Publication:
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

Issued Date

2018-03-01

Resource Type

Article

ISSN

20446055

DOI

10.1136/bmjopen-2017-020019

Other identifier(s)

2-s2.0-85044235775

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

BMJ Open. Vol.8, No.3 (2018)

Suggested Citation

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 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. BMJ Open. Vol.8, No.3 (2018). doi:10.1136/bmjopen-2017-020019 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/46934

Research Projects

Organizational Units

Authors

Journal Issue

Thesis

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

Author(s)

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

Other Contributor(s)

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

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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/46934

Collections

Scopus 2018