Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III
EuroIntervention
; 13(4): 432-439, 2017.
Article
em En
| SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1062707
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
AIMS:
We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant. METHODS ANDRESULTS:
The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis...
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Coleções:
06-national
/
BR
Base de dados:
SES-SP
/
SESSP-IDPCPROD
Assunto principal:
Doenças Cardiovasculares
/
Estudos de Casos e Controles
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Stents Farmacológicos
/
Coração
Tipo de estudo:
Observational_studies
Idioma:
En
Revista:
EuroIntervention
Ano de publicação:
2017
Tipo de documento:
Article