title: Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry.
abstract: OBJECTIVE
  This study was designed to evaluate whether rapid endothelialization of stainless steel stents with a functional endothelium prevents stent thrombosis and reduces the restenotic process.
  
  
  BACKGROUND
  A "pro-healing" approach for prevention of post-stenting restenosis is theoretically favored over the use of cytotoxic or cytostatic local pharmacologic therapies. It is believed that the central role of the vascular endothelium is to maintain quiescence of the underlying media and adventitia.
  
  
  METHODS
  Sixteen patients with de novo coronary artery disease were successfully treated with implantation of endothelial progenitor cell (EPC) capture stents.
  
  
  RESULTS
  Complete procedural and angiographic success was achieved in all 16 patients. The nine-month composite major adverse cardiac and cerebrovascular events (MACCE) rate was 6.3% as a result of a symptom-driven target vessel revascularization in a single patient. There were no other MACCE despite only one month of clopidogrel treatment. At six-month follow-up, mean angiographic late luminal loss was 0.63 +/- 0.52 mm, and percent stent volume obstruction by intravascular ultrasound analysis was 27.2 +/- 20.9%.
  
  
  CONCLUSIONS
  This first human clinical investigation of this technology demonstrates that the EPC capture coronary stent is safe and feasible for the treatment of de novo coronary artery disease. Further developments in this technology are warranted to evaluate the efficacy of this device for the treatment of coronary artery disease.
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Jiro
authors.initials: J
authors.lastname: Aoki
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Heleen
authors.initials: H
authors.lastname: van Beusekom
authors.forename: Andrew T L
authors.initials: AT
authors.lastname: Ong
authors.forename: Eugene P
authors.initials: EP
authors.lastname: McFadden
authors.forename: Georgios
authors.initials: G
authors.lastname: Sianos
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
authors.forename: Pim J
authors.initials: PJ
authors.lastname: de Feyter
authors.forename: H Richard
authors.initials: HR
authors.lastname: Davis
authors.forename: Stephen
authors.initials: S
authors.lastname: Rowland
authors.forename: Michael J B
authors.initials: MJ
authors.lastname: Kutryk
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000175:diagnosis / Q000628:therapy*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D018952:Antigens, CD34 / Q000276:immunology*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D019160:Endosonography; D042783:Endothelial Cells / Q000276:immunology*; D005240:Feasibility Studies; D005260:Female; D005352:Fibromuscular Dysplasia / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D018189:Immunomagnetic Separation; D008297:Male; D059630:Mesenchymal Stem Cells / Q000276:immunology*; D008875:Middle Aged; D011446:Prospective Studies; D011475:Prosthesis Failure; D012042:Registries; D015607:Stents; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018952:Antigens, CD34; D020099:Coated Materials, Biocompatible