A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access.

Objective: Previous studies on arteriovenous fistulas have demonstrated the potential benefit of drug coated balloons (DCBs) in maintaining the patency of dialysis access. However, stenoses involving stent grafts were excluded from these studies. Therefore, the aim was to evaluate the effectiveness of DCBs in treating stent graft stenosis.

Methods: This was a prospective, single blinded, randomised controlled study. From March 2017 to April 2021, 40 patients with dysfunctional vascular access owing to stent graft stenosis were randomised to treatment with a DCB or conventional balloon. Clinical follow up was scheduled at one, three, and six months, and angiographic follow up was performed six months after the intervention. The primary outcome was angiographic late luminal loss at six months, and secondary outcomes included target lesion and access circuit primary patency at six months.

Results: Thirty-six participants completed follow up angiography. The DCB group had a superior mean late luminal loss at six months compared with the control group (1.82 mm ± 1.83 mm vs. 3.63 mm ± 1.08 mm, respectively, p = .001). All 40 patients completed clinical follow up. The DCB group had a superior six month target lesion primary patency compared with the control group [hazard ratio (HR) 0.23, 95% confidence interval (CI) 0.07 - 0.71; p = .005). Additionally, the DCB group had a numerically higher six month access circuit primary patency rate than the control group, although the difference was not statistically significant (HR 0.54, 95% CI 0.26 - 1.11, p = .095).

Conclusion: Conventional balloon angioplasty is not durable in stent graft stenosis treatment. Treatment with DCBs provides less angiographic late luminal loss and potentially superior primary patency of the target lesion than treatment with conventional balloons. [ClinicalTrials ID: NCT03360279.].