Two-year clinical results of a polymer-free, paclitaxel-eluting stent: the ELUTES trial.

AIMS:The ELUTES Study was a dose-finding trial to determine clinical safety and angiographic efficacy of a polymer-free, paclitaxel-eluting stent. The aim of this paper is to present the longer term follow-up. METHODS AND RESULTS:192 patients with de novo lesions were randomised to either control or one of four doses of paclitaxel directly applied to a Cook Incorporated V-Flex Plus stent without polymer. The six-month data has been previously published and showed a dose-response effect on diameter stenosis, late loss and binary stenosis, with the highest dose density achieving benefit for late loss and diameter stenosis. Binary restenosis was 3% in this group vs. 21% in controls.Clinical follow-up data has been obtained in 152 patients (79%) to 24 months and shows sustained effects with no evidence of late stent thrombosis, suggesting drug-eluting non-polymer stents are clinically safe. CONCLUSIONS:Non-polymer, paclitaxel-coated stents effectively inhibited angiographic parameters of restenosis. The stent system appeared safe with no recorded late stent thrombosis.