Guy's and St Thomas' NHS Foundation Trust, London, SE1 9RT, UK.
King's College London, London, SE1 9RT, UK.
Trials. 2024 Oct 31;25(1):734. doi: 10.1186/s13063-024-08502-1.
In view of the conflicting results from previous studies, the benefit of paclitaxel-coated balloons for arteriovenous fistulas is uncertain and equipoise remains. Although an industry-led trial testing the efficacy of sirolimus-coated balloons in AVFs is in progress, the benefit of sirolimus-coated balloons for arteriovenous fistulas is currently unknown. The purpose of this trial is to compare the efficacy of additional paclitaxel-coated or sirolimus-coated balloons on outcomes after a plain balloon fistuloplasty to preserve the patency of arteriovenous fistulae used for haemodialysis.
The study design is a multicentre randomised controlled trial. Following a successful plain balloon fistuloplasty, participants will be randomised to further treatment with a paclitaxel-coated balloon, a sirolimus-coated balloon, or an uncoated control balloon. We will recruit 642 patients, each with one or two treatment segments, over a 3-year period. Patients will remain in the trial and be followed up for 1 year. The primary endpoint is time to loss of treatment segment primary patency. Cox-proportional hazards models will be used to estimate hazard ratios for the time to loss of treatment segment primary patency for each treatment group relative to the control group. Analysis of the primary endpoint will be based on treatment segments rather than participants and a shared frailty will be estimated to account for the clustering of treatment segments within patients. Secondary endpoints are time to loss of primary patency at any treatment segment; time to end of access circuit primary patency; time to AVF abandonment; number of radiological or surgical interventions; adverse events; intima-media thickness and degree of stenosis at 3 months on ultrasound; and patient quality of life assessed by EQ-5D-5L and VASQoL.
The three-armed design in this proposal will provide an answer on the efficacy of both paclitaxel- and sirolimus-coated balloons in the same trial. This trial is likely to provide a clear answer regarding the efficacy of drug-coated balloons for arteriovenous fistulas.
ISRCTN ISRCTN40182296. Registered on 4 August 2023.
鉴于先前研究结果存在冲突，紫杉醇涂层球囊在动静脉瘘中的益处尚不确定，目前仍存在争议。虽然一项由行业主导的试验正在进行中，以测试西罗莫司涂层球囊在动静脉瘘中的疗效，但西罗莫司涂层球囊在动静脉瘘中的益处目前尚不清楚。本试验旨在比较紫杉醇涂层或西罗莫司涂层球囊在普通球囊血管成形术后对维持用于血液透析的动静脉瘘通畅的效果。
研究设计为多中心随机对照试验。在成功进行普通球囊血管成形术后，参与者将被随机分配进一步接受紫杉醇涂层球囊、西罗莫司涂层球囊或未涂层对照球囊治疗。我们将在 3 年内招募 642 名患者，每位患者有 1 或 2 个治疗段。患者将继续参与试验，并随访 1 年。主要终点是治疗段通畅率丧失的时间。将使用 Cox 比例风险模型估计每个治疗组相对于对照组治疗段通畅率丧失的风险比。主要终点分析将基于治疗段而不是参与者进行，并且将估计共享脆弱性以解释患者内治疗段的聚类。次要终点是任何治疗段通畅率丧失的时间；通路回路通畅率丧失的时间；动静脉瘘废弃的时间；放射学或手术干预的次数；不良事件；3 个月时超声检查的内-中膜厚度和狭窄程度；以及通过 EQ-5D-5L 和 VASQoL 评估的患者生活质量。
本研究设计中的三臂设计将在同一试验中提供紫杉醇和西罗莫司涂层球囊疗效的答案。该试验可能会明确回答药物涂层球囊在动静脉瘘中的疗效。
ISRCTN ISRCTN40182296。注册于 2023 年 8 月 4 日。
