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Randomized Controlled Trial for Paclitaxel-coated Balloon versus Plain Balloon Angioplasty in Dysfunctional Hemodialysis Vascular Access: 12-month Outcome from a Nonsponsored Trial

医学 气球 血管成形术 切割气球 血液透析 外科 随机对照试验 失调家庭 紫杉醇 血管通路 内科学 支架 化疗 再狭窄 精神科
作者
Skyi Yin-Chun Pang,Karen C.L. Au-Yeung,Grace Y.L. Liu,Ronald On‐Ho Tse,Donna Lai,Warren K W Leung,Ka Leung Mo,Chung Ngai Tang,Patricia Chun‐Ling Yih
出处
期刊:Annals of Vascular Surgery [Elsevier BV]
卷期号:72: 299-306 被引量:14
标识
DOI:10.1016/j.avsg.2020.10.005
摘要

Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access.This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated.40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/- 15.8% for DCB and 69.5 +/- 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/- 38.4 mm and 50.2 +/- 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007).Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial.
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