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

Abstract

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.

Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

“…Sirolimus-coated angioplasty balloons are now available, and these have potential in the treatment of AVFs. 31 There has been an increase in mortality linked with the use of paclitaxel-coated balloons in patients with peripheral vascular disease. 32 The number of deaths were not sufficient to inform this point.…”

Utility of Sirolimus Coated Balloons for Salvaging Dysfunctional Arteriovenous Fistulae: One Year Results From the MATILDA trial

“…The TLPP and circuit access patency rates at six months were previously reported at 29/35 (83%) and 17/25 (68%), respectively. 6 At 12 months, TLPP and circuit access patency dropped to 22/38 (58%) and 12/27 (44%), respectively. Secondary patency rates were 31/32 (97%) and 27/29 (93%) at six and 12 months, respectively (Fig.…”

“…Further patient demographics and procedural details have been published previously. 6 Based on a performance goal of 70% for TLPP, the sample size of 33 had at least 80% power to demonstrate non-inferiority using a margin of 10% compared with the known six month TLPP of approximately 40% with CBA. 3 Trial approval was obtained from the local Human Research Ethics Committee (CIRB ref: 2018/2557).…”

Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results

“…16 Based on previously reported clinical studies, the potent antiproliferative properties of sirolimus make it a useful agent to reduce the risk of restenosis for at least several months post-angioplasty, justifying its use on DCBs. 20,27,28 Sirolimus release interferes with fibroblast and smooth muscle cell proliferation as well as the proliferation of inflammatory cells. These three cell types are largely responsible for the restenotic cascade resulting from tissue responses to vascular injury secondary to angioplasty.…”