Speaker: Time to ‘move on’ from mortality-related concerns of paclitaxel-coated devices
Contemporary data suggest paclitaxel-coated devices do not elevate mortality risk in patients with peripheral artery disease, and they should be used more routinely, according to a speaker.
As Healio previously reported, a summary-level meta-analysis of pivotal trials of paclitaxel-coated devices published in December 2018 found elevated mortality risk associated with the devices compared with controls at 2 and 5 years in patients with PAD. Debate over the safety of the devices has continued since then.
“I would propose that the concerns of 3 years ago have been shown to be erroneous and largely attributable to ascertainment bias,” Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM, professor of radiology and surgery at Icahn School of Medicine at Mount Sinai and executive vice chairman in the department of diagnostic, molecular and interventional Radiology for the Mount Sinai Health System, said during a presentation at the International Symposium on Endovascular Therapy. “When you review contemporary data sets, this mortality risk is simply not being observed. We should largely move on from the concerns of 2018-19 and advocate for the best technology for our patients.”
Drug-coated devices are worth using in revascularization procedures for patients with symptomatic PAD, he said, because “every single prospective randomized trial of a drug-coated balloon with paclitaxel vs. control in the femoral artery has demonstrated superior clinical efficacy. This technology is consistently effective and superior to non-drug-based technology. It’s very difficult to discount that.”
Drug-coated balloons and stents are associated with 2-year target lesion revascularization rates of 10% to 15%, Lookstein said. “When I was in training 20 years ago, if you had told me that I would have a technology that had 85% freedom from target lesion revascularization at 2 years for my patients with symptomatic PAD, I would say you’re being overly optimistic, that would be a significant improvement on the existing clinical results. Yet we have this technology now available to all of our patients.”
The data that went into the controversial meta-analysis were more than 10 years old, but newer data with more thorough follow-up have not shown that paclitaxel-coated devices confer elevated risk for mortality, Lookstein said, citing 4-year data from the ILLUMENATE trial of a DCB (Stellarex, Philips), data with more than 3 years of follow-up from the VOYAGER PAD trial of drug-coated devices vs. uncoated devices, recent prospective and retrospective studies using data from the Vascular Quality Initiative database and aggregate data from Medicare and private insurance databases.
“The question should be that if you are truly advocating for your patients, is it appropriate to not offer drug delivery? It has been shown time and time again to have the highest benefit in terms of clinical outcomes,” he said.
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Lookstein R. CLI and Complex PAD. Presented at: International Symposium on Endovascular Therapy; Jan. 16-19, 2022; Hollywood, Florida (hybrid meeting).