Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Dialysis Access: Results from a Randomized Controlled Trial.

PURPOSE: To compare the clinically-assessed intervention-free period (IFP) of paclitaxel-coated balloon (PCB) vs conventional balloon angioplasty (CBA) for the treatment of symptomatic central venous stenosis (CVS) in dialysis access.

MATERIALS AND METHODS: Within 20 months, 40 dialysis patients (19/40 arteriovenous fistulae [AVFs] and 21/40 arteriovenous grafts [AVGs]) were randomized to undergo angioplasty either with a PCB (PCB group, n = 20; 14/20 male; age: 56.7) or CBA (CBA group, n = 20; 15/20 male; age: 57). There were 15/20 restenotic lesions in PCB group and 12/20 in CBA group. In 25/40 cases, patients had an ipslateral catheter insertion in the past. Primary endpoint was clinically-assessed intervention-free period (IFP) of the treated segment at 6 months, while secondary endpoints included complication rates during follow-up period and identification of factors influencing IFP.

RESULTS: Median IFP was significantly better in PCB group (PCB group: 179 days, vs CBA group: 124.5 days, P = .026). Mean follow-up period was 180 days (range, 5-479). There was no significant difference between AVGs and AVFs (P = .17), treatment of de novo vs restenotic lesions (P = .33), or prior presence of catheter insertion (P = .21). No complications were observed. In restenotic lesions in PCB group, longitudinal comparison between treatments also showed a significant difference in favor of PCB treatment (median IFP in PCB* group 177 vs 91 days in CBA* group; P = .01).

CONCLUSIONS: In this prospective study, PCB had significantly better results compared with CBA for the treatment of symptomatic central venous stenosis in dialysis access. Retrospective longitudinal comparison of treatments in the same patients also showed a significant difference in favor of PCBs.