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More Bad News for Drug-Eluting Stents
Two studies published in the Journal of the American Medical Association show that the risk of heart attack or death is about doubled when drug-eluting stents are used off-label, reports Bloomberg News. One study showed that after one year, the complication rate (deaths, heart attacks, additional procedures required) was 17.5% for off-label patients, compared to 8.9% for on-label patients.
May 9, 2007
1 Min Read
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This is potentially significant because FDA estimates that drug-eluting stents are used off-label about 60% of the time (though the studies put that number closer to 50%). The other study didn't find much of a difference.That the procedure is riskier for patients with more complicated lesions than those used in the clinicial trials is not news. But there are now numbers to quantify that risk, and patients need to be aware of them. Unfortunately, the numbers from the one study will probably also be used as ammunition by the technology's detractors.
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