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Downloaded from Rationale and design for the treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions (DEFI ITIO ⅡⅡⅡ Trial) ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-020019 Article Type: Protocol Date ubmitted by the Author: 10-Oct-2017 Complete List of Authors: 'hang, Junjie* Nanjing ,irst -ospital, Department of Cardiology .ao, /iaofei* Nanjing ,irst -ospital, Department of Cardiology -an, 0L* The .eneral -ospital of henyang Military, Department of Cardiology 1an, Jing* Nanjing -eart Center, Department of Cardiology Tao, Ling* /ijing -ospital, 2th Military Medical 3niversity, Department of Cardiology .e, 'hen* Nanjing ,irst -ospital, Department of Cardiology Tresu5osol, Damras* Medicine iriraj -ospital, Mahidol 3niversity, cardiology http://bmjopen.bmj.com/ Lu, hu* Taicang People‘s -ospital, Department of Cardiology Ma, Li5un* Anhui Provincial -ospital, Department of Cardiology Li, ,eng* -uainan Eastern -ospital, Department of Cardiology 0ang, ong* 0i8in People‘s -ospital, Department of Cardiology 'hang, Jun* Cang9hou Central -ospital, Department of Cardiology Munawar, Muhammad* Binawaluya Cardiac Center, Department of Cardiology Li, Li* .uang9hou Red Cross -ospital, Department of Cardiology 'hang, Ruiyan* hanghai Ruijin -ospital, Department of Cardiology on October 1, 2021 by guest. 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'eng, -esong* Tongji -ospital, Tongji Medical College, -ua9hong 3niversity of cience and Technology, Department of Cardiology antoso, Teguh* Medistra -ospital, 3niversity of Indonesia, cardiology /ie, Ping* .ansu Provincial -ospital, Department of Cardiology Jin, 'ening* Beijing An9hen -ospital, Department of Cardiology -an, Leng* Changshu ,irst People‘s -ospital, Department of Cardiology 0in, Wei--sian* Cheng--sin .eneral -ospital, cardiology Qian, /uesong* 'hangjiagang ,irst People‘s -ospital, Department of Cardiology Li, Qihua* Chang9hou -ospital of Traditional Chinese Medicine, Department of Cardiology -ong, Lang* Jiang8i Provincial People's -ospital, Department of Cardiology Paiboon, Chotnoparatpat* Bang5ok .eneral -ospital, cardiology Wang, 0an* /ia6Men 'hongshan -ospital, cardiology Liu, Lijun* -uainan ,irst People‘s -ospital, Department of Cardiology 'hou, Lei* Jintan People‘s -ospital, cardiology Wu, /ueming* Wu8i Third People 's -ospital, cardiology Wen, hangyu* Daqing Oil .eneral -ospital, cardiology Lu, Qinghua* The econd -ospital of handong 3niversity, cardiology 0uan, Junqiang* /inyang Central -ospital, cardiology For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 24 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020019 on 6 March 2018. Downloaded from 1 2 3 4 Chen, Lianglong* ,ujian 3nion -ospital, cardiology Lavarra, ,rancesco; Jilin -eart -ospital, cardiology 5 RodrAgue9, Alfredo E. * Otamendi -ospital, cardiology 6 'hou, Limin* Chu9hou ,irst People 's -ospital, cardiology 7 Ding, hiqin* -uainan /inhua -ospital, cardiology 8 Cichairuangthum, 1itigon* Bangplee -ospital, cardiology 9 'hu, 0uansheng* -uai‘an econd People‘s -ospital, cardiology 10 0u, Mengyue* Qingdao ,uwai -ospital, cardiology Chen, Chan* The Affiliated -ospital of .uangdong Medical 3niversity, 11 cardiology 12 heiban, Imad* Peder9oli -ospital, cardiology 13 /ia, 0ong* The Affiliated -ospital of /u9hou Medical 3niversity, cardiology 14 Tian, 0ulong* /uyi People‘s -ospital, cardiology 15 hang, 'henglu * Wu8i -uishan District People‘s -ospital, cardiology 16 Jiang, Qing* Anqing ,irst People‘s -ospital, cardiology For peer'hen, 0onghong* review Liyang -ospital ofonly Traditional Chinese Medicine, 17 cardiology 18 Wang, /in* Lianyungang -ospital of Traditional Chinese Medicine, 19 cardiology 20 0e, ,ei* Nanjing ,irst -ospital, Department of Cardiology 21 Tian, Nailiang* Nanjing ,irst -ospital, Department of Cardiology 22 Lin, ong* Nanjing ,irst -ospital, Department of Cardiology Liu, 'hi9hong* Nanjing ,irst -ospital, Department of Cardiology 23 Chen, hao-Liang* Nanjing ,irst -ospital, Nanjing Medical 3niversity, 24 Department of Cardiology 25 coronary bifurcation lesions, systematic two-stent techniques, provisional 26 1eywords: 27 stenting technique 28 29 30 31 http://bmjopen.bmj.com/ 32 33 34 35 36 37 38 39 on October 1, 2021 by guest. Protected copyright. 