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Updated: Jul 6, 2026
Autologous Endothelial Progenitor Cell-Seeding Technology and Biocompatibility Testing For Cardiovascular Devices in Large Animal Model
Published on: September 9, 2011
Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective
Marco Miglionico1, Giuseppe Patti, Andrea D'Ambrosio
1Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy.
Insights
Endothelial progenitor cell (EPC) capture stents demonstrated safety and effectiveness in high-risk patients, showing no stent thrombosis. Further studies are needed to compare them with current stent types.
Area of Science:
- Cardiovascular Medicine
- Biomaterials Science
- Interventional Cardiology
Background:
- The Genous R-stent is designed to promote endothelial layer formation by capturing endothelial progenitor cells (EPCs).
- This technology aims to reduce stent thrombosis and restenosis by creating a functional endothelial lining.
- Antibodies on the stent surface specifically target EPCs.
Purpose of the Study:
- To prospectively evaluate the outcomes of implanting EPC capture stents.
- To assess the safety and efficacy of this novel stent in patients with high-risk features.
- To determine the mid-term clinical performance of EPC capture stents.
Main Methods:
- Eighty patients received 93 EPC capture stents between November 2005 and March 2007.
- Patients presented with high-risk features including diabetes, unstable coronary syndromes, and complex lesions.
- Outcomes were assessed for acute success, stent thrombosis, and mid-term clinical events.
Main Results:
- Acute success rate was 98% with no in-hospital death or emergency bypass.
- No instances of acute or subacute stent thrombosis were observed.
- At a mean follow-up of 14 months, event-free survival was 86% and target lesion revascularization-free survival was 90%.
Conclusions:
- EPC capture stents are safe and effective, providing satisfactory immediate and mid-term results.
- The study found no evidence of stent thrombosis with this device.
- Larger randomized trials are required to compare EPC capture stents with drug-eluting and bare metal stents.
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.
