Purpose: 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).
Materials and methods: Between November 2016 and November 2017, 30 consecutive patients (mean 68.8 ± 12.7 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 ± 94.5 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 (> 50%) 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.
Results: 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 ± 0.68 mm at 6 months. Freedom from TLR was 89% at 12 months. The rate of ulcer healing was 76% at 12 months.
Conclusion: 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.
Keywords: Below the knee; Critical limb ischemia; Drug eluting ballons.