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.

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From: American Heart Journal(Vol. 234)
Publisher: Elsevier B.V.
Document Type: Article
Length: 782 words

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Abstract :

Background 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. Trial design 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. Conclusions 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. Author Affiliation: (a) Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (b) Division of Cardiology, Daqing Oilfield General Hospital, Daqing, China (c) Division of Cardiology, Guangdong Provincial People's Hospital, Guangzhou, China (d) Division of Cardiology, Harbin First Hospital, Harbin, China (e) Division of Cardiology, The 4th Affiliated Hospital of Harbin Medical University, Harbin, China (f) Division of Cardiology, China-Japan Friendship Hospital, Changchun, China (g) Division of Cardiology, Liaocheng People's Hospital, Liaocheng, China (h) Division of Cardiology, Mudanjiang Cardiovascular Hospital, Mudanjiang, China (i) Division of Cardiology, Beijing Huaxin Hospital, the First Hospital of Tsinghua University, Beijing, China (j) Division of Cardiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China (k) Division of Cardiology, Shanghai Fourth People's Hospital, Shanghai, China (l) Division of Cardiology, Beijing Anzhen Hospital, Capital Medical Hospital, Beijing, China (m) Division of Cardiology, Sichuan Province People's Hospital, Chengdu, China (n) Division of Cardiology, Tianjin 4th People's Hospital, Tianjin, China (o) Division of Cardiology, Tianjin Medical University General Hospital, Tianjin, China (p) Division of Cardiology, Wuhan Asia heart Hospital, Wuhan, China (q) Division of Cardiology, Shenzhen Hospital, The University of Hong Kong, Shenzhen, China (r) Division of Cardiology, XuZhou Central Hospital, Xuzhou, China (s) Division of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China (t) Division of Cardiology, Zhejiang Greentown Cardiovascular Hospital, Zhejiang, China (u) Division of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (v) Division of Cardiology, The 7th People's Hospital of Zhengzhou, Zhengzhou, China (w) Division of Cardiology, Fuwai Hospital Chinese Academy of Medical Science, Shenzhen, China (x) Division of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China (y) Division of Cardiology, The First Affiliated Hospital of Zhongshan University, Guangzhou, China (z) Division of Cardiology, Sun Yat-Sen Memorial Hospital, Zhongshan University, Guangzhou, China (aa) Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China * Reprint requests: Jun-Jie Zhang, MD, PhD; Shao-Liang Chen, MD, Nanjing First Hospital, Nanjing Medical University, No. 68 Changle Road, 210006 Nanjing, China. Article History: Received 22 September 2020; Accepted 15 January 2021 (footnote)# Drs Ge and Kan contributed equally to this work. Byline: Zhen Ge, MD (a,#), Jing Kan, MBBS (a,#), Xiao-Fei Gao, MD (a), Xiang-Quan Kong, MD, PhD (a), Guang-Feng Zuo, MD (a), Fei Ye, MD (a), Nai-Liang Tian, MD (a), Song Lin, MD (a), Zhi-Zhong Liu, MD (a), Zhi-Qi Sun, MD (b), Peng-Cheng He, MD (c), Lin Wei, MD (d), Wei Yang, MD (e), Yu-Quan He, MD (f), Yu-Zeng Xue, MD (g), Lian-Min Wang, MD (h), Li-Fu Miao, MD (i), Jun Pu, MD (j), Ya-Wu Sun, MD (k), Shao-Ping Nie, MD (l), Jian-Hong Tao, MD (m), Shang-Yu Wen, MD (n), Qing Yang, MD (o), Xi Su, MD (p), Qi-Cheng Yao, MD (q), Yi-Jie Huang, MD (r), Yong Xia, MD (s), Fa-Rong Shen, MD (t), Chun-Guang Qiu, MD (u), You-Lin Mao, MD (v), Qiang Liu, MD (w), Xin-Qun Hu, MD (x), Zhi-Min Du, MD (y), Ru-Qiong Nie, MD (z), Ya-Ling Han, MD (aa), Jun-Jie Zhang, MD, PhD (a,*), Shao-Liang Chen, MD [chmengx@126.com] (a,*)

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Gale Document Number: GALE|A654331867