The following statement has been issued by the SVS:
ROSEMONT, Ill., March 6, 2019 – The Society for Vascular Surgery (SVS), the premier scientific organization devoted to the treatment of vascular disease, is concerned about a recent article in the Journal of the American Heart Association suggesting higher rates of two- and five-year mortality in patients with peripheral arterial disease (PAD) treated with paclitaxel delivering devices.
Clarification of data is a matter of critical importance to our patients afflicted with vascular disease, the physicians who treat them and our industry partners who develop and market these devices.
As such, the SVS has established a Task Force on Paclitaxel Safety to evaluate all available data related to paclitaxel use in patients with PAD.
Led by SVS President-Elect Dr Kim Hodgson, the task force is soliciting the participation of all industry partners who have conducted randomized controlled trials of paclitaxel devices in patients with PAD in a “mega” analysis of combined patient-level data.
“Only with this enhanced statistical analysis can a valid answer be found for surgeons and patients,” said Dr. Hodgson. “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.”