Genous endothelial progenitor cell capturing stent vs. the Taxus Liberte stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study.
OBJECTIVE
The purpose of this study was to evaluate the Genous(TM) endothelial progenitor cell capturing stent vs. the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions with a high-risk of coronary restenosis.


RESULTS
We randomly assigned 193 patients with lesions carrying a high risk of restenosis to have the Genous stent or the Taxus stent implanted. Lesions were considered high risk of restenosis if one of the following applied: chronic total occlusion, lesion length >23 mm, vessel diameter <2.8 mm, or any lesion in a diabetic patient. At 1-year, the rate of the primary end point, target vessel failure (TVF), was 17.3% in the Genous stent group when compared with 10.5% in the Taxus stent group [risk difference (RD) 6.8%, 95% CI -3.1 to 16.7%], a difference predominantly due to a higher incidence of repeat revascularization in patients treated with the Genous stent. In contrast, no stent thrombosis was observed in the Genous stent group compared to 4 stent thromboses in the Taxus stent group (RD -4.2%; 95% CI -10.3 to 0.3%). Repeat angiography between 6 and 12 months in a subgroup of patients showed a significantly higher late loss in the Genous stent compared with the Taxus stent (1.14 +/- 0.64 and 0.55 +/- 0.61 mm).


CONCLUSIONS
In patients with lesions carrying a high risk of restenosis, the Genous stent resulted in a non-significant higher rate of TVF compared with the Taxus stent mainly due to more repeat revascularizations in the Genous stent group. There were four stent thromboses with Taxus stent, none with the Genous stent.
Beijk
Marcel A M
MA
Department of Cardiology, Academic Medical Center, University of Amsterdam, B2-137 Meibergdreef 9, PO Box 22660, 1105 AZ Amsterdam, The Netherlands.
Klomp
Margo
M
Verouden
Niels J W
NJ
van Geloven
Nan
N
Koch
Karel T
KT
Henriques
José P S
JP
Baan
Jan
J
Vis
Marije M
MM
Scheunhage
Esther
E
Piek
Jan J
JJ
Tijssen
Jan G P
JG
de Winter
Robbert J
RJ
D000368:Aged; D023903:Coronary Restenosis / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D042783:Endothelial Cells; D004730:Endothelium, Vascular; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D010865:Pilot Projects; D012307:Risk Factors; D016037:Single-Blind Method; D013234:Stem Cells; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage
D050257:Tubulin Modulators; D017239:Paclitaxel