Sirolimus-coated balloon with a microsphere-based technology for the treatment of de novo or restenotic coronary lesions
Cardiovasc. revasc. med
; (45)Sept. 2022.
Artigo
em Inglês
| CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1400560
Biblioteca responsável:
BR79.1
ABSTRACT
BACKGROUND:
Non stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions.METHODS:
This was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions.RESULTS:
A total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up.CONCLUSION:
The novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
CONASS
/
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Stents
/
Angiografia Coronária
/
Stents Farmacológicos
Idioma:
Inglês
Revista:
Cardiovasc. revasc. med
Ano de publicação:
2022
Tipo de documento:
Artigo
Instituição/País de afiliação:
Advanced Medical Research Institute Hospital/IN
/
Grant Medical Foundation, Ruby Hall Clinic/IN
/
Heart Institute (InCor), University of São Paulo/BR
/
Heart Institute, Medanta The Medicity Hospital/IN
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Institute Dante Pazzanese of Cardiology/BR
/
Magnum Heart Institute/IN
/
Research Institute at Heart Hospital (hcor)/BR
/
Seth Sukhlal Karnani Memorial Hospital/IN