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Bare Metal and Drug Eluting Stents Compared

A study published last week in the New England Journal of Medicine compared to the utility of drug coated and bare metal stents used for off label indications. The primary finding was that there was no difference in outcomes following one year of follow-up.

Researchers from the University of Pittsburgh Graduate School of Public Health evaluated data collected by the National Heart, Lung, and Blood Institute Dynamic Registry. Over 6,500 patients were registered and accompanying data available was the type of stent use and the indication for placement.

Procedures were considered off-label in cases were stents were placed to unblock bypass graft lesions, left main coronary artery disease, ostial, bifurcated, or totally occluded lesions in addition to restenotic lesions. Lesions treated with a diameter smaller than 2.5 mm, greater than 3.75 mm, or longer than 30 mm were also considered off label use.

Data indicated that a larger proportion of bare metal stents (54.7 percent) were placed for off-label indications compared to the drug eluting stents (48.7 percent). Alternatively, patients with co-existing diseases including hypertension, coronary artery disease in more than one artery, previous heart procedures, kidney disease, and diabetes were more likely to have a drug eluting stent placed.

Following twelve months of follow-up, no significant differences in adjusted risk of mortality or myocardial infarction were noted between the two groups. Revascularization was noted to be significantly lower among the patients who received drug coated stents. As such, patients who had bare metal stents placed were at higher risk for repeat revascularization.

January 30, 2008 Related topics: Standards, Medical Devices & Products, Trends, Quality, Safety, Errors, Cardiology

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