%0 Journal Article
%T One
%A Bruno Trimarco
%A Donato Gerardi
%A Doncho Kotasov
%A Drago Zhelev
%A Eugenio Stabile
%A Fabio Magliulo
%A Giovanni Esposito
%A Giuseppe Giugliano
%A Kim Taeymans
%A Peter Goverde
%A Vassil Chervenkoff
%J Journal of Endovascular Therapy
%@ 1545-1550
%D 2019
%R 10.1177/1526602818823557
%X Purpose: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease. Methods: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-¦Ìm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1¡À10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0¡À41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2¡À41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2¡À30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0¡À39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ¡Ý2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. Results: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%. Conclusion: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials
%K balloon angioplasty
%K drug-coated balloon
%K drug-eluting balloon
%K femoropopliteal segment
%K in-stent restenosis
%K occlusion
%K paclitaxel
%K popliteal artery
%K stenosis
%K superficial femoral artery
%K target lesion revascularization
%U https://journals.sagepub.com/doi/full/10.1177/1526602818823557