title: Safety and efficacy of different paclitaxel-eluting balloons in a porcine model.
abstract: OBJECTIVE
  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.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain. Electronic address: aperez@secardiologia.es.
authors.forename: Armando
authors.initials: A
authors.lastname: Pérez de Prado
authors.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain.
authors.forename: Claudia
authors.initials: C
authors.lastname: Pérez-Martínez
authors.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Cuellas Ramón
authors.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Regueiro Purriños
authors.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Diego Nieto
authors.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Gonzalo-Orden
authors.affiliation: Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Molina Crisol
authors.affiliation: Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain.
authors.forename: Alex
authors.initials: A
authors.lastname: Gómez Castel
authors.affiliation: Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Duocastella Codina
authors.affiliation: Grupo Cardiovascular (HemoLeon) de la Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad y Hospital de León, León, Spain.
authors.forename: Felipe
authors.initials: F
authors.lastname: Fernández-Vázquez
mesh_terms: D000818:Animals; D023903:Coronary Restenosis / Q000188:drug therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D023421:Models, Animal; D017239:Paclitaxel / Q000008:administration & dosage*; D011474:Prosthesis Design; D013552:Swine; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel
keywords: Animal model; Balón liberador de paclitaxel; Modelo animal; Paclitaxel-eluting balloon; Reparación vascular; Restenosis; Stent; Vascular healing