Drug-eluting stents not as good in real world
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The new generation of stents—tiny mesh tubes used to prop open clogged coronary arteries—may not perform quite as well as studies suggest in preventing re-blockage.
The stents release drugs that are intended to prevent over-growth of the artery walls that can cause the artery to close up again. According to a report in this week’s Journal of the American Medical Association, however, rates of blood-clot formation reported with drug-eluting stents are higher in real-world settings than those achieved in clinical trials.
In clinical trials, the rate of blood-clots occurrences in stents after 9 to 12 months has ranged from 0.4 percent to 0.6 percent, depending on the type of drug-eluting stent.
By contrast, the new findings suggest that the rate in actual practice is at least twice as high—about 1.3 percent.
The findings stem from a study of 2229 patients treated with sirolimus-eluting or paclitaxel-eluting stents at hospitals in Germany and Italy between April 2002 and January 2004.
At 9-months follow-up, the rates of stent clotting were 1.3 percent and 1.7 percent in the sirolimus and paclitaxel stent groups, respectively, Dr. Antonio Colombo, from EMO Centro Cuore Columbus in Milan, and colleagues report.
So why aren’t the outcomes in the real world as good as those seen in clinical trials? The authors suggest it may be that the stenting procedure is being offered more widely, to treat “more complex lesions and patients.”
SOURCE: Journal of the American Medical Association, May 4, 2005.
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