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Drug-Coated Stents Better Than Bare-Metal Ones in Complex Cases
Date:2/4/2008

s of a possible higher risk of artery reblockage in the coated-stent group.

Stents have been very much in the news lately, with studies such as one that found equal effectiveness of the two drug-coated stents now available in the American market, one sold by Boston Scientific, the other by Cordis.

That study was funded by the two companies, as was the newly reported Wake Forest study. Applegate said that financing of the study by industry did not affect the results of the research. "They had absolutely no influence on the study design, the acquisition of data, the interpretation of data or the scripting of the manuscript," he said.

Its getting harder to do meaningful medical research in the United States for a variety of reasons, said an accompanying editorial by Dr. Cindy Grines, vice chief of academic affairs at William Beaumont Hospital in Royal Oak, Mich. The somewhat frightening "off-label" designation, which means the U.S. Food and Drug Administration hasn't approved that use, is necessary because of the difficulty of conducting trials in the United States, she explained.

"Eighty percent of the studies now are being done outside the United States," Grines said.

Some of the blame goes to the complex rules imposed by the FDA, she said, but the propensity for people claiming damage to file suits also has a constraining effect.

"There are Web sites with legal advice," Grines said. "So, it is very defensive medicine that people are practicing. A consent form might be 10 pages long to do a simple study, which becomes financially undoable in most institutions. It would be really nice if we could have more ability to do these studies here."

More information

You can learn why and how stents are used from the American Heart Association.



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