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Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial
Haude, Michael; Ince, Hüseyin; Abizaid, Alexandre; Toelg, Ralph; Lemos, Pedro Alves; von Birgelen, Clemens; Christiansen, Evald Høj; Wijns, William; Neumann, Franz-Josef; Kaiser, Christoph; Eeckhout, Eric; Lim, Soo Teik; Escaned, Javier; Onuma, Yoshinobu; 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 Am Urban. Berlin. DE
  • Abizaid, Alexandre; Instituto de Cardiologia Dante Pazzanese. São Paulo. BR
  • Toelg, Ralph; Terzzentrum Segeberger Kliniken GmbH. Bad Segeberg. DE
  • Lemos, Pedro Alves; Instituto do Coração-HCFMUSP, University of São Paulo. São Paulo. BR
  • von Birgelen, Clemens; Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente. Enschede. NL
  • Christiansen, Evald Høj; Department of Cardiology, Aarhus University Hospital. Aarhus. DK
  • Wijns, William; Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital. Aalst. BE
  • Neumann, Franz-Josef; Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen. Bad Krozingen. DE
  • Kaiser, Christoph; Department of Cardiology, University Hospital. Basel. CH
  • Eeckhout, Eric; Department of Cardiology, Lausanne University Hospital. Lausanne. CH
  • Lim, Soo Teik; Department of Cardiology, National Heart Center Singapore. Singapore. SG
  • Escaned, Javier; Division of Cardiology, Hospital Clinico San Carlos. Madrid. ES
  • Onuma, Yoshinobu; Cardialysis BV. The Netherlands. NL
  • Garcia-Garcia, Hector M; Interventional Cardiology, MedStar Washington Hospital Center, Washington. Washington. US
  • Waksman, Ron; Interventional Cardiology, MedStar Washington Hospital Center. Washington. US
Eur. heart j ; 37(35): 2701-2709, 2016.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1062639
Biblioteca responsável: BR79.1
Localização: BR79.1
ABSTRACT

Aims:

Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomesof a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesiumscaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. Methods and

results:

The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novolesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at6 months, and—if subjects consented—at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42patients in-segment late lumen loss 0.20 + 0.21 mm vs. 0.25 + 0.22 mm, P » 0.117, D 0.05 + 0.21 mm (95%CI 20.01;0.12); in-scaffold late lumen loss 0.37 + 0.25 mm vs. 0.39 +0.27 mm, P » 0.446, D 0.03 + 0.22 (95%CI 20.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroboratedthe QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause,one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional eventoccurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienceda definite or probable scaffold thrombosis...
Assuntos
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Coleções: Bases de dados nacionais / Brasil Base de dados: Sec. Est. Saúde SP / SESSP-IDPCPROD Assunto principal: Doença da Artéria Coronariana / Stents / Sonhos / Magnésio Tipo de estudo: Estudo diagnóstico Idioma: Inglês Revista: Eur. heart j Ano de publicação: 2016 Tipo de documento: Artigo Instituição/País de afiliação: Cardialysis BV/NL / Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital/BE / Department of Cardiology, Aarhus University Hospital/DK / Department of Cardiology, Lausanne University Hospital/CH / Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente/NL / Department of Cardiology, National Heart Center Singapore/SG / Department of Cardiology, University Hospital/CH / Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban/DE / Division of Cardiology, Hospital Clinico San Carlos/ES / Instituto de Cardiologia Dante Pazzanese/BR
Buscar no Google
Coleções: Bases de dados nacionais / Brasil Base de dados: Sec. Est. Saúde SP / SESSP-IDPCPROD Assunto principal: Doença da Artéria Coronariana / Stents / Sonhos / Magnésio Tipo de estudo: Estudo diagnóstico Idioma: Inglês Revista: Eur. heart j Ano de publicação: 2016 Tipo de documento: Artigo Instituição/País de afiliação: Cardialysis BV/NL / Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital/BE / Department of Cardiology, Aarhus University Hospital/DK / Department of Cardiology, Lausanne University Hospital/CH / Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente/NL / Department of Cardiology, National Heart Center Singapore/SG / Department of Cardiology, University Hospital/CH / Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban/DE / Division of Cardiology, Hospital Clinico San Carlos/ES / Instituto de Cardiologia Dante Pazzanese/BR
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