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.
OBJECTIVE
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.


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.
Kardiologische Praxis und Praxisklinik, Munich, Germany.
Sigmund
S
Silber
Peter
P
Damman
Margo
M
Klomp
Marcel A
MA
Beijk
Manfred
M
Grisold
Expedito E
EE
Ribeiro
Harry
H
Suryapranata
Jaroslaw
J
Wójcik
Kui
K
Hian Sim
Jan G P
JG
Tijssen
Robbert J
RJ
de Winter
D057005:Bioengineering; D020099:Coated Materials, Biocompatible; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control*; D003331:Coronary Vessels; D042783:Endothelial Cells / Q000166:cytology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012042:Registries; D013234:Stem Cells / Q000166:cytology*; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors