The meta-analysis that suggested there was a link between paclitaxel-coated devices and heightened mortality compared to bare devices was described as a “typhoon in a teapot” at this year’s EuroPCR meeting, according to a report from MedScape.
Dr. Alexandra Lansky of Yale University School of Medicine, who authored the organization’s formal statement on the matter, reportedly questioned the findings of the meta-analysis at the EuroPCR meeting, pointing out that multiple analyses have since failed to replicate the results of the meta-analysis with drug-coated balloons.
“So, the position is that currently there is no strong evidence for a mortality signal,” she said, according to MedScape.
Lansky also said that the methods employed in the meta-analysis have limitations, like limited long-term data; the study reported more than 80% loss of patients at four to five years.
The meta-analysis, which was published in the Journal of the American Heart Association in December last year, prompted investigators for multiple trials to stop their studies.
Led by Dr. Konstantinos Katsanos, researchers examined data from 28 trials and found a 68% relative risk increase in all-cause death with paclitaxel-coated devices after two years and a 93% relative risk increase after five years compared to therapy with an un-coated balloon.
In March, the FDA told doctors that a preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices.
But the agency also urged doctors to interpret these data with caution.
Lansky echoed that ultimately doctors will make the call about what’s best for their patients. Until the field has more robust data to prove otherwise, “there is no strong evidence to justify changing clinical practice and clinicians should continue to use best judgment,” she said.