Objective: To report the efficacy and safety of a drug-coated balloon (Ranger, Boston Scientific) in patients with dysfunctional autogenous arteriovenous fistula.
Methods: In this investigator-initiated, prospective observational cohort study, 25 participants with dysfunctional arteriovenous fistula were enrolled from January 2018 to June 2019. The drug-coated balloon was applied after successful vessel preparation by high-pressure balloon angioplasty. The primary endpoint was the target lesion primary patency rate at 6 months. The secondary outcome included anatomical and clinical success rate, postoperative major adverse events within 30 days, and the target lesion primary patency rate at 12 months. Statistical analysis of the data was performed. The χ test or Fisher's exact test was used for analyzing categorical variables, and continuous variables were analyzed using Student's t-test. Also, Kaplan-Meier analysis was used to evaluate the target lesion primary patency days with the log-rank test.
Results: At 6 months, the target lesion primary patency rate was 68% in the drug-coated balloon treatment group. The anatomical and clinical success rates were 100%. One patient had thrombosed access 10 days after the index procedure, and two died of cardiovascular events 4 months after the operation. Subgroup analysis showed that the early recurrent stenosis group had non-inferior mean drug-coated balloon primary patency days (less than 90 days after prior percutaneous angioplasty, n = 10) compared with the late recurrence group (prior PTA patency days more than 90 days, n = 10), 179.3 ± 102.9 versus 257.1 ± 71 days (p = 0.153). DCB angioplasty had significant improvement in primary patency days for early recurrent stenosis (67.7 ± 19.3 vs 179.3 ± 102.9, p < 0.001).
Conclusions: The results demonstrated the appliance of Ranger DCB in stenotic AVFs is a safe and effective treatment modality, especially for early recurrent AVF stenosis.
Keywords: Paclitaxel-coated balloon; arteriovenous fistula; balloon angioplasty; endovascular treatments; hemodialysis access.