Safety and efficacy of zotarolimus-eluting stents in the treatment of diabetic coronary lesions in Chinese patients: The RESOLUTE-DIABETES CHINA Study†佐他莫司药物洗脱支架治疗中国糖尿病人群冠状动脉病变的安全性和有效性研究: RESOLUTE-DIABETES CHINA研究
Zhengbin Zhu
Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
Department of Cardiology, Cardiovascular Research Institution, Shanghai Jiaotong University School of Medicine, Shanghai, China
Search for more papers by this authorYongjian Wu
Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China
Search for more papers by this authorZhujun Shen
Department of Cardiology, Peking Union Medical College Hospital, Beijing, China
Search for more papers by this authorYawei Xu
Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai, China
Search for more papers by this authorYigang Li
Department of Cardiology, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
Search for more papers by this authorYan Wang
Department of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Fuzhou, China
Search for more papers by this authorXi Su
Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
Search for more papers by this authorBao Li
Department of Cardiology, Shanxi Cardiovascular Hospital, Xian, China
Search for more papers by this authorTiemin Jiang
Department of Cardiology, The Affiliated Hospital of Armed Police Logistics College, Tianjin, China
Search for more papers by this authorJinfa Jiang
Department of Cardiology, Shanghai Tongji Hospital, Shanghai, China
Search for more papers by this authorLefeng Wang
Department of Cardiology, Beijing Chao-Yang Hospital, Beijing, China
Search for more papers by this authorShenghu He
Department of Cardiology, Northern Jiangsu People's Hospital, Yangzhou, China
Search for more papers by this authorXueqi Li
Department of Cardiology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China
Search for more papers by this authorHongwei Li
Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Search for more papers by this authorYin Liu
Department of Cardiology, Tianjin Chest Hospital, Tianjin, China
Search for more papers by this authorYujie Zhou
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Search for more papers by this authorQiang Tang
Department of Cardiology, Peking University Shougang Hospital, Beijing, China
Search for more papers by this authorYundai Chen
Department of Cardiology, Military General Hospital of Beijing PLA, Beijing, China
Search for more papers by this authorWeiyi Fang
Department of Cardiology, Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
Search for more papers by this authorLi Jiang
Department of Cardiology, Tong Ren Hospital, Shanghai Jiaotong University of Medicine, Shanghai, China
Search for more papers by this authorChengzhi Lu
Department of Cardiology, Tianjin First Center Hospital, Tianjin, China
Search for more papers by this authorJincheng Guo
Department of Cardiology, Beijing Luhe Hospital, Capital Medical University, Beijing, China
Search for more papers by this authorJianjun Zhang
Department of Cardiology, Shanghai Pudong New Area Gongli Hospital, Shanghai, China
Search for more papers by this authorShaoliang Chen
Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
Search for more papers by this authorYong Xia
Department of Cardiology, The Affiiliated Hospital of Xuzhou Medical University, Xuzhou, China
Search for more papers by this authorHongchao Zheng
Department of Cardiology, Shanghai Xuhui Central Hospital, Shanghai, China
Search for more papers by this authorBin Wang
Department of Cardiology, Aerospace Center Hospital, Beijing, China
Search for more papers by this authorDaifu Zhang
Department of Cardiology, Pudong New Area People's Hospital, Shanghai, China
Search for more papers by this authorLiuliu Feng
Department of Cardiology, Shidong Hospital of Shanghai Yangpu District, Shanghai, China
Search for more papers by this authorLijiang Tang
Department of Cardiology, Zhejiang Hospital, Hangzhou, China
Search for more papers by this authorPeng Xu
Department of Cardiology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, China
Search for more papers by this authorXuebo Liu
Department of Cardiology, Shanghai East Hospital Affiliated to Tong Ji University School of Medicine, Shanghai, China
Search for more papers by this authorCorresponding Author
Ruiyan Zhang
Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
Department of Cardiology, Cardiovascular Research Institution, Shanghai Jiaotong University School of Medicine, Shanghai, China
Correspondence
Ruiyan Zhang, Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, No. 197 Rui Jin Er Road, 3rd Floor, 12th Building, Shanghai 200025, China.
