Drug-Coated Devices: How Health Policy Drives Interventional Radiology Practice

Purpose: In December 2018, the Journal of the American Heart Association published a meta-analysis study that found an increased risk of death among patients treated with paclitaxel-coated devices. In June 2019, the Circulatory System Devices Panel of the US Food and Drug Administrations (FDA) Medical Devices Advisory Committee called for more data collection. We summarize the debate on safety of drug-coated endovascular devices and directions for interventional radiology advocacy related to peripheral arterial disease (PAD).

Materials and Methods: Systematic analysis of the FDA Medical Devices Advisory Committee meeting materials and electronic query of current literature related to drug-eluting stents and drug-coated balloons (DCBs) were performed.

Results: PAD affects more than 118 million people worldwide with percutaneous transluminal angioplasty (PTA) and stenting being the mainstream therapies. A 2014 premarket randomized clinical trials meta-analysis demonstrated paclitaxel-coated devices to offer strong clinical efficacy and a good safety profile in the femoropopliteal artery interventions. After the devices became FDA approved, new trials showed a concern for increased risk of amputations and mortality. Updated systematic review by Katsanos et al in 2018 showed an increased risk of late death after interventions with paclitaxel devices compared with uncoated devices. In March 2019, the FDA recommended limited use of DCBs only in patients at particularly high risk for restenosis. The FDA meeting panel concluded that a late mortality signal with the use of paclitaxel-coated devices was present, but multiple limitations in the available data exist, and additional clinical trials are needed. The indication of repeat femoropopliteal interventions was added for DCB use. A September 2019 study by Ouriel et al identified no mortality differences between DCB angioplasty and PTA as well as no dose–response relationships or clustering of causes of death.

Conclusions: Multiple studies demonstrate clinical superiority of the drug-eluting devices. A safety concern about an increased mortality rate in patients treated with DCBs arose during the analysis of several heterogeneous premarket studies and resulted in FDA recommendations for limited use of DCBs. Most recent safety studies do not support correlation between paclitaxel-coated devices and mortality rate. Support of further research and focused political advocacy are encouraged to maintain patients’ access to effective treatments.