Use of the Ranger Paclitaxel-Coated Balloon in Patients With Chronic Limb-Threatening Ischemia: Short-Term Safety and Efficacy Results From Singapore

Abstract

Chronic limb-threatening ischemia, also known as critical limb ischemia (CLI), is the most advanced stage of peripheral arterial disease (PAD), and patients have high risk of major lower-limb amputation and mortality. An endovascular-first approach has become the preferred revascularization strategy for these patients. The aim of the study was to evaluate the safety and short-term efficacy of the Ranger paclitaxel-coated balloon (PCB; Boston Scientific) in the setting of CLI. Methods. This was a single-center, single-arm, multi-investigator, prospective study of CLI patients who underwent endovascular revascularization using the Ranger PCB from July 2019 to November 2019 at Singapore General Hospital in Singapore. Data were retrieved from the Vascular Quality Initiative database recently set up at this institution. Primary lesion patency, amputation-free survival (AFS), freedom from target-lesion revascularization (TLR), and complete wound healing were the efficacy endpoints of interest at 6 months post intervention. Results. A total of 84 patients (87 limbs; 229 lesions) were enrolled. Fifty-one of the 84 patients (60.7%) were men. Baseline characteristics included diabetes mellitus in 76/84 patients (90.5%), chronic renal impairment in 25/84 patients (29.8%), and Rutherford category 6 foot wounds in 22/87 limbs (24.7%). TASC D lesions were present in 63/229 lesions (27.9%) and moderate/severe vessel wall calcification was present in 167/229 lesions (72.9%). Immediate technical success was achieved in 218/229 lesions (95.2%) with no device-related mortality at 30 days. Primary patency rates at 3 months and 6 months were 76/82 (92.7%) and 69/81 (85.2%), respectively. Six-month primary patency rates of below-the-knee (BTK) lesions treated with and without Ranger balloons were 89/94 (94.7%) and 34/41 (82.9%), respectively (P=.03). Six-month AFS occurred in 68/78 (87.2%) and freedom from TLR occurred in 73/81 (90.1%). Six-month complete wound healing rate was respectable, at 28/50 (56.0%). Conclusion. Use of the Ranger PCB showed favorable outcomes and short-term patency rates, especially in the BTK region, in what is an otherwise challenging patient cohort. Extended follow-up is awaited to evaluate the long-term safety and efficacy of the balloon.