Can KDOQI Intervention Rate Target Be Met With Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulas: Post-hoc Analysis of the IN.PACT AV Access Randomized Clinical Trial.

Abstract

RATIONALE & OBJECTIVE A key Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 Vascular Access Guidelines target is to have ≤3 percutaneous or surgical interventions per year to maintain arteriovenous fistula (AVF) patency. We hypothesized first, that the number of interventions to maintain long-term AVF patency conducted in a rigorous clinical trial could be adequately documented and compared against KDOQI targets, and second, that the use of drug-coated balloons (DCB) could reduce the rate of thrombosis and interventions to maintain AVF patency more than standard uncoated balloon angioplasty (PTA). STUDY DESIGN Post-hoc analysis of the IN.PACT AV Access randomized clinical trial. SETTING & PARTICIPANTS Outpatient adult hemodialysis patients with previously matured AVFs that had de novo or non-stented re-stenotic lesions enrolled between April 2017 and May 2018 in the United States, Japan and New Zealand. INTERVENTION Patients were randomized to receive percutaneous transluminal angioplasty with the IN.PACT AV DCB or PTA. OUTCOMES Rate of interventions to maintain access target lesion and access circuit patency and rate of access circuit thrombosis were calculated in both intervention groups and compared against the KDOQI 2019 guideline targets. RESULTS Of the 330 participants randomized, 133 patients completed their 3-year visit. The number of interventions per AVF-year to maintain access circuit patency through 36 months was 1.39 for the DCB group and 1.66 for the PTA group (rate difference -0.28 [-0.47, -0.08]; P = 0.01). The access circuit thrombosis rate was 0.041 in the DCB group and 0.069 in the PTA group (rate difference -0.028 [-0.065, 0.0082]; P=0.1). LIMITATIONS Exclusion of AVF with prior thrombosis and small sample size at 36 months. CONCLUSIONS Both DCB and PTA groups met the KDOQI targets of ≤3 percutaneous or surgical interventions per year to maintain AVF patency. The need for reinterventions to maintain patency and thrombosis rate was reduced with the use of DCB compared with PTA through 36 months. FUNDING None.