Zhuang Kun Da, Wei Mark Wang Qi, Min Shaun Xavier Chan Ju, Gogna Apoorva, Venkatanarasimha Nanda, Patel Ankur, Er Jasmine Chua Ming, Irani Farah Gillan, Leong Sum, Too Chow Wei, Chandramohan Sivanathan, Tay Kiang Hiong, Tan Bien Soo
Department of Vascular and Interventional Radiology, Singapore General Hospital, Singapore.
Interv Radiol (Higashimatsuyama). 2024 Dec 13;10:e20240030. doi: 10.22575/interventionalradiology.2024-0030. eCollection 2025 Mar 28.
To evaluate the feasibility and preliminary evidence of the efficacy of combined cutting balloon and drug-coated balloon angioplasty for the treatment of arteriovenous fistula stenoses resistant to conventional balloon angioplasty. From August 2018 to January 2019, 19 patients (mean age = 64.9 ± 8.6 years; males = 63%) with resistant arteriovenous fistula stenosis, defined as >30% residual stenosis after conventional balloon angioplasty, were enrolled into this single-center prospective pilot study. The resistant arteriovenous fistula stenoses were treated with a cutting balloon followed by a drug-coated balloon. The primary outcome measure was 6-month target lesion patency. The degree of residual stenosis after conventional balloon angioplasty was 48.8 ± 11.3%, decreasing to 18.7 ± 10.4% after combined cutting and drug-coated balloon angioplasty. Technical success, defined as < 30% residual stenosis, was achieved in 94.7% (18 of 19 stenoses). The 6-month target lesion patency was 100%, while the 6-month access circuit primary patency was 94.7% (n = 18/19) due to recurrent non-target lesion stenosis. No venous rupture or major complication was encountered. This pilot study provides evidence to support the conduct of a phase 3 randomized clinical trial to prove the superiority of a cutting balloon and drug-coated balloon combination for resistant arteriovenous fistula stenoses.
评估联合使用切割球囊和药物涂层球囊血管成形术治疗对传统球囊血管成形术耐药的动静脉内瘘狭窄的可行性及疗效的初步证据。2018年8月至2019年1月，19例对传统球囊血管成形术耐药的动静脉内瘘狭窄患者（平均年龄 = 64.9 ± 8.6岁；男性占63%）被纳入这项单中心前瞻性试点研究，耐药的动静脉内瘘狭窄定义为传统球囊血管成形术后残余狭窄>30%。采用切割球囊随后再用药物涂层球囊治疗耐药的动静脉内瘘狭窄。主要观察指标为6个月时靶病变通畅率。传统球囊血管成形术后残余狭窄程度为48.8 ± 11.3%，联合使用切割球囊和药物涂层球囊血管成形术后降至18.7 ± 10.4%。技术成功率（定义为残余狭窄<30%）为94.7%（19处狭窄中的18处）。6个月时靶病变通畅率为100%，而由于非靶病变复发狭窄，6个月时通路循环初级通畅率为94.7%（n = 18/19）。未发生静脉破裂或严重并发症。这项试点研究为开展一项3期随机临床试验提供了证据，以证明切割球囊和药物涂层球囊联合应用治疗耐药动静脉内瘘狭窄的优越性。
