Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective single-center registry in high-risk patients.
OBJECTIVE
To prospectively evaluate the outcome with circulating endothelial progenitor cell (EPC) capture stent implantation in a cohort of consecutive patients with high-risk angiographic and/or clinical features.


BACKGROUND
Genous R-stent is a stainless steel coronary stent covered with antibodies specific to EPC's surface antigens, designed to promote the formation of a confluent functional endothelial layer over the device; conceivably, this may prevent both stent thrombosis and restenosis.


METHODS
From November 2005 to March 2007, 80 patients received 93 EPC capture stents at Campus Bio-Medico, University of Rome. Patients had two or more of the following high-risk features: diabetes mellitus (33%), unstable coronary syndromes (73%), left ventricular dysfunction (8%), multivessel intervention (9%), B2/C lesions (56%).


RESULTS
Acute success was achieved in 79/80 patients (98%), without Q-wave myocardial infarction (MI), in-hospital death or emergency bypass surgery; no patient had acute or subacute stent thrombosis. Follow-up was available in 78 patients (mean 14 +/- 4 months): noncardiac death occurred in one patient, acute MI in one patient; no patient required bypass surgery; 10 patients (13%) underwent percutaneous target lesion revascularization (TLR); three patients (4%) had reintervention on a nontarget vessel. Kaplan-Meyer life-table analysis showed event-free survival of 86% and TLR-free survival of 90% at one and a half year follow-up.


CONCLUSIONS
The cell capture stent is safe and effective, with satisfactory immediate results and mid-term outcome, without evidence of stent thrombosis. Whether those devices represent a viable alternative to currently available drug-eluting or bare metal stents will need to be evaluated in larger randomized studies.
Miglionico
Marco
M
Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy.
Patti
Giuseppe
G
D'Ambrosio
Andrea
A
Di Sciascio
Germano
G
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D000906:Antibodies / Q000008:administration & dosage*; D018952:Antigens, CD34 / Q000276:immunology*; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000209:etiology / Q000276:immunology / Q000401:mortality / Q000503:physiopathology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000276:immunology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D042783:Endothelial Cells / Q000276:immunology*; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012107:Research Design; D013193:Stainless Steel; D013234:Stem Cells / Q000276:immunology*; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
D000906:Antibodies; D018952:Antigens, CD34; D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D013193:Stainless Steel