Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas : A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study)

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Björkman , P , Weselius , E -M , Kokkonen , T , Rauta , V , Alback , A & Venermo , M 2019 , ' Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas : A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study) ' , Scandinavian Journal of Surgery , vol. 108 , no. 1 , pp. 61-66 . https://doi.org/10.1177/1457496918798206

Title: Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas : A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study)
Author: Björkman, P.; Weselius, E. -M.; Kokkonen, T.; Rauta, V.; Alback, A.; Venermo, M.
Contributor: University of Helsinki, Clinicum
University of Helsinki, Verisuonikirurgian yksikkö
University of Helsinki, Nefrologian yksikkö
University of Helsinki, Verisuonikirurgian yksikkö
University of Helsinki, Verisuonikirurgian yksikkö
Date: 2019-03
Language: eng
Number of pages: 6
Belongs to series: Scandinavian Journal of Surgery
ISSN: 1457-4969
URI: http://hdl.handle.net/10138/314799
Abstract: Background and Aims: Stenosis due to intimal hyperplasia and restenosis after initially successful percutaneous angioplasty are common reasons for failing arteriovenous fistulas. The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of arteriovenous fistula stenosis. Design: Single-center, parallel group, randomized controlled trial. Block randomized by sealed envelope 1:1. Materials and Methods: A total of 39 patients with primary or recurrent stenosis in a failing native arteriovenous fistulas were randomized to drug-coated balloon (n=19) or standard balloon angioplasty (n=20). Follow-up was 1year. Primary outcome measure was target lesion revascularization. Results: In all, 36 stenoses were analyzed; three patients were excluded due to technical failure after randomization. A total of 88.9% (16/18) in the drug-coated balloon group was revascularized or occluded within 1year, compared to 22.2% (4/18) of the stenoses in the balloon angioplasty group (relative risk for drug-coated balloon 7.09). Mean time-to- target lesion revascularization was 110 and 193days after the drug-coated balloon and balloon angioplasty, respectively (p=0.06). Conclusions: With 1-year follow-up, the target lesion revascularization-free survival after drug-coated balloon-treatment was clearly worse. The reason for this remains unknown, but it may be due to differences in the biological response to paclitaxel in the venous arteriovenous fistula-wall compared to its antiproliferative effect in the arterial wall after drug-coated balloon treatment of atherosclerotic occlusive lesions. Trial registration: ClinicalTrials.gov NCT03036241
Subject: Arteriovenous-access
drug-coated balloons
neointimal hyperplasia
paclitaxel
dialysis fistula
restenosis
ELUTING BALLOON
RESTENOSIS
INJURY
INFLAMMATION
HYPERPLASIA
EXPERIENCE
ARTERIES
FAILURE
GRAFTS
3126 Surgery, anesthesiology, intensive care, radiology
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