Meeting Planned To Discuss Drug-Eluting Device Death Risk
Executive Summary
Two trials of paclitaxel-coated devices to treat peripheral arterial disease have been halted in recent weeks due to reports the devices were tied to a higher mortality risk. Endovascular physician group VIVA is organizing a February meeting to discuss the issue. Two trials of paclitaxel-coated devices to treat peripheral arterial disease have been halted in recent weeks due to reports the devices were tied to a higher mortality risk. Endovascular physician group VIVA is organizing a February meeting to discuss the issue.
You may also be interested in...
‘Alarming’ Paclitaxel-Coated Device Findings Trigger UK Safety Probe
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.
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.
SCAI, Manufacturers Defend Peripheral Paclitaxel Devices Against Doubts
The Society for Cardiovascular Angiography and Interventions’ Vascular Disease Council says the recent meta-analysis finding a higher long-term mortality risk with paclitaxel-eluting peripheral devices can only be viewed as hypothesis-generating. The long-term risks of these devices should be investigated with patient-level data, SCAI argues. Several clinical data presentations at the recent LINC meeting in Leipzig showed comparable mortality rates with paclitaxel-eluting devices as comparable non-drug-eluting devices.