IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months

• Published in: Journal of vascular and interventional radiology Vol. 34; no. 12; pp. 2093 - 2102.e7
• Main Authors: Lookstein, Robert, Haruguchi, Hiroaki, Suemitsu, Kotaro, Isogai, Naoko, Gallo, Vincent, Madassery, Sreekumar, Misra, Sanjay, Wang, Hong, Roffe, Phally S, Holden, Andrew
• Format: Journal Article
• Language: English
• Published: United States 01-12-2023
• Subjects: Angioplasty, Balloon - adverse effects; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease - diagnostic imaging; Peripheral Arterial Disease - therapy; Popliteal Artery; Prospective Studies; Single-Blind Method; Thrombosis - diagnostic imaging; Thrombosis - etiology; Thrombosis - therapy; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
• ISSN: 1051-0443; 1535-7732
• DOI: 10.1016/j.jvir.2023.07.007

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.
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.
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).
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.