Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial.
Catheter Cardiovasc Interv
; 95(2): 175-184, 2020 02.
Article
em En
| MEDLINE
| ID: mdl-31033154
ABSTRACT
OBJECTIVES:
To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.BACKGROUND:
The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.METHODS:
Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months.RESULTS:
In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.CONCLUSIONS:
These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Polímeros
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Doença da Artéria Coronariana
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Fármacos Cardiovasculares
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Sirolimo
/
Implantes Absorvíveis
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Estenose Coronária
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Stents Farmacológicos
/
Intervenção Coronária Percutânea
/
Everolimo
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
Asia
/
Europa
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article