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Real-world studies show no mortality signal related to paclitaxel-coated devices
Unlike with meta-analyses of randomized controlled trials, seven real-world studies of patients with peripheral artery disease have shown no long-term mortality signal related to use of paclitaxel-coated devices, a speaker said at the International Symposium on Endovascular Therapy.
“There is no difference in survival following treatment with drug-coated vs. non-drug-coated devices in unadjusted and adjusted analyses in seven real-world population studies,” Eric A. Secemsky, MD, MSc, RPVI, FACC, FSVM, director of vascular intervention in the CardioVascular Institute at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, said during a presentation.
He provided results from seven real-world studies — five from the United States and two from Germany — of patients with PAD treated with drug-coated or uncoated devices. The only drug-coated devices approved for PAD treatment in the U.S. use paclitaxel.
In the first of three analyses of patients from CMS databases, among 16,560 Medicare beneficiaries who had femoropopliteal artery revascularization in 2016, during a median of 389 days, the mortality rate was 32.5% in those who received drug-coated devices and 34.3% in those who received uncoated devices (adjusted HR = 0.97; 95% CI, 0.91-1.04), Secemsky said.
In the second CMS analysis, of 51,546 patients admitted for peripheral artery revascularization with a drug-eluting stent or a bare-metal stent between December 2012 and November 2015, during a median follow-up of 2 years, the mortality rate was 51.7% in the DES group and 50.1% in the BMS group (aHR = 0.98; 95% CI, 0.93-1.03), he said.
In the third CMS analysis, of 152,473 Medicare beneficiaries who had femoropopliteal artery revascularization between 2015 and 2017 followed for a median of 799 days, those treated with a drug-coated device had a lower mortality rate than those treated with an uncoated device (weighted analysis, 44.7% vs. 46.1%; aHR = 0.94; 95% CI, 0.93-0.96), according to Secemsky, who noted the findings were similar when the analysis was restricted only to those who would likely have qualified for a randomized trial.
In the OPTUM cohort of 20,536 patients with private insurance or Medicare Advantage treated for PAD with devices between 2015 and 2017, the mortality rates at a median follow-up of 763 days were virtually identical between those treated with drug-coated (14.85%) and uncoated devices (14.94%; HR = 1.09; 95% CI, 0.98-1.22), he said.
A propensity-matched cohort derived from nearly 7,000 patients from the Vascular Quality Initiative did not suggest an elevated mortality risk in patients with PAD treated with drug-coated devices compared with those who had other treatments, and there was also no such signal observed in two cohorts from patients in BARMER health insurance data in Germany, he said.
“Well-conducted large observational studies demonstrate no mortality signal,” Secemsky said. “There was also no difference in survival in subgroups.”
The SAFE-PAD study involving CMS data is being designed with input from the FDA to evaluate ongoing risk, and will include follow-up for at least 5 years and sensitivity analyses to evaluate the influence of unmeasured confounding, he said. – by Erik Swain
Reference:
Secemsky EA. Session 4. Late-Breaking and Hot Topics in Endovascular Therapy. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 22-25, 2020; Hollywood, Fla.
Disclosure: Secemsky reports he consults for BD/Bard, Cardiovascular Systems Inc., Cook Medical, Medtronic and Philips, received grant/research support from AstraZeneca, BD/Bard, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Medtronic and Philips, and serves on the speakers bureau for BD/Bard, Cook Medical and Medtronic.