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Drug-Coated Stents: The Real Risks

Use for Complex Heart Disease May Be Riskier Than Once Thought

Putting Stent Risk Into Perspective continued...

The problem, Harrington says in an editorial accompanying the new studies, is that the U.S. device-safety system is flawed. There simply isn't a reliable system for systematically following up on -- and reporting -- what happens when newly approved implanted devices are used in the real world.

So what patients should do, Harrington says, is ask their doctors about the evidence that a drug-coated stent would be effective and safe for them as individuals.

If a patient is in the "on-label" group, the evidence is good. If the patient is in the "off-label" group, there isn't a lot of evidence -- and doctors should explain why they think a drug-coated stent's benefits might outweigh its risks.

"Doctors need to say, yes, we know that when we use these devices off label, there is a higher risk," Harrington tells WebMD. "The doctor should say, 'Here is how I interpret the evidence available, and here is how it applies to your situation.' This does not mean don't use the stents outside their approved indications, but if you start to do that, you'd better have a pretty good reading on what the risks are."

All of the experts who spoke to WebMD stressed one additional point: Anyone who gets a drug-coated stent, on- or off-label, must be willing to take anticlotting medications for a year or more.

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