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.

Abstract

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.

TRIAL REGISTRATION NUMBER:

NCT02284750; Pre-results.

• 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
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 3 Pg. e020019 (03 06 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 29511018 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Topics

• Aged
• Angioplasty, Balloon, Coronary (methods)
• Coronary Artery Disease (pathology, surgery)
• Coronary Stenosis (therapy)
• Coronary Vessels (pathology, surgery)
• Drug-Eluting Stents
• Female
• Humans
• Male
• Middle Aged
• Myocardial Infarction (etiology, prevention & control)
• Percutaneous Coronary Intervention (methods)
• Prospective Studies
• Prosthesis Design
• Research Design
• Stents
• Treatment Outcome