Tel: +86 21 6437 0045 extn 673328
Fax: +86 21 6445 7177
Email: [email protected]
Search for more papers by this authoron behalf of the RESOLUTE-DIABETES CHINA Investigators
Search for more papers by this authorZhengbin Zhu
Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
Department of Cardiology, Cardiovascular Research Institution, Shanghai Jiaotong University School of Medicine, Shanghai, China
Search for more papers by this authorYongjian Wu
Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China
Search for more papers by this authorZhujun Shen
Department of Cardiology, Peking Union Medical College Hospital, Beijing, China
Search for more papers by this authorYawei Xu
Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai, China
Search for more papers by this authorYigang Li
Department of Cardiology, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
Search for more papers by this authorYan Wang
Department of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Fuzhou, China
Search for more papers by this authorXi Su
Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
Search for more papers by this authorBao Li
Department of Cardiology, Shanxi Cardiovascular Hospital, Xian, China
Search for more papers by this authorTiemin Jiang
Department of Cardiology, The Affiliated Hospital of Armed Police Logistics College, Tianjin, China
Search for more papers by this authorJinfa Jiang
Department of Cardiology, Shanghai Tongji Hospital, Shanghai, China
Search for more papers by this authorLefeng Wang
Department of Cardiology, Beijing Chao-Yang Hospital, Beijing, China
Search for more papers by this authorShenghu He
Department of Cardiology, Northern Jiangsu People's Hospital, Yangzhou, China
Search for more papers by this authorXueqi Li
Department of Cardiology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China
Search for more papers by this authorHongwei Li
Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Search for more papers by this authorYin Liu
Department of Cardiology, Tianjin Chest Hospital, Tianjin, China
Search for more papers by this authorYujie Zhou
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Search for more papers by this authorQiang Tang
Department of Cardiology, Peking University Shougang Hospital, Beijing, China
Search for more papers by this authorYundai Chen
Department of Cardiology, Military General Hospital of Beijing PLA, Beijing, China
Search for more papers by this authorWeiyi Fang
Department of Cardiology, Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
Search for more papers by this authorLi Jiang
Department of Cardiology, Tong Ren Hospital, Shanghai Jiaotong University of Medicine, Shanghai, China
Search for more papers by this authorChengzhi Lu
Department of Cardiology, Tianjin First Center Hospital, Tianjin, China
Search for more papers by this authorJincheng Guo
Department of Cardiology, Beijing Luhe Hospital, Capital Medical University, Beijing, China
Search for more papers by this authorJianjun Zhang
Department of Cardiology, Shanghai Pudong New Area Gongli Hospital, Shanghai, China
Search for more papers by this authorShaoliang Chen
Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
Search for more papers by this authorYong Xia
Department of Cardiology, The Affiiliated Hospital of Xuzhou Medical University, Xuzhou, China
Search for more papers by this authorHongchao Zheng
Department of Cardiology, Shanghai Xuhui Central Hospital, Shanghai, China
Search for more papers by this authorBin Wang
Department of Cardiology, Aerospace Center Hospital, Beijing, China
Search for more papers by this authorDaifu Zhang
Department of Cardiology, Pudong New Area People's Hospital, Shanghai, China
Search for more papers by this authorLiuliu Feng
Department of Cardiology, Shidong Hospital of Shanghai Yangpu District, Shanghai, China
Search for more papers by this authorLijiang Tang
Department of Cardiology, Zhejiang Hospital, Hangzhou, China
Search for more papers by this authorPeng Xu
Department of Cardiology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, China
Search for more papers by this authorXuebo Liu
Department of Cardiology, Shanghai East Hospital Affiliated to Tong Ji University School of Medicine, Shanghai, China
Search for more papers by this authorCorresponding Author
Ruiyan Zhang
Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
Department of Cardiology, Cardiovascular Research Institution, Shanghai Jiaotong University School of Medicine, Shanghai, China
Correspondence
Ruiyan Zhang, Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, No. 197 Rui Jin Er Road, 3rd Floor, 12th Building, Shanghai 200025, China.
