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Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial

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机构: [1]Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China [2]Department of Cardiology, The General Hospital of Shenyang Military, Shenyang, China [3]Department of Cardiology, Nanjing Heart Center, Nanjing, China [4]Department of Cardiology, Xijing Hospital, 4th Military Medical University, Xi'an, China [5]Department of Cardiology, Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand [6]Department of Cardiology, Taicang People’s Hospital, Taicang, China [7]Department of Cardiology, Anhui Provincial Hospital, Hefei, Anhui, China [8]Department of Cardiology, Huainan Eastern Hospital, Huainan, China [9]Department of Cardiology, Yixin People’s Hospital, Yixing, China [10]Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China [11]Department of Cardiology, Binawaluya Cardiac Center, Jakarta, Indonesia [12]Department of Cardiology, Guangzhou Red Cross Hospital, Guangzhou, Guangdong, China [13]Department of Cardiology, Shanghai Ruijin Hospital, Shanghai, China [14]Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [15]Department of Cardiology, Medistra Hospital, University of Indonesia, Jakarta, Indonesia [16]Department of Cardiology, Gansu Provincial Hospital, Lanzhou, China [17]Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China [18]Department of Cardiology, Changshu First People’s Hospital, Changshu, China [19]Department of Cardiology, Cheng-Hsin General Hospital, Taipei, China [20]Department of Cardiology, Zhangjiagang First People’s Hospital, Zhangjiagang, China [21]Department of Cardiology, Changzhou Hospital of Traditional Chinese Medicine, Changzhou, China [22]Department of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China [23]Department of Cardiology, Bangkok General Hospital, Bangkok, Thailand [24]Department of Cardiology, Xia’Men Zhongshan Hospital, Xia'men, China [25]Department of Cardiology, Huainan First People’s Hospital, Huainan, China [26]Department of Cardiology, Jintan People’s Hospital, Jintan, China [27]Department of Cardiology, Wuxi Third People's Hospital, Wuxi, China [28]Department of Cardiology, Daqing Oil General Hospital, Daqing, China [29]Department of Cardiology, The Second Hospital of Shandong University, Ji’nan, China [30]Department of Cardiology, Xinyang Central Hospital, Xinyang, Henan, China [31]Department of Cardiology, Fujian Union Hospital, Fuzhou, China [32]Department of Cardiology, Jilin Heart Hospital, Changchun, China [33]Department of Cardiology, Otamendi Hospital, Buenos Aires, Argentina [34]Department of Cardiology, Chuzhou First People's Hospital, Chuzhou, China [35]Department of Cardiology, Huainan Xinhua Hospital, Huainan, China [36]Department of Cardiology, Bangplee Hospital, Bangkok, Thailand [37]Department of Cardiology, Huai’an Second People’s Hospital, Huai’an, China [38]Department of Cardiology, Qingdao Fuwai Hospital, Qingdao, China [39]Department of Cardiology, The Affiliated Hospital of Guangdong Medical University, Guangzhou, China [40]Department of Cardiology, University of Turin, Turin, Italy [41]Department of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China [42]Department of Cardiology, Xuyi People’s Hospital, Xuyi, China [43]Department of Cardiology, Wuxi Huishan District People’s Hospital, Wuxi, China [44]Department of Cardiology, Anqing First People’s Hospital, Anqing, China [45]Department of Cardiology, Liyang Hospital of Traditional Chinese Medicine, Liyang, China [46]Department of Cardiology, Lianyungang Hospital of Traditional Chinese Medicine, Lianyungang, China
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关键词: coronary bifurcation lesions provisional stenting technique systematic two-stent techniques

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Introduction Provisional stenting (PS) for simple coronary bifurcation lesions is the mainstay of treatment. A systematic two-stent approach is widely used for complex bifurcation lesions (CBLs). However, a randomised comparison of PS and two-stent techniques for CBLs has never been studied. Accordingly, the present study is designed to elucidate the benefits of two-stent treatment over PS in patients with CBLs. Methods and analysis This DEFINITION II study is a prospective, multinational, randomised, endpoint-driven trial to compare the benefits of the two-stent technique with PS for CBLs. A total of 660 patients with CBLs will be randomised in a 1:1 fashion to receive either PS or the two-stent technique. The primary endpoint is the rate of 12-month target lesion failure defined as the composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularisation. The major secondary endpoints include all causes of death, MI, target vessel revascularisation, in-stent restenosis, stroke and each individual component of the primary endpoints. The safety endpoint is the occurrence of definite or probable stent thrombosis. Ethics and dissemination The study protocol and informed consent have been approved by the Institutional Review Board of Nanjing First Hospital, and accepted by each participating centre. Written intotnied consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences.

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出版当年[2017]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
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第一作者机构: [1]Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China
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通讯机构: [1]Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China [3]Department of Cardiology, Nanjing Heart Center, Nanjing, China
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