One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry

Abstract

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-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 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±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 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.

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

“…Twenty-six studies, 12 retrospective and 14 prospective, fulfilled the inclusion criteria (Table 1). 9,10,35–58 A total of 2108 CLTI patients (mean age 71.3±4.4 years; 67% men) who were treated with DCB for peripheral atherosclerotic lesions were analyzed. Major risk factors were hypertension (91%, 1339/1478), diabetes (69%, 1138/1642), dyslipidemia (63%, 1101/1756), smoking (46%, 799/1754), coronary artery disease (41%, 602/1,468), and end-stage renal disease (26%, 389/1490).…”

“…9,10,35,37,41,49,52,53,56,58 During 12-month follow-up in 11 studies, 9,35,37,40,41,49,50,53,55,56,58 82% (95% CI 76% to 87%; I 2 =73.7%) of the lesions remained patent, while the pooled TLR rate was 11% (95% CI 7% to 15%; I 2 =57.8%) in 12 studies. 9,10,35,40–42,50,52,53,55,56,58 The pooled incidences of all-cause mortality in 12 studies 9,10,36,41,42,47,49,50,52,53,56,58 and major amputation in 13 studies 9,10,37,40–42,47,49,50,52,53,56,58 at the end of follow-up were 8% (95% CI 5% to 13%; I 2 =75.9%) and 7% (95% CI 3% to 14%; I 2 =89.6%), respectively. Three studies 40,41,49 reported complete wound healing and ulcer reg...…”

“…Twenty-six studies, 12 retrospective and 14 prospective, fulfilled the inclusion criteria (Table 1). Twenty-one studies 9,35,[38][39][40][41][42][43]45,46,[48][49][50][51][52][53][54][55][56][57][58] provided information regarding the antiplatelet regimen prior to and after the endovascular therapy. In most studies, dual antiplatelet therapy (DAPT) was prescribed after the endovascular repair for at least 1 to 3 months and after that point aspirin was primarily prescribed as single, lifelong antiplatelet therapy.…”

“…For 16 studies 9,10,[35][36][37][40][41][42]44,49,50,52,53,55,56,58 the primary target lesion was in the femoropopliteal segment (n=1315), while the other 10 studies 38,39,43,[45][46][47][48]51,54,57 involved the infrapopliteal arteries (n=793). In 11 studies with data about inflow/outflow disease, these nontarget lesions were treated at the discretion of the operator using standard techniques.…”

“…The overall procedural success of DCB angioplasty was 98% (95% CI 95% to 100%; I 2 =87.7%) based on data from 16 studies. 9,10,35,38,39,[47][48][49][50][51][52][53][55][56][57][58] In 13 studies (918 patients) reporting adverse event data, 9,10,35,41,42,45,47,49,[51][52][53]56,58 DCB angioplasty was complicated by thrombosis/distal embolization in 1.2% (n=11), local hematoma in 5.9% (n=54), and residual dissection in 24% (n=220) of the cases. An iatrogenic perforation (n=3) and pseudoaneurysms at the access site with extravasation of contrast (n=3) were also observed.…”