Comparison of intravascular ultrasound-guided with angiography-guided double kissing crush stenting for patients with complex coronary bifurcation lesions: Rationale and design of a prospective, randomized, and multicenter DKCRUSH VIII trial

医学 血管内超声 临床终点 心肌梗塞 支架 随机对照试验 放射科 再狭窄 血运重建 多中心研究 多中心试验 血管造影 心脏病学 外科
作者
Zhen Ge,Jing Kan,Xiaofei Gao,Xiangquan Kong,Guang‐Feng Zuo,Fei Ye,Nai‐Liang Tian,Song Lin,Zhizhong Liu,Zhiqi Sun,Pengcheng He,Lin Wei,Wei Yang,Yuquan He,Yuzeng Xue,Lianmin Wang,Li-fu Miao,Jun Pu,Ya-Wu Sun,Shaoping Nie,Tao Jian-hong,Shangyu Wen,Qing Yang,Xi Su,Qi-Cheng Yao,Yudan Huang,Yong Xia,Farong Shen,Chunguang Qiu,Youlin Mao,Qiang Liu,Xinqun Hu,Zhimin Du,Ruqiong Nie,Yaling Han,Jun‐Jie Zhang,Shao‐Liang Chen
出处
期刊:American Heart Journal [Elsevier]
卷期号:234: 101-110 被引量:13
标识
DOI:10.1016/j.ahj.2021.01.011
摘要

Double kissing (DK) crush approach for patients with coronary bifurcation lesions, particularly localized at distal left main or lesions with increased complexity, is associated with significant reduction in clinical events when compared with provisional stenting. Recently, randomized clinical trial has demonstrated the net clinical benefits by intravascular ultrasound (IVUS)-guided implantation of drug-eluting stent in all-comers. However, the improvement in clinical outcome after DK crush treatment guided by IVUS over angiography guidance for patients with complex bifurcation lesions have never been studied in a randomized fashion. DKCRUSH VIII study is a prospective, multicenter, randomized controlled trial designed to assess superiority of IVUS-guided vs angiography-guided DK crush stenting in patients with complex bifurcation lesions according to DEFINITION criteria. A total of 556 patients with complex bifurcation lesions will be randomly (1:1 of ratio) assigned to IVUS-guided or angiography-guided DK crush stenting group. The primary end point is the rate of 12-month target vessel failure, including cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization. The secondary end points consist of the individual component of primary end point, all-cause death, myocardial infarction, and in-stent restenosis. The safety end point is the incidence of definite or probable stent thrombosis. An angiographic follow-up will be performed for all patients at 13 months and clinical follow-up will be continued annually until 3 years after the index procedure. DKCRUSH VIII trial is the first study designed to evaluate the differences in efficacy and safety between IVUS-guided and angiography-guided DK crush stenting in patients with complex true bifurcation lesions. This study will also provide IVUS-derived criteria to define optimal DK crush stenting for bifurcation lesions at higher complexity.
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