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学科主题: 临床医学
题名:
Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial
作者: Zhang Yaojun1,2; Chen Fang3; Muramatsu, Takashi2; Xu Bo4; Li Zhanquan5; Ge Junbo6; He Qing7; Yang Zhijian8; Li Shumei9; Wang Lefeng10; Wang Haichang11; He Ben12; Li Kang13; Qi Guoxian14; Li Tianchang15; Zeng Hesong16; Peng Jianjun17; Jiang Tieming18; Zeng Qiutang19; Zhu Jianhua20; Fu Guosheng21; Bourantas, Christos V.2; Serruys, Patrick W.2; Huo Yong22
关键词: Nano stent ; polymer-free ; sirolimus-eluting stent ; clinical outcomes ; late lumen loss
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2014-06-05
DOI: 10.3760/cma.j.issn.0366-6999.20133148
卷: 127, 期:11, 页:2153-2158
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: IN-VIVO ASSESSMENT ; DRUG ; METAANALYSIS ; THROMBOSIS ; OUTCOMES ; COVERAGE ; SAFETY ; DES
英文摘要:

Background First generation drug-eluting stents (DES) were associated with a high incidence of late stent thrombosis (ST), mainly due to delayed healing and re-endothelization by the durable polymer coating. This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent (SES) in the treatment of patients with de novo coronary artery lesions.

Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES (Lepu Medical Technology, Beijing, China) in the treatment of patients with de novo native coronary lesions. The primary endpoint was in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction or target lesion revascularization.

Results A total of 291 patients (Nano group: n=143, Partner group: n=148) were enrolled in this trial from 19 Chinese centers. The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months (P <0.001). The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES (0.34 +/- 0.42) mm vs. (0.30 +/- 0.48) mm, P=0.21). The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% (P=0.75) at 2 years follow-up. The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES (0.8% vs. 0.7%, 0.8% vs. 1.5%, both P=1.00).

Conclusions In this multicenter randomized Nano trial, the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions. Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.

语种: 英语
项目资助者: Lepu Medical Technology, Beijing, China
WOS记录号: WOS:000339034300030
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/61463
Appears in Collections:北京大学第一临床医学院_心血管内科_期刊论文

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作者单位: 1.Erasmus MC, Thoraxctr, NL-3015 CE Rotterdam, Netherlands
2.Beijing Hosp, Dept Cardiol, Beijing 100730, Peoples R China
3.Nanjing Med Univ, Nanjing Hosp 1, Dept Cardiol, Nanjing 210006, Jiangsu, Peoples R China
4.Capital Med Univ, Beijing Anzhen Hosp, Dept Cardiol, Beijing 100029, Peoples R China
5.Beijing Fuwai Hosp, Dept Cardiol, Beijing 100037, Peoples R China
6.Liaoning Prov Peoples Hosp, Dept Cardiol, Shenyang 110016, Liaoning, Peoples R China
7.Fudan Univ, Zhongshan Hosp, Dept Cardiol, Shanghai 200032, Peoples R China
8.Jiangsu Prov Peoples Hosp, Dept Cardiol, Nanjing 210029, Jiangsu, Peoples R China
9.Jilin Univ Changchun, Affiliated Hosp 2, Dept Cardiol, Jilin 130041, Jilin, Peoples R China
10.Capital Med Univ, Beijing Chaoyang Hosp, Dept Cardiol, Beijing 100020, Peoples R China
11.Fourth Mil Med Univ, Xijing Hosp, Dept Cardiol, Xian 710032, Shanxi, Peoples R China
12.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Cardiol, Shanghai 200127, Peoples R China
13.Capital Med Univ, Beijing Xuanwu Hosp, Dept Cardiol, Beijing 100053, Peoples R China
14.China Med Univ, Affiliated Hosp 1, Dept Cardiol, Shenyang 110001, Liaoning, Peoples R China
15.Capital Med Univ, Beijing Tongren Hosp, Dept Cardiol, Beijing 100730, Peoples R China
16.Huazhong Univ Sci & Technol, Tongji Sch Med, Affiliated Tongji Hosp, Dept Cardiol, Wuhan 430032, Hubei, Peoples R China
17.Capital Med Univ, Beijing Millennium Monument Hosp, Dept Cardiol, Beijing 100038, Peoples R China
18.Tianjin Armed Policemen Hosp, Dept Cardiol, Tianjin 300162, Peoples R China
19.Huazhong Univ Sci & Technol, Tongji Sch Med, Affiliated Union Med Hosp, Dept Cardiol, Wuhan 430022, Hubei, Peoples R China
20.Zhejiang Univ, Affiliated Hosp 1, Dept Cardiol, Hangzhou 310003, Zhejiang, Peoples R China
21.Zhejiang Univ, Sch Med, Sir Run Run Shaw Hosp, Dept Cardiol, Hangzhou 310016, Zhejiang, Peoples R China
22.Peking Univ, Hosp 1, Dept Cardiol, Beijing 100034, Peoples R China

Recommended Citation:
Zhang Yaojun,Chen Fang,Muramatsu, Takashi,et al. Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial[J]. CHINESE MEDICAL JOURNAL,2014,127(11):2153-2158.
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