Randomized, Double-Blind, Multicenter Study of the Polymer-Based 17-b Estradiol-Eluting Stent for Treatment of Native Coronary Artery Lesions: Six-Month Results of the ETHOS I Trial
Catheterization and Cardiovascular Interventions
; 70(5): 654-660, 2007.
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1061890
Biblioteca responsável:
BR79.1
Localização: BR79.1
RESUMO
Objectives:
The ETHOS I trial was the first in-human experience evaluating the safety and efficacy of two different release formulations of the 17-b estradiol-eluting RStent TM 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 slowrelease (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% 6 14%, 33% 6 11%, and 31% 6 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 6 0.49 mm, 0.86 6 0.53 mm, and 0.84 6 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-b estradiol-eluting R-StentTM, in either slowor moderate-release formulations, was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls.
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Doença da Artéria Coronariana
/
Stents
/
Reestenose Coronária
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Inglês
Revista:
Catheterization and Cardiovascular Interventions
Ano de publicação:
2007
Tipo de documento:
Artigo
Instituição/País de afiliação:
College of Physicians and Surgeons, Columbia University/US
/
Instituto Dante Pazzanese de Cardiologia/BR
/
X-Cell Medical Inc Monmouth Junction, New Jersey/US