ORIGINAL ARTICLE   

Italian Journal of Vascular and Endovascular Surgery 2017 June;24(2):35-40

DOI: 10.23736/S1824-4777.17.01282-7

Copyright © 2017 EDIZIONI MINERVA MEDICA

language: English

Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: results of a randomized clinical trial

Lodewijk J. ROOSEN ¹ ✉, Yusuf KARAMERMER ², Jan A. VOS ³, Gijs M. de JONG ⁴, Willem J. BOS ⁵, Otto E. ELGERSMA ¹

¹ Department of Radiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands; ² Department of Radiology, Jeroen Bosch Hospital, Den Bosch, The Netherlands; ³ Department of Radiology, Antonius Hospital, Nieuwegein, The Netherlands; ⁴ Department of Nephrology, Albert Schweitzer Hospital, Dordrecht, The Netherlands; ⁵ Department of Nephrology, Antonius Hospital, Nieuwegein, The Netherlands

BACKGROUND: Fistula failure is frequently caused by stenosis. Percutaneous transluminal angioplasty (PTA) has a poor patency, as it induces intima hyperplasia and hence recurrent stenosis. Paclitaxel-coated balloons (PCB) have shown good results in treating stenosis in coronary and lower extremity arteries compared to conventional balloon angioplasty (CBA). This study compares secondary patency rates of PCB to CBA in recurrent stenosis in haemodialysis fistula.
METHODS: In this multicenter trial 34 patients with recurrent stenosis in their fistula were randomized for either CBA (N.=18) or PCB (N.=16). Follow-up interval was set 3, 6, 9 and 12 months with duplex ultrasonography. Primary endpoints were occlusion, re-stenosis grade >50% or blood flow measurements <600 mL/min. Reintervention was planned within two to seven days.
RESULTS: One patient was lost in follow up. One patient in the PCB group had an early complication with thrombosis of the fistula due to an allergic reaction to the contrast agent. Another patient had a subtotal occlusion a few hours after intervention. The cause was not entirely clear. 5 patients reached their endpoint prematurely by the cause of death. In this total group of 34 patients no beneficial effects were seen in the PCB group. The primary patency defined as the target lesion revascularization (TLR) free interval in this group was 130 days compared to the mean TLR free interval for CBA of 189 days (P=0.197).
CONCLUSIONS: Our study does not support the use of paclitaxel coated balloons to prevent recurrent stenosis in hemodialysis fistulae.

KEY WORDS: Angioplasty, balloon - Paclitaxel - Renal dialysis - Hyperplasia