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Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial
Xu, Bo1; Dou, Kefei1; Yang, Yuejin1; Lv, Shuzheng2; Wang, Lefeng3; Wang, Haichang4; Li, Zhanquan5; Wang, Lei6; Chen, Yundai7; Huo, Yong8; Li, Wei1; Kirtane, Ajay J.9; Gao, Runlin1
关键词Biodegradable Polymer In-stent Late Lumen Loss Noya Stent Safety
刊名EUROINTERVENTION
2012-11-01
DOI10.4244/EIJV8I7A122
8期:7页:796-802
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Cardiac & Cardiovascular Systems
研究领域[WOS]Cardiovascular System & Cardiology
关键词[WOS]SINGLE-CENTER REGISTRY ; 1ST HUMAN-EXPERIENCE ; SUCCESSFUL IMPLANTATION ; DIABETIC-PATIENTS ; FIREBIRD ; MASSACHUSETTS ; THROMBOSIS ; OUTCOMES ; DISEASE ; 6-MONTH
英文摘要

Aims: This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions.

Methods and results: The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2 (TM) stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11 +/- 0.18 mm vs. 0.14 +/- 0.23 mm, p=0.16; non-inferiority p < 0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p > 0.05, respectively).

Conclusions: The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355)

语种英语
WOS记录号WOS:000313918700007
资助机构Medfavour Medical (Beijing, China) ; Medfavour Medical
引用统计
被引频次:16[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/54788
专题北京大学第一临床医学院
作者单位1.Columbia Univ, Med Ctr, New York, NY USA
2.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
3.Liaoning Prov Peoples Hosp, Shenyang, Peoples R China
4.Chinese PLA Med Univ, Beijing, Peoples R China
5.Fuwai Hosp, Natl Ctr Cardiovasc Dis China, Beijing, Peoples R China
6.Capital Med Univ, Affiliated Anzhen Hosp, Beijing, Peoples R China
7.Capital Med Univ, Affiliated Chaoyang Hosp, Beijing, Peoples R China
8.Fourth Mil Med Univ, Affiliated Xijing Hosp, Xian 710032, Peoples R China
9.Capital Med Univ, Affiliated Friendship Hosp, Beijing, Peoples R China
推荐引用方式
GB/T 7714
Xu, Bo,Dou, Kefei,Yang, Yuejin,et al. Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial[J]. EUROINTERVENTION,2012,8(7):796-802.
APA Xu, Bo.,Dou, Kefei.,Yang, Yuejin.,Lv, Shuzheng.,Wang, Lefeng.,...&Gao, Runlin.(2012).Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial.EUROINTERVENTION,8(7),796-802.
MLA Xu, Bo,et al."Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial".EUROINTERVENTION 8.7(2012):796-802.
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