title: 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.
abstract: 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.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. aabizaid@uol.com.br
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Aurea J
authors.initials: AJ
authors.lastname: Chaves
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Karl
authors.initials: K
authors.lastname: Hauptmann
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: William
authors.initials: W
authors.lastname: Baumbach
authors.forename: Hari
authors.initials: H
authors.lastname: Shankar
authors.forename: Ralf
authors.initials: R
authors.lastname: Muller
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.forename: Amanda G M R
authors.initials: AG
authors.lastname: Sousa
authors.forename: J Eduardo
authors.initials: JE
authors.lastname: Sousa
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: 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
chemical_list: D011108:Polymers; D004958:Estradiol