Safety and efficacy of different paclitaxel-eluting balloons in a porcine model.

Abstract

INTRODUCTION AND OBJECTIVES:

Paclitaxel-eluting balloons have shown high antiproliferative efficacy in the treatment and prevention of restenosis. Nevertheless, not all available devices are equally effective, which makes it interesting to compare results in a preclinical model. Our objective was to assess the preclinical efficacy and safety of different devices.

METHODS:

We implanted 51 metallic stents (Architect(®), iVascular) in 17 domestic swine (mean, 25 [3] kg), inserting 1 stent per major coronary artery. Stent postdilatation was performed with different control balloons (n=10) or paclitaxel-eluting balloons: paclitaxel-eluting balloon 1 (iVascular) (n=15); paclitaxel-eluting balloon 2 (iVascular) (n=16) and In.Pact Falcon(®) (Medtronic) (n=10). The restenosis rate (using angiography and histomorphometry) and vascular healing parameters (balloon-related vascular injury score, endothelialization rate, and fibrin and inflammation scores) were analyzed at 28 days.

RESULTS:

The distinct paclitaxel-eluting balloons showed a similar degree of stenosis at follow-up, which was significantly lower than that in the control group: diameter stenosis was 9% (12%) vs 34% (18%) by angiography (P<.0001) and was 22% (8%) vs 51% (18%) by histomorphometry (P<.0001). Scores for vascular injury (mean, 0.6 [0.5]) and inflammation (mean, 0.8 [0.3]) were uniformly low across all groups. Drug effect markers differed significantly between the paclitaxel-eluting balloons and control groups, with lower endothelialization rates (87% [10%] vs 99% [2%]; P=.0007) and higher fibrin scores (2.1 [0.7] vs 0.4 [0.5]; P<.0001) in the paclitaxel-eluting balloons groups. There were no differences between the different paclitaxel-eluting balloons.

CONCLUSIONS:

In this preclinical model, the paclitaxel-eluting balloons studied significantly reduced in-stent restenosis compared with the control balloons. Although there were no findings of persistent vascular injury or inflammation, delayed endothelialization and fibrin aggregate suggest a drug deposition response.

• Authors: Armando Pérez de Prado, Claudia Pérez-Martínez, Carlos Cuellas Ramón, Marta Regueiro Purriños, Alejandro Diego Nieto, José M Gonzalo-Orden, María Molina Crisol, Alex Gómez Castel, Luis Duocastella Codina, Felipe Fernández-Vázquez
• Journal: Revista espanola de cardiologia (English ed.) (Rev Esp Cardiol (Engl Ed)) Vol. 67 Issue 6 Pg. 456-62 (Jun 2014) ISSN: 1885-5857 [Electronic] Spain
• PMID: 24863594 (Publication Type: Comparative Study, Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Chemical References

• Paclitaxel

Topics

• Animals
• Coronary Restenosis (drug therapy)
• Drug-Eluting Stents (adverse effects)
• Models, Animal
• Paclitaxel (administration & dosage)
• Prosthesis Design
• Swine
• Treatment Outcome