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Questions Surrounding Drug-Coated Stents Persist

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Patients who received drug-coated stents after a heart attack are nearly five times more likely to die within 6 to 24 months afterwards when compared to patients who received older “bare metal” stents according to a recent study presented at the European Society of Cardiology meeting in Vienna last week. This study analyzed 2,300 patients in 14 countries who are included in the GRACE Registry and noted a mortality rate of 8.6% after 6 months.

Dr. Steg, a Paris cardiologist involved in the study, hypothesized that the higher death rate shown may be attributable to the differences in the amount of time required for re-endothelisation and healing after placement of a stent. This process occurs within weeks or only a few months with bare metal stents. The process takes much longer with drug-eluting stents, which may result in improper positioning of the drug-coated stents over time leading to the formation of blood clots (or late-stent thrombosis).

Johnson & Johnson (manufacturer of the Cypher drug-coated stent) and Boston Scientific (manufacturer of the Taxus drug-coated stent) both criticized the study as being inconsistent with their own studies and others published recently, including a Swedish study presented at the same conference. The authors of this latest study urged cardiologists to use caution in choosing drug-eluting stents for their patients until data from long-term studies is available. Apparently some of these warnings are being heeded, as sales for drug-coated stents have fallen precipitously in the past few months as safety concerns emerged. Both of these manufacturers reported a 25% decrease in sales of drug-coated stents for the first quarter of 2007.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.