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First-in-man randomised comparison of a novel sirolimuselutingstent with abluminal biodegradable polymer and thinstrutcobalt-chromium alloy: INSPIRON-I trial
Ribeiro, Expedito E; Campos, Carlos M; Ribeiro, Henrique B; Lopes, Augusto C; Esper, Rodrigo B; Meirelles, George X; Perin, Marco A; Abizaid, Alexandre; Lemos, Pedro A.
Afiliação
  • Ribeiro, Expedito E; Instituto do Coração. São Paulo. BR
  • Campos, Carlos M; Instituto do Coração. São Paulo. BR
  • Ribeiro, Henrique B; Instituto do Coração. São Paulo. BR
  • Lopes, Augusto C; Massachusetts Institute of Technology. Cambridge. US
  • Esper, Rodrigo B; Instituto do Coração. São Paulo. BR
  • Meirelles, George X; Hospital do Servidor Publico Estadual. São Paulo. BR
  • Perin, Marco A; Instituto do Coração. São Paulo. BR
  • Abizaid, Alexandre; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Lemos, Pedro A; Instituto do Coração. São Paulo. BR
EuroIntervention ; 09: 1380-1384, 2013. ilus
Article em En | SES-SP, SESSP-IDPCPROD, SES-SP | ID: biblio-1062681
Biblioteca responsável: BR79.1
Localização: BR79.1
ABSTRACT
The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-elutingstent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromiumalloy.Methods and

results:

This is a randomised, multicentre comparison between Inspiron and a stent with thesame metallic structure but without polymer coating or drug elution (Cronus). The primary objective was toevaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstructionas measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE).Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographiccharacteristics of both groups were similar. At six months, the in-segment LLL was reduced in theInspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), aswell as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidenceof MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesionrevascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis.

Conclusions:

Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloyproved effective in reducing restenosis at six months.
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Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Stents / Reestenose Coronária / Stents Farmacológicos Tipo de estudo: Clinical_trials Idioma: En Revista: EuroIntervention Ano de publicação: 2013 Tipo de documento: Article
Buscar no Google
Adicionar na Minha BVS
Imprimir
XML
Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Stents / Reestenose Coronária / Stents Farmacológicos Tipo de estudo: Clinical_trials Idioma: En Revista: EuroIntervention Ano de publicação: 2013 Tipo de documento: Article