Drug Coated Balloons vs. Conventional Balloon Angioplasty for Bypass Vein Graft stenosis – A Randomized Controlled Trial

Abstract

Introduction - Stenosis and restenosis are known complications of endovascular treatment of native arteries and bypass vein grafts in peripheral arterial disease (PAD). (1,2) This may lead to loss of the bypass graft, which can be a problem due to the limited availability of autologous vein material. Drug-coated balloons seem to be effective in the treatment of native artery stenosis (3). The biomechanical and anatomical properties of vein grafts differ greatly from native arteries, and less is known about the potential of drug-coated devices in this field. One randomized trial did not demonstrate benefit from use of DCBs over BA in bypass vein grafts. (4) Similar results were observed in a retrospective study comparing BA to DCB in peripheral grafts (5). The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of vein graft stenoses. Design: Single-center, parallel, randomized controlled trial. Block randomized by sealed envelope 1:1. Methods - 60 patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to drug-coated balloon (DCB) (n=30) or standard balloon angioplasty (BA) (n=30). Follow-up was 1 year. Primary outcome measures were target lesion revascularization (TLR) and graft occlusion. Primary assisted patency and secondary patency were also assessed. Results - 57 cases were ultimately included in the study. 3 randomized cases were excluded due to primary technical failure (graft rupture during predilatation and bail-out stenting (N=2), aborted procedure (N=1)). Six patients died during follow-up (DCB 4, BA 2) and one patient underwent major amputation (BA group). 23 patients underwent re-revascularization of the same segment (DCB 10/29, 34.5 % vs. BA 13/28, 46.4 %, p=0.333). The overall TLR-rate at one year was 34.5 % and 46.4 % in the DCB and BA groups respectively (p=0.33). 5/57 (8.8 %) grafts occluded during the follow-up, 1/29 (3.4 %) and 4/28 (14.3 %) in the DCB and BA groups respectively (p=0.36). Secondary patency was 100 % in the DCB group compared to 89.3% in the BA group (p=0.076). In subanalysis including only de novo lesions TLR was significantly lower in grafts that were treated with DCB compared to BA (15 % vs. 18.9 %, P=0.03). Conclusion - There is a trend toward benefit from DCBs in the treatment of graft stenosis; this difference is significant in previously untreated lesions. There has been hesitation towards using drug-coated balloons as a first choice in the treatment of graft stenosis. Our results suggest that this hesitation might be unfounded, especially in de novo lesions. More data is needed to accurately select which lesions will benefit from DCBs. Furthermore; histological studies on paclitaxel uptake and response in the arterialized venous wall are warranted.