Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fistula in hemodialysis patients.

BACKGROUND: To evaluate early and mid-term outcomes of Freeway paclitaxel-releasing balloons (Eurocor GmbH, Bonn, Germany) in hemodialysis patients with recurrent stenosis of arteriovenous fistula.

METHODS: Between July 2013 and December 2016 27 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a Freeway balloon. About inclusion criteria, all patients were previously treated at the target lesion with a standard balloon angioplasty (BA). The intervals in months between standard BA and procedure with DCB (time BA-DCB) and between procedure with DCB and new restenosis (time DCB-restenosis) were evaluated and compared with T-test. 2-year estimated outcomes in terms of survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis (TLR) were assessed with Kaplan-Meier curves.

RESULTS: Technical success was obtained in 96.3% of the cases. During the follow-up (mean duration 13.6 months, range 1-33) 13 patients (48.1%) had a new restenosis. Mean time BA-DCB was 4.8 months, and the mean time DCB-restenosis was 7.6 months with a statistically significant difference at T-test (P<0.001). Estimated 2-year rates of primary patency, primary assisted patency, secondary patency, and freedom from TLR were 31.8%, 76.4%, 90.5%, and 30.2%, respectively.

CONCLUSIONS: In our experience Freeway paclitaxel-releasing balloons were effective in the treatment of recurrent stenosis in hemodialysis patients previously treated with standard BA. At follow-up about half of patients had no new target lesion restenosis and the time to a new restenosis was much longer compared to recurrence of stenosis after standard BA.