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 +/- 0.34 mm and late luminal loss was 0.01 +/- 0.21 mm. 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. (C) 2016 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.