It’s called a drug-coated stent. Millions of chest pain and heart attack sufferers have received these tiny coils that actually ooze medicine. They are placed in the arteries to keep them from squeezing shut again. In the last several years, some doctors believed them to be better than the plain old metal ones. In fact, six million people have received them in the few years they have been available.
Information just released shows doctors now believe these stents could raise the risk of life-threatening blood clots months and even years later. The risk came mainly to those who went off their Plavix, an anti-clotting drug.
Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking Plavix earlier than now recommended. Because of this risk, thousands of people are being urged to take Plavix until more is learned.
According to the Associated Press, these concerns have forced the Food and Drug Administration to begin a two-day meeting on Thursday with two manufactures of the drug-coated stents. The companies, Boston Scientific Corp. and Johnson & Johnson say the stents have been used to open the arteries of millions of people in the United States.
The companies also say the devices’ benefits outweigh the risks, even though patients could face a small but significant risk of blood clots.
Both companies say the use of the drug-coated stents reduces the need for a follow-surgery to reopen arteries, a benefit not found when using the previous bare-metal stents. In fact, Johnson & Johnson said there is no significant difference in clotting, heart attacks or death rates between its stent and the bare-metal stents.
The FDA is also looking to an outside panel of experts to seek advice on a wide range of questions including whether to update their labels with new warnings or even change federal recommendations on how long people should take blood thinners like Plavix or aspirin following stent surgery. The FDA is looking into more research on the stents already on the market and others it is in the process of considering for approval.
If you or someone you know has a drug-coated stent, it’s best to check with a doctor on what’s the best thing to do. Meanwhile, I’ll keep a check on these meetings and do a follow up story on the results.