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Evaluating Intervention Rates for Dysfunctional Arteriovenous Fistulas: Post-hoc Analysis of the IN.PACT AV Access
Anjana Gopal1, Hiroaki Haruguchi2, Andrew Holden3
1Department of Medicine, Division of Nephrology, University Health Network, Toronto, Ontario, Canada.
Insights
Drug-coated balloons (DCB) reduced interventions and thrombosis for arteriovenous fistula (AVF) patency compared to standard angioplasty. Both methods met KDOQI targets, demonstrating effective AVF maintenance.
Area of Science:
- Nephrology
- Vascular Surgery
- Interventional Radiology
Background:
- Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 guidelines recommend ≤3 interventions/year for arteriovenous fistula (AVF) patency.
- Drug-coated balloons (DCB) may offer improved outcomes over standard percutaneous transluminal angioplasty (PTA) for AVF maintenance.
Purpose of the Study:
- To evaluate if interventions for AVF patency in a clinical trial align with KDOQI targets.
- To compare the efficacy of DCB versus PTA in reducing thrombosis and reintervention rates for AVF maintenance.
Main Methods:
- Post-hoc analysis of the IN.PACT AV Access randomized clinical trial.
- Adult hemodialysis patients with AVFs and de novo or re-stenotic lesions were randomized to DCB or PTA.
- Intervention rates and thrombosis rates were calculated and compared to KDOQI 2019 targets over 36 months.
Main Results:
- Both DCB and PTA groups achieved KDOQI targets (≤3 interventions/year).
- The DCB group required fewer interventions for patency (1.39/AVF-year) versus PTA (1.66/AVF-year) (P=0.01).
- Access circuit thrombosis rates were lower in the DCB group (0.041) compared to PTA (0.069), though not statistically significant (P=0.1).
Conclusions:
- Both DCB and PTA effectively maintain AVF patency within KDOQI guidelines.
- DCB demonstrated a significant reduction in reinterventions and a trend towards lower thrombosis rates compared to PTA over 36 months.
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.
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