title: Inhibition of neointimal hyperplasia with a novel zotarolimus coated balloon catheter.
abstract: BACKGROUND
  Non stent based delivery of antiproliferative agents using drug coated balloon catheters may offer additional flexibility and efficacy in a broad range of applications. The lipophilic antiproliferative drug zotarolimus makes it a potential candidate for balloon delivery. The aim of the present study was to evaluate the safety and efficacy of a prototype zotarolimus coated balloon (ZCB) catheter in comparison to a zotarolimus eluting stent (ZES) in the porcine coronary overstretch model.
  
  
  METHODS
  Eighty-four stents (diameters 3.0 and 3.5 mm; length 15 mm) were implanted in LAD and Cx of 42 domestic pigs: control (TriMaxx, Abbott, polymer coated stent without drug, implanted with uncoated PCI catheter, n = 56); ZES (ZoMaxx, Abbott, stent coated with zotarolimus in polymer, implanted with uncoated PCI catheter, n = 14); ZCB (TriMaxx, Abbott, polymer coated stent without drug, implanted with zotarolimus coated PCI catheter, n = 14). Drug content of the vessel wall (n = 9) was measured about 10-30 min post intervention with ZCB in additional pigs.
  
  
  RESULTS
  Immediately after ZCB treatment 101 ± 31 μg of zotarolimus was detected in the coronary arteries. After 28 days ZES led to a reduction of neointimal area from 4.32 ± 1.45 to 3.32 ± 1.11 mm2 (P = 0.019 vs. control). The effect of neointimal inhibition was more pronounced with the novel ZCB (2.79 ± 1.43 mm², P = 0.001 vs. control). Inflammation score was significantly reduced in vessels treated with the ZCB (0.75 ± 0.86 compared to control (1.45 ± 0.94, P = 0.013) and ZES (1.65 ± 0.90, P = 0.012).
  
  
  CONCLUSIONS
  Zotarolimus coated balloons and stents were found to effectively reduce neointimal proliferation in the porcine coronary model. Inflammation scores were significantly reduced after treatment with the coated balloon. Zotarolimus balloon coating might be a novel option in preventing and treating restenosis.
authors.affiliation: Department of Internal Medicine III, University of Saarland, 66421 Homburg/Saar, Germany. bodo.cremers@uks.eu
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: John L
authors.initials: JL
authors.lastname: Toner
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Schwartz
authors.forename: Randolf
authors.initials: R
authors.lastname: von Oepen
authors.forename: Ulrich
authors.initials: U
authors.lastname: Speck
authors.forename: Nicola
authors.initials: N
authors.lastname: Kaufels
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
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: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D000818:Animals; D023903:Coronary Restenosis / Q000517:prevention & control; D003331:Coronary Vessels / Q000293:injuries / Q000473:pathology*; D004195:Disease Models, Animal; D054855:Drug-Eluting Stents / Q000009:adverse effects; D006965:Hyperplasia; D058426:Neointima / Q000628:therapy; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013552:Swine
chemical_list: C489443:zotarolimus; D020123:Sirolimus