Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease

Paclitaxel-coated balloons and paclitaxel-eluting stents are intended to treat both new and recurring atherosclerotic lesions in the femoropopliteal artery (located in the upper leg). The balloon and stent work to mechanically open the blocked blood vessel. Paclitaxel is delivered from the balloon or stent to prevent scar tissue formation in the blood vessel that can re-narrow the artery.

Paclitaxel-coated balloons and stents have been shown to improve blood flow to the legs and decrease the need for repeat procedures to reopen blocked blood vessels.

The FDA issued a letter to health care providers on July 11, 2023, with recommendations for health care providers, that are also provided below.

Recommendations for Health Care Providers

Discuss the risks and benefits of all available PAD treatment options, including paclitaxel-coated devices, with your patients.
Continue routine monitoring of patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.
Report adverse events or suspected adverse events experienced by patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Clinical Evidence for Paclitaxel-Coated Devices

Based on the FDA's review of the totality of the available data and analyses, as described below, we have determined that the data does not support an excess mortality risk for paclitaxel-coated devices.

2018: A meta-analysis of randomized trials published in the Journal of the American Heart Association (JAHA) in late 2018 suggested an increased mortality rate beginning after two years in PAD patients treated with paclitaxel-coated balloons and stents compared to patients treated with control devices (non-coated balloons or bare metal stents). The specific cause for the increased late mortality risk has not been determined.

2019: The FDA notified health care providers of the potential late mortality safety signal in letters to health care providers on January 17, 2019 and March 15, 2019.

On June 19-20, 2019, the FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to discuss and make recommendations on the potential late mortality signal after treatment with paclitaxel-coated balloons and stents. The FDA's meta-analysis of long-term follow-up data from the pivotal premarket randomized trials for paclitaxel-coated devices used to treat PAD showed an increased risk of late mortality in study subjects treated with paclitaxel-coated devices compared to those treated with uncoated devices. The relative risk for increased mortality at five years was 1.57 (95% confidence interval 1.16 – 2.13).

The FDA updated its notification to health care providers on August 7, 2019. Based on the analysis and advisory panel recommendations, the FDA took additional steps including working with manufacturers on updates to device labeling and informed consent documents for ongoing clinical trials to incorporate information about the late mortality risk.

2019-2023: Since the Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting and the FDA's Letter to Health Care Providers on August 7, 2019, additional data from the RCTs has become available. The FDA has worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for new data generation.

Device manufacturers collaborated in an updated meta-analysis that included additional studies, more complete vital status information, and longer-term follow-up compared to prior studies. In these studies, patient follow-up ranged from 2 to 5 years, with data from most studies available out to 5 years. FDA clinicians and statisticians reviewed the study data and concluded that he updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.

The FDA also reviewed additional analyses of the mortality signal, including the SWEDEPAD trial interim analysis, the VOYAGER PAD study, the German BARMER Health Insurance study, the U.S. Veterans Health Administration study, and the Medicare SAFE-PAD study. None of these studies, with mean or median follow-up ranging from 1.7 to 3.5 years, found a late mortality safety signal associated with paclitaxel-coated devices. Longer-term follow-up in several of these studies is ongoing.

U.S. Food and Drug Administration

Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease

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Recommendations for Health Care Providers

Clinical Evidence for Paclitaxel-Coated Devices

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