Objectives: The ETHOS I trial was the first in‐human experience evaluating the safety and efficacy of two different release formulations of the 17‐β estradiol‐eluting R‐Stent™ versus uncoated control stents for the treatment of patients with single de novo native coronary lesions. Background: Estrogens were reported to inhibit neointimal proliferation and to accelerate endothelial regeneration after coronary angioplasty and thus could be an ideal compound to deliver on a stent for the purpose of reducing in‐stent restenosis. Methods: Ninety‐five patients were randomized to receive a slow‐release (n = 32) or the moderate release (n = 31) formulations or the bare metal stent (n = 32). The primary end point was the 6‐month percent in‐stent volume obstruction by intravascular ultrasound (IVUS). Results: Diabetes was present in 29.5% of patients; the mean reference vessel diameter was 2.90 mm; and the mean lesion length was 13.5 mm. Primary endpoint, 6‐month percent in‐stent volume obstruction by IVUS, did not differ significantly between the 3 groups (31% ± 14%, 33% ± 11%, and 31% ± 14%, P = 0.83). Secondary endpoints also did not differ significantly between the groups including 6‐month rates of in‐lesion binary angiographic restenosis (13.3%, 14.3%, and 12.5%, P = 0.98), in‐stent late loss (0.82 ± 0.49 mm, 0.86 ± 0.53 mm, and 0.84 ± 0.46 mm, P = 0.97), target lesion revascularization (12.5%, 6.9%, and 6.5%, P = 0.64), and major adverse cardiac events (18.8%, 10.3%, and 6.5%, P = 0.31). Conclusions: In this first‐in‐man randomized trial, the 17‐β estradiol‐eluting R‐Stent™, in either slow‐ or moderate‐release formulations, was well‐tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. © 2007 Wiley‐Liss, Inc.

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   |wiki=    Wicri/Rhénanie
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   |texte=   Randomized, double‐blind, multicenter study of the polymer‐based 17‐β estradiol‐eluting stent for treatment of native coronary artery lesions: Six‐month results of the ETHOS I trial
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