Ample published data from from large, observational datasets, randomized-controlled trial (RCT) subgroup analyses and long-term follow-up from pivotal paclitaxel-coated device RCTs have not been able to replicate an association between such devices and mortality, an expert analysis recently published online by the American College of Cardiology (ACC) concludes.
The commentary—entitled “An update on the late mortality signal associated with paclitaxel-coated devices—delved into the “far-reaching” consequences of the meta-analysis by Konstantinos Katsanos, MD, of the University of Patras, Patras, Greece) and colleagues that was published in the Journal of the American Heart Association (JAHA) in December 2018. Katsanos et al found an increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery in their systematic review and meta‐analysis of RCTs.
The ACC expert analysis authors, Anna Katherine Krawisz, MD and Eric Alexander Secemsky, MD, reference the numerous studies that failed to demonstrate an increase in mortality among patients treated with paclitaxel-coated devices compared with those treated with non-coated devices—including one in the Society for Vascular Surgery’s Vascular Quality Initiative (VQI) registry.
“In summary, since the publication of the Katsanos meta-analysis, there has been ample data published or presented from large, observational datasets, subgroup analyses from RCTs, and long-term follow-up from the pivotal PCD RCTs,” they write. “None of these studies has been able to replicate an association between [paclitaxel-coated devices] and mortality.
“Furthermore, several studies have now analyzed causes of death in patients who were treated with [paclitaxel-coated] versus non-[paclitaxel-coated devices] and have not found significant differences between groups.
“Lastly, no clear mechanism relating paclitaxel to death has been described, and a dose-response relationship between paclitaxel and mortality has not been established. As this controversy is now approaching two years, the vascular community awaits next steps from the [Food and Drug Administration] and other regulatory bodies in determining the long-term future of [paclitaxel-coated devices].”