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学科主题: 临床医学
题名:
Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes froth the FIREMAN registry
作者: Li Yan1; Li Cheng-xiang1; Wang Hai-chang1; Xu Bo2,3; Fang Wei-yi4; Ge Jun-bo5; Wang Wei-min6; Qiao Shu-bin2,3; Chen, Jack-P7,8; Shen Wen-kuang9; Jiang Hong10; Cong Hong-liang11; Pu Xiao-qun12; Qin Yong-wen13; Jin Hui-gen14; Cao Yu15; Huang He16; FIREMAN Investigators
关键词: coronary artery disease ; sirolimus-eluting sent ; off-label use ; clinical outcomes
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2011-03-20
DOI: 10.3760/cma.j.issn.0366-6999.2011.06.004
卷: 124, 期:6, 页:817-824
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]: BARE-METAL STENTS ; OFF-LABEL USE ; ARTERY-DISEASE ; THROMBOSIS ; INTERVENTION ; IMPLANTATION ; TRIALS
英文摘要:

Background Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary,objective of the FIREMAN registry was,to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.

Methods The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.

Results Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11(1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21 +/- 0.40) mm in-segment and (0.23 +/- 0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.

Conclusions The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656) Chin Med J 2011;124(6):817-824

语种: 英语
WOS记录号: WOS:000289040900004
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63356
Appears in Collections:北京大学第二临床医学院_心血管内科_期刊论文

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作者单位: 1.St Josephs Heart & Vasc Inst, Atlanta, GA USA
2.Northside Hosp, Atlanta, GA USA
3.Fourth Mil Med Univ, Dept Cardiol, Xijing Hosp, Xian 710032, Shaanxi, Peoples R China
4.Chinese Acad Med Sci, Dept Cardiol, FuWai Hosp, Beijing 100037, Peoples R China
5.Peking Union Med Coll, Beijing 100037, Peoples R China
6.Shanghai Jiao Tong Univ, Sch Med, Dept Cardiol, Shanghai Chest Hosp, Shanghai 200030, Peoples R China
7.Shanghai Fudan Univ, Sch Med, Dept Cardiol, Shanghai Zhongshan Hosp, Shanghai 200032, Peoples R China
8.Peking Univ, Peoples Hosp, Dept Cardiol, Beijing 100044, Peoples R China
9.Mayo Clin, Rochester, MN 55905 USA
10.Wuhan Univ, Dept Cardiol, Peoples Hopsital, Wuhan 430060, Hubei, Peoples R China
11.Tianjin Chest Hosp, Dept Cardiol, Tianjin 300051, Peoples R China
12.Cent S Univ, Dept Cardiol, Xiangya Affiliated Hosp 1, Changsha 410008, Hunan, Peoples R China
13.Second Mil Med Univ, Changhai Hosp, Dept Cardiol, Shanghai 200433, Peoples R China
14.Putuo Dist Cent Hosp, Shanghai 200060, Peoples R China
15.Cent S Univ, Xiangya Affiliated Hosp 3, Dept Cardiology, Changha 410008, Hunan, Peoples R China
16.Xiangtan Cent Hosp, Xiangtan 411100, Hunan, Peoples R China

Recommended Citation:
Li Yan,Li Cheng-xiang,Wang Hai-chang,et al. Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes froth the FIREMAN registry[J]. CHINESE MEDICAL JOURNAL,2011,124(6):817-824.
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