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

Abstract

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. Single-center, parallel group, randomized controlled trial. Block randomized by sealed envelope 1:1. 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 1 year. Primary outcome measure was target lesion revascularization. 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 1 year, 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 193 days after the drug-coated balloon and balloon angioplasty, respectively (p = 0.06). 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.