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Drug-coated balloon for the treatment of small vessel disease: 9 months of angiographic results and 12 months of clinical outcomes of the PEPCAD China SVD study

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单位: [1]Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China. [2]National Clinical Research Center for Interventional Medicine, Shanghai, China. [3]Department of Cardiology, Sir Run Run Shaw Hospital, Zhenjiang University School of Medicine, Hangzhou, China. [4]Department of Cardiology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China. [5]Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China. [6]Department of Cardiology, Zhongda Hospital Southeast University, Nanjing, China. [7]Department of Cardiology, Chinese PLA General Hospital, Beijing, China. [8]Department of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. [9]Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [10]Department of Cardiology, Beijing Hospital of the Ministry of Health, Beijing, China. [11]Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [12]Department of Cardiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China. [13]Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. [14]Department of Cardiology, Central Hospital of Putuo District, Shanghai, China. [15]Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. [16]Department of Cardiology, Qilu Hospital of Shandong University, Ji'nan, China. [17]Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China. [18]Department of Cardiology, Jiangsu Province Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. [19]Department of Cardiology, The First Hospital of China Medical University, Shenyang, China. [20]Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
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关键词: coronary artery disease drug‐coated balloon percutaneous coronary intervention small vessel disease

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Whether the drug-coated balloons (DCBs)-alone strategy was superior to plain old balloon angioplasty (POBA) in treating SVD remains unknown.We aimed to evaluate the efficacy and safety of DCBs for the treatment of coronary de novo small vessel disease (SVD) and provide further evidence for extending the clinical indications of DCBs. (ChiCTR1800014966).Eligible patients were randomized at a 2:1 ratio to receive DCB treatment or POBA in this prospective, multicenter clinical trial. The reference vessel diameter of lesions was visually assessed to be 2.0 to 2.75 mm. The primary endpoint of the study was angiographic in-segment late luminal loss (LLL) at the 9-month follow-up to demonstrate the superiority of DCB treatment to POBA in SVD. The composite clinical endpoints included clinically driven target lesion revascularization (CD-TLR), target lesion failure (TLF), major adverse cardiac events (MACEs), and thrombosis at the 12-month follow-up.A total of 270 patients were enrolled (181 for DCB, 89 for POBA) at 18 centers in China. The primary endpoint of 9-month in-segment LLL in the intention-to-treat population was 0.10 ± 0.33 mm with DCB and 0.25 ± 0.38 mm with POBA (p = 0.0027). This difference indicated significant superiority of DCB treatment (95% CI: -0.22, -0.04, psuperiority  = 0.0068). The rates of the clinical endpoints-CD-TLR, TLF, and MACEs-were comparable between groups. No thrombosis events were reported.DCB treatment of de novo SVD was superior to POBA with lower 9-month in-segment LLL. The rates of clinical events were comparable between the two devices.© 2022 Wiley Periodicals LLC.

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出版当年[2022]版:
大类 | 3 区 医学
小类 | 4 区 心脏和心血管系统
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
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出版当年[2021]版:
Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
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Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

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第一作者单位: [1]Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China. [2]National Clinical Research Center for Interventional Medicine, Shanghai, China.
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通讯机构: [1]Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China. [2]National Clinical Research Center for Interventional Medicine, Shanghai, China. [*1]Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Rd, Shanghai 200032, China.
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