Please cite this article in press as: Kitrou PM, et al. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol (2014), http://dx.doi.org/10.1016/j.ejrad.2014.11.037 ARTICLE IN PRESS G Model EURR-6964; No. of Pages 6 European Journal of Radiology xxx (2014) xxx–xxx Contents lists available at ScienceDirect European Journal of Radiology j ourna l h om epage: www.elsevier.com/locate/ejrad Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472) Panagiotis M. Kitrou a,∗ , Konstantinos Katsanos b , Stavros Spiliopoulos a , Dimitris Karnabatidis a , Dimitris Siablis a a Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion 26504, Greece b Department of Interventional Radiology, Guy’s and St. Thomas’ Hospitals, NHS Foundation Trust, King’s Health Partners, London SE1 7EH, United Kingdom a r t i c l e i n f o Article history: Received 15 May 2014 Received in revised form 25 November 2014 Accepted 28 November 2014 Keywords: Drug-eluting balloons Dialysis Restenosis Neointimal hyperplasia a b s t r a c t Objective: To report the final results and cost-effectiveness analysis of a prospective randomized con- trolled trial investigating drug-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of failing dialysis access (NCT01174472). Methods: 40 patients were randomized to angioplasty with either DEB (n = 20) or BA (n = 20) for treat- ment of significant venous stenosis causing a failing dialysis access. Both arteriovenous fistulas (AVF) and synthetic arteriovenous grafts (AVG) were included. Angiographic follow up was scheduled every two months. Primary endpoints were technical success and target lesion primary patency at 1 year. Cumula- tive and survival analysis was performed. Incremental net benefit (INB) and incremental cost effectiveness ratio (ICER) were calculated and the cost-effectiveness acceptability curve (CEAC) was drawn. Results: Baseline variables were equally distributed between the two groups. At 1 year, cumulative target lesion primary patency was significantly higher after DEB application (35% vs. 5% after BA, p < 0.001). Overall, median primary patency was 0.64 years in case of DEB vs. 0.36 years in case of BA (p = 0.0007; unadjusted HR = 0.27 [95%CI: 0.13–0.58]; Cox adjusted HR = 0.23 [95%CI: 0.10–0.50]). ICER was 2198 Euros (D ) per primary patency year of dialysis access gained. INB was 1068D (95%CI: 31–2105D ) for a willingness-to-pay (WTP) threshold of 5000D (corresponding acceptability probability >97%). Conclusion: DEB angioplasty may be a cost-effective option that significantly improves patency after angioplasty of venous stenoses of failing vascular dialysis access. Further large-scale randomized trials are warranted. © 2014 Elsevier Ireland Ltd. All rights reserved. 1. Introduction Plain balloon angioplasty (BA) has been considered for years the method of choice for endovascular treatment of venous stenosis in failing arteriovenous fistula (AVF) or synthetic arteriovenous graft (AVG) dialysis access [1,2]. However, short-term restenosis lead- ing to increased re-intervention and access thrombosis events has limited its clinical efficacy [1]. In 2010, results from a multi-center randomized trial reported that self-expandable stent graft deploy- ment is a valid alternative that may outweigh traditional BA for the treatment of venous juxta-anastomotic stenosis of AVGs [3]. ∗ Corresponding author at: Patras University Hospital, Interventional Radiology Department, Patras P.C. 26500, Greece Tel.: +30 2613603218; fax: +30 2613603218. E-mail address: panoskitrou@gmail.com (P.M. Kitrou). Recently, percutaneous transluminal angioplasty using drug- eluting balloons (DEB) has been reported to inhibit neointimal hyperplasia and consequently reduce restenosis in the superficial femoral artery [4] and in coronary artery in-stent restenosis [5]. DEB technology is based on the combination of angioplasty and local drug delivery made possible through specially designed carri- ers applied on the balloon surface, that enable the adhesion and effective delivery of the cytotoxic drug on the vessel wall. The main advantage of DEB drug-delivery technology over drug-eluting stents is the inhibition of neointimal hyperplasia without the per- manent placement of a metallic mesh known to incite a continuous inflammatory and a chronic mechanical irritation to the vessel wall [6]. This motivated the authors to investigate DEB for angioplasty of failing dialysis access. Previously published interim 6-month outcomes of the present study have shown that DEB angioplasty resulted in significantly http://dx.doi.org/10.1016/j.ejrad.2014.11.037 0720-048X/© 2014 Elsevier Ireland Ltd. All rights reserved.