Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry

Abstract Objectives To evaluate the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry. Background The long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolim...

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Autores principales: Yi Dai, Rutao Wang, Fengying Chen, Yaojun Zhang, Yi Liu, He Huang, Ping Yang, Ruining Zhang, Bo Zheng, Chao Gao, Yundai Chen, Ling Tao
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Publicado: BMC 2021
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spelling oai:doaj.org-article:7b084df3d73e4d87beadc2a0686829452021-11-14T12:07:29ZClinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry10.1186/s12872-021-02356-01471-2261https://doaj.org/article/7b084df3d73e4d87beadc2a0686829452021-11-01T00:00:00Zhttps://doi.org/10.1186/s12872-021-02356-0https://doaj.org/toc/1471-2261Abstract Objectives To evaluate the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry. Background The long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolimus-eluting Nano plus stent (Lepu Medical, Beijing, China) is limited. Methods The NANO all-comers Registry trial was a prospective, multicenter clinical registry conducted in 26 centers in China between August 2016 and January 2017. A total of 2481 consecutive patients were exclusively treated with the Nano plus stent. The primary clinical endpoint, target lesion failure (TLF, defined as cardiac death, target vessel nonfatal myocardial infarction, and clinically driven target lesion revascularization [CD-TLR]), was analyzed at 3 years. Results At 3 years, 2295 patients (92.5%) were followed. The incidence of TLF was 6.8% (168/2481). The rate of cardiac death was 3.8% (94/2481), target vessel nonfatal myocardial infarction 0.7% (18/2481), and CD-TLR 2.9% (68/2481). The rate of definite/probable stent thrombosis was 0.5% (13/2481). The risk factors of diabetes mellitus, acute myocardial infarction, age, chronic renal failure, in-stent restenosis, chronic total occlusion, and left ventricular ejection fraction < 40% were the independent predictors of 3-year TLF. Conclusions At three years, the rate of TLF was relatively low in patients treated with the polymer-free Nano plus stent. The polymer-free Nano plus stent showed a favorable safety and efficacy profile in real-world patients. Clinical trial registration URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02929030.Yi DaiRutao WangFengying ChenYaojun ZhangYi LiuHe HuangPing YangRuining ZhangBo ZhengChao GaoYundai ChenLing TaoBMCarticleReal-world populationPercutaneous coronary interventionsPolymer-free drug-eluting stentTarget lesion failureDiseases of the circulatory (Cardiovascular) systemRC666-701ENBMC Cardiovascular Disorders, Vol 21, Iss 1, Pp 1-8 (2021)
institution DOAJ
collection DOAJ
language EN
topic Real-world population
Percutaneous coronary interventions
Polymer-free drug-eluting stent
Target lesion failure
Diseases of the circulatory (Cardiovascular) system
RC666-701
spellingShingle Real-world population
Percutaneous coronary interventions
Polymer-free drug-eluting stent
Target lesion failure
Diseases of the circulatory (Cardiovascular) system
RC666-701
Yi Dai
Rutao Wang
Fengying Chen
Yaojun Zhang
Yi Liu
He Huang
Ping Yang
Ruining Zhang
Bo Zheng
Chao Gao
Yundai Chen
Ling Tao
Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry
description Abstract Objectives To evaluate the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry. Background The long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolimus-eluting Nano plus stent (Lepu Medical, Beijing, China) is limited. Methods The NANO all-comers Registry trial was a prospective, multicenter clinical registry conducted in 26 centers in China between August 2016 and January 2017. A total of 2481 consecutive patients were exclusively treated with the Nano plus stent. The primary clinical endpoint, target lesion failure (TLF, defined as cardiac death, target vessel nonfatal myocardial infarction, and clinically driven target lesion revascularization [CD-TLR]), was analyzed at 3 years. Results At 3 years, 2295 patients (92.5%) were followed. The incidence of TLF was 6.8% (168/2481). The rate of cardiac death was 3.8% (94/2481), target vessel nonfatal myocardial infarction 0.7% (18/2481), and CD-TLR 2.9% (68/2481). The rate of definite/probable stent thrombosis was 0.5% (13/2481). The risk factors of diabetes mellitus, acute myocardial infarction, age, chronic renal failure, in-stent restenosis, chronic total occlusion, and left ventricular ejection fraction < 40% were the independent predictors of 3-year TLF. Conclusions At three years, the rate of TLF was relatively low in patients treated with the polymer-free Nano plus stent. The polymer-free Nano plus stent showed a favorable safety and efficacy profile in real-world patients. Clinical trial registration URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02929030.
format article
author Yi Dai
Rutao Wang
Fengying Chen
Yaojun Zhang
Yi Liu
He Huang
Ping Yang
Ruining Zhang
Bo Zheng
Chao Gao
Yundai Chen
Ling Tao
author_facet Yi Dai
Rutao Wang
Fengying Chen
Yaojun Zhang
Yi Liu
He Huang
Ping Yang
Ruining Zhang
Bo Zheng
Chao Gao
Yundai Chen
Ling Tao
author_sort Yi Dai
title Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry
title_short Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry
title_full Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry
title_fullStr Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry
title_full_unstemmed Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry
title_sort clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the nano multicenter registry
publisher BMC
publishDate 2021
url https://doaj.org/article/7b084df3d73e4d87beadc2a068682945
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