J Vasc Interv Radiol. 2023 Jul 15:S1051-0443(23)00508-0. doi: 10.1016/j.jvir.2023.07.007. Online ahead of print.
ABSTRACT
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 (DCB) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA.
MATERIALS AND METHODS: Participants at 29 international sites were randomized 1:1 IN.PACT AV DCB (n=170): PTA (n=160). Outcomes through 36 months include target lesion and access circuit primary patency (TLPP, ACPP; composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and adverse events involving the access circuit.
RESULTS: TLPP was 52.1% in the DCB group compared to 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared to 28.6% in the PTA group through 36 months (both log-rank p<0.001). ACPP was 39.4% in the DCB group compared to 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared to 16.6% in the PTA group through 36 months (both log-rank p<0.001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared to 18.3% in the PTA group (log-rank p=0.040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared to 30.8% in the PTA group (log-rank p=0.71).
CONCLUSION: This study demonstrated superior TLPP and ACPP in DCB compared to PTA with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.
PMID:37460061 | DOI:10.1016/j.jvir.2023.07.007
