Maleux Geert, van der Linden Edwin, Heijboer Roeland J J, Serafino Gian Piero, Wüst Aloys F J, Dol Johan A, Gabriels Karen, Pattynama Peter
University Hospitals Leuven, Leuven, Belgium.
Haaglanden Medisch Centrum, Den Haag, The Netherlands.
J Endovasc Ther. 2025 Oct;32(5):1580-1588. doi: 10.1177/15266028231215212. Epub 2023 Dec 6.
to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae.
consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure.
The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas.
APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated.Clinical ImpactAPERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.
评估APERTO紫杉醇涂层球囊血管成形术与标准血管成形术治疗功能失调的血液透析分流管和自体动静脉内瘘的安全性和有效性。
纳入因潜在的流出静脉狭窄导致透析功能障碍的连续患者，并按1:1随机分为APERTO紫杉醇药物涂层球囊组（研究组）或标准经皮腔内血管成形术组（对照组）。主要终点是根据标准化的肾脏病预后质量倡议（KDOQI）指南，从治疗到透析通路功能障碍的时间，通过Kaplan-Meier生存曲线进行评估，并采用对数秩分析检验其显著性。次要终点包括初次血管成形术的器械、技术和临床成功率。
该研究纳入了103例患者（研究组n = 51），其中有33例为前臂新发功能失调的自体动静脉内瘘（共79例）（60例在前臂）。纳入的患者大多数为男性，平均年龄69.8岁，表现为前臂自体动静脉内瘘功能失调。纳入的患者均未发生与器械相关的并发症。分别接受紫杉醇药物涂层球囊和经皮腔内血管成形术治疗的患者中，在初次手术后1年时无需再次干预即可获得功能性血液透析通路的患者分别为10例（19.6%）和5例（9.6%）（p = 0.612）。在自体瘘的新发病变中，发现紫杉醇药物涂层球囊（n = 5；25%）优于经皮腔内血管成形术（n = 1；11%），但差异无统计学意义（p = 0.953）。
APERTO紫杉醇药物涂层球囊是一种用于处理功能失调的血液透析通路的安全球囊导管；然而，与经皮腔内血管成形术相比，使用APERTO紫杉醇药物涂层球囊进行血管内初次狭窄治疗后，未能证明血液透析回路有更长时间的充分功能。临床影响APERTO紫杉醇药物涂层球囊导管是一种用于处理功能失调的血液透析通路的安全器械。与传统血管成形术球囊相比，APERTO药物涂层球囊不会使血液透析回路有更长时间的充分功能。在自体瘘的新发病变中，发现APERTO药物涂层球囊有非显著性益处。
