
  • Meiqi Wu,
  • Chao Ren,
  • Song Xue,
  • Zhenhai Huang,
  • Zhixin Hao,
  • Zhichao Lai,
  • Bao Liu,
  • Marcus Hacker,
  • Zhenyu Liu,
  • Xiang Li,
  • Li Huo

摘要

Background

Fibroblast activation plays a key role in plaque instability and coronary artery disease (CAD) progression. In-stent restenosis (ISR) remains a major complication after percutaneous coronary intervention (PCI), increasing the risk of major adverse cardiovascular events (MACEs). This study primarily aimed to investigate whether coronary [¹⁸F]AlF-NOTA-FAPI-04 uptake is associated with major adverse cardiovascular events (MACEs) in symptomatic post-PCI patients, and secondarily to explore its ability to differentiate ISR from in-stent non-restenosis (ISnR) and to evaluate longitudinal changes under lipid-lowering therapy.

Methods

In this prospective single-centre observational cohort study, we enrolled symptomatic CAD patients with a history of PCI A total of 76 symptomatic CAD patients (30 with acute coronary syndrome [ACS] and 46 with stable coronary syndrome [SCS]) underwent FAPI PET/CT imaging. Twenty-two non-CVD individuals served as controls. Coronary SUVmax and TBR were measured. The primary endpoint was the occurrence of MACEs, while the secondary endpoint was changes in FAPI uptake on follow-up PET/CT. The effects of Lipid-lowering therapy(LLT) on coronary FAPI uptake were also evaluated.

Results

FAPI uptake was significantly higher in ACS (SUVmax: 4.06 ± 1.81, TBR: 4.51 ± 2.20) than in SCS (SUVmax: 2.47 ± 1.82, TBR: 2.89 ± 2.23, P < 0.05). ISR plaques exhibited markedly elevated FAPI uptake (SUVmax: 4.06 ± 1.91, TBR: 4.69 ± 2.25) compared to ISnR plaques (SUVmax: 1.69 ± 0.72, TBR: 1.88 ± 0.91, P < 0.0001). Exploratory analyses suggested a trend toward higher MACE risk with elevated uptake, but survival differences were not significant.

Conclusion

FAPI PET/CT enables non-invasive assessment of fibroblast-driven plaque activity, particularly in ISR, and identifies high-risk coronary plaques linked to MACEs. While LLT did not significantly modify fibroblast activity in the short term, further studies are needed to explore its long-term effects on plaque stability. (FAPI-PLAQUE Study, NCT06280287).

Graphical abstract