Drug-Coated Stents Have Dark Side
Cost of Improved Artery-Opening Devices: Small Death Risk
2 Steps Forward, 1 Step Back continued...
As the artery heals, new cells grow over the inside of the stent, essentially making it part of the blood vessel.
Unfortunately, the body tends to see the stent as a foreign object. Sometimes, scar tissue forms inside the stent, once again blocking the artery.
New drug-eluting stents are coated with a polymer that slowly releases a powerful drug. This drug keeps scar tissue from forming.
Unfortunately, it also slows the healing process. That's a problem -- because until the blood vessel heals inside of the stent, there's a risk of deadly blood clots.
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."