Updated Guidance on Paclitaxel-Coated Devices

The doctors review the historical controversy surrounding the potential late-mortality risks associated with Paclitaxel-coated devices, discuss more recent literature on the safety and efficacy of DCBs, and examine the implications of the FDA’s updated guidance in 2023. This update was made possible through collaborative efforts across specialties and regulatory bodies to establish best practices for vascular interventions. They also delve into patient selection criteria, lesion characteristics, and practical considerations for choosing between DCBs and other revascularization options. Each provider shares their treatment algorithm for DCB use in peripheral arterial disease.

Dr. Park uses DCBs as a first-line treatment for patients with complete occlusions, CLTI symptoms, or lifestyle-limiting claudication, with adjunctive stenting sometimes required afterwards. In his experience, DCBs work best in lesions shorter than 100 mm and are preferable in locations where stenting is not feasible, such as across the knee joint.

Dr. Parikh similarly prefers DCBs over plain balloon angioplasty and places stents in longer lesions. He notes that Hunter’s canal is a challenging area to treat with DCBs alone and may require atherectomy or intravascular lithotripsy. He recommends considering drug-eluting stents as a proactive measure to prevent more costly interventions for future restenosis.