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 24 BMJ Open: first published as 10.1136/bmjopen-2017-020019 on 6 March 2018. Downloaded from 1 2 3 Rationale and design for the treatment effects of systematic two-stent and provisional 4 stenting techniques in patients with complex coronary bifurcation lesions 5 6 (DEFINITION ⅡⅡⅡ Trial) 7 8 Jun-Jie Zhang,1 Xiao-Fei Gao,1 Ya-Ling Han,2 Jing Kan,3 Ling Tao,4 Zhen Ge,1 Damras 9 Tresukosol,5 Shu Lu,6 Li-Kun Ma,7 Feng Li,8 Song Yang,9 Jun Zhang,10 Muhammad Munawar,11 10 12 13 14 15 16 17 11 Li Li, Rui-Yan Zhang, He-Song Zeng, Teguh Santoso, Ping Xie, Ze-Ning Jin, Leng 12 Han,18 Wei-Hsian Yin,19 Xue-Song Qian,20 Qi-Hua Li,21 Lang Hong,22 Chotnoparatpat 13 Paiboon,23 Yan Wang,24 Li-Jun Liu,25 Lei Zhou,26 Xue-Ming Wu,27 Shang-Yu Wen,28 Qing-Hua 14 Lu,29 Jun-Qiang Yuan,30 Liang-Long Chen,31 Francesco Lavarra,32 Alfredo E. Rodríguez,33 15 16 Li-Min Zhou,34 Shi-QinFor Ding, peer35 Kitigon Vichairuangthum, review36 Yuan-Shengonly Zhu,37 Meng-Yue Yu,38 17 Chan Chen,39 Imad Sheiban,40 Yong Xia,41 Yu-Long Tian,42 Zheng-Lu Shang,43 Qing Jiang,44 18 Yong-Hong Zhen,45 Xin Wang,46 Fei Ye,1 Nai-Liang Tian,1 Song Lin,1 Zhi-Zhong Liu,1 19 1,3 20 Shao-Liang Chen, * 21 22 Zhang JJ and Gao XF contributed equally to this work. 23 24 25 *Correspondence author: Department of cardiology, Nanjing First Hospital, Nanjing 26 27 Medical University; No. 68 Changle road, 210006 Nanjing, China; Tel & Fax: 28 29 +86-25-52208048; E-mail: [email protected]. 30 31 http://bmjopen.bmj.com/ 32 33 34 35 36 37 38 39 on October 1, 2021 by guest. Protected copyright. 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 1 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 24 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020019 on 6 March 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction: Provisional stenting (PS) for simple coronary bifurcation lesions is the 6 7 mainstay of treatment. Systematic two-stent approach is widely used for complex 8 9 bifurcation lesions (CBLs). However, randomized comparison of PS and two-stent 10 11 techniques for CBLs has never been studied. Accordingly, the present study is designed to 12 13 elucidate the benefits of two-stent treatment over PS in patients with CBLs. 14 15 Methods and analysis: The DEFINITION Ⅱ study is a prospective, multinational, 16 For peer review only 17 randomized, endpoint-driven trial to compare the benefits of two-stent technique with PS 18 19 for CBLs. A total of 660 patients with CBLs will be randomized in a 1:1 fashion to receive 20 21 either PS or two-stent technique. The primary endpoint is the rate of 12-month target lesion 22 23 failure (TLF) defined as the composite of cardiac death, target vessel myocardial infarction 24 25 (MI), and target lesion revascularization (TLR). The major secondary endpoints include all 26 27 cause death, MI, target vessel revascularization (TVR), in-stent restenosis, stroke, and each 28 29 individual component of the primary endpoint. The safety endpoint is the occurrence of 30 31 definite or probable stent thrombosis (ST). http://bmjopen.bmj.com/ 32 33 Ethics and dissemination: The study protocol and informed consent have been reviewed 34 35 and approved by the Institutional Review Board at each participating center. The written 36 37 informed consent was obtained from all enrolled patients. Findings of the study will be 38 published in a peer-reviewed journal, and disseminated at conferences. 39 on October 1, 2021 by guest. Protected copyright. 40 Trial registration number: NCT02284750; Pre-results. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 2 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 24 BMJ Open: first published as 10.1136/bmjopen-2017-020019 on 6 March 2018. Downloaded from 1 2 3 Strengths and limitations of this study 4 This is the first prospective, multinational, randomized, endpoint-driven trial to 5 6 compare the systematic two-stent and provisional stenting (PS) techniques in patients 7 with complex coronary bifurcation lesions (CBLs).