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.
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.
Aoki
Jiro
J
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Serruys
Patrick W
PW
van Beusekom
Heleen
H
Ong
Andrew T L
AT
McFadden
Eugene P
EP
Sianos
Georgios
G
van der Giessen
Willem J
WJ
Regar
Evelyn
E
de Feyter
Pim J
PJ
Davis
H Richard
HR
Rowland
Stephen
S
Kutryk
Michael J B
MJ
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
D000911:Antibodies, Monoclonal; D018952:Antigens, CD34; D020099:Coated Materials, Biocompatible