Friday, December 08, 2006

Issues with drug coated stents

In another chapter in the stent wars, the New York Times wrote on Dec. 8 about current issues with drug-coated stents:

After presentations Dec. 7 from the two companies [J&J, Boston Scientific] and a handful of other researchers, panel members disagreed about how strong the evidence was that the delayed clotting risk was a serious problem compared with the risks of using older, less expensive bare metal stents. Overall death and heart attack rates for the clinical trial patients were so low and so similar for the two groups after four years that the experts said much bigger and longer trials would be needed to answer the questions from the Food and Drug Administration.


The biggest concern for some panelists was whether the late clotting risk would continue for as long as patients had the drug-coated stents. What looks like no disadvantage at four years could become a major one over time in that case.

“I’ve seen nothing to date to suggest the problem goes away,” said Dr. Steven Nissen, a panel member who is head of the cardiovascular division of the Cleveland Clinic.


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