The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.This is a reasonable recommendation based on the paucity of data that exists to date. Look for new package inserts and for cardiologists contining their current treatments. Once formal recommendations are issued, some big trials like the SYNTAX trial, which compares stent therapy to cardiac bypass surgery for three-vessel and left main coronary disease, might need to change their consent forms and duration of clopidogrel (Plavix) therapy in the stent-treated arm.
For patients with drug-eluting stents, be sure to check with your doctor if additional Plavix and aspirin therapy are warranted in your case. Here is the FDA's "on-label" use for Boston Scientific's TAXUS stent (pdf file):
The TAXUS Express 2 Paclitaxel-Etuting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions < 28mm in length in native coronary arteries > 2.5 to < 3.75 mm in diameter.And for Cordis' Cypher stent (pdf file):
The CYPHER® Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length < 30 mm in native coronary arteries with a reference vessel diameter of > 2.5 to < 3.5 mm.Your doctor can help you sort this out and most patients will be just fine, but some may need slightly longer anti-platelet therapy with aspirin and clopidogrel (Plavix).