First-in-man randomised comparison of a novel sirolimuselutingstent with abluminal biodegradable polymer and thinstrutcobalt-chromium alloy: INSPIRON-I trial
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
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BR
Base de dados:
SES-SP
/
SESSP-IDPCPROD
Assunto principal:
Stents
/
Reestenose Coronária
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Stents Farmacológicos
Tipo de estudo:
Clinical_trials
Idioma:
En
Revista:
EuroIntervention
Ano de publicação:
2013
Tipo de documento:
Article