Drug-Coated Stents Have Dark Side
Cost of Improved Artery-Opening Devices: Small Death Risk
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.
New Stents on the Way
Tomorrow's drug-coated stents may solve the blood-clotting problem.
One strategy is to make the drug-carrying polymer dissolve when its job is done. Another strategy is to make stents that dissolve entirely. One company working on this problem is Biosensors International.
"With any new advance in science, there is always a 'Gotcha!' and it appears there is a very small risk of late blood-clotting with some of the first-generation stent designs," Biosensors Chief Technology Officer John Shulze tells WebMD. "We believe we have a solution for that."
Biosensors has developed a drug-eluting polymer stent coating that dissolves over time. Shulze says small clinical trials show it works. But he warns that larger studies will be needed.