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Paclitaxel-coated balloons and stents are used to improve blood flow to the legs and decrease the likelihood of repeat procedures to reopen blocked blood vessels.
Medical device regulators around the world have been reviewing incidents associated with paclitaxel-coated products following the publication in December 2018 of a meta-analysis of randomised controlled trials in the Journal of the American Heart Association (JAHA).
The JAHA meta-analysis concluded there was increased risk of death following application of paclitaxel‐coated balloons and stents in the femoral and popliteal arteries of the lower limbs. It argued that further investigations were urgently warranted.
US Food and Drug Administration (FDA)
Following publication of the JAHA meta-analysis, the US Food and Drug Administration (FDA) disseminated a letter on 17 January 2019 to peripheral interventionalists and vascular medicine physicians alerting them to the issue. The FDA published a further update on 15 March 2019 alerting health care providers that a preliminary analysis had shown a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products compared to patients treated with uncoated devices. On 7 August 2019 the FDA published further information following its analysis of information provided to it at an advisory panel meeting in June 2019.
Since this time, on 11 July 2023 the FDA published further information following its review of the totality of the available data and analyses.
Collaboration in an updated meta-analysis that included additional studies, more complete vital status information, and longer-term follow-up compared to prior studies was performed. In these studies, patient follow-up ranged from 2 to 5 years, with data from most studies available out to 5 years. The study data concluded that the updated randomized controlled trials (RCTs) meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.
Additional analyses by the FDA of the mortality signal were also reviewed by international regulators, 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.
The FDA stated:
We have determined that the data does not support an excess mortality risk for paclitaxel-coated devices. The FDA previously communicated about this topic in 2019 and is now providing updated information.
Medicines and Health products Regulatory Agency (MHRA)
The Medicines and Health products Regulatory Agency (MHRA) in the United Kingdom has also undertaken a review of the issue. Its expert advisory committee has provided advice in relation to further published recommendations for ongoing use on 4 June 2019. Their advice includes:
- Not to use these devices in routine treatment of patients with intermittent claudication
- Use these devices in patients with critical limb ischaemia is an appropriate option in accordance with NICE guidance;
- Assess the relative risks on an individual patient basis
- Ensure informed consent includes a risk-benefit discussion regarding the uncertainty in long-term outcomes; and
- Patient follow-up should be life-long.
Therapeutic Goods Administration (TGA)
There are currently 10 paclitaxel-coated products included in the Australian Register of Therapeutic Goods (ARTG) and the TGA has undertaken an appraisal of the JAHA meta-analysis and its methodology, along with other recent studies and meta-reviews.
Review of the TGA’s data of adverse events in Australia have not shown a signal like the one described by the FDA. Adverse events reported to the TGA associated with these devices relate mostly to balloon and stent deployment issues. Most events occurred on the day of implantation and there have been no deaths reported.
Recommendations
The TGA recommends that health care providers:
- Continue to make treatment decisions based on the individual patient’s needs.
- Continue monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents as per required follow up.
- When making treatment recommendations, ensure educated informed consent as part of standard process.
- Discuss the risks and benefits of all available peripheral arterial disease (PAD) treatment options with your patients.
- 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.[1]
Footnotes
| [1] | https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting |
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What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
Disclaimer
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.