Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective single-center registry in high-risk patients

Catheter Cardiovasc Interv. 2008 Apr 1;71(5):600-4. doi: 10.1002/ccd.21437.

Abstract

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.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Antibodies / administration & dosage*
  • Antigens, CD34 / immunology*
  • Coated Materials, Biocompatible
  • Coronary Restenosis / etiology
  • Coronary Restenosis / immunology
  • Coronary Restenosis / mortality
  • Coronary Restenosis / physiopathology
  • Coronary Restenosis / prevention & control*
  • Coronary Stenosis / immunology
  • Coronary Stenosis / mortality
  • Coronary Stenosis / physiopathology
  • Coronary Stenosis / therapy*
  • Endothelial Cells / immunology*
  • Female
  • Hospital Mortality
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Infarction / prevention & control
  • Platelet Aggregation Inhibitors / therapeutic use
  • Prospective Studies
  • Prosthesis Design
  • Registries
  • Research Design
  • Stainless Steel
  • Stem Cells / immunology*
  • Stents*
  • Thrombosis / etiology
  • Thrombosis / prevention & control
  • Time Factors
  • Treatment Outcome
  • Wound Healing

Substances

  • Antibodies
  • Antigens, CD34
  • Coated Materials, Biocompatible
  • Platelet Aggregation Inhibitors
  • Stainless Steel