“Ranger BTK” a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia

Abstract

Restenosis remains a limitation of endovascular angioplasty with a patency of 30% in BTK at 12 months. Several studies on drug-coated balloons have not demonstrated any improvements in terms of patency and target lesions revascularization in BTK lesions. This prospective single-centre cohort study evaluates the safety and efficacy of a new generation low-dose drug-coated balloon (DCB) with a reduced crystalline structure to treat below the knee (BTK) lesions in patients with critical limb ischemia (CLI). Between November 2016 and November 2017, 30 consecutive patients (mean 68.8\u2009±\u200912.7 years, 6 female) with BTK lesions and CLI were included in this single-centre, prospective non-randomized cohort study. All patients with rest pain and/or ischemic wound associated with BTK lesions were included in the study. Mean lesion length was 133.6\u2009±\u200994.5 mm and 18(60%) were chronic total occlusions. The primary safety outcome parameter was a composite of all-cause mortality and major amputation at 6 months. The primary efficacy outcome parameter was the primary angiographic patency at 6 months (defined as freedom from clinically driven target lesion revascularization and the absence of significant restenosis (>\u200950%) as determined by core laboratory angiography assessment. Immediate technical success, late lumen loss (LLL), clinical target lesion revascularization (TLR) and ulcer healing rates at 12 months were also evaluated. Immediate technical success was 97%(29/30): one patient had an acute thrombosis at the completion of index procedure. Primary safety outcome parameter was 94%(28/30): one patient underwent major amputation and one patient died of other comorbidities at 2 months. Another patient had a major amputation at 7.5 months. Angiographic follow-up was available in 20 patients. Primary angiographic patency was 57%(12/21 lesions), and LLL was 0.99\u2009±\u20090.68 mm at 6 months. Freedom from TLR was 89% at 12 months. The rate of ulcer healing was 76% at 12 months. Ranger DCB balloons to treat CLI patients demonstrated a positive trend with good safety outcomes parameters. Further randomized studies are needed to understand the usefulness compared to POBA