One-year clinical outcomes and multislice computed tomography angiographic results following implantation of the NeoVas bioresorbable sirolimus-eluting scaffold in patients with single de novo coronary artery lesions.
Catheter Cardiovasc Interv
; 91(S1): 617-622, 2018 02 15.
Article
em En
| MEDLINE
| ID: mdl-29392879
ABSTRACT
BACKGROUND:
Tremendous efforts have been made to establish the concept of vascular restoration therapy with a fully bioresorbable scaffold for coronary artery disease. With an improved scaffold design and technologies, the novel NeoVas scaffold has shown promising clinical performance at 6 months follow-up.OBJECTIVE:
The aim of this study was to investigate the 1 year clinical outcomes and multislice computed tomography (MSCT) angiographic results after implantation of the NeoVas scaffold in patients with single de novo coronary artery lesions.METHODS:
The NeoVas first-in-man study was a prospective, two-center, single-arm study enrolling 31 patients who were eligible for the treatment. The composite endpoint of target lesion failure (TLF)-defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (TLR)-was assessed. Of the 31 patients scheduled for 1 year clinical follow-up, 29 patients received MSCT examinations.RESULTS:
At 1 year follow-up, there was only 1 (3.2%) TLF, attributed to 1 patient who suffered ischemia-driven TLR at 181 days postprocedure. No cardiac deaths or scaffold thrombosis were observed. MSCT analysis demonstrated excellent vessel patency, with a median in-scaffold lumen area of 10.6 mm2 (interquartile range [IQR] 8.2-11.7 mm2 ) and a minimal lumen diameter of 2.7 mm (IQR 2.4-3.0 mm).CONCLUSIONS:
This study demonstrated the safety and efficacy of the NeoVas scaffold for patients with single de novo coronary artery lesions at 1 year of follow-up. Noninvasive MSCT data confirmed vessel patency and the maintenance of vessel dimensions following implantation of the NeoVas bioresorbable sirolimus-eluting scaffold.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Doença da Artéria Coronariana
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Fármacos Cardiovasculares
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Angiografia Coronária
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Sirolimo
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Implantes Absorvíveis
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Stents Farmacológicos
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Tomografia Computadorizada Multidetectores
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Intervenção Coronária Percutânea
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Angiografia por Tomografia Computadorizada
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article