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Clinical research

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

1. Kardiologische Praxis und Praxisklinik, Munich, Germany; 2. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; 3. Klinische Abteilung fur Kardiologie, Medizinische Universitatsklinik, Graz, Austria; 4. Incor, The Heart Institute of the University of São Paulo, São Paulo, Brazil; 5. Isala Klinieken, Locatie Weezenlanden, Zwolle, The Netherlands; 6. Department of Cardiology, Medical University of Lublin, Lublin, Poland; 7. Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, Sarawak, Malaysia

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.

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