Karunanithy Narayan, Mesa Irene Rebollo, Dorling Anthony, Calder Francis, Katsanos Konstantinos, Semik Vikki, Robinson Emily, Peacock Janet, Das Neelanjan, Forman Colin, Lawman Sarah, Steiner Kate, Wilkins C Jason, Robson Michael G
Department of Interventional Radiology, Guy's and St Thomas' NHS Trust, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
Biostatistics Department, King's College London, London, SE5 8AF, UK.
Trials. 2016 May 12;17(1):241. doi: 10.1186/s13063-016-1372-7.
The initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40-50 % at 1 year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae.
METHODS/DESIGN: We have designed a multicentre, double-blind randomised controlled trial to test the superiority of paclitaxel-coated balloons for preventing restenosis after fistuloplasty in patients with a native arteriovenous fistula. Two hundred and eleven patients will be followed up for a minimum of 1 year. Inclusion criteria include a clinical indication for a fistuloplasty, an access circuit that is free of synthetic graft material or stents, and a residual stenosis of 30 % or less after plain balloon fistuloplasty. Exclusion criteria include a synchronous venous lesion in the same access circuit, location of the stenosis central to the thoracic inlet or a thrombosed access circuit at the time of treatment. The primary endpoint is time to end of target lesion primary patency. This is defined as a clinically-driven radiological or surgical re-intervention at the treatment segment, thrombosis that includes the treatment segment, or abandonment of the access circuit due to an inability to re-treat the treatment segment. Secondary endpoints include angiographic late lumen loss, time to end of access circuit cumulative patency, the total number of interventions, and quality of life. The trial is funded by the National Institute for Health Research.
We anticipate that this trial will provide rigorous data that will determine the efficacy of additional paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis.
ISRCTN14284759 . Registered on 28 October 2015.
用于血液透析的动静脉内瘘狭窄的初始治疗方法是放射学球囊扩张术或血管成形术。血管成形术的益处通常是短暂的，据报道1年时无干预生存率为40%-50%。既往小型研究和观察性数据表明，紫杉醇涂层球囊可能有助于改善狭窄性动静脉内瘘造瘘术后的结局。
方法/设计：我们设计了一项多中心、双盲随机对照试验，以检验紫杉醇涂层球囊在预防自体动静脉内瘘患者造瘘术后再狭窄方面的优越性。211例患者将至少随访1年。纳入标准包括造瘘术的临床指征、无合成移植物材料或支架的通路、普通球囊造瘘术后残余狭窄30%或更低。排除标准包括同一通路中的同步静脉病变、狭窄位于胸廓入口中心部位或治疗时通路血栓形成。主要终点是靶病变初次通畅结束时间。这被定义为在治疗节段进行临床驱动的放射学或外科再次干预、包括治疗节段的血栓形成、或因无法再次治疗治疗节段而放弃通路。次要终点包括血管造影晚期管腔丢失、通路累积通畅结束时间、干预总数和生活质量。该试验由英国国家卫生研究院资助。
我们预计该试验将提供严谨的数据，以确定额外的紫杉醇涂层球囊造瘘术与仅普通球囊造瘘术相比在维持用于血液透析的动静脉内瘘通畅方面的疗效。
ISRCTN14284759。于2015年10月28日注册。
