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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 from the FIREMAN registry

LI Yan SHEN Wen-kuang JIANG Hong CONG Hong-liang PU Xiao-qun QIN Yong-wen JIN Hui-gen CAO Yu HUANG He LI Cheng-xiang WANG Hai-chang XU Bo FANG Wei-yi GE Jun-bo WANG Wei-min QIAO Shu-bin CHEN Jack-P

中华医学杂志（英文版）2011，Vol.124Issue(6)：817-824,8.

中华医学杂志（英文版）2011，Vol.124Issue(6)：817-824,8.DOI:10.3760/cma.j.issn.0366-6999.2011.06.004

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 from the FIREMAN registry

LI Yan ¹SHEN Wen-kuang ²JIANG Hong ³CONG Hong-liang ⁴PU Xiao-qun ⁵QIN Yong-wen ⁶JIN Hui-gen ⁷CAO Yu ⁸HUANG He ⁹LI Cheng-xiang ¹WANG Hai-chang ¹XU Bo ¹⁰FANG Wei-yi ¹¹GE Jun-bo ¹²WANG Wei-min ¹³QIAO Shu-bin ¹⁰CHEN Jack-P¹⁴

作者信息

1. Department of Cardiology, Xijing Hospital Affiliated to Fourth Military Medical University, Xi'an, Shaanxi 710032, China
2. Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
3. Department of Cardiology, People's Hopsital Affiliated to Wuhan University, Wuhan, Hubei 430060, China
4. Department of Cardiology, Tianjin Chest Hospital, Tianjin 300051,China
5. Department of Cardiology, Xiangya First Affiliated Hospital,Central South University, Changsha, Hunan 410008, China
6. Department of Cardiology, Changhai Hospital Affiliated to Second Military Medical University, Shanghai 200433, China
7. Putuo Districit Central Hospital, Shanghai 200060, China
8. Department of Cardiology, Xiangya Third Affiliated Hospital,Central South Universtiy, Changha, Hunan 410008, China
9. Xiangtan Central Hospital, Xiangtan, Hunan 411100, China
10. Department of Cardiology, FuWai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
11. Department of Cardiology, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China
12. Department of Cardiology, Shanghai Zhongshan Hospital Affiliated to Shanghai Fudan University School of Medicine,Shanghai 200032, China
13. Department of Cardiology, Peking University People's Hospital,Beijing 100044, China
14. Saint Joseph's Heart and Vascular Institute and Northside Hospital,Atlanta, GA, USA
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摘要

Abstract

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)

关键词

coronary artery disease/sirolimus-eluting stent/off-label use/clinical outcomes

Key words

coronary artery disease/sirolimus-eluting stent/off-label use/clinical outcomes

引用本文复制引用

LI Yan,SHEN Wen-kuang,JIANG Hong,CONG Hong-liang,PU Xiao-qun,QIN Yong-wen,JIN Hui-gen,CAO Yu,HUANG He,LI Cheng-xiang,WANG Hai-chang,XU Bo,FANG Wei-yi,GE Jun-bo,WANG Wei-min,QIAO Shu-bin,CHEN Jack-P..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 from the FIREMAN registry[J].中华医学杂志（英文版）,2011,124(6):817-824,8.

基金项目

This study was partly supported by grants from National Natural Science Foundation of China (No.30670861,No.30871055 and No.81070171),Beijing Natural Science Foundation (No.7082081),and Specilized Research Fund for the Doctoral Program of High Education of China (No.20070023047). （No.30670861,No.30871055 and No.81070171）

中华医学杂志（英文版）

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ISSN：0366-6999

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