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Published on: July 9, 2020
IN.PACT AV Access Post-Approval Study of a Paclitaxel Drug-Coated Balloon for the Treatment of Dysfunctional
Sanjay Misra1, Clinton Atkinson2, Meghan Dermody3
1Division of Vascular and Interventional Radiology, Department of Radiology, Mayo Clinic, Rochester, Minnesota.
Insights
Drug-coated balloons (DCBs) demonstrated safety and effectiveness in treating arteriovenous fistula (AVF) lesions in hemodialysis patients. The study met its primary endpoint for serious infection rates, supporting DCB use for AVF interventions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Nephrology
Background:
- Arteriovenous fistulas (AVFs) are crucial for hemodialysis access.
- Lesions in AVFs can compromise dialysis efficacy and patient outcomes.
- Drug-coated balloons (DCBs) offer a potential treatment for de novo and restenotic AVF lesions.
Purpose of the Study:
- To evaluate the 12-month safety and effectiveness of DCB treatment for native AVF lesions.
- To assess serious infection rates and mortality in patients undergoing DCB treatment for AVFs.
- To determine the patency rates (target lesion primary patency and access circuit primary patency) following DCB intervention in AVFs.
Main Methods:
- Prospective, multicenter, single-arm IN.PACT AV Post-Approval Study.
- 159 participants (163 lesions) received DCB treatment.
- Primary endpoint: serious infection rate; Secondary endpoint: 12-month mortality; Ancillary endpoints: patency rates and reinterventions.
Main Results:
- The study met the primary endpoint with a 13.4% serious infection rate.
- All-cause mortality was 19.4% at 12 months.
- 12-month target lesion primary patency was 70.2% and access circuit primary patency was 52.6%.
Conclusions:
- DCB treatment for AVF lesions met the primary safety endpoint with a low serious infection rate.
- Achieved patency rates suggest durable effectiveness of DCBs in AVFs.
- Results support the safety and efficacy of paclitaxel DCBs for de novo and restenotic AVF lesions.
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.
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