Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study

Aims To assess the serial changes of de novo coronary lesions treated with paclitaxel-coated balloon (PCB) using intravascular ultrasound virtual histology (IVUS-VH) and fractional flow reserve (FFR). Method and Results This prospective observational study enrolled 27 patients with coronary artery disease treated with PCB who underwent coronary angiography, IVUS-VH and FFR before, immediately after intervention and at 9 months. 28 de novo lesions were successfully treated with PCB. Angiographic late luminal loss was 0.02 +/- 0.27mm. Mean vessel and lumen areas showed increase at 9 months (12.0 +/- 3.5mm(2) to 13.2 +/- 3.9mm(2), p <0.001; and 5.4 +/- 1.2mm(2) to 6.5 +/- 1.8mm(2), p <0.001, respectively). Although mean plaque area was unchanged (6.6 +/- 2.6mm(2) to 6.6 +/- 2.4mm(2), p = 0.269), percent atheroma volume decreased significantly (53.4 +/- 7.9% to 49.5 +/- 6.4%, p = 0.002). The proportion of plaque compositions including fibrous, fibrofatty, dense calcium and necrotic core by IVUS-VH was unchanged at 9 months. The FFR of the treated lesion was 0.71 +/- 0.13 pre-procedure, 0.87 +/- 0.06 post-procedure and 0.84 +/- 0.06 at follow-up. Conclusions De novo coronary lesions treated with PCB showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up.