- Peripheral arterial occlusive disease patients treated with a paclitaxel-coated device for chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC) had higher long-term survival, freedom from major cardiovascular events and better amputation-free survival than a control group that received uncoated devices, a retrospective study utilizing German health insurance claims published Wednesday in the European Journal of Vascular and Endovascular Surgery found.
- The study's release comes about six months after FDA held an advisory committee meeting examining the safety of such devices after a meta-analysis published in the Journal of the American Heart Association found an increased risk of death associated with the use of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs.
- Data from nearly 38,000 patients were included, using claims between 2010 and 2018 from BARMER, Germany's second largest insurance fund. The study received funding from the German Joint Federal Committee. The study's main research group also gets funding from units of Bayer, B. Braun and the Foundation of the University Heart and Vascular Centre Hamburg.
Medical device manufacturers of paclitaxel-coated devices, including BD, Philips, Medtronic, Cook Medical and Boston Scientific, have maintained the safety profile of the devices outweigh the risks, arguing the late mortality signal is not present after taking into account additional data.
The new study, conducted by researchers at Research Group GermanVasc, Weill Cornell Medical College, Beth Israel Deaconess Medical Centre, University of Vermont Medical Centre and BARMER, may bolster manufacturers' argument.
"Interestingly, the results of the current study are inconsistent with the central findings and conclusions of a meta-analysis in 2018," the study authors wrote. "Higher rates of amputations following the application of paclitaxel coated devices possibly responsible for survival differences could not be confirmed. In addition, a delayed effect leading to long term differences was not observed."
Instead, the study found differences in survival that "were immediately noticeable one year after the index procedure."
But the study has limitations given it is a retrospective observational study, and "only a properly powered RCT would be suitable to confirm or refute the signal identified in the recently published meta-analysis," the authors acknowledged.
"It is possible that the experience of the centre performing the procedures and the follow up of those patients play a major role increasing the overall survival of the target population," they wrote. "Furthermore, information on specific devices, doses of paclitaxel delivered, or paclitaxel applied during coronary or cancer treatment could not be collected validly."
FDA is working with manufacturers to conduct new randomized controlled trials into the safety profile of paclitaxel-coated devices, the agency said in August.
Still, Art Sedrakyan, a healthcare policy and research professor at Weill Cornell Medical College and co-author the study, said on Twitter the research is a critical piece of evidence for FDA regulators to consider.
"The results of this study provide important information for physicians caring for patients with PAOD, which should be considered in addition to data from RCTs," the study authors wrote.