Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial
Cardiovasc Diagn Ther
; 5(4): 264-270, 2015.
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1061810
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
Background:
The Inspiron sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier NCT01093391).Methods:
A total of 57 patients (60 lesions) were randomly allocated in a 21 ratio to treatment with the Inspiron SES vs. its equivalent Cronus bare metal stent (BMS, both by Scitech Medical, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years.Results:
Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11)...
Texto completo:
Disponível
Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Polímeros
/
Sirolimo
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Stents Farmacológicos
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Intervenção Coronária Percutânea
Tipo de estudo:
Ensaio clínico controlado
/
Estudo prognóstico
Idioma:
Inglês
Revista:
Cardiovasc Diagn Ther
Ano de publicação:
2015
Tipo de documento:
Artigo
Instituição/País de afiliação:
Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo/BR
/
Heart Institute-InCor, University of São Paulo/BR
/
Hospital Israelita Albert Einstein/BR
/
Hospital do Servidor Publico Estadual/BR
/
Institute of Medical Engineering and Science, Massachusetts Institute of Technology/US
/
Instituto Dante Pazzanese de Cardiologia/BR