Tel: +86 21 6437 0045 extn 673328
Fax: +86 21 6445 7177
Email: [email protected]
Search for more papers by this authoron behalf of the RESOLUTE-DIABETES CHINA Investigators
Search for more papers by this authorAbstract
enBackground
The RESOLUTE-DIABETES CHINA study was specifically designed to investigate the safety and efficacy of Resolute zotarolimus-eluting stents (ZES; Medtronic, Santa Rosa, CA, USA) in the treatment of diabetic coronary lesions in the Chinese population.
Methods
In all, 945 patients with de novo native coronary lesions and type 2 diabetes mellitus were recruited at 32 cardiac centers across the Chinese mainland and were implanted with Resolute ZES. The primary endpoint was target vessel failure (TVF); secondary endpoints were clinical outcomes, namely all-cause death, stroke, bleeding, target lesion revascularization (TLR), target vessel revascularization (TVR), non-TVR, and stent thrombosis (ST). The follow-up period for all endpoints was 12 months after the procedure.
Results
In all, 933 patients (98.73%) had clinical follow-up at 12 months. The rate of TVF was 11.60%, whereas the rate of occurrence of secondary endpoints was 5.47%, with four patients (0.43%) having subacute or late ST. There were no significant differences in TVF rates comparing patients with different HbA1c levels or receiving different glucose control treatments (all P > 0.05). Patients with multivessel lesions had higher TVF rates (95% confidence intervals) than those with single-vessel lesions (16.76% [12.10%–22.97%) vs 9.72% [7.79%–12.11%], respectively; P = 0.006). There were no significant differences in TVF rates in patients with or without small vessels, bifurcated lesions, or chronic total occlusions (all P > 0.05). [Correction added on 17 January 2019, after first online publication: in the second sentence of Results section, “TLF” was changed to “TVF”.].
Conclusions
Resolute ZES may perform well in the Chinese diabetic population, especially in those with poor glucose control, complex lesions, and certain unfavorable clinical features. Further studies are needed to determine why ZES perform well in this population.
Abstract
zh摘要
背景
RESOLUTE-DIABETES CHINA研究设计针对中国糖尿病合并冠脉病变人群，考察应用Resolute佐他莫司药物洗脱支架(ZES，美敦力，美国加州圣罗莎)施行介入治疗的有效性和安全性。
方法
在中国32家心脏中心入选共945例2型糖尿病合并冠状动脉原位病变的患者并植入ResoluteZES。研究主要终点为靶血管治疗失败(target vessel failure，TVF)，次要终点为其他临床事件，包括全因死亡、卒中、出血事件、靶病变血运重建、靶血管血运重建、非靶血管血运重建和支架内血栓事件。所有终点随访时间为术后12个月。
结果
所有入选患者中，共933例(98.73%)患者完成了12个月的临床随访。TVF发生率为11.60%，次要终点发生率为5.47%，包括4例(0.43%)亚急性或晚期支架内血栓事件。亚组分析显示在不同血糖控制水平或接受不同降糖治疗的患者中，TVF发生率并无显著差异(P均> 0.05)。合并多支冠脉血管病变的患者TVF发生率显著高于单支血管病变患者(16.76% [12.10%-22.97%) vs 9.72% [7.79%-12.11%]，respectively；P = 0.006)。在有或无小血管病变、分叉病变或慢性闭塞的亚组中，TVF发生率无显著差异(P均> 0.05)。[首次在线出版后，于2019年1月17日进行了修改, 将结果部分第2句话中“TLF”改为“TVF”]。
结论
Resolute ZES治疗中国糖尿病合并冠脉病变患者人群，尤其是具有血糖控制不佳、复杂病变等不良临床特征患者人群表现良好。但仍需更多研究证实为何ZES在该人群中发挥良好疗效。
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