Drug Coated Stent Proposed Guidelines Up for Public Comment
March 26th, 2008 amy
The long-awaited drug coated stents proposed guidelines have finally been posted by the FDA, following more than two years worth of concern that drug-eluting stents may cause deadly blood-clotting more often than bare metal stents.
Per the FDA,approximately one million U.S. patients undergo procedures to treat hardening or blockages of the heart arteries, a condition that can cause angina and heart attacks. Some 650,000 of these patients are treated with drug-eluting stents, a scaffolding device that is placed into the arteries to prop them open. Drug-eluting stents have a coating that slowly releases a drug to prevent the growth of scar tissue that may accumulate after the initial procedure opens the artery. Re-accumulation of scar tissue can mean additional procedures to keep arteries open and preserve adequate blood flow.
Categorized as both a drug and a device, drug coated stents have been in a special class of caution with many physicians since 2006. The American Journal of Medicine, in December of 2006, published a study which found blood clotting to be 4-5 times more likely to occur with drug eluting stents than with the older bare metal stents. While many researchers advised patients with drug coated stents to take anti-clotting drugs for as many as six months following the procedure, some doctors chose to stop using drug-eluting stents in hopes of sparing their patients’ lives.
The FDA invites public comment on the draft guidance for 120 days, after which time the guidelines will be revised and finalized.
