The debate over drug-coated stents

In the last year, concerns have been raised that implanted drug-coated stents have increased the risk of blood clots. FDA officials met over a two-day period in December to discuss the safety of these medical devices.
Stephen_Heuser: Hi folks - this is Steve Heuser, medical-device reporter for the business section. I've been covering the debate over drug-coated stents since last fall, and happy to take your questions. But remember, I'm not a doctor so can't offer any medical advice.

AC: Do all hospitals use them now? Had stent put in August. What's the likelyhood that it is one of the drug coated ones?
Stephen_Heuser: Something like 80 to 90% of stents used in hospitals are drug-coated these days. It shouldn't be hard for you to find out - your cardiologist will know what kind you have.

AC: Is there anything that you can do to prevent the build up from happening if you have one installed?
Stephen_Heuser: The main thing is to keep taking blood-thinning drugs as long as they are prescribed by your doctor -- for most people, this is Plavix and aspirin. Studies are finding that when people stop taking Plavix prematurely, it increases the risk of a clot.

susan: What are the long term affects of staying on Plavix beyond the recommended 6 months? Could this help decrease the potential of clots? Does the risk of clots decrease after a certain amount of time?
Stephen_Heuser: It's becoming very common for doctors to extend their Plavix prescriptions for a year or more. People have the usual Plavix side effects, such as easy bleeding. Your last question is a very good one: The longest-term patients have had drug-coated stents for only about 5 years, so the numbers are still coming in. So far, it appears that a low clot risk does continue indefinitely.
Stephen_Heuser: OK, I just got a question from FDA A-OK about whether the FDA will start requiring bigger long-term safety studies. We don't know exactly what the FDA is going to do -- their stent advisory panel is in the second day of a two-day public meeting on stents right now. But it seems clear not only from this meeting, but also what they've been saying for several months, that they're going to start focusing a lot more on what happens *after* devices are approved. Long-term safety studies will almost certainly be part of deal. Also, a number of major hospitals and health networks have started to analyze their own stent-safety data, so we'll be learning a lot more even after this meeting ends.

Anthony: Hi Stephen! Do you think J&J had prior knowledge of this problem and attempted to hide it?
Stephen_Heuser: Hi, interesting question. Since the companies control the data from their own trials, we don't know exactly what they saw in individual trial patients - we only see the overall statistics. There was actually some discussion of shorter-term clotting when the J&J stent was first approved in 2003, but that's not necessarily the same long-term phenomenon people are talking about now. To this day, J&J maintains their Cypher stent doesn't have statistically more clotting than bare-metal stents, although other doctors following Cypher patients disagree.

Miki: If they find they are NOT safe, they can't be removed? Replaced? If they can? What risks would that surgery pose?
Stephen_Heuser: They can't be removed - the stent becomes a permanent part of the artery wall. If the artery heals properly around the stent, this appears to be perfectly safe. Doctors wouldn't perform surgery just to remove a stent - they'd most likely tell you to be diligent about taking blood-thinners.

AC: Speaking of statistics - so far what percentage of people with these stents are having problems with clotting?
Stephen_Heuser: This is one of the questions the FDA is hashing out right now. It appears to depend on what kind of problem you had in the first place -- people with relatively simple artery trouble have a very low risk of clotting, something like 0.5%. But stents are also used in people with more complex artery problems, and the rates appear to be higher there. The FDA is still searching for hard answers to this question, and in Maryland right now they're being presented with data from doctors and the stent companies.

neil: I have 5 Cypher stents put in Sept. 6 06 , Iam having a mri on Jan. 31,07 , will this be safe?
Stephen_Heuser: Stents are considered safe in MRI machines. The Mayo clinic did a small study of this (http://www.mayoclinic.org/checkup-2003/dec-mri.html) and I believe both major stentmakers have been cleared by the FDA for MRI compatibility.

adastra: i just got a DE stent, on Plavix & aspirin... having uncontrollable nosebleeds (4 in last month). How many people have this kind of problem on Plavix?
Stephen_Heuser: Nosebleeds do occur on Plavix, but if they're recurrent or uncontrollable you should definitely call your doctor. I'd invite anyone else out there on Plavix to weigh in -- What are you experiencing?

hr: Stephen - do you think J&J and Boston Scientific knew about clotting problems early on and failed to bring it public?
Stephen_Heuser: I'm sure they saw occasional clots in the early data, but that doesn't mean they were hiding anything. I went to one forum sponsored by Boston Scientific more than a year ago where the clotting risk was discussed in a hotel ballroom room full of cardioloigsts. However, the company didn't formally approach the FDA about it until this past summer, when they said a new analysis of their daat showed the risk was "statistically significant" - i.e., unlikely to be explained by random chance.

hr: What do you think will come out of this FDA meeting today?
Stephen_Heuser: Well, I'm not there, so it's hard for me to measure the tone of the questions they're asking. But so far the agency seems to be comfortable with the use of drug-coated stents in the type of patient for which they were originally approved - relatively simple artery blockages. The big question today is, What about everyone else? More than half of all stents are put into riskier patients - people with heart attacks, long blockages, multiple arteries blocked. The FDA will take a hard look at whether those people can safely get drug-coated stents. It may also come up with new recommendations for how long people should take Plavix - but we'll see. It's a long hearing.

hr: how do you find out about symposiums or forums presented by the stent manufacturers, FDA or other interested parties that one can attend. I'd like to educate myself more on the issue and see what's going on first hand (literaly speaking)..
Stephen_Heuser: The FDA posts everything on its website, but it's not especially easy to navigate. There is a Stent Q&A here: http://www.fda.gov/hearthealth/treatments/medicaldevices/stentqa.html
Stephen_Heuser: Both Boston Scientific and Johnson & Johnson have websites, and if you go to the "investor" section and watch the "news," you'll see the occasional corporate releases about stent safety. But the companies don't hold public forums -- they generally present info at medical conferences.
Stephen_Heuser: A couple of websites keep very close track of this issue. One of them is Angioplasty.org, and another is TheHeart.org. Angioplasty.org has some discussion forums, and TheHeart.org does a good job of covering all the medical conference news.

Ani1: I have had a Cordis put into my RCA in 2003, they claim to have put 2 in, any problems with stents that long ago?
Stephen_Heuser: Cordis is the name of the stent manufacturer (owned by J&J) - if you got their Cypher stent, then you have a drug-eluting stent. It was first approved in 2003. It's worth asking your doctor.
Stephen_Heuser: OK - that's all the time we have. Thanks very much for participating in the chat. We'll be posting updates on the FDA meeting today on Boston.com, and we'll keep covering this issue in the future. In the meantime, you can email me directly at sheuser@globe.com. Thanks -- Steve