TITLE: Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial.
BACKGROUND:The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch™ sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention.
METHODS:Single-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years) end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anaesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months.
RESULTS:47 stenotic target lesions treated and 24/33 (72.7%) patients were for restenosis. Main indications for intervention was low/dropping access flow (21/33; 63.6%) and most common target lesion was in the juxta-anastomosis (19/47; 40.4%). There was 100% technical and procedural success. There were no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 46/47 (97.9%) and 29/35 (82.9%) respectively. Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively. There was one (2.9%) death at 6 months and 4/33 (12.1%) overall to date, all from patients' underlying co-morbidities.
CONCLUSIONS:SCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature.
SOURCE: Tang TY, Soon S, Yap C, et al. Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial[J]. PLoS One, 2020,15(10):e0241321. DOI: 10.1371/journal.pone.0241321.
背景:这项初步研究的目的是评估MagicTouch西罗莫司涂层球囊(SCB)导管(Concept Medical Inc.,坦帕,佛罗里达州,美国)的安全性和有效性,以改善动静脉内瘘(AVF)的通畅性以及从头开始和反复出现狭窄。 MATILDA报告了干预后3个月和6个月的早期结果。
方法:单中心、单目标、前瞻性、试探性研究对33例(18男性;平均年龄64.7±11.6岁)终末期肾功能衰竭的亚洲AVF失功的亚洲患者进行了SCB血管成形术,该手术于2019年5月至2020年1月进行。所有操作流程在不使用镇静剂的情况下进行局部麻醉并作为日间手术进行。所有患者均接受双重抗血小板治疗,为期3个月,并在3个月和6个月时进行双功超声检查。
结果:治疗的狭窄目标病变为47例,再狭窄率为24/33(72.7%)。干预的主要指征是通路流量低/下降(21/33; 63.6%),最常见的目标病变是近吻合口(19/47; 40.4%)。技术和程序上取得了100%的成功。没有与SCB相关的围手术期并发症。在3个月和6个月时,目标病变的一期通畅率分别为46/47(97.9%)和29/35(82.9%)。 3个月和6个月时的通路通畅率分别为31/33(93.9%)和17/25(68%)。截至6个月,有1例(2.9%)死亡,迄今为止总共有4/33例(12.1%)死亡,均来自患者的潜在合并症。
结论:对于亚洲血液透析患者来说,SCB血管成形术治疗失功AVF通路是一种安全有效的方法,以六个月比较,甚至不比文献中报道的紫杉醇数据更好。
启发:药物球囊有较好的通畅率,可以作为反复狭窄的处理方案选择之一。