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 Yaojun Chen Fang Takashi Muramatsu Xu Bo Li Zhanquan Ge Junbo He Qing Yang Zhijian Li Shumei Wang Lefeng Wang Haichang He Ben Li Kang Qi Guoxian Li Tianchang Zeng Hesong Peng Jianjun Jiang Tieming Zeng Qiutang Zhu Jianhua Fu Guosheng Christos V. Bourantas Patrick W. Serruys Huo Yong 

机构地区：[1]Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China [2]Thoraxcenter, Erasmus Medical Center, Rotterdam, 3015CE, The Netherlands [3]Department of Cardiology, Beijing Fuwai Hospital, Beijing 100037, China [4]Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, Liaoning 110016, China [5]Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China [6]Department of Cardiology, Beijing Hospital, Beijing 100730, China [7]Department of Cardiology, Jiangsu Provincial People's Hospital, Nanjing, Jiangsu 210029, China [8]Department of Cardiology, Second Affiliated Hospital of Jilin University Changchun, Jilin, Jilin 130041, China [9]Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China [10]Department of Cardiology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shanxi 710032, China [11]Department of Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China [12]Department of Cardiology, Beijing Xuanwu Hospital, Capital Medical University, Beijing 100053, China [13]Department of Cardiology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning 110001, China [14]Department of Cardiology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China [15]Department of Cardiology, Affiliated Tongji Hospital, Huazhong University of Science and Technology, Tongji School of Medicine, Wuhan, Hubei 430032, China [16]Department of Cardiology, Beijing Millennium Monument Hospital, Capital Medical University, Beijing 100038, China [17]Department of Cardiology, Tianjin Armed Policemen Hospital, Tianjin 300162, China [18]Department of Cardiology, Affiliated Union Medical Hospital of Huazhong University of Science and Technology, Tongji School of Medicine, Wuhan, Hubei 430022, China [19]Department of Cardiology, First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang 310003, China

出　　处：《Chinese Medical Journal》2014年第11期2153-2158,共6页中华医学杂志（英文版）

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.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.

关 键 词：Nano stent polymer-free sirolimus-eluting stent clinical outcomes late lumen loss 

分 类 号：TQ336.1[化学工程—橡胶工业] Q51[生物学—生物化学]