title: Long-term effects on vascular healing of bare metal stents delivered via paclitaxel-coated balloons in the porcine model of restenosis.
abstract: BACKGROUND
  Clinical trials have consistently demonstrated benefits of paclitaxel-coated balloons (PCB) in particular clinical situations such as in-stent restenosis and peripheral vascular interventions. However, the long-term vascular effects of bare metal stents (BMS) delivered via PCB (PCB+BMS) are still unknown. The aim of this study was to assess the long-term effects of PCB+BMS on vascular healing and neointimal formation (NF).
  
  
  METHODS
  A total of 208 stents: 56 BMS crimped on PCB, 50 BMS crimped on uncoated balloons (UCB+BMS), 52 Taxus and 50 Cypher stents were implanted in normal coronary arteries of 104 pigs using 1.2:1.0 stent-to-artery ratio. Follow-up occurred at 3, 7, 28, 90, and 180 days. Vascular effects were assessed based on angiographic and histological analysis. Endothelialization was evaluated using an anti von-Willebrand Factor stain.
  
  
  RESULTS
  At 28 days, delivery of a BMS using a PCB led to a significant reduction in NF compared to the UCB+BMS and the Taxus stent (P < 0.01). Between 28 and 180 days, the progression of NF tended to be lower in the PCB+BMS compared to all DES groups. At 90 days, the PCB+BMS (2.56 ± 0.43) and the Taxus stents (2.60 ± 0.59) had a trend toward higher inflammatory scores compared to the UCB+BMS group (1.85 ± 1.13, P = 0.09). By 180 days, inflammation and NF had completely normalized between the groups. Expression of peristrut vWF was comparable among all tested groups at 28 days.
  
  
  CONCLUSIONS
  The long-term pattern of vascular healing occurring following PCB+BMS deployment appears to be comparable to what has been reported with DES technologies.
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Milewski
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
authors.forename: Michael S
authors.initials: MS
authors.lastname: Aboodi
authors.forename: Melanie
authors.initials: M
authors.lastname: Biedermann
authors.forename: Troels
authors.initials: T
authors.lastname: Thim
authors.forename: Bettina
authors.initials: B
authors.lastname: Kelsch
authors.forename: Greg L
authors.initials: GL
authors.lastname: Kaluza
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000818:Animals; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D049109:Cell Proliferation; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D003331:Coronary Vessels / Q000378:metabolism / Q000473:pathology*; D004195:Disease Models, Animal; D054855:Drug-Eluting Stents; D042783:Endothelial Cells / Q000378:metabolism / Q000473:pathology; D004867:Equipment Design; D008670:Metals; D058426:Neointima; D017239:Paclitaxel / Q000008:administration & dosage*; D011474:Prosthesis Design; D015607:Stents; D013552:Swine; D013556:Swine, Miniature; D013997:Time Factors; D014841:von Willebrand Factor / Q000378:metabolism
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D014841:von Willebrand Factor; D017239:Paclitaxel