Evaluating Intervention Rates for Dysfunctional Arteriovenous Fistulas: Post-hoc Analysis of the IN.PACT AV Access Trial.

RATIONALE &

OBJECTIVE

A key target of the Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 vascular access guidelines is to have ≤3 percutaneous or surgical interventions per year to maintain arteriovenous fistula (AVF) patency. We hypothesized that the number of interventions to maintain long-term AVF patency as conducted in a rigorous clinical trial could be adequately documented and compared against KDOQI targets and that the use of drug-coated balloons (DCB) could reduce the rate of thrombosis and interventions to maintain AVF patency more than the standard percutaneous transluminal angioplasty (PTA) with an uncoated balloon.

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 nonstented restenotic lesions enrolled between April 2017 and May 2018 in the United States, Japan, and New Zealand.

EXPOSURE: Patients were randomized to receive PTA with the IN.PACT AV DCB or a standard balloon.

OUTCOME: 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 visits. 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 standard PTA group (rate difference, -0.28 [95% CI, -0.47 to -0.08], P = 0.01). The access circuit thrombosis rate was 0.041 in the DCB group and 0.069 in the standard PTA group (rate difference, -0.028 [95% CI, -0.065 to 0.0082], P = 0.1).

LIMITATIONS: Exclusion of AVF with prior thrombosis and small sample size at 36 months.

CONCLUSIONS

Both DCB and standard 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 standard PTA through 36 months.