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Drug-Coated Stents Have Dark Side

Cost of Improved Artery-Opening Devices: Small Death Risk

The Benefits

Stents have revolutionized the treatment of blocked arteries. They've vastly reduced the need for bypass surgery.

And the new drug-eluting stents have greatly decreased the risk of stent blockage. The newly identified risk does not outweigh the overall benefit of the new stents.

Johnson & Johnson subsidiary Cordis Corp. and Boston Scientific make the two drug-eluting stents that now have FDA approval.

Boston Scientific did not respond to WebMD's interview request.

Cordis spokeswoman Mariela Melendez notes that patients who get bare-metal stents also may rarely suffer sudden cardiac death and heart attacks.

"At the end of the day, we believe this is a rare event," Melendez tells WebMD. "It is a significant challenge that we take very seriously. We want to get to the bottom of this. But at this point, we don't see much difference between bare-metal stents and drug-coated stents."

Most of the blood clots that lead to death or heart attack happen when patients stop taking anticlotting drugs.

Currently, combination treatment with Plavix and aspirin is recommended for all patients for the first year. Patients who can tolerate this treatment even longer may be able to avoid the additional risk.

"In the end, it is a wash with respect to the risk of death or heart attack," Bhatt says. "For the right patient, a drug-eluting stent is the best option. But for the wrong patient, someone that has a bleeding problem or a recurrent gastrointestinal bleeding issue such as diverticulitis, the drug-eluting strategy may not be so great for them. Because keeping them on aspirin and Plavix for a long while would be a bad thing."

Bottom Line for Patients

What does all this mean for the millions of people with drug-coated stents in their bodies? Medical journalist Miriam Shuchman, MD, reviewed the stent issue for the Nov. 9 issue of The New England Journal of Medicine.

"It is true the risk for any given patient is small -- but patients need to talk with their doctors," Shuchman tells WebMD.

"They will be hearing they need to stay on their Plavix and aspirin for longer than they initially thought," she says.

"Where this does not lead is to a situation where patients must say, 'Take it out.' The level of risk is not such that you would do that," Shuchman says. "I did not hear any doctor say that was indicated."

Bhatt says doctors and patients may have been a bit too enthusiastic about drug-coated stents. They are not, he says, the last word in treating blocked arteries.

"Thinking that drug-eluting stents are for every patient and for all lesions is wrong. The use of drug-eluting stents got ahead of the science," he says. "But I would not hesitate to put in drug-eluting stents merely because of the recent attention this issue has received."

What does the FDA say?

It's calling for a "more formal evaluation." That may come as soon as December, when the FDA has scheduled a meeting of device manufacturers, researchers, and heart experts.

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