Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Aug;27(4):682-693.
doi: 10.1111/1744-9987.13966. Epub 2023 Jan 23.

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

Hiroaki Haruguchi  1 , Kotaro Suemitsu  2 , Naoko Isogai  3 , Masaaki Murakami  4 , Masahiko Fujihara  5 , Kazuhiro Iwadoh  6 , Jeremiah Menk  7 , Hiroko Ookubo  8 , Tomonari Ogawa  9 ; IN.PACT AV Access Investigators
Affiliations
Randomized Controlled Trial

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

Hiroaki Haruguchi et al. Ther Apher Dial. 2023 Aug.

Abstract

Purpose: There is a lack of adjudicated and prospectively randomized published outcomes on the use of drug-coated balloons (DCB) to treat dysfunctional arteriovenous fistula in Asian patients. This post hoc subgroup analysis of 112 Japanese participants from the global IN.PACT AV Access trial reports outcomes through 12 months.

Materials and methods: Participants were treated with DCB (n = 58) or standard non-coated percutaneous transluminal angioplasty (PTA) balloons (n = 54). Outcomes included target lesion primary patency (TLPP), access circuit primary patency, and safety.

Results: Through 6 months, TLPP was 86.0% (49/57) in the DCB group and 49.1% (26/53) in the PTA group (p < 0.001). Through 12 months, TLPP was 67.3% (37/55) in the DCB group and 43.4% (23/53) in the PTA group (p = 0.013).

Conclusion: In this post hoc analysis of Japanese participants from the IN.PACT AV Access trial, participants treated with DCB had higher TLPP through 6 and 12 months compared with PTA.

Keywords: balloon angioplasty; dialysis access; drug-coated balloon; hemodialysis fistula; randomized trial; renal failure.

PubMed Disclaimer

References

REFERENCES

    1. Jager KJ, Kovesdy C, Langham R, Rosenberg M, Jha V, Zoccali C. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int. 2019;96(5):1048-50.
    1. Nitta K. 2019 annual dialysis data report, JSDT renal data registry. Nihon Toseki Igakkai Zasshi. 2020;53(12):579-632.
    1. Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, et al. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis. 2020;75(4 Suppl 2):S1-S164.
    1. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689-99.
    1. Khawaja AZ, Cassidy DB, Al Shakarchi J, McGrogan DG, Inston NG, Jones RG. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis. J Vasc Access. 2016;17(2):103-10.

Publication types

Substances

Grants and funding

LinkOut - more resources