Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive
Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.
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The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.
New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.
An expert advisory group set up by UK regulators has been given a few months to review the safety of paclitaxel-eluting balloons and stents in the treatment of patients with peripheral arterial disease, following a recent study that produced worrying results.