Factors associated with early and late losses of primary patency following drug-coated balloon for dysfunctional arteriovenous fistula.

OBJECTIVE: This study aimed to evaluate the effectiveness of a drug-coated balloon (DCB) for the treatment of dysfunctional arteriovenous fistulas (AVFs) and to identify the risk factors associated with early and late losses of primary patency following DCB in real-world practice.

METHODS: This multicenter, retrospective study included 407 patients (72 ± 11 years, 64.1% males) with dysfunctional AVFs (juxta-anastomotic lesion location in 58.7% of cases, mean size 1.2 mm, mean length 54 mm) who underwent DCB for the first time for the treatment of dysfunctional AVF. The primary outcome measure was the loss of primary patency after DCB. The secondary outcome measures were the factors associated with early (<90 days) and late (⩾90 days) losses of primary patency after DCB.

RESULTS: The primary patency rates 6 and 12 months after DCB were 72.5% ± 2.3% and 40.1% ± 2.7%, respectively. The factors associated with the early loss of primary patency were de novo lesions (adjusted hazard ratio [HR], 7.91; [95% confidence interval (CI), 1.90-32.97]; p = 0.005), endovascular treatment (EVT) history within the previous 90 days (adjusted HR, 9.29; [95% CI, 3.09-27.92]; p < 0.001) and juxta-anastomotic stenosis (adjusted HR, 0.30; [95% CI, 0.13-0.70]; p = 0.005). The factors associated with a late loss of primary patency included EVT history within the previous 90 days (adjusted HR, 2.52; [95% CI, 1.89-3.38]; p < 0.001) and pre-dilation balloon size (adjusted HR, 1.99; [95% CI, 1.50-2.64]; p < 0.001).

CONCLUSIONS: DCB is an effective device to prolong the patency of dysfunctional AVFs in most cases. De novo lesions and their locations were associated with an early loss of primary patency, whereas the vessel preparation balloon size was associated with a late loss of primary patency. EVT history within the previous 90 days was associated with early and late losses of primary patency.