Swinnen Jan John, Hitos Kerry, Kairaitis Lukas, Gruenewald Simon, Larcos George, Farlow David, Huber David, Cassorla Gabriel, Leo Christopher, Villalba Laurencia M, Allen Richard, Niknam Farshid, Burgess David
1 Department of Surgery, The University of Sydney, Westmead Hospital, Westmead, NSW, Australia.
2 Westmead Research Centre for Evaluation of Surgical Outcomes, Department of Surgery, The University of Sydney, Westmead Hospital, Westmead, NSW, Australia.
J Vasc Access. 2019 May;20(3):260-269. doi: 10.1177/1129729818801556. Epub 2018 Sep 18.
Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis.
This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12 months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6 months (unblinded due to timeliness).
Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6 months, decline in late lumen loss was 0.23 ± 0.03 mm/month for Sham and 0.045 ± 0.03 mm/month for drug-eluting balloon arm, a significant difference (0.18 mm, p = 0.0002). At 12 months, this difference persisted at 0.12 mm (p = 0.0003). At 6 months, significant difference in late lumen loss for instent restenoses (p = 0.0004) was observed, with non-significant difference for unstented restenoses (p = 0.065). Mean time for freedom from reintervention was 10.14 months for Sham versus 42.39 months for drug-eluting balloon (p = 0.001). The same was shown for instent (p = 0.014) and unstented (p = 0.029) restenoses. Qa decline rate at 6 months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). The difference was significant (36.48 mL/min; p = 0.02) and persisted to 12 months (p = 0.44).
Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12 months. Drug-eluting balloon significantly increases freedom from reintervention at 12 months with these effects true in stented and unstented fistulas.
自体动静脉血液透析瘘管狭窄的血管内治疗具有较高的再次干预率。我们研究了药物洗脱球囊在复发性血液透析瘘管狭窄治疗中的效果。
这是一项由研究者发起并实施的随机、对照、前瞻性、盲法、多中心试验。复发性自体动静脉血液透析瘘管狭窄患者接受标准血管内治疗加药物洗脱球囊或标准血管内治疗加未涂层球囊（假手术）。主要终点是在6周、3个月、6个月和12个月时超声检查试验区域的晚期管腔丢失。次要终点是免于对索引试验区域进行再次干预以及瘘管血流量（Qa）下降。在6个月时进行中期分析（因及时性而解除盲法）。
132例复发性狭窄患者（48%为裸镍钛合金支架）被随机分组，70例接受药物洗脱球囊治疗，62例接受假手术治疗。在6个月时，假手术组晚期管腔丢失的下降速度为0.23±0.03mm/月，药物洗脱球囊组为0.045±0.03mm/月，差异显著（0.18mm，p = 0.0002）。在12个月时，这种差异持续存在，为0.12mm（p = 0.0003）。在6个月时，观察到支架内再狭窄的晚期管腔丢失有显著差异（p = 0.0004），而无支架再狭窄差异不显著（p = 0.065）。免于再次干预的平均时间，假手术组为10.14个月，药物洗脱球囊组为42.39个月（p = 0.001）。支架内（p = 0.014）和无支架（p = 0.029）再狭窄情况也是如此。6个月时Qa下降率，假手术组为36.89mL/min/月，药物洗脱球囊组为0.41mL/min。差异显著（36.48mL/min；p = 0.02），并持续到12个月（p = 0.44）。
紫杉醇药物洗脱球囊显著延迟了复发性自体动静脉血液透析瘘管狭窄血管成形术后的再狭窄，这种效果持续到12个月。药物洗脱球囊显著增加了12个月时免于再次干预的几率，在有支架和无支架的瘘管中均有此效果。
