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.
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.
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Marcos Danillo Peixoto
MD
Oliveira
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Expedito E
EE
Ribeiro
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Carlos M
CM
Campos
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Henrique B
HB
Ribeiro
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Bruno L R
BL
Faillace
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Augusto C
AC
Lopes
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Rodrigo B
RB
Esper
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
George X
GX
Meirelles
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Marco A
MA
Perin
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Alexandre
A
Abizaid
1 Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil ; 2 Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil ; 3 Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA ; 4 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; 5 Cardiology Department, Hospital do Servidor Publico Estadual, São Paulo, Brazil ; 6 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Pedro A
PA
Lemos
Biodegradable polymer (BP); long-term outcomes; percutaneous coronary intervention (PCI); sirolimus-eluting stent (SES)