There's no question that there has been a flurry of media coverage related to drug-eluting stents (DES) over the past six months. In the fall of 2006, the FDA issued an initial statement related to concerns about new data that suggested a small, but significant increased risk of stent thrombosis (clotting) in patients who have been treated with cardiovascular DES. While the new data raised important questions, the Agency did not have enough information to draw any substantial conclusions. In early December of 2006, the FDA’s Circulatory Systems Devices Advisory Panel met with goals of providing a forum for the presentation of related clinical data and addressing the appropriate duration of medicinal therapy in DES patients (aspirin plus clopidogrel). Panel members and speakers included interventional and non-interventional cardiologists, cardiovascular surgeons and the manufacturers of the two approved DES products, Boston Scientific and Cordis. (Photo: TAXUS® Express²™ Paclitaxel-Eluting Coronary Stent System, Source: Boston Scientific)
The Panel had the following recommendations regarding DES when they are used in accordance with their approved indications:
