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Meta-analysis of paclitaxel-coated balloons in CLI ‘should have no meaningful impact’
A recent meta-analysis detecting a signal of harm at 1 year in patients with below-the-knee lesions treated with paclitaxel-coated balloons is flawed and should not impact clinical practice, a speaker said at the International Symposium on Endovascular Therapy.
“This analysis is very poorly constructed and conducted, and therefore should have no meaningful impact on this high-risk, in-need critical limb ischemia population, especially given the marked improvement in patency documented in the same manuscript,” William A. Gray, MD, system chief of cardiovascular services at Main Line Health and president of Lankenau Heart Institute in Wynnewood, Pennsylvania, said during a presentation.
As Healio previously reported, the meta-analysis found that in patients with below-the-knee lesions, treatment with paclitaxel-coated balloons conferred worse amputation-free survival at 1 year compared with treatment with uncoated balloons.
Despite that finding, the meta-analysis did not detect a difference in death (OR = 1.39; 95% CI, 0.94-2.07) or major amputations (OR = 1.39; 95% CI, 0.94-2.07) at 1 year, Gray said.
While the authors of the meta-analysis suggested a dose effect because the one study of a low-dose device did not show a relationship with mortality, the sample sizes were not large enough to support that theory, he said.
Also problematic is that the meta-analysis by the same group that began the paclitaxel-coated device controversy found a mortality signal at 2 years and 5 years, but not at 1 year, according to Gray.
“This brings the entire mechanistic explanation, which was already a tortured one, into even further question,” he said.
Other problems with the below-the-knee meta-analysis include mixing studies with 6-month and 1-year endpoints, including two studies that were not peer-reviewed, and not completely or accurately accounting for the loss to follow-up or withdrawals, Gray said.
In addition, “the uncoated balloon group is likely not paclitaxel-naive for the entirety of the analysis,” he said. “Paclitaxel device approvals in the EU and U.S. preceded all of the trial data.” – by Erik Swain
Reference:
Gray WA. Session 2: Improving Outcomes and Prognosis for Critical Limb Ischemia. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 22-25, 2020; Hollywood, Fla.
Disclosure: Gray reports he consults for Abbott Vascular, Boston Scientific, Cook Medical, Medtronic, Shockwave Medical and W.L. Gore and Associates, received research/grant support from Abbott Vascular, Boston Scientific, Intact Vascular, Shockwave Medical and W.L. Gore and Associates, and holds equity in Biocardia, Contego Medical and Silk Road Medical.