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Drug-Coated Stent Study Confirms Effectiveness

Posted by Jane Akre
Tuesday, February 05, 2008 12:23 PM EST
Category: On The Road, Major Medical, Protecting Your Family, In The Workplace
Tags: FDA and Prescription Drugs, Medical Devices, Medical Malpractice, Wrongful Death

Drug coated heart stents are shown to be effective even in complicated cases.

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  • American Heart Association on stents 
  • American College of Cardiology Journal 

Complex arterial blockages mend better with drug-coated stents over the bare-metal kind.

That is the conclusion of Dr. Robert J. Applegate of Wake Forest University, reporting in the February 12th issue of the Journal of the American College of Cardiology.

Primary is that drug-eluding stents are very effective in simpler problems, says Dr. Applegate.  

The stents are flexible tubes implanted with drugs to keep blood vessels open after angioplasty surgery to remove a clot.  

“Then their effectiveness was broadened to all patients who underwent stent treatment, even in off-label use. All the benefits present in the early trials are showing in the patients that have these high-risk features," he tells the Washington Post.

By high risk features he means diabetes, kidney failure, blockages that have been there awhile or a recent heart attack.  Previously these have raised concerns about using drug-emitting stents. But Dr. Applegate says “We saw them to be effective in these patients.”

In the Wake Forest study, the results of 1,285 people with complications who got drug-coated stents after angioplasty were compared to 1,164 people with bare-metal stents. 

The drug-coated stent population fared better after two years. Incidence of nonfatal heart attacks or deaths was 29 percent lower for that group.

In addition, the drug coating seems to make the stents safer in terms of future clotting which was roughly half of those with bare-metal stents.

In the same issue, a study of 310 people finds those with drug-coated stents eventually had a possibility of a higher risk of artery reblockage.

The Wake Forest study was funded by the two companies that make stents, Boston Scientific and Cordis. Dr. Applegate says they had no influence on the design of the study, the data or its interpretation or the final manuscript.

And in a commentary on the future of U.S. medical research, an accompanying editorial says it’s increasingly difficult to do “off-label” studies and 80 percent are being conducted out of the country.  Complex rules by the FDA and the fear of lawsuits are driving researchers out of this country it says.  #

  

 

 


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