IN.PACT AV access randomized trial: Japan cohort outcomes through 12 months

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Nephrology

Background:

• Dysfunctional arteriovenous fistulas (AVF) pose challenges in hemodialysis access.
• Limited data exists on drug-coated balloons (DCB) for AVF treatment in Asian populations.
• The IN.PACT AV Access trial provides a global perspective on DCB efficacy.

Purpose of the Study:

• To evaluate the efficacy of DCB versus percutaneous transluminal angioplasty (PTA) in Japanese patients with AVF.
• To analyze target lesion primary patency (TLPP) and safety outcomes.
• To address the lack of prospective, randomized data in this specific demographic.

Main Methods:

• A post hoc subgroup analysis of 112 Japanese participants from the IN.PACT AV Access trial.
• Randomized treatment with DCB (n=58) or standard PTA balloons (n=54).
• Assessment of TLPP, access circuit primary patency, and safety up to 12 months.

Main Results:

• At 6 months, TLPP was 86.0% for DCB vs. 49.1% for PTA (p<0.001).
• At 12 months, TLPP remained significantly higher for DCB at 67.3% vs. 43.4% for PTA (p=0.013).
• No specific safety concerns were highlighted in the abstract.

Conclusions:

• DCB treatment resulted in superior TLPP compared to PTA in Japanese AVF patients.
• The findings support the use of DCB for treating dysfunctional AVF in this population.
• This analysis contributes valuable data to the existing body of evidence on DCB efficacy.