First-in-human Serial Assessment of Therapeutic Modification in Coronary Plaque using Optical Coherence Tomography-Fluorescence Lifetime Imaging

초록

BACKGROUND Fluorescence lifetime imaging (FLIm) visualizes molecular features of atherosclerosis, but in vivo compositional changes after therapeutic plaque modification remain unexplored. We conducted a first-in-human serial assessment using a fully integrated intravascular optical coherence tomography (OCT)-FLIM system. METHODS Total 39 patients with significant coronary artery disease underwent OCT-FLIM at baseline and six months (NCT04835467). Target lesions were treated with drug-coated balloons (DCBs), while non-target lesions (mild-to-moderate stenosis) received medical therapy. Macrophage-driven inflammation and healed plaque (HP) burden were quantitatively analyzed using FLIm-derived signatures. RESULTS A total of 31 target and 61 non-target lesions were assessed. DCB treatment was successful in 82.1% (32/39) of patients. OCT-FLIM enabled real-time, quantitative compositional analysis. At six months, DCB-treated lesions showed reduced inflammation (Inflammation-FL: 5.58±0.46 to 5.29±0.26 nsec, p<0.001) and HP burden (Healed Plaque-FL: 4.97±0.25 to 4.80±0.25 nsec, p<0.001), suggesting a shift toward more stable plaque composition (Figure). Non-target lesions showed no significant changes. Reductions in inflammation and HP were correlated (R = -0.487, p<0.001) and associated with lower achieved LDL-cholesterol levels (R=-0.443 and R=-0.239, respectively). CONCLUSION OCT-FLIM revealed favorable molecular changes following DCB treatment, with reduction in inflammatory and HP components. These findings support the synergistic effect of DCB and optimal medical therapy in stabilizing atherosclerotic plaques.