Clinical results after coronary stenting with the Genous™ Bio-engineered R stent™: 12-month outcomes of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

Abstract

AIMS:

e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous™ EPC capturing R stent™. Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis.

METHODS AND RESULTS:

We planned a 5,000 patient registry with ≥1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received ≥1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively.

CONCLUSIONS:

Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST.

• Authors: Sigmund Silber, Peter Damman, Margo Klomp, Marcel A Beijk, Manfred Grisold, Expedito E Ribeiro, Harry Suryapranata, Jaroslaw Wójcik, Kui Hian Sim, Jan G P Tijssen, Robbert J de Winter
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 6 Issue 7 Pg. 819-25 (Feb 2011) ISSN: 1969-6213 [Electronic] France
• PMID: 21252015 (Publication Type: Journal Article)

Chemical References

• Coated Materials, Biocompatible
• Platelet Aggregation Inhibitors

Topics

• Bioengineering
• Coated Materials, Biocompatible
• Coronary Disease (mortality, therapy)
• Coronary Restenosis (prevention & control)
• Coronary Vessels
• Endothelial Cells (cytology)
• Humans
• Male
• Middle Aged
• Platelet Aggregation Inhibitors (therapeutic use)
• Registries
• Stem Cells (cytology)
• Stents (adverse effects)
• Treatment Outcome