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学科主题: 临床医学
题名:
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
作者: 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
发表日期: 2012-11-01
DOI: 10.4244/EIJV8I7A122
卷: 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
项目资助者: Medfavour Medical (Beijing, China) ; Medfavour Medical
WOS记录号: WOS:000313918700007
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54788
Appears in Collections:北京大学第一临床医学院_期刊论文

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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

Recommended Citation:
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.
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