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Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study
Simonsen, Jo Krogsgaard; Holck, Emil Nielsen; Carrié, Didier; Frey, Norbert; Lutz, Matthias; Weber-Albers, Joachim; Dudek, Dariusz; Chevalier, Bernard; Daemen, Joost; Dijkstra, Jouke; Maule, Camilla Fox; Neghabat, Omeed; Lassen, Jens Flensted; Anderson, Jeffrey; Christiansen, Evald Hoj; Holm, Niels Ramsing; Abizaid, Alexandre.
Afiliação
  • Simonsen, Jo Krogsgaard; Aarhus University Hospital. Arhus. DK
  • Holck, Emil Nielsen; Aarhus University Hospital. Arhus. DK
  • Carrié, Didier; University Hospital Rangueil. Toulouse. FR
  • Frey, Norbert; University Medical Center Schleswig-Holstein. kiel. DE
  • Lutz, Matthias; University Medical Center Schleswig-Holstein. Kiel. DE
  • Weber-Albers, Joachim; St. Johannes Hospital Dortmund. Dortmund. DE
  • Dudek, Dariusz; University Hospital Krakow. Jagiellonian University Medical College. Cracóvia. PL
  • Chevalier, Bernard; Cardiovascular Institute Paris Sud (ICPS). Massy. FR
  • Daemen, Joost; Department of Cardiology, Erasmus Universite Rotterdam. Roterdã. NL
  • Dijkstra, Jouke; Leiden University Medical Center. Leiden. NL
  • Maule, Camilla Fox; Aarhus University Hospital. Aarhus. DK
  • Neghabat, Omeed; Aarhus University Hospital. Aarhus. DK
  • Lassen, Jens Flensted; The Heart Center Rigshospitalet Copenhagen. Copenhage. DK
  • Anderson, Jeffrey; Reva Medical. San Diego. US
  • Christiansen, Evald Hoj; Aarhus University Hospital. Arhus. DK
  • Holm, Niels Ramsing; Aarhus University Hospital. Arhus. DK
  • Abizaid, Alexandre; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
Open Heart ; 6(1): 1-9, Fev. 2019. ilustração, tabela, gráfico
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024948
Biblioteca responsável: BR79.1
Localização: BR79.1
ABSTRACT

OBJECTIVES:

We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Phantom bioresorbable scaffold (BRS).

BACKGROUND:

The Phantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favorable mid-term clinical and angiographic outcomes. METHODS AND

RESULTS:

FANTOM II was a prospective, single arm study with implantation of the Phantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm2 and 5.7±1.4 mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm2 and 5.6±1.4 mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm2 at baseline to 7.2±1.4 mm2 at 6 months (p=0.12), and from 7.4±1.5 mm2 to 7.3±1.4 mm2 at 9 months. Strut malposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months.

CONCLUSIONS:

The novel Phantom BRS had favorable healing patterns at 6-month and 9-month follow-up as malposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil. (AU)
Assuntos

Texto completo: Disponível Coleções: Bases de dados nacionais / Brasil Base de dados: Sec. Est. Saúde SP / SESSP-IDPCPROD Assunto principal: Doença da Artéria Coronariana / Tomografia de Coerência Óptica / Stents Farmacológicos Tipo de estudo: Guia de prática clínica Idioma: Inglês Revista: Open Heart Ano de publicação: 2019 Tipo de documento: Artigo Instituição/País de afiliação: Aarhus University Hospital/DK / Cardiovascular Institute Paris Sud (ICPS)/FR / Department of Cardiology, Erasmus Universite Rotterdam/NL / Instituto Dante Pazzanese de Cardiologia/BR / Leiden University Medical Center/NL / Reva Medical/US / St. Johannes Hospital Dortmund/DE / The Heart Center Rigshospitalet Copenhagen/DK / University Hospital Krakow/PL / University Hospital Rangueil/FR

Texto completo: Disponível Coleções: Bases de dados nacionais / Brasil Base de dados: Sec. Est. Saúde SP / SESSP-IDPCPROD Assunto principal: Doença da Artéria Coronariana / Tomografia de Coerência Óptica / Stents Farmacológicos Tipo de estudo: Guia de prática clínica Idioma: Inglês Revista: Open Heart Ano de publicação: 2019 Tipo de documento: Artigo Instituição/País de afiliação: Aarhus University Hospital/DK / Cardiovascular Institute Paris Sud (ICPS)/FR / Department of Cardiology, Erasmus Universite Rotterdam/NL / Instituto Dante Pazzanese de Cardiologia/BR / Leiden University Medical Center/NL / Reva Medical/US / St. Johannes Hospital Dortmund/DE / The Heart Center Rigshospitalet Copenhagen/DK / University Hospital Krakow/PL / University Hospital Rangueil/FR
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