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
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 andresults:
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, andif subjects consentedat 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...
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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
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Department of Cardiology, Aarhus University Hospital/DK
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Department of Cardiology, Lausanne University Hospital/CH
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Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente/NL
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Department of Cardiology, National Heart Center Singapore/SG
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Department of Cardiology, University Hospital/CH
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Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban/DE
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Division of Cardiology, Hospital Clinico San Carlos/ES
/
Instituto de Cardiologia Dante Pazzanese/BR