Two trials paused after study linked paclitaxel-coated devices to late mortality
Two trials designed to test the use of drug-eluting devices in patients with peripheral artery disease (PAD) were halted soon after a meta-analysis linked paclitaxel-coated balloons and stents to a significantly increased risk of death beyond one year post-implantation.
That analysis, covered last week in Cardiovascular Business, found paclitaxel-coated devices were associated with similar survival rates as non-drug-eluting implants at one year. But at two years, the drug-coated devices were linked to all-cause death rates of 7.2 percent—a relative increase of 68 percent over the 3.8 percent observed in the control arm of the meta-analysis.
At five years, the crude death rates were 14.7 percent and 8.1 percent, respectively, for paclitaxel-coated devices versus the control group.
A week after these findings were published in the Journal of the American Heart Association, investigators from the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials announced they were suspending recruitment for their respective studies.
“Whilst the population of the reviewed trials differs from those in the BASIL-3 trial, it is clearly important new information that may cause concerns for the BASIL-3 trial in relation to patient safety,” the BASIL-3 investigators said in a statement issued Dec. 13. “As such, it raises the need to consider whether changes to the trial protocol and patient information are required. We have therefore decided to suspend recruitment to the trial, pending further discussions.”
The statement recommended participating centers continue to follow currently enrolled patients according to the study protocol but not recruit new patients into the trial.
Likewise, SWEDEPAD’s study management team met with its data safety monitoring committee and settled on a recommendation “to promptly pause further inclusion in both SWEDEPAD 1 and SWEDEPAD 2, ”which are studying amputation rates and health-related quality of life, respectively, for patients with PAD.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.