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Rodent Inferior Vena Cava Venoplasty Balloon Model
Published on: May 24, 2024
Randomized Controlled Study of Sirolimus-Coated Balloons for Dysfunctional Hemodialysis Fistulas
Chieh Suai Tan1, Ru Yu Tan1, Pei Ho2,3
1Department of Renal Medicine, Singapore General Hospital, Singapore.
Kidney International Reports
|June 15, 2026
Summary
Sirolimus-coated balloons (SCBs) significantly improved 6-month access circuit primary patency (ACPP) in patients with dysfunctional arteriovenous fistulas (AVFs). This intervention offers a promising solution for maintaining AVF function in hemodialysis patients.
Area of Science:
- Vascular Surgery
- Interventional Nephrology
- Medical Device Technology
Background:
- Restenosis after balloon angioplasty frequently causes arteriovenous fistula (AVF) dysfunction in hemodialysis patients.
- Maintaining AVF patency is crucial for effective hemodialysis access.
- Sirolimus-coated balloons (SCBs) are a potential therapeutic option to prevent restenosis.
Purpose of the Study:
- To evaluate the efficacy of sirolimus-coated angioplasty balloons (SCBs) in improving access circuit primary patency (ACPP).
- To assess the impact of SCBs on dysfunctional, nonthrombosed AVFs in patients undergoing maintenance hemodialysis.
Main Methods:
- A multicenter, single-blinded, randomized controlled trial involving 170 patients with dysfunctional AVFs.
- Patients received either plain balloon angioplasty (PBA) followed by SCB treatment or placebo balloons.
- The primary endpoint was ACPP at 6 months post-procedure; secondary endpoints included 12-month patency and safety.
Main Results:
- Six-month ACPP was significantly higher in the SCB group (70.1%) compared to the placebo group (56.7%) (P = 0.03).
- While 12-month patency showed a significant difference in per-protocol analysis (36.4% vs. 25.2%; P = 0.04), it was not significant in intention-to-treat analysis (37.1% vs. 27.7%; P = 0.07).
- Adverse events were infrequent, with no 30-day mortality in either group.
Conclusions:
- Sirolimus-coated balloons (SCBs) effectively improve 6-month ACPP in patients with dysfunctional AVFs, including those with multiple stenotic lesions.
- The short-term safety profile of SCBs in this context is reassuring.
- SCBs represent a valuable adjunct to PBA for enhancing AVF function and longevity.
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