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Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae: A Randomized Controlled Trial

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机构： [1]Vascular Surgery Department, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Jiaotong University, Shanghai, China. [2]Blood Purification Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou, China. [3]Nephrology Department, Beijing Haidian Hospital, Beijing, China. [4]Nephrology Department, The First Hospital of Hebei Medical University, Hebei Medical University, Shijiazhuang, China. [5]Vascular Surgery Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing Medical University, Chongqing, China. [6]Nephrology Department, Shaoyifu Hospital, Zhejiang Medical University, Hangzhou, China. [7]Nephrology Department, Zhejiang Provincial People's Hospital, Hangzhou, China. [8]Vascular and Interventional Radiology Department, Nanfang Hospital, Southern Medical University, Guangzhou, China. [9]Cardiology Department, Guangdong Provincial People's Hospital, Guangzhou, China. [10]Vascular Surgery Department, Chinese PLA General Hospital, Beijing, China. [11]Vascular Surgery Department, Tongren Hospital, Capital Medical University, Beijing, China.

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The aim of this study was to evaluate the efficacy and safety of paclitaxel-coated balloons (AcoArt Orchid) in treating dysfunctional arteriovenous fistulae.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.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).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.AcoArt III/Arterio-venous Fistula in China, NCT03366727.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Nephrology.

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出版当年[2023]版：

大类 | 1 区

医学

小类 | 1 区泌尿学与肾脏学

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区泌尿学与肾脏学

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出版当年[2022]版：

Q1 UROLOGY & NEPHROLOGY

最新[2023]版：

Q1 UROLOGY & NEPHROLOGY

影响因子： 8.5 最新[2023版] 8.7 最新五年平均 9.8 出版当年[2022版] 9.9 出版当年五年平均 10.624 出版前一年[2021版] 8.5 出版后一年[2023版]

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第一作者机构： [1]Vascular Surgery Department, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Jiaotong University, Shanghai, China.

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