This study aimed to assess the healing response, as evidenced through temporal morphological and functional changes, following paclitaxel-coated balloon (PCB) treatment of de novo coronary lesions. This retrospective, observational study, included patients with significant de novo coronary lesions who were treated with PCB and had serial angiographic, intravascular ultrasound virtual histology (IVUS-VH), fractional flow reserve (FFR) measurements, and optical coherence tomography (OCT) performed before balloon angioplasty (BA), after BA, and at 9-month follow-up. A total of 20 patients (21 lesions) were included in this study. After PCB treatment, IVUS showed significant increases in the mean vessel area (12.0 ± 2.2 mm2 to 13.8 ± 2.5 mm2, p = 0.023), and mean lumen area (5.6 ± 1.2 mm2 to 7.0 ± 1.5 mm2, p = 0.003). Coronary flow was restored after BA with an FFR value of 0.87 ± 0.04 which was sustained at 9-month follow-up with no significant decrease (0.83 ± 0.08, p = 0.329). Serial OCT analysis showed that at 9-month follow-up dissections after BA sealed in 14 lesions (67%), whilst the macrophages decreased from 10 (50%) to 7 (35%) lesions, and the cap thickness of plaque increased from 0.12 ± 0.06 mm to 0.17 ± 0.09 mm (p = 0.007). PCB treatment for de novo coronary lesions showed persistent anatomical and functional patency at mid-term follow-up. Plaque modification, vascular remodeling, and plaque stabilization were also observed during follow-up.
Keywords: De novo coronary lesions; Fractional flow reserve; Optical coherence tomography; Paclitaxel-coated balloon; Vessel remodeling.