In response to the updated letter to healthcare providers from the US Food and Drug Administration (FDA), the Society for Vascular Surgery (SVS) released a letter from SVS president Michel Makaroun and Kim Hodgson, chair of the SVS paclitaxel safety task force and president-elect of the SVS. The Society formed the paclitaxel safety task force earlier this year.
The SVS letter states that since their initial communication announcing the formation of the task force, “two additional developments regarding paclitaxel-delivering devices have prompted this member update.”
The developments are outlined as the following:
- Two recent industry notifications indicate that data contrary to previous reports throw additional doubt on results
- After their own preliminary analysis of long-term follow-up data from the IDE trials revealed a similar mortality signal, the FDA issued a recommendation that surgeons consider “alternative treatment options” to paclitaxel devices for most peripheral arterial disease (PAD) patients until the science is further clarified. That communication came just two months after the FDA had advised no significant changes in clinical practice other than close surveillance and discussing the issue with patients.
The letter continues: “As previously communicated, the SVS is concerned about the recent publication in the Journal of the American Heart Association suggesting higher rates of two- and five-year mortality in patients with PAD treated with paclitaxel-delivering devices.
“As you may recall, several weeks ago the Society announced a new SVS Paclitaxel Safety Task Force, whose mission is to facilitate the performance and interpretation of an individual patient data (IPD) meta-analysis using patient-level, randomised controlled trial data from our industry partners.
“While the decision of how to treat is always up to the physician, the cloud over paclitaxel has darkened with these new findings and advisories. At bare minimum a documented discussion with the patient and a detailed description of the perceived benefits of a paclitaxel device are prudent if one is to be used in this climate.
“Given the conflicting conclusions about a paclitaxel dose effect, even proceeding but choosing a lower dose device seems unsubstantiated.
“The SVS continues to believe that only an independent patient data meta-analysis—as we are planning—will yield the conclusive answers we need. We remain troubled by the recent reports of re-analyses of existing datasets, pooled analyses of randomised controlled trials and other ‘series,’ as we believe that the findings of these statistically inferior analyses bring no additional clarity, cannot be relied upon for guidance and distract us from the analysis that needs to be performed.
“While debate about a possible mechanism for, or even existence of this effect continues, knowledgeable trialists have concluded that clarification will only be possible by performance of such an IPD meta-analysis of combined trial data. We will keep you apprised of our progress in this endeavour.”