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-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.
Assuntos
Estenose Coronária/terapia , Estradiol/administração & dosagem , Stents , Análise de Variância , Brasil , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/patologia , Reestenose Coronária/prevenção & controle , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/patologia , Método Duplo-Cego , Sistemas de Liberação de Medicamentos , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Estudos Prospectivos , Resultado do TratamentoRESUMO
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.
Assuntos
Doença da Artéria Coronariana , Reestenose Coronária , StentsRESUMO
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.