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Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III
Haude, Michael; Ince, Hüseyin; Kische, Stephan; Abizaid, Alexandre; Tölg, Ralph; Lemos, Pedro Alves; van Mieghem, Nicolas M; Verheye, Stefan; von Birgelen, Clemens; Christiansen, Evald Høj; Wijns, William; Garcia-Garcia, Hector M; Waksman, Ron.
Afiliação
  • Haude, Michael; Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH. Neuss. DE
  • Ince, Hüseyin; Department of Cardiology, Vivantes Klinikum im Friedrichshain and Vivantes Klinikum Am Urban. Berlin. DE
  • Kische, Stephan; Department of Cardiology, Vivantes Klinikum im Friedrichshain. Berlin. DE
  • Abizaid, Alexandre; Instituto de Cardiologia Dante Pazzanese. Sao Paulo. BR
  • Tölg, Ralph; Herzzentrum Segeberger Kliniken GmbH. Bad Segeberg. DE
  • Lemos, Pedro Alves; Instituto do Coração – HCFMUSP, University of Sao Paulo. Sao Paulo. BR
  • van Mieghem, Nicolas M; Thoraxcenter, Erasmus Medical Center. Rotterdam. NL
  • Verheye, Stefan; Interventional Cardiology, Middelheim Hospital. Antwerp. BE
  • von Birgelen, Clemens; Medisch Spectrum Twente, Thoraxcentrum Twente. Enschede. NL
  • Christiansen, Evald Høj; Aarhus University Hospital. Aarhus. DK
  • Wijns, William; Cardiovascular Research Center Aalst, OLV Hospital. Aalst. BE
  • Garcia-Garcia, Hector M; Interventional Cardiology, MedStar Washington Hospital Center Washington. Washington. US
  • Waksman, Ron; Interventional Cardiology, MedStar Washington Hospital Center. Washington. US
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 AND

RESULTS:

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...
Assuntos
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Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Doenças Cardiovasculares / Estudos de Casos e Controles / Stents Farmacológicos / Coração Tipo de estudo: Observational_studies Idioma: En Revista: EuroIntervention Ano de publicação: 2017 Tipo de documento: Article
Buscar no Google
Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Doenças Cardiovasculares / Estudos de Casos e Controles / Stents Farmacológicos / Coração Tipo de estudo: Observational_studies Idioma: En Revista: EuroIntervention Ano de publicação: 2017 Tipo de documento: Article