Evidence map›Paper›PMID 26331110›Full record

ArticleCardiovascular diagnosis and therapy2015

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.

Marcos Danillo Peixoto Oliveira, Expedito E Ribeiro, Carlos M Campos, Henrique B Ribeiro, Bruno L R Faillace, Augusto C Lopes, Rodrigo B Esper, George X Meirelles, Marco A Perin, Alexandre Abizaid and 1 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cardiovascular diagnosis and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01093391 (A Randomized Trial of Bare Metal Stent), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01093391 phase3completednot on this map

A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)

TypeinterventionalSponsorScitech Produtos Medicos SARan2010 to 2015Enrolled63ConditionsCoronary Artery DiseaseArmsDRUG ELUTING STENT, BARE METAL STENT
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Marcos Danillo Peixoto Oliveira1 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 Ribeiro1 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 Campos1 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 Ribeiro1 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 Faillace1 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 Lopes1 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 Esper1 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 Meirelles1 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 Perin1 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 Abizaid1 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 Lemos1 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.
Hospital Israelita Albert Einstein · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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).

methodsA 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.

resultsBaseline 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.

conclusionsThe 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.

Indexed as

Biodegradable polymer (BP)long-term outcomespercutaneous coronary intervention (PCI)sirolimus-eluting stent (SES)

Identifiers

PMID26331110
PMCPMC4536482
OpenAlexW1942656362

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.