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

The current endovascular standard of care for the treatment conduit stenosis in dialysis access is conventional balloon angioplasty (CBA),1Lok C.E. Huber T.S. Lee T. Shenoy S. Yevzlin A.S. Abreo K. et al.KDOQI Vascular Access Guideline Work Group. KDOQI clinical practice guideline vascular access: 2019 update.Am J Kidney Dis. 2020; 75: S1-S164Abstract Full Text PDF PubMed Scopus (297) Google Scholar,2Schmidli J. Widmer M.K. Basile C. de Donato G. Gallieni M. Gibbons C.P. al.Editor's Choice - Access: 2018 Clinical Practice Guidelines European Society Surgery (ESVS).Eur Vasc Endovasc Surg. 2018; 55: 757-818Abstract (238) Scholar achieving approximately 31% primary patency at 12 months.3Kennedy S.A. Mafeld Baerlocher M.O. Jaberi A. Rajan D.K. Drug-coated hemodialysis circuits: a systematic review and meta-analysis.J Interv Radiol. 2019; 30: 483-494Abstract (30) Paclitaxel coated balloons (PCBs) have been used to offset neointimal hyperplasia (NIH) process increase target lesion revascularisation (TLR) free duration, but results PCB use AV are mixed date.3Kennedy Scholar,4Trerotola S.O. Saad T.F. Roy-Chaudhury P. Lutonix A.V.C.T.I. randomized trial paclitaxel-coated arteriovenous fistula stenosis: 2-year subgroup analysis.J 31: 1-14Abstract (31) Furthermore, their has questioned meta-analysis by Katsanos al., suggesting an increased mortality risk when lower limb arena,5Katsanos Spiliopoulos Kitrou Krokidis Karnabatidis D. Risk death following application stents femoropopliteal artery leg: controlled trials.J Am Heart Assoc. 7e011245Crossref (503) although this not corroborated any subsequent analysis, using patient level data. Sirolimus, like paclitaxel, potent antiproliferative agent that prevents activation smooth muscle cells after injury. However, unlike sirolimus beneficial anti-inflammatory effects broader therapeutic range. Until recently it difficult package onto stentless platform, which can deliver directly vessel wall adequate quantity inhibit NIH. MagicTouch novel (SCB) catheter (Concept Medical Inc., Tampa, FL, USA), uses proprietary nanolute technology designed improve lipophilicity bioavailability sirolimus. Sirolimus converted into submicron sized particles encapsulated phospholipid drug nanocarriers. Submicron carriers mimic body lipids liberate achieve antirestenotic activity. dose corresponds 1.25 μg/mm2. MAgicTouch Intervention Leap Dialysis (MATILDA; NCT04698512) single arm prospective pilot enrolled 33 Asian patients with end stage renal failure (18 males, mean age 64.7 ± 11.6 years; 64% diabetic nephropathy), failing AVF novo recurrent stenoses. efficacy endpoint was (TLPP) six months. There were 47 lesions (34/47, 72% lesions) percentage length 84 10% 35 19 mm, respectively. Further demographics procedural details published previously.6Tang T.Y. Soon S.X. Yap C.J. Chan S.L. Tan R.Y. Pang S.C. al.Early (6 months) study investigate safety dysfunctional arterio-venous fistulas: (MATILDA) Trial.PLOS ONE. 15e0241321Crossref (4) Based on performance goal 70% TLPP, sample size had least 80% power demonstrate non-inferiority margin compared known month TLPP 40% CBA.3Kennedy Trial approval obtained from local Human Research Ethics Committee (CIRB ref: 2018/2557). All pre-dilated high pressure non-compliant (Mustang, Boston Scientific, Marlborough, MA, USA) effacement recoil < 30% mandatory elution. 100% technical success. no peri-procedural complications related SCB. circuit rates months previously reported 29/35 (83%) 17/25 (68%), respectively.6Tang At months, dropped 22/38 (58%) 12/27 (44%), Secondary 31/32 (97%) 27/29 (93%) respectively (Fig. 1). Mean time TLR 6.8 2.1 duration 10.6 4.3 juxta-anastomosis (portion immediately adjacent to, within 5 cm of, arterial anastomosis) main location re-intervention (16/38; 42%). 4/33 (12%) deaths attributable patient’s underlying comorbidities (three cases ischaemic heart disease one cerebral accident) 2.3, 6.5, 7.5, 8.7 3/29 (10%) thromboses months; two abandoned. Seven 10 AVFs re-intervened upon between timepoints those average 1.0 re-interventions already performed prior enrolment. This first study, albeit small series direct comparator arm, publish year data SCB circuit. Despite initial encouraging results, drop disappointing comparable paclitaxel date same points (PCB pooled 75% 53% respectively).3Kennedy Kaplan–Meier curve morphology comparing difference CBA similar studies. effect groups becomes less longer follow up period observed, where curves tend converge. delivered, penetrates, remains vessel, probably differs PCBs different types excipient likely explain effect. decay over may decline periods, suggests need perform repeated elution fistuloplasty obtain TLPP. nanocarriers allow more efficient load be delivered retention, reflect improved ultimately top well required as passes. research area RCTs setting against urgently. In conclusion, circuits appears safe modality haemodialysis patients, device adverse events TYT received honoraria Concept travel give presentations.