SVS Establishes Task Force on Paclitaxel Safety

 

March 6, 2019—The Society for Vascular Surgery (SVS) announced the creation of a Task Force on Paclitaxel Safety to evaluate all available data related to paclitaxel use in patients with peripheral artery disease (PAD). SVS President-Elect Kim Hodgson, MD, will lead the task force.

According to SVS, the task force is requesting the participation of all industry partners who have conducted randomized controlled trials of paclitaxel devices in patients with PAD for what is described as a “mega” analysis of combined patient-level data.

The task force was created because of concerns raised in a study published on December 6, 2018, that suggested that there were higher rates of 2- and 5-year mortality in patients with PAD treated with paclitaxel-delivering devices.

In the SVS announcement, Dr. Hodgson stated, “Only with this enhanced statistical analysis can a valid answer be found for surgeons and patients. This report has created uncertainty about the safety of what has been considered ground-breaking technology. We need to analyze all the data collectively to get valid answers, as single-trial analyses are inadequate."

For links to all of Endovascular Today's coverage and other key documents on the continuing discussion regarding paclitaxel in PAD, please visit this page.

 

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