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Title: 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
Authors: Jun Jie Zhang
Xiao Fei Gao
Ya Ling Han
Jing Kan
Ling Tao
Zhen Ge
Damras Tresukosol
Shu Lu
Li Kun Ma
Feng Li
Song Yang
Jun Zhang
Muhammad Munawar
Li Li
Rui Yan Zhang
He Song Zeng
Teguh Santoso
Ping Xie
Ze Ning Jin
Leng Han
Wei Hsian Yin
Xue Song Qian
Qi Hua Li
Lang Hong
Chotnoparatpat Paiboon
Yan Wang
Li Jun Liu
Lei Zhou
Xue Ming Wu
Shang Yu Wen
Qing Hua Lu
Jun Qiang Yuan
Liang Long Chen
Francesco Lavarra
Alfredo E. Rodríguez
Li Min Zhou
Shi Qin Ding
Kitigon Vichairuangthum
Yuan Sheng Zhu
Meng Yue Yu
Chan Chen
Imad Sheiban
Yong Xia
Yu Long Tian
Zheng Lu Shang
Qing Jiang
Yong Hong Zhen
Xin Wang
Fei Ye
Nai Liang Tian
Song Lin
Zhi Zhong Liu
Shao Liang Chen
Cheng Hsin General Hospital
Gansu Province People's Hospital
Shenyang General Hospital of PLA
Xinhua Hospital
Anhui Provincial Hospital
Guangzhou Red Cross Hospital
Beijing Anzhen Hospital
Xijing Hospital
Universitas Indonesia
Shandong University
Fuwai Hospital
Huazhong University of Science and Technology
Ruijin Hospital
Bangkok Hospital Medical Center
XuZhou Medical University
Guangdong Medical University
Nanjing Medical University
Università degli Studi di Torino
Faculty of Medicine, Siriraj Hospital, Mahidol University
Sanatorio Otamendi y Miroli
Bangplee Hospital
Huainan Eastern Hospital
Wuxi Huishan District People's Hospital
Anqing First People's Hospital
Chuzhou First People's Hospital
Cangzhou Central Hospital
Yixin People's Hospital
Zhangjiagang First People's Hospital
Jilin Heart Hospital
Xuyi People's Hospital
Huai'an Second People's Hospital
Binawaluya Cardiac Center
Xia'Men Zhongshan Hospital
Fujian Union Hospital
Wuxi Third People's Hospital
General Hospital of Daqing Oil Field
Taicang People's Hospital
Nanjing Heart Center
Huainan First People's Hospital
Jintan People's Hospital
Lianyungang Hospital of Traditional Chinese Medicine
Liyang Hospital of Traditional Chinese Medicine
Jiangxi Provincial People's Hospital
Changshu First People's Hospital
Changzhou Hospital of Traditional Chinese Medicine
Xinyang Central Hospital
Keywords: Medicine
Issue Date: 1-Mar-2018
Citation: BMJ Open. Vol.8, No.3 (2018)
Abstract: © 2018 Article author(s) (or their employer(s) unless otherwise stated in the text of the article). All rights reserved. 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 informed consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences.
ISSN: 20446055
Appears in Collections:Scopus 2018

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