“Evolution of Drug-Coated Devices for the Treatment of Chronic Limb Threatening Ischemia”

Abstract

For patients with Chronic Limb Threatening Ischemia (CLTI), endovascular approaches to revascularization are often employed as a component of multimodality care aimed at limb preservation. However, patients with CLTI are also prone to treatment failure, particularly following balloon angioplasty alone. Drug-coated devices utilizing Paclitaxel were developed to decrease restenosis but have been primarily studied in patients presenting with claudication. In recent years, data have emerged which describe the efficacy of drug-coated devices in the treatment of patients with CLTI. Concurrently, there has been major controversy surrounding the use of drug-coated devices in peripheral arterial disease. A historical narrative of the development and use of drug-coated devices for peripheral arterial disease is presented, along with discussion of major trials. Evidence argues that paclitaxel-based therapies for peripheral arterial disease (PAD) do not increase mortality risk compared to nondrug-coated devices. In CLTI patients, paclitaxel-based balloons and stents provide superior patency and freedom reintervention compared to nondrug-coated devices when treating femoropopliteal disease. However, the use of Paclitaxel-based therapies for below-the-knee (BTK) interventions has not been shown to provide clinically meaningful outcomes compared to nondrug-based therapies. Newer generation antiproliferative agents (Sirolimus, Everolimus) and delivery systems (bioabsorbable scaffolds) hold promise for BTK interventions with early data suggesting decreased rates of major amputation or major adverse limb events.