In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial
Int J Cardiol
; 255(mar): 22-28, 2018. tab, graf, ilus
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1063465
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
RATIONALE Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES:
We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS ANDRESULTS:
The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months...
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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
/
Sirolimo
/
Stents Farmacológicos
Idioma:
Inglês
Revista:
Int J Cardiol
Ano de publicação:
2018
Tipo de documento:
Artigo
Instituição/País de afiliação:
Aarhus University Hospital, Skejby/DK
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Medisch Spectrum Twente, Thoraxcentrum Twente/NL
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Cardiovascular Research Center Aalst, OLV Hospital/BE
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Herzzentrum Segeberger Kliniken GmbH/DE
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Hospital Clinico San Carlos/ES
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Instituto de Cardiologia Dante Pazzanese/BR
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LKEB, Leiden University/NL
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MedStar Washington Hospital Center/US
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Städtische Kliniken Neuss, Lukaskrankenhaus GmbH/DE
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University of Sao Paulo/BR