Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae

作者全名："Zhao, Yiping; Wang, Pei; Wang, Yuzhu; Zhang, Lihong; Zhao, Yu; Li, Hua; He, Qiang; Liu, Hao; Luo, Jianfang; Jia, Xin; Yu, Zhengya; Guo, Wei; Zhang, Lan"

作者地址："[Zhao, Yiping; Zhang, Lan] Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Vasc Surg Dept, Pujian Rd 160, Shanghai 200127, Peoples R China; [Wang, Pei] Zhengzhou Univ, Affiliated Hosp 1, Blood Purificat Ctr, Zhengzhou, Peoples R China; [Wang, Yuzhu] Beijing Haidian Hosp, Nephrol Dept, Beijing, Peoples R China; [Zhang, Lihong] Hebei Med Univ, Hosp 1, Nephrol Dept, Shijiazhuang, Peoples R China; [Zhao, Yu] First Affiliated Hosp Chongqing Med Univ, Affiliated Hosp 1, Vasc Surg Dept, Chongqing, Peoples R China; [Li, Hua] Zhejiang Med Univ, Shaoyifu Hosp, Nephrol Dept, Hangzhou, Peoples R China; [He, Qiang] Zhejiang Prov Peoples Hosp, Nephrol Dept, Hangzhou, Peoples R China; [Liu, Hao] Southern Med Univ, Nanfang Hosp, Vasc & Intervent Radiol Dept, Guangzhou, Peoples R China; [Luo, Jianfang] Guangdong Prov Peoples Hosp, Cardiol Dept, Guangzhou, Peoples R China; [Jia, Xin; Guo, Wei] Chinese Peoples Liberat Army Gen Hosp, Vasc Surg Dept, Fuxing Rd 28, Beijing 100853, Peoples R China; [Yu, Zhengya] Capital Med Univ, Tongren Hosp, Vasc Surg Dept, Beijing, Peoples R China"

通信作者："Zhang, L (通讯作者)，Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Vasc Surg Dept, Pujian Rd 160, Shanghai 200127, Peoples R China.; Guo, W (通讯作者)，Chinese Peoples Liberat Army Gen Hosp, Vasc Surg Dept, Fuxing Rd 28, Beijing 100853, Peoples R China."

来源：CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001167008500001

JCR分区：Q1

影响因子：8.5

年份：2023

卷号：　

期号：　

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结束页：　

文献类型：Article; Early Access

关键词：arteriovenous fistula; chronic dialysis; chronic hemodialysis; clinical trial; dialysis access; hemodialysis access

摘要："Background The aim of this study was to evaluate the efficacy and safety of paclitaxel-coated balloons (AcoArt Orchid) in treating dysfunctional arteriovenous fistulae. Methods The drug-eluting balloon for arteriovenous (AV) fistula in China trial was a prospective, multicenter, randomized controlled study. Patients who had >= 50% venous stenosis of the AV fistula and symptoms indicating significant hemodynamic changes were included. After successful predilation with a high-pressure balloon (residual stenosis <= 30%), patients were randomized 1:1 to either a paclitaxel-coated balloon or an uncoated control balloon. The primary efficacy outcome was assessed at 6 months, and safety assessment was conducted within 30 days of the procedure. The 12-month results were also analyzed. Results The study included 244 patients, equally distributed between the two groups. The primary target lesion patency was 91% (106/116) for the drug-coated balloon (DCB) group and 67% (79/118) for the plain balloon catheter group, representing a difference of 24.63% (95% confidence interval, 14.68 to 34.58; P < 0.001). The secondary efficacy end point was primary target lesion patency at 12 months, which was 66% (74/112) for the DCB group and 46% (52/112) for the plain balloon catheter group (95% confidence interval, 6.57 to 32.08; P = 0.004). The mean number of reinterventions per patient to maintain target lesion patency during the 12 months after the index procedure was 0.39 (48/122) in the DCB group and 0.77 (94/122) in the plain balloon catheter group (P = 0.001). The primary safety end point did not differ between groups (P = 0.25). Conclusions AcoArt Orchid DCB showed better primary patency rates compared with plain balloon angioplasty for treating stenotic lesions in dysfunctional hemodialysis AV fistulae at 6 and 12 months. It required fewer repeated interventions and had comparable safety in 1 year."

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