Tang Tjun Yip, Soon Shereen Xue Yun, Yap Charyl Jia Qi, Chan Sze Ling, Tan Ru Yu, Pang Suh Chien, Choke Edward Tieng Chek, Tan Chieh Suai, Chong Tze Tec
Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.
Duke NUS Graduate Medical School, Singapore, Singapore.
J Vasc Access. 2023 Jul;24(4):591-598. doi: 10.1177/11297298211043083. Epub 2021 Sep 2.
Aim of Arch V SUPERA-LUX was to evaluate the safety and efficacy of the combination therapy of SUPERA™ (, Santa Clara, CA, USA) helical stent implantation and Passeo-18 Lux™ ( Asia Pacific Pte Ltd, Singapore) drug coated balloon (DCB) elution to treat recurrent cephalic arch stenosis (CAS) in the setting of AV access dysfunction.
Investigator-initiated, single-center, single-arm prospective pilot study of 20 end-stage renal failure Asian patients with a dysfunctional brachiocephalic fistula. All had symptomatic recurrent CAS within 6 months of prior intervention. The lesion was pre-dilated with a standard high-pressure balloon (Biotronik Passeo-35 HP balloon). The DCB (Passeo-18 Lux™) is subsequently inflated and the SUPERA™ stent deployed to sit 2 mm distal to the cephalic arch and covering the CAS but within the DCB zone. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 6- and 12-months.
There were 9 (45%) males and mean age was 67 ± 11.0 years. Mean time from prior procedure was 113 ± 68 days and main indication for reintervention was high venous pressure (9/20, 45%). Technical success was 100% and there were no peri-procedural complications related to either stent or DCB deployment. Target lesion primary patency at 6- and 12-months was 10/18 (55%) and 5/16 (31%), respectively. Mean time to target lesion re-intervention was 170 ± 82 days. Circuit access patency was 8/18 (44%) and 2/16 (13%) at 6- and 12-months respectively and mortality was 3/20 (15%) attributed to the patients' underlying co-morbidities.
Dual prong strategy of using SUPERA™ stenting and Passeo-18 Lux™ drug elution for recurrent CAS, although safe, was no more efficacious than conventional balloon angioplasty or stenting alone. Development of an intense inflammatory reaction within the stent led to reinterventions of a number of cases with suboptimal results.
Arch V SUPERA-LUX的目的是评估SUPERA™（美国加利福尼亚州圣克拉拉）螺旋支架植入与Passeo-18 Lux™（新加坡亚太私人有限公司）药物涂层球囊（DCB）洗脱联合治疗动静脉通路功能障碍情况下复发性头臂干动脉狭窄（CAS）的安全性和有效性。
由研究者发起的单中心、单臂前瞻性试点研究，纳入20例患有功能障碍性头臂动静脉内瘘的终末期肾衰竭亚洲患者。所有患者在先前干预后6个月内均出现有症状的复发性CAS。病变先用标准高压球囊（百多力Passeo-35 HP球囊）进行预扩张。随后充盈DCB（Passeo-18 Lux™）并植入SUPERA™支架，使其位于头臂干动脉远端2mm处并覆盖CAS，但在DCB区域内。所有患者均接受3个月的双重抗血小板治疗，并在6个月和12个月时进行双功超声随访。
有9例（45%）男性，平均年龄为67±11.0岁。距上次手术的平均时间为113±68天，再次干预的主要指征是静脉压升高（9/20，45%）。技术成功率为100%，且没有与支架或DCB植入相关的围手术期并发症。6个月和12个月时靶病变的原发性通畅率分别为10/18（55%）和5/16（31%）。靶病变再次干预的平均时间为170±82天。6个月和12个月时通路通畅率分别为8/18（44%）和2/16（13%），死亡率为3/20（15%），归因于患者的基础合并症。
使用SUPERA™支架置入术和Passeo-18 Lux™药物洗脱治疗复发性CAS的双管齐下策略虽然安全，但并不比传统球囊血管成形术或单纯支架置入术更有效。支架内强烈炎症反应的发生导致一些病例再次干预，结果不理想。
