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Abstract: TH-OR48

Long-Term Intervention Rate with Drug-Coated Balloons for Dysfunctional Arteriovenous (AV) Fistulas: Meeting KDOQI Targets in the IN.PACT AV Access Trial

Session Information

Category: Dialysis

  • 803 Dialysis: Vascular Access


  • Gopal, Anjana, University of Toronto, Toronto, Ontario, Canada
  • Lok, Charmaine E., University of Toronto, Toronto, Ontario, Canada

A key KDOQI Guidelines target is to have ≤3 percutaneous or surgical interventions per year to maintain AV fistula (AVF) patency. We aimed to define the intervention and thrombosis rates per AVF-years through 36 months from the IN.PACT AV Access trial.


This global, 29-center, single-blinded pivotal study randomized participants with de novo or non-stented restenotic obstructive lesion(s) of upper extremity AVF 1:1 to treatment with an IN.PACT AV paclitaxel drug-coated balloon (DCB; n=170) or standard percutaneous transluminal angioplasty (PTA; n=160). Participants were followed for 36 months; intervention rates and fistula-years of use were captured and compared to KDOQI guidelines target. 36 month thrombosis rates were compared between DCB and PTA groups.


Of the 330 participants randomized, 133 completed their 3-year visit. Including the index procedure, the rates of intervention ranged 1.24-2.55 per AVF-year for DCB group and 1.48-3.06 per AVF-year for PTA group (Table). The cumulative incidence rate of access circuit thrombosis at 36 months was 8.2% (10) in DCB group and 18.3% (19) in PTA group with a hazard ratio of 0.457 (95% confidence interval: 0.212- 0.983; P = 0.04).


The need for interventions to maintain patency and thrombosis rate was reduced with use of DCB compared with PTA at the 1-, 2-, and 3-year timepoints post index procedure for the treatment of dysfunctional AVF. At the 3-year timepoint, both DCB and PTA groups met the KDOQI targets for AVF interventions per year to maintain patency.

Number of target lesion interventions per fistula years
 IN. PACT AV DCBStandard PTA   
Target lesion interventionsNo. of eventsNo. of AVF yearsRate per AVF yearNo. of eventsNo. of AVF yearsRate per AVF yearRate ratio
[95% CI]
Rate difference [95% CI]P value
Through 180 days20279.12.5523075.33.060.84[0.69, 1.01]-0.49[-1.02, 0.04]0.069
Through 360 days263149.21.76302140.62.150.82[0.7, 0.97]-0.38[-0.7, -0.06]0.021
Through 720 days363266.81.36395245.41.610.85[0.73, 0.98]-0.24[-0.46, -0.03]0.023
Through 1080 days424343.01.24449303.71.480.84[0.73, 0.96]-0.24[-0.42, -0.06]0.009

AVF, arteriovenous fistula; DCB, drug-coated balloon; No, number; PTA, percutaneous transluminal angioplasty.