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

Rev Esp Cardiol (Engl Ed). 2016 Nov;69(11):1026-1032. doi: 10.1016/j.rec.2016.03.026. Epub 2016 Jun 16.
[Article in English, Spanish]

Abstract

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.

Keywords: Balón recubierto de paclitaxel; De novo coronary lesion; Fractional flow reserve; Lesión coronaria de novo; Optical coherence tomography; Paclitaxel-coated balloon; Reserva fraccional de flujo; Respuesta vascular; Tomografía de coherencia óptica; Vascular response.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Angina Pectoris / etiology
  • Angina Pectoris / therapy*
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / methods
  • Antineoplastic Agents, Phytogenic / therapeutic use*
  • Coronary Angiography
  • Coronary Restenosis
  • Coronary Stenosis / complications
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / therapy*
  • Female
  • Fractional Flow Reserve, Myocardial
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / therapeutic use*
  • Prospective Studies
  • Tomography, Optical Coherence
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Paclitaxel