The FDA Panel on Drug-Eluting Stents - Day 1

Yesterday, in the first day of a 2-day meeting of the FDA's Circulatory Systems Devices Advisory Panel on drug-eluting stents (DES), the panel agreed unanimously that for on-label usage of DES, while there is an increased risk of late stent thrombosis (occlusion of the stent due to formation of a blood clot), there is no overall increase in risk for death or heart attack with DES as compared to bare metal stents. However, there is also no decrease in death or heart attack compared to bare metal stents.

On-label usages of DES accounts for less than half of DES placements.

Regarding the use of clopidogrel (Plavix) and aspirin after DES placement, the panel fell back on their mandate to only recommend changes to product labeling when there is clear data from randomized trials to support such changes. There are no randomized trials that were designed to answer this question. Thus, with the on-label usage of DES the panel recommended no real change to the FDA labeling of 3 months of Plavix after receiving a Cypher stent and 6 months after a Taxus stent - but they did support language from a recent American College of Cardiology/American Heart Association statement that patients ideally stay on Plavix and aspirin for up to a year unless the risk of bleeding is high.

The panel will take up the off-label usage of DES in their deliberations today.

For more on yesterday's meeting of the FDA panel, click here.