Paclitaxel Versus Plain Balloon Angioplasty Compared in Treatment of Symptomatic Central Venous Stenosis in Dialysis Access
June 14, 2017—Results from a randomized controlled trial comparing the clinically assessed intervention-free period (IFP) of paclitaxel-coated balloon (PCB) angioplasty versus conventional balloon angioplasty (CBA) for the treatment of symptomatic central venous stenosis in dialysis access were published by Panagiotis M. Kitrou, MD, et al in Journal of Vascular and Interventional Radiology (JVIR; 2017;28:811–817).
Forty dialysis patients (19 with arteriovenous fistulas [AVFs] and 21 with arteriovenous grafts [AVGs]) were enrolled within a period of 20 months. The patients were randomized to undergo angioplasty using either a PCB (n = 20; 14 men; age, 56.7 years) or CBA (n = 20; 15 men; age, 57 years). There were 15 restenotic lesions in the PCB group and 12 in the CBA group. In 25 of the 40 cases, patients had a previous ipslateral catheter insertion. The primary endpoint was the clinically assessed IFP of the treated segment at 6 months, and secondary endpoints included complication rates during the follow-up period and identification of factors influencing the IFP.
In JVIR, the investigators reported that the median IFP was significantly better in the PCB group versus CBA group (179 days vs 124.5 days; P = .026). The mean follow-up period was 180 days (range, 5–479 days). There was no significant difference between AVGs and AVFs (P = .17), treatment of de novo versus restenotic lesions (P = .33), or previous catheter insertion (P = .21). No complications were observed. In restenotic lesions in the PCB group, longitudinal comparison between treatments also showed a significant difference in favor of PCB treatment versus CBA (median IFP, 177 vs 91 days; P = .01).
In this prospective study, the PCB group had significantly better results compared with the CBA group in terms of treatment for symptomatic central venous stenosis in dialysis access. Furthermore, retrospective longitudinal comparison of the treatments in the same patients also showed a significant difference in favor of PCBs, concluded the investigators in JVIR.