Study Protocol of Sirolimus-coated bAlloon Versus pAclitaxel-coated balloon angioplasty for the treatment of dysfunctional ArterioVenous Fistula (SAVE AVF)

Abstract Background Dysfunction of arteriovenous fistula (AVF) remains a significant morbidity for patients who are suffering from end-stage-kidney-disease (ESKD). The primary cause of dysfunction in AVF is due to stenosis from neointimal hyperplasia. Plain old balloon angioplasty (POBA) has been the standard of care for the treatment of AVF stenosis however the average patency rates remain poor. Drug-coated balloon (DCB) represents an emerging alternative to POBA in prolonging the patency of AV access. Paclitaxel-coated balloon (PCB) is currently the most widely studied DCB as compared to second generation DCB, sirolimus-coated balloon (SCB). Methods This is a single center, prospective and retrospective double arm registry study that is investigator driven to compare the efficacy and safety of the two DCBs in the real-world setting in Singapore. A total of 200 eligible participants will be recruited and followed-up for 12-months. The primary endpoint is the patency rates at 6-month while the secondary endpoints are the patency rates and the number of repeat interventions needed to maintain patency at 6-and 12-months. Discussion Drug-coated balloon is an emerging device in endovascular intervention of AV access. PCB was the most used DCB, until its safety concern was raised recently due to the findings of increasing risk of death following application of PCB in femoro-popliteal artery of the leg. Compared to paclitaxel, sirolimus is cytostatic in its action with a high safety margin and has anti-inflammatory effects. It has a high transfer rate to the vessel wall and effectively inhibits neointimal hyperplasia. There have not been head-to-head comparison of PCB and SCB in the treatment of dysfunctional AV access; hence through this study, we will be able to study the safety and efficacy of the two DCBs in the real-world setting. Trial registration: ClinicalTrials.gov Identifier: NCT05333640 on 19 April 2022