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IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical
Robert Lookstein1, Hiroaki Haruguchi2, Kotaro Suemitsu3
1Department of Diagnostic, Molecular, and Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
Drug-coated balloons (DCBs) significantly improved target lesion and access circuit patency in dialysis fistulas compared to standard angioplasty over 36 months. DCBs also reduced access circuit thrombosis, showing long-term benefits for hemodialysis access maintenance.
Area of Science:
- Vascular Surgery
- Interventional Radiology
- Nephrology
Background:
- Arteriovenous fistulas are crucial for hemodialysis access.
- Lesions in native upper extremity fistulas often require intervention.
- Drug-coated balloons (DCBs) offer a potential improvement over standard angioplasty.
Purpose of the Study:
- To report 36-month outcomes of the IN.PACT AV Access study.
- Compare drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) for fistula lesions.
- Evaluate target lesion and access circuit patency, reinterventions, and adverse events.
Main Methods:
- Prospective randomized trial with 330 participants.
- Randomization to IN.PACT AV DCB (n=170) or standard PTA (n=160).
- Assessment of target lesion primary patency (TLPP) and access circuit primary patency (ACPP) at 36 months.
Main Results:
- 36-month TLPP: 43.1% for DCB vs. 28.6% for PTA (P < .001).
- 36-month ACPP: 26.4% for DCB vs. 16.6% for PTA (P < .001).
- Lower access circuit thrombosis in DCB group (8.2% vs. 18.3%, P = .040).
Conclusions:
- DCBs demonstrate superior long-term patency compared to PTA for upper extremity fistula lesions.
- DCB treatment significantly reduces access circuit thrombosis.
- No significant difference in 3-year mortality between groups.
Purpose:
To present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA.
Materials And Methods:
Participants at 29 international sites were randomized 1:1 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit.
Results:
TLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P < .001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P < .001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P = .040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P = .71).
Conclusions:
This study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.
