Department of Vascular Surgery, Singapore General Hospital, Singapore.
Duke NUS Graduate Medical School, Singapore.
J Vasc Access. 2023 Sep;24(5):1008-1017. doi: 10.1177/11297298211067059. Epub 2021 Dec 30.
Aim of this pilot clinical study was to evaluate the safety and efficacy of the ™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients.
Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months.
There was one subject dropout so final = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients' underlying co-morbidities.
Fistuloplasty using the novel ™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.
本临床试验旨在评估雷帕霉素洗脱球囊（SEB）治疗亚洲血液透析患者失功动静脉瘘（AVF）的安全性和有效性。
前瞻性单中心、多研究者、非连续、非盲法单臂试验。2020 年 5 月至 11 月，40 例终末期肾病伴功能不良 AVF 的亚洲患者接受 SEB 血管成形术。所有狭窄病变均采用高压顺应性球囊血管成形术预处理，然后进行 SEB 血管成形术。主要研究终点为 30 天内靶病变一期通畅率和回路通畅率。所有患者接受双联抗血小板治疗 1 个月，并在 6 个月时进行超声检查。
1 例患者脱落，最终 39 例（平均年龄 65.0±11.9；男性 26 例[66.7%]）和 43 个靶病变接受治疗。干预的主要指征为通路流量下降（24/39；61.5%），最常见的靶病变位于吻合口附近（24/43；54.5%）。技术和程序成功率均为 100%。SEB 无不良事件发生。3 个月和 6 个月时靶病变一期通畅率分别为 39/41（95.1%）和 28/39（71.8%）。3 个月和 6 个月时回路通畅率分别为 35/37（94.6%）和 22/35（62.9%）。3 例（7.7%）死亡均归因于患者基础合并症。
在 6 个月时，新型 SEB 用于治疗功能不良的 AVF 回路似乎是安全有效的，但现在需要更大规模的随机对照研究来确定其与普通球囊血管成形术相比的真正疗效。
