Two-year clinical results of a polymer-free, paclitaxel-eluting stent: the ELUTES trial
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Published on: January 21, 2020
Neil Swanson1, Ivan De Scheerder, Bernard Chevalier
1Department of Cardiology, University Hospitals of Leicester, Glenfield Hospital, Leicester, United Kingdom.
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.
