The document is the work of the Multi-Specialty and Multi-Society Coalition for Patient Safety With Paclitaxel Technologies, which includes three leading vascular surgical membership bodies: the Society for Vascular Surgery (SVS), the Vascular and Endovascular Surgery Society (VESS), and the Society for Clinical Vascular Surgery (SCVS).

The US Food and Drug Administration (FDA) tasked the coalition with putting together bullet points that reflect the current evidence around the hot topic of paclitaxel devices.

The American College of Cardiology, American College of Radiology, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, and the Society of Interventional Radiology make up the remainder of the membership bodies on the coalition.

“The coalition bullet points reflect the current evidence surrounding this complex topic and is designed to help institutions and members to use when discussing increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents,” the coalition stated.

“The statements are intended to summarise the current state of the evidence and to serve as starting points for discussion. We recognise this is a complex issue and the talking points and are not intended to take the place of thoughtful, individualised discussions with patients.

“The ability to effectively communicate risk and benefit of revascularisation is key part of procedure selection. Please consider the following statement in your discussions and informed consent process.” The document follows in full.

Peripheral vascular intervention talking points for informing patients about the paclitaxel safety signal

A recent meta-analysis of randomised trials suggests an increased mortality rate after two years in peripheral artery disease (PAD) patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal disease compared to patients treated with uncoated balloons or bare metal stents. The FDA recommends that physicians discuss the risks and benefits of all available treatment options with their PAD patients.

To this end, a Multi-Specialty Paclitaxel Coalition (American College of Cardiology, American College of Radiology, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society of Interventional Radiology, Society for Vascular Surgery, Vascular and Endovascular Surgery Society, and the Society for Clinical Vascular Surgery), representing the majority of specialists who evaluate and treat patients with PAD, developed the following talking points, which have been reviewed by the FDA, that physicians/providers may consider when discussing PAD treatment options with their patients:
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