Risks of Drug-Coated Stents Divide Federal Review Panel

There is growing evidence that relatively new drug-coated stents may increase the odds of deadly clots forming in the arteries. Many experts agree, however, that this does not mean the risks outnumber the benefits. A panel was called together to discuss the issues by the FDA. The group quickly decided that the increased clot formation was due mainly to two drug-coated stents, Taxus, from Boston Scientific, and Cypher, from Johnson & Johnson. Most of the group agrees that a longer trial will be needed to tell if the problem is significant. Many are worried that a longer trial may result in even more serious repercussions on patients. At the very least, the panel agrees that warnings should be issued on all of the products. I found this interesting because we had discussed drug coated stents briefly in biomechanics. Statistics show that drug-coated stents are twice as effective as normal stents. That makes it a very difficult decision to decide if the risks are worth the benefits.

http://www.nytimes.com/2006/12/08/health/08stent.html