SCAI RESPONDS TO FDA PANEL FINDINGS WITH ADVISORY ON DRUG-ELUTING STENTS

The Society for Cardiovascular Angiography and Interventions (SCAI), an international group representing invasive and interventional cardiologists, released a clinical alert Jan. 11 advising physicians on the steps they can take to reduce the risk of late thrombosis, or clotting, from the use of drug-eluting stents.

The document follows hearings held by the FDA's Circulatory Systems Device Panel last month on that risk. The panel concluded that more clinical trials are needed to determine the degree of actual risk, and that off-label use of the devices may need to be restricted in patients with certain conditions.

SCAI's clinical alert has been published online in the group's journal, Catheterization and Cardiovascular Interventions. The alert focuses on the importance of careful patient selection, meticulous stent implantation and consistent use of medications to prevent the delayed formation of blood clots.