Background: A “pro-healing” approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from drug eluting stents to treat coronary artery disease. Promoting accelerated endothelialization of the stent, endothelial progenitor cell capturing stents (ECS) have shown promising results in studies with patients carrying non-complex lesions. The purpose of this study was to evaluate the GenousTM ECS versus the Taxus Liberte' paclitaxel-eluting stent (PES) in patients with coronary lesions.

Methods: During the study period (2010–2012) all consecutive patients receiving ECS were retrospectively compared to age, sex and lesion location matched controls receiving PES. 6-months angiographic and long term clinical outcomes were analyzed. The primary endpoint was the cumulative long-term major adverse cardiac events (MACE).

Results: Out of 908 patients analyzed (454 ECS and 454 PES), 811 (89.3%) were available for up to 60 months follow-up (FU) (mean 34.5±16.8 months). The primary end point occurred in 33.5% (ECS) versus 14.8% (PES) resulting in a hazard ratio of 3.4 (95% Cl: 2.29–4.04; p<0.0001) and included cardiac death (7.3% versus 4.4%; p=0.09), myocardial infarction (2.2% versus 5.3%; p=0.02), and target vessel revascularisation (TVR) (24.0% versus 10.4%; p<0.0001). The incidence of definitive/probable stent thrombosis (ST) was 0.4% versus 0.9% (p=0.69); very late (>1 year) ST occurred in one patient in each group (0.2%).

A total of 513 patients (58.7%) underwent 6-months angiographic follow-up. Target lesion revascularisation, TVR, and MACE were significantly more frequent in the ECS group (13.8% versus 4.5%; 15.9% versus 4.5%; and 16.7% versus 6.2%, respectively; p<0.0001 for all).

Conclusions: Within 3 years FU implantation of the ECS in patients with de-novo coronary lesions resulted in a significant higher rate of the primary endpoint compared to PES. This was mainly driven by repeat revascularizations, the number of stent thromboses was low in both groups.

Title

European Heart Journal

Publisher

Oxford University Press

Publisher Country

United Kingdom

Publication Type

Prtinted only

Volume

38

Year

2017

Pages

191