IN.PACT AV Access Post-Approval Study of a Paclitaxel Drug-Coated Balloon for the Treatment of Dysfunctional Arteriovenous Dialysis Circuits.

PURPOSE: To report the 12-month safety and effectiveness data of a drug-coated balloon (DCB) for the treatment of de novo or restenotic (nonstented) lesions in native arteriovenous fistulae (AVFs) in patients requiring hemodialysis.

MATERIALS AND

METHODS

The IN.PACT AV Post-Approval Study is a prospective, multicenter, single-arm study conducted in the United States. In the primary cohort, 159 eligible participants (163 lesions) received DCB treatment at 15 sites and are included in this analysis. The primary endpoint was the serious infection rate through 12 months, including pneumonia but excluding coronavirus disease 2019, relative to a 30% performance goal. The secondary endpoint was 12-month mortality. Ancillary endpoints included, but were not limited to, target lesion primary patency (TLPP), access circuit primary patency (ACPP), and reinterventions through 24 months. An angiographic core laboratory adjudicated reinterventions and an independent Clinical Events Committee adjudicated events.

RESULTS

The study met the primary endpoint with a serious infection rate of 13.4% (95% CI, 8.9%-20.1%) through 12 months. All-cause mortality was 19.4% (14.0%-26.5%). TLPP and ACPP through 12 months were 70.2% (61.8%-77.1%) and 52.6% (44.0%-60.5%), respectively. Means of 0.6 (± 1.0 SD) and 0.7 (± 1.1 SD) interventions were required within 12 months to maintain target lesion patency and access circuit patency, respectively, with a target lesion revascularization rate of 38.9% (31.4%-47.5%).

CONCLUSIONS

The primary endpoint was met with a low serious infection rate. The TLPP and ACPP outcomes showed the durability of DCB treatment for AVFs. Results support the safety and effectiveness of paclitaxel DCBs for treating de novo and restenotic AVF lesions.