First-in-human evaluation of a novel poly-L-lactide based sirolimus-eluting bioresorbable vascular scaffold for the treatment of de novo native coronary artery lesions: MeRes-1 trial
EuroIntervention
; 13(4): 415-423, 2017.
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1062706
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
AIMS:
The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. METHODS ANDRESULTS:
The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%...
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Técnicas In Vitro
/
Doença da Artéria Coronariana
/
Humanos
/
Sirolimo
Idioma:
Inglês
Revista:
EuroIntervention
Ano de publicação:
2017
Tipo de documento:
Artigo
Instituição/País de afiliação:
AIIMS/IN
/
Apollo Hospitals/IN
/
DMCH/IN
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Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center/NL
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Fortis Escorts Heart Institute/IN
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Fortis Flt. Lt. Rajan Dhall Hospital/IN
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G.B. Pant Hospital/IN
/
Imperial College London/GB
/
Instituto Dante Pazzanese de Cardiologia/BR
/
LTMGH/IN