TY - JOUR AU - Oliveira, Marcos Danillo Peixoto AU - Ribeiro, Expedito E. AU - Campos, Carlos M. AU - Ribeiro, Henrique B. AU - Faillace, Bruno L. R. AU - Lopes, Augusto C. AU - Esper, Rodrigo B. AU - Meirelles, George X. AU - Perin, Marco A. AU - Abizaid, Alexandre AU - Lemos, Pedro A. PY - 2015 TI - 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 JF - Cardiovascular Diagnosis and Therapy; Vol 5, No 4 (August 12, 2015): Cardiovascular Diagnosis and Therapy Y2 - 2015 KW - N2 - 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 2:1 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). The rate of death/MI was similar between the groups, but there was a significant decrease in the risk of repeat revascularization in the Inspiron group compared to the control arm TLR (0.0% vs . 23.5% respectively, P=0.02). There were no stent thromboses in the study population. Conclusions: The novel Inspiron™ SES showed a sustained safe and effective clinical profile after 4-year of follow-up, with very low adverse events and null stent thrombosis (ST) occurrence. UR - https://cdt.amegroups.org/article/view/7153