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

BackTable Vascular & Interventional

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.

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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.

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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

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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