Enhancing drug-coated balloon outcomes in infrapopliteal artery disease: a clinical overview of retrievable scaffold therapy

Chronic limb-threatening ischemia resulting from infrapopliteal artery disease is associated with a high risk of limb loss and mortality. Endovascular treatments such as percutaneous transluminal angioplasty, drug-coated balloons (DCBs), and bare metal stents have demonstrated suboptimal long-term outcomes in this challenging patient population. Spur is an innovative retrievable scaffold therapy (RST) designed to improve the efficacy of DCB angioplasty in infrapopliteal lesions by providing acute mechanical support and facilitating improved drug delivery, without leaving a permanent implant. This review examines the current limitations of existing treatments for infrapopliteal disease, summarizes the evidence from three prospective clinical trials using RST, and illustrates the use of the device with two case reports. These studies consistently demonstrated that vessel preparation using RST prior to DCB provided high primary patency rates with a low risk of major amputation and target lesion reintervention over mid-term follow-up. While these findings compare favorably with previous studies of endovascular therapy for infrapopliteal artery disease, future randomized trials with RST are necessary to confirm these benefits.