Randomized, double-blind, multicenter study of the polymer-based 17-beta estradiol-eluting stent for treatment of native coronary artery lesions: six-month results of the ETHOS I trial.
OBJECTIVE
The ETHOS I trial was the first in-human experience evaluating the safety and efficacy of two different release formulations of the 17-beta 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-beta 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.
Abizaid
Alexandre
A
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. aabizaid@uol.com.br
Chaves
Aurea J
AJ
Leon
Martin B
MB
Hauptmann
Karl
K
Mehran
Roxana
R
Lansky
Alexandra J
AJ
Baumbach
William
W
Shankar
Hari
H
Muller
Ralf
R
Feres
Fausto
F
Sousa
Amanda G M R
AG
Sousa
J Eduardo
JE
Grube
Eberhard
E
D000704:Analysis of Variance; D001938:Brazil; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D004958:Estradiol / Q000008:administration & dosage*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
D011108:Polymers; D004958:Estradiol