Serial Morphological and Functional Assessment of the Paclitaxel-coated Balloon for de Novo Lesions.

INTRODUCTION AND OBJECTIVES: There is limited data on the serial morphological and functional assessment of paclitaxel-coated balloon treatment using coronary angiography, optical coherence tomography, and fractional flow reserve. METHODS: In this prospective, single-center observational study, patients with de novo lesions were treated with the paclitaxel-coated balloon. Serial angiographic, optical coherence tomography and fractional flow reserve measurements were performed before and after plain old balloon angioplasty, as well as at 9-month follow-up. RESULTS: Twenty patients (21 lesions) were enrolled in this study. The reference vessel diameter was 2.68±0.34mm and late luminal loss was 0.01±0.21mm. The median changes in the minimal lumen area between pre- and postplain old balloon angioplasty, and postplain old balloon angioplasty and follow-up were an increase of 75.2% [interquartile range of 37.2 to 164.7] and 50.0% [interquartile range of 1.1% to 64.5%], respectively. Intimal dissections were seen in all postprocedural optical coherence tomography images, and 66.6% of them were sealed on follow-up optical coherence tomography (median 278 days). The fractional flow reserve distal to the target lesion was 0.71±0.14 predilatation, 0.87±0.04 postdilatation, and 0.83±0.08 at follow-up. CONCLUSIONS: The paclitaxel-coated balloon restores coronary blood flow by means of plaque modification, causing an increment in minimal lumen area. At 9-month follow-up, coronary flow was sustained and the luminal patency was the result of suppressed luminal narrowing progression from local drug effects on the de novo coronary lesions.