Randomized Controlled Study of Sirolimus-Coated Balloons for Dysfunctional Hemodialysis Fistulas

Restenosis following balloon angioplasty remains a major cause of arteriovenous fistula (AVF) dysfunction in patients receiving maintenance hemodialysis. We evaluated whether the use of sirolimus-coated angioplasty balloons (SCBs) improves access circuit primary patency (ACPP) in patients with dysfunctional, nonthrombosed AVFs.

In this investigator-initiated, multicenter, single-blinded, randomized controlled trial (ClinicalTrials.gov identifier: NCT04409912), we enrolled 170 patients from 3 tertiary teaching hospitals in Singapore. Patients with dysfunctional AVFs, including those with single or multiple stenotic lesions within the access circuit, were included. Following successful plain balloon angioplasty (PBA) (< 30% residual stenosis on digital subtraction angiography), the patients were randomly assigned, using a centralized web-based system, to receive additional treatment with SCB (n = 83) or placebo balloons (n = 87). During the 12-month follow-up, the patients and their managing physicians were blinded to the study treatment and placebo. The proceduralists and coordinators could not be blinded because of visible differences between the balloons. The primary end point was ACPP during the first 6 months after the index procedure. Secondary end points included 12-month patency and safety outcomes.

In both intention-to-treat (ITT) and per-protocol (PP) analyses, 6-month ACPP was significantly higher in the SCB group than in the placebo group (P = 0.03). At 6 months, 70.1% (95% confidence interval [CI]: 58.7-78.8) of patients treated with SCB remained patent, compared with 56.7% (95% CI: 45.5-66.4) in the placebo group. At 12 months, the difference in patency was not statistically significant in the ITT analysis (37.1% vs. 27.7%; P = 0.07) but remained significant in the PP analysis (36.4% vs. 25.2%; P = 0.04). Adverse events were infrequent and no deaths occurred within 30 days in both groups.

Use of SCB following successful PBA improved 6-month ACPP in patients with dysfunctional AVFs, including those with multiple stenotic lesions. Short-term safety findings were reassuring.