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
Oliveira, Marcos Danillo Peixoto; Ribeiro, Expedito E; Campos, Carlos M; Ribeiro, Henrique B; Faillace, Bruno LR; Lopes, Augusto C; Esper, Rodrigo B; Meirelles, George X; Perin, Marco A; Abizaid, Alexandre; Lemos, Pedro A.
Cardiovasc Diagn Ther
; 5(4): 264-270, 2015.
Artículo
en Inglés
| SES-SP, SESSP-IDPCPROD, SES-SP | ID: biblio-1061810
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)...
Biblioteca responsable:
BR79.1
Ubicación: BR79.1
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