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Autologous Endothelial Progenitor Cell-Seeding Technology and Biocompatibility Testing For Cardiovascular Devices in Large Animal Model
Published on: September 9, 2011
One-year clinical outcome in an unselected patient population treated with the Genous™ endothelial progenitor cell
Margo Klomp1, Marcel A M Beijk, Jan G P Tijssen
1Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Insights
This study evaluated the 1-year outcomes of the endothelial progenitor cell (EPC) capturing stent in 405 patients. The stent demonstrated good clinical results, with low rates of stent thrombosis and comparable outcomes in diabetic patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Novel coronary stent designed to capture endothelial progenitor cells (EPCs) using CD34+ antibodies.
- Accelerated endothelialization is hypothesized to reduce restenosis and stent thrombosis.
Purpose of the Study:
- To assess the 1-year clinical outcomes of an EPC-capturing coronary stent in a large, unselected patient cohort.
- To evaluate the safety and efficacy of this novel stent in a real-world setting.
Main Methods:
- A total of 405 unselected patients underwent percutaneous coronary intervention with the EPC-capturing stent.
- Patients included those with complex lesions and high estimated risk of restenosis.
Main Results:
- The 1-year composite primary endpoint (cardiac death, MI, TLR) was 13.3%, primarily driven by target lesion revascularization (10.9%).
- Definite and probable stent thrombosis rates were low (0.5% and 0.7%).
- Patients at high risk for restenosis had a higher primary endpoint rate (16.1%) compared to low-risk patients (9.0%).
Conclusions:
- The EPC-capturing stent demonstrated favorable 1-year clinical outcomes in a real-world population.
- Ongoing large randomized trials will further evaluate the long-term safety and efficacy of this stent.
Objective:
We assessed the 1-year clinical outcome in a large cohort of unselected patients treated with an endothelial progenitor cell (EPC) capturing coronary stent.
Background:
The novel EPC capturing stent is coated with CD34+ antibodies that bind circulating EPCs to the stent surface, thereby accelerating endothelialization of the stent struts; it is hypothesized that this may prevent restenosis and stent thrombosis.
Methods:
A total of 405 unselected patients were treated percutaneously with the EPC capturing stent. The majority of patients had complex lesions with an estimated high risk of restenosis.
Results:
The primary endpoint defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 1-year was 13.3%, mainly attributable to TLR which was 10.9%. The occurrence of definite and probable ST was low, 0.5 and 0.7%, respectively. Based on the risk of restenosis, in patients with an estimated high risk of restenosis (n = 249), the composite primary endpoint was 16.1% versus 9.0% in patients with an estimated low risk (n = 155). Moreover, the 1 year clinical outcomes in diabetic patient compared well with the nondiabetic patients.
Conclusion:
In this single-center study, the 1-year clinical follow-up in a "real-world" population treated with the EPC capturing stent showed good results. Currently, large randomized studies are conducted to evaluate the long-term safety and efficacy of this stent.