Ep. 470 Updated Guidance on Paclitaxel-Coated Devices with Dr. Sahil Parikh and Dr. John Park

The use of drug-coated balloons (DCBs) for peripheral arterial disease has been controversial in the past. However, new data and updated FDA guidance have helped these devices regain popularity. In this episode of the BackTable Podcast, Dr. Ally Baheti hosts a discussion with Dr. Sahil Parikh, an interventional cardiologist in New York City, and Dr. John Park, a vascular surgeon in Omaha. --- CHECK OUT OUR SPONSOR BD Lutonix https://www.bd.com/en-us/products-and-solutions/products/product-families/lutonix-drug-coated-balloon-pta-catheters --- SYNPOSIS They 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. --- TIMESTAMPS 00:00 - Introduction 02:14 - History of DCB and Controversy 07:46 - Updated Research and 2023 FDA Guidelines 16:44 - Importance of Collaboration and Patient Preference 26:34 - DCB Treatment Algorithms 33:31 - Drug-Eluting Stents 35:46 - Approach for Patients with Claudication 37:22 - DCB Sizing and Dose --- RESOURCES Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials (2018): https://www.ahajournals.org/doi/10.1161/JAHA.118.011245 FDA- Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality–Letter to Health Care Providers (2018): www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting FDA- Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health Care Providers (2023): https://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis (2023): https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02189-X/abstract