PURPOSE A controlled, prospective, multicenter, randomized trial to compare primary patency after angioplasty with a drug-coated balloon versus plain angioplasty balloon in stenosis of dysfunctional fistulae and grafts for hemodialysis. MATERIALS AND METHODS A total of 136 patients (148 angioplasties) at four centers were randomized to receive a drug-coated balloon or plain angioplasty balloon after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival. RESULTS Primary patency after angioplasty was higher in the group treated with the drug-coated balloon than the plain angioplasty balloon (153.01 to 141.69 days at 6 months; 265.78 to 237.83 days at 12 months). Drug-coated balloon angioplasty resulted in superior patency after 6 and 12 months, but this result was not statically significant (P = 0.068 at 6 months; P = 0.369 at 12 months). There was no relation between target lesion patency and the other variables studied. Overall mortality in the plain angioplasty balloon group was higher (9% vs. 5.7%) but not statistically significant. CONCLUSIONS Drug-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 6 and 12 months, but this result was not statistically significant. Both arms show equivalent complications and similar mortality. LEVEL OF EVIDENCE Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.

中文翻译：

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紫杉醇球囊与高压球囊相比一年后对血液透析狭窄瘘管的疗效：一项对照，多中心，随机试验。

目的进行一项对照，前瞻性，多中心，随机试验，比较在使用功能不全的瘘管和移植物进行血液透析的狭窄时，用药物涂层球囊与普通血管成形术球囊进行血管成形术后的通畅性。材料与方法在使用高压球囊进行满意的血管成形术后，将四个中心的总共136例患者（148个血管成形术）随机分配到接受药物涂层球囊或普通血管成形术球囊。纳入标准是通过多普勒超声和/或血管造影证实的血管功能障碍的临床体征。主要终点是目标病变的通畅度，定义为有效完成时间与血管成形术后6和12个月再狭窄出现之间的时间。次要终点包括狭窄位置之间的关系，既往的血管成形术，人口统计学变量和生存率。结果在用药物涂层球囊治疗的组中，血管成形术后的原发通畅率高于单纯血管成形术球囊（6个月时为153.01至141.69天； 12个月时为265.78至237.83天）。药物涂层球囊血管成形术在6和12个月后通畅，但这一结果在静态上并不显着（6个月时P = 0.068； 12个月时P = 0.369）。目标病变的通畅性与研究的其他变量之间没有关系。普通血管成形术球囊组的总死亡率较高（9％比5.7％），但无统计学意义。结论药物涂层球囊血管成形术可使功能障碍性外周血管通路在6和12个月时具有较好的存活率，但该结果无统计学意义。两组均显示相同的并发症和相似的死亡率。证据级别Ia，治疗研究，RCT。EBM等级将以1-5的等级为基础。