6-Month clinical and angiographic outcomes of a novel radiopaquesirolimus-eluting bioresorbable vascular scaffold
JACC cardiovasc. interv
; 10(18): 1832-1838, 2017. tab
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1064050
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 mm) that facilitate device delivery and precise target lesion treatment. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length #20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 0.40 mm (n » 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%). The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Doença das Coronárias
/
Implantes Absorvíveis
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Inglês
Revista:
JACC cardiovasc. interv
Ano de publicação:
2017
Tipo de documento:
Artigo
Instituição/País de afiliação:
CHU Toulouse Rangueil/FR
/
Columbia University Medical Center/US
/
Institut Hospitalier J. Cartier/FR
/
Instituto Dante Pazzanese de Cardiologia/BR
/
REVA Medica/US
/
St.-Johannes-Hospital/DE
/
Szpital Uniwersytecki w Krakowie/PL
/
Universitätsklinikum Schleswig-Holstein/DE