Paclitaxel-related mortality risk not observed in Medicare Advantage cohort
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In a retrospective, adjusted analysis of Medicare Advantage beneficiaries who underwent peripheral vascular interventions, there was no evidence of an elevated mortality risk due to paclitaxel-coated devices.
The data, presented by Eric A. Secemsky, MD, MSc, RPVI, FACC, FSCAI, FSVM, at a VIVA late-breaking clinical trials livestream, were consistent with previous analyses of Medicare beneficiaries.
As Healio previously reported, concern about long-term mortality risk posed by paclitaxel-coated devices used in patients with peripheral artery disease began after a summary-level meta-analysis of randomized controlled trials was published in December 2018. The FDA held a panel meeting on the issue and decided to allow the devices to remain on the market if manufacturers revised their labeling.
Secemsky, who is director of vascular intervention at Beth Israel Deaconess Medical Center, director of vascular research at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and assistant professor of medicine at Harvard Medical School, and colleagues analyzed via inverse probability of treatment weighting 16,796 Medicare Advantage beneficiaries (mean age, 73 years; 44% were women; 50.8% with critical limb ischemia) who underwent endovascular revascularization for PAD between April 2015 and December 2017. He said the researchers were blinded to the outcomes until after the weighting.
“It’s notable that patients who enroll in Medicare Advantage often have higher self-reported health status and cognitive function” compared with other Medicare beneficiaries, Secemsky said during his presentation. “This tends to be a healthier subgroup than the overall Medicare fee-for-service population.”
After a median follow-up of 2.66 years, in the weighted analysis, there was no difference in all-cause mortality between patients who had a procedure with a paclitaxel-coated device and patients who had one with an uncoated device (45.8% vs. 43.2%, respectively; adjusted HR = 1.03; 95% CI, 0.96-1.1), Secemsky said during his presentation.
Among patients who were treated with balloon angioplasty, 44.1% of those treated with a paclitaxel-coated balloon died during follow-up compared with 42% of those treated with an uncoated balloon (aHR = 1; 95% CI, 0.92-1.08), he said.
Among those treated with stents, 46.9% of those who received a drug-eluting stent died during follow-up compared with 44.8% of those who received a bare-metal stent (aHR = 1.02; 95% CI, 0.88-1.18), he said.
The results did not differ by age, sex, presence/absence of CLI, location of procedure or number of comorbidities, according to the researchers.
“An important question at the [FDA panel meeting] was whether low-comorbid patients might have less competing risks and more evidence of paclitaxel-related mortality, and we did not find any difference based on how many comorbidities you had in this analysis,” Secemsky said.
During a panel discussion following the presentation, Maureen P. Kohi, MD, associate professor of clinical radiology and chief of interventional radiology at the University of California, San Francisco, said it was notable that the analysis included 44% women, which “does substantiate the fact that we need more women in our primary investigational device exemption clinical trials if we want to make accurate assessments of long-term and mortality outcomes when it comes to the general population.”
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Secemsky EA, et al. Late-Breaking Clinical Trials Livestream. Presented at: VIVA; June 25, 2020 (virtual session).
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