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A Prospective Multicenter Randomized Controlled Trial for Comparing Drug-Coated and Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Arteriovenous Grafts

  • Clinical Investigation
  • VENOUS INTERVENTIONS
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts.

Materials and Methods

This prospective, multicenter, randomized clinical trial enrolled 190 patients with venous anastomotic stenosis in arteriovenous grafts at five participating hospitals. During pre-dilation, 4 patients dropped out due to ruptures requiring further treatment (n = 2) and residual stenosis of > 30% (n = 2). On successful pre-dilation with a 7 mm conventional balloon, patients were randomized to undergo either a 7 mm drug-coated balloon (n = 94) or conventional balloon angioplasty (n = 92).

The primary out-come measure was target lesion primary patency at 3 and 6 months. The secondary out-come measures included target lesion primary patency at 12 months and access circuit primary patency at 6 and 12 months, clinical and technical success rates, and 12-month mortality differences between the groups.

Results

The target lesion primary patency and access circuit patency rates at 3 and 6 months were significantly higher in drug-coated balloon angioplasty group as compared to conventional balloon angioplasty group. The technical and clinical success rates were 100% for both the groups. As a procedure-related complication, anastomotic site rupture occurred during pre-dilation in 4 cases. The number of deaths during the 12-month follow-up was one for each group. The number of early thrombotic events (at < 3 months) was significantly higher in the drug-coated balloon group (p = 0.002).

Conclusion

Drug-coated balloon angioplasty was more effective and safer for the treatment of dysfunctional arteriovenous grafts compared to conventional balloon angioplasty.

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Acknowledgements

Authors thank SH Kwon and HJ Noh (nephrologists) for their help in the follow-up of the patients. We also thank SH Park for statistical advice and support.

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Authors and Affiliations

  1. Department of Radiology, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, 59 Daesagwan-gil, Hannam-dong, Yongsan-gu, Seoul, 04401, South Korea

    Dong Erk Goo & Yong Jae Kim

  2. Department of Radiology, Konkuk University Hospital, Konkuk University College of Medicine, Seoul, Korea

    Sang Woo Park

  3. Department of Radiology, Seoul St Mary’s Hospital, Catholic University College of Medicine, Seoul, Korea

    Ho Jong Cheon

  4. Department of Radiology, Uijeongbu St Mary’s Hospital, Catholic University College of Medicine, Uijeongbu, Korea

    You Dong Won

  5. Department of Radiology - Intervention Division, Nowon Eulji University Hospital, 68 Hangeul biseok-ro, Nowon-gu, Seoul, 01830, Korea

    Seung Boo Yang

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  1. Dong Erk Goo
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  3. Sang Woo Park
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Contributions

DE Goo and SW Park were in charge of the study conception and design. Material preparation and data collection were performed by DE Goo, YJ Kim, SW park, HJ Cheon, YD Won, and SB Yang. The first manuscript was written by DE Goo and SW Park, and all authors read and approved the final manuscript.

Corresponding author

Correspondence to Dong Erk Goo.

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Conflict of interest

This study was financially supported by Medtronic.

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Goo, D.E., Kim, Y.J., Park, S.W. et al. A Prospective Multicenter Randomized Controlled Trial for Comparing Drug-Coated and Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Arteriovenous Grafts. Cardiovasc Intervent Radiol 47, 36–44 (2024). https://doi.org/10.1007/s00270-023-03536-5

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  • DOI: https://doi.org/10.1007/s00270-023-03536-5

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