The Society for Vascular Surgery (SVS), the premier scientific organisation devoted to the treatment of vascular disease, is concerned about a recent article in the Journal of the American Heart Association (JAHA) by Konstantinos Katsanos et al 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 patients afflicted with vascular disease, the physicians who treat them and our industry partners who develop and market these devices, the SVS states in a press release.
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 randomised 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,” says Hodgson. “This report has created uncertainty about the safety of what has been considered ground-breaking technology. We need to analyse all the data collectively to get valid answers, as single trial analyses are inadequate.”