Análisis de la eficacia y la seguridad de distintos balones liberadores de paclitaxel en un modelo animal |
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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 |
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Institution: | 1. Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, España;2. Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, España |
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Abstract: | Introduction and objectivesPaclitaxel-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.MethodsWe 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.ResultsThe 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.ConclusionsIn 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.Full English text available from:www.revespcardiol.org/en |
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Keywords: | BLP baló n liberador de paclitaxel |
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