AimsThe purpose of this study was to evaluate the GenousTM 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 resultsWe 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).ConclusionIn 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.

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

In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation.

Drug-eluting stents have been demonstrated to significantly reduce clinical and angiographic restenosis in patients with coronary artery disease compared with bare-metal stents. Intuitively, however, a prohealing approach for the prevention of in-stent restenosis by promoting accelerated re-endothelialization is favored over the aggressive pharmacologic cytotoxic and cytostatic approach of the drug-eluting stents. The endothelial progenitor cell-capturing stent attracts circulating CD43(+) progenitor cells that bind to the stent surface and differentiate into a functional endothelial layer. It is theorized that the accelerated establishment of the endothelial layer covering the stent struts will reduce the risk of neointimal hyperplasia and smooth muscle cell proliferation. The safety and efficacy have been demonstrated in the nonrandomized Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth (HEALING) studies, and the device received a CE mark in 2005. This article reviews the realization of the endothelial progenitor cell-capturing stent, its relevance compared with other stent types, current evidence on clinical performance, and future perspectives. At present, the larger randomized Tri-stent Adjudication Study (TRIAS) that is ongoing will directly compare the clinical usefulness of this new endothelial progenitor cell-capturing stent with bare-metal stents and drug-eluting stents.