title: Preclinical evaluation of a novel polyphosphazene surface modified stent.
abstract: BACKGROUND
  Treatment options for patients with coronary artery disease at high risk for bleeding complications are limited. The aim of the current preclinical study was to evaluate neointimal coverage, endothelial recovery, inflammation and thrombogenicity in a novel thin-strut (71μm thickness) Cobalt Chromium (CoCr) stent modified with a nano-thin Polyzene®-F (PzF) surface coating.
  
  
  RESULTS
  Twenty-eight single PzF nano-coated stents and 20 bare metal control stents (BMS) were implanted in the coronary arteries of 24 pigs, with scheduled 5- (n=5), 28- (n=13), and 90-day (n=6) follow-up in addition to overlapping configuration (n=6 each), examined at 28-days. Histomorphometric analysis showed significantly lower neointimal thickness in PzF nano-coated stents than BMS controls at both 28- and 90-days (p=0.023 and 0.005) and reduced inflammation (p=0.06 and 0.13). Endothelial coverage over luminal surfaces at all time points was similar between nano-coated stents and BMS controls. We conducted supplementary in-vitro experiments using human monocytes and an ex-vivo swine carotid-jugular arterio-venous shunt model to better understand the healing properties afforded by the PzF nano-coating. Overall, the PzF-nano-coating showed reduced monocyte adhesion and thrombus formation compared to the un-coated controls.
  
  
  CONCLUSIONS
  Stents modified with a nano-thin PzF-coating implanted in healthy swine indicate favorable vascular healing properties shown by reduced neointimal hyperplasia and inflammation, along with resistance to thrombus formation in an ex-vivo shunt model over unmodified stents.
authors: CVPath Institute, Inc., Gaithersburg, MD, United States. Electronic address: dr.koppara@gmail.com.
authors: Tobias
authors: T
authors: Koppara
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Kenichi
authors: K
authors: Sakakura
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Erica
authors: E
authors: Pacheco
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Qi
authors: Q
authors: Cheng
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: XiaoQing
authors: X
authors: Zhao
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Eduardo
authors: E
authors: Acampado
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Aloke V
authors: AV
authors: Finn
authors: CeloNova BioSciences, Inc., San Antonio, TX, United States.
authors: Mark
authors: M
authors: Barakat
authors: Clinique Axium, Service de Cardiologie, Aix en Provence, France.
authors: Luc
authors: L
authors: Maillard
authors: CeloNova BioSciences, Inc., San Antonio, TX, United States.
authors: Jane
authors: J
authors: Ren
authors: CeloNova BioSciences, Inc., San Antonio, TX, United States.
authors: Mahesh
authors: M
authors: Deshpande
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Frank D
authors: FD
authors: Kolodgie
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Michael
authors: M
authors: Joner
authors: CVPath Institute, Inc., Gaithersburg, MD, United States.
authors: Renu
authors: R
authors: Virmani
mesh_terms: D000818:Animals; D020099:Coated Materials, Biocompatible / Q000494:pharmacology; D003331:Coronary Vessels / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D054855:Drug-Eluting Stents; D004730:Endothelium, Vascular / Q000187:drug effects / Q000503:physiopathology*; D006801:Humans; D008422:Materials Testing / Q000379:methods; D008962:Models, Theoretical; D009000:Monocytes / Q000502:physiology; D058426:Neointima / Q000188:drug therapy*; D009943:Organophosphorus Compounds / Q000494:pharmacology*; D011108:Polymers / Q000494:pharmacology*; D011474:Prosthesis Design; D013499:Surface Properties; D013552:Swine
chemical_list: D020099:Coated Materials, Biocompatible; D009943:Organophosphorus Compounds; D011108:Polymers; C108974:poly(phosphazene)
keywords: Bare metal stent; Coronary artery disease; Percutaneous coronary intervention