A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry / 中华医学杂志(英文版)
Chinese Medical Journal
; (24): 1848-1854, 2023.
Article
em En
| WPRIM
| ID: wpr-1007585
Biblioteca responsável:
WPRO
ABSTRACT
BACKGROUND@#The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.@*METHODS@#The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.@*RESULTS@#A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.@*CONCLUSION@#The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.@*CLINICAL TRIAL REGISTRATION@#ClinicalTrials.gov, NCT03916432.
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Índice:
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Assunto principal:
Polímeros
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Trombose
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Fatores de Tempo
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Doença da Artéria Coronariana
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Fármacos Cardiovasculares
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Sistema de Registros
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Estudos Prospectivos
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Fatores de Risco
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Estudos de Coortes
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Resultado do Tratamento
Limite:
Humans
Idioma:
En
Revista:
Chinese Medical Journal
Ano de publicação:
2023
Tipo de documento:
Article