title: Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model.
abstract: BACKGROUND
  Drug-eluting balloon (DEB) catheters coated with paclitaxel in a water-soluble matrix have shown beneficial effects in the treatment and prevention of restenosis in the porcine coronary overstretch model and in clinical trials. Adherence of paclitaxel, same dose, on another recently introduced coated percutaneous coronary intervention (PCI) catheter (DIOR) is mediated by a roughened balloon surface. Only scarce experimental and clinical data has been published on the new coating method. The aim of the present study was to compare the safety and efficacy of the two coatings in the porcine model.
  
  
  RESULTS
  Twenty-eight stainless steel stents were implanted in the left anterior descending and circumflex coronary arteries of 14 domestic pigs using either matrix-coated (n = 8), roughened DEB (n = 9), or uncoated PCI catheters, which served as control (n = 11). After 28 days, quantitative angiography and histomorphometry of the stented arteries were performed. Matrix-coated DEB led to a highly significant (P < 0.01) reduction of all parameters indicating neointimal proliferation compared to both, uncoated control and the roughened DEB; late lumen loss in-segment was 0.4 +/- 0.2, 1.9 +/- 0.5, and 1.4 +/- 0.5 mm, respectively. In contrast, the roughened DEB failed to produce statistically significant effects on angiographic measures of stenosis or morphometric parameters such as maximal neointimal thickness and luminal area, except for neointimal area (5.7 +/- 1.5 mm(2) in the control group, 4.1 +/- 1.7 mm(2) roughened DEB, P < 0.05 vs. control, and 2.5 +/- 0.8 mm(2) matrix-coated DEB, P < 0.01 vs. control).
  
  
  CONCLUSIONS
  Inhibition of neointimal proliferation in the porcine coronary overstretch model by paclitaxel depends critically on the coating method.
authors.affiliation: Klinik für Innere Medizin III, Kardiologie, Angiologie, Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany. bodo.cremers@uks.eu
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Melanie
authors.initials: M
authors.lastname: Biedermann
authors.forename: Dirk
authors.initials: D
authors.lastname: Mahnkopf
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D000818:Animals; D002404:Catheterization / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible / Q000008:administration & dosage; D023903:Coronary Restenosis / Q000517:prevention & control* / Q000601:surgery*; D004195:Disease Models, Animal; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006083:Graft Occlusion, Vascular / Q000209:etiology* / Q000517:prevention & control*; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage*; D013552:Swine; D050257:Tubulin Modulators / Q000008:administration & dosage
chemical_list: D020099:Coated Materials, Biocompatible; D050257:Tubulin Modulators; D017239:Paclitaxel