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Randomized Controlled Trial
. 2010 May;31(9):1055-64.
doi: 10.1093/eurheartj/ehp476. Epub 2009 Nov 18.

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

Marcel A M Beijk  1 , Margo Klomp, Niels J W Verouden, Nan van Geloven, Karel T Koch, José P S Henriques, Jan Baan, Marije M Vis, Esther Scheunhage, Jan J Piek, Jan G P Tijssen, Robbert J de Winter
Affiliations
Randomized Controlled Trial

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

Marcel A M Beijk et al. Eur Heart J. 2010 May.

Abstract

Aims: 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.

Methods and 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).

Conclusion: 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.

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Figures

Figure 1
Figure 1
Kaplan–Meier curve. Event-free survival of target vessel failure among patients who received a Genous stent and those who received a Taxus Liberté stent.
Figure 2
Figure 2
Kaplan–Meier curve. Percentage of patients on dual antiplatelet therapy during 1-year follow-up.
Figure 3
Figure 3
Cumulative frequency distribution curve. Percentage diameter stenosis of the high-risk lesions of Genous stent treated patients (70 lesions in 53 patients) and the Taxus Liberté stent treated patients (53 lesions in 37 patients) with complete QCA data.
See this image and copyright information in PMC

Comment in

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