FDA Drug-Eluting Stent Safety Panel Testimony

On December 7-8, 2006, the FDA convened a panel to discuss and make recommendations regarding the safety of drug-eluting stents. At this panel the Editor of Angioplasty.Org and a patient who has posted to this Forum both gave presentations. The Editor's testimony can be found here; the patient's here. Following are comments from readers.

Current Postings (30):

• Walt -- we've cross-posted your story on our Forum Topic about "Stent Thrombosis" and we'll respond to you in that topic. Thanks for telling your story.
Angioplasty.Org Staff, Angioplasty.Org, April 28, 2008

• My name is Walt and I had a major cardiac event July 7, 2007 and they found two blockages, 90% and 70% in the same artery. On 07/09/2007, they implanted two TAXUS drug eluting stents with absolutely no explanation to the difference between BMS and DES, nor any information about that I would have to be on Plavix with Aspirin the rest of my life. I am on three other meds also. I also had a pace maker/defibrillator put in the next day. On Jan. 6th, 2008 I had a stent thrombosis with absolutely no warning. I fell into a snow bank next to where I was washing my car to die, but the defibrillator shocked me three times to get my heart started again. (The Dr. showed me the read out from defibrillator of the event.) (One week prior to the stent thrombosis I was out of Plavix over the weekend (2 days), huge mistake.) Went back to hospital to find 95% and 70% blockage at both TAXUS stents in just 6 months. Stent thrombosis in most cases is fatal where restenosis is more gradual in forming. It looks to me like the drug companies win in both cases, triple cost of stents, (about $2,500 each) and the addiction to Plavix for life (about %1500 per year) or die. If I would have known then what I have research now, I would have never let them implant drug eluting stents the first time. They replaced the stent blockage at the TAXUS stents, with the BMS half in the TAXUS stent and half in the vain. I now find out that if you have had a stent thrombosis, you have a 1 in 6 chance of having another. Not look forward to another shocking experience. By the way one week later, Jan. 13, 2008 while watching TV, my defibrillator shocked me four times for no reason at all. My heart was working just fine. What are my options, I am 66 years old, never smoked, 200 lb. six foot and thought I was in great health.
Walt Beermann, Primerica Financial Services, Denver, Colorado, USA, April 17, 2008

• To: Rick...How are you doing now? I too have distal blockages and two arteries occluded. No bypass but so many DES stents. My angina left me after the fifth stent but returned 15 months later. Docs are not concerned. This makes me sooo dang angry that they do not have answers on the stents or new possible blockages. Rick, thank you for speaking on our behalf at the December convention.

Roseanne from Massachusetts. I could have written your exact words too. I think after a few years on Plavix, every other day may be the way to go but of course doctors will say NO. I too have heart burn like no tomorrow. I am on nexium and have now bought stock in Maalox and pepcid AC. yes, I feel it is the stents doing this...I cannot lay on my left side either. I have breast pain ever since the stents were placed. My doctors are still "out to lunch" on most of my post ills since the stent placement.
Sue, Katy, Texas, USA, March 2, 2007

• Mike -- your angry post brings up issues which we'd like to address, and we hope you don't mind, but we had to edit it down for length and repetitiveness -- we believe we have left the essence of your complaints intact. First off, there were, at the time of the hearing, several major news articles about the potential "conflicts of interest" of FDA panel members. We would assume that's how you know about this in the first place. And, as you say, the FDA has posted these "redacted" notices on their web site (this meeting page has all the info about the Panel, including transcripts). So no one's hiding this. The reality is that most top cardiologists are highly sought after to run trials or advise the various device companies about their products. Wouldn't you want the best people helping you design your new stent? This is a good thing, but it can be a complicated relationship. However, if the financial arrangements are out front, any bias the researcher might show is there for all his/her peers to see and to criticize if they feel it is unduly influencing judgment. All major meetings require that these arrangements be published -- for example, every PowerPoint presentation made at last Fall's TCT meeting started with a slide of disclosures (our favorite was from Dr. Sigmund Silber of Germany who stated he owns no stock in any of the medical device companies because his wife won't let him).

You bring up the Vioxx matter. To the FDA's credit, they invited a broad range of cardiologists to sit on the December panel. That included both Drs. Steve Nissen and Eric Topol, the team that was instrumental in uncovering the problems with Vioxx and ultimately getting it removed from the market. They are not regular members of the Circulatory Devices Panel -- they were asked to help the FDA and were very vocal during the meeting. As was written in our Editor's blog, the FDA Panel was a "Catalytic Converter" -- it didn't change the labeling, but it clearly had an effect. Drug-eluting stent sales are down, physicians are being more cautious in deciding if DES are the right devices for a particular patient (and in many, if not most, they are) and the major medical groups just issued a strong "Joint Science Advisory" addressing the issues. So the FDA panel was a very important and commendable event. The device manufacturers were forced to defend their data and there was most definitely a rigorous airing of the issues -- in public. With public comment, as well.

The issues with Plavix, compliance, etc. are important ones, and ones which we at Angioplasty.Org have been covering and advocating for since drug-eluting stents were introduced in 2003. One of the biggest deficiencies, hopefully now being corrected, is the understanding by both patients and physicians that DES and antiplatelet therapy are a package deal: you can't have one without the other. And if a patient can't or won't be likely to take a year of Plavix and aspirin, then perhaps that patient should not be getting a drug-eluting stent (as we've written, the DES is like a Ferrari -- it's top of the line performance but requires special maintenance). This is one of the many points in the recent "Science Advisory" issued by the ACC, AHA, SCAI, etc.

If you're interested, your might want to check out the 8 minute epilogue to the video documentary we produced -- it's the clip called "Devices, Ethics and Money". It contains interviews with many of the pioneering physicians in this field and might give you some perspective on these issues. We hope we've adequately addressed some of your complaints.
Angioplasty.Org Staff, Angioplasty.Org, January 30, 2007

• Why arent you covering the fact that several FDA panelists have/still do get paid big bucks by these stent manufacturerors . Its a published fact that at least 6 have signed waivers and yet deleted the specific companies and amounts around the time of FDA's so called review. You can view thier waivers on the FDA website . Its easy to access this info. What ever happened to REAL NEWS Arent these folks that told us Vioxx was O.K. What a win for PLavix makers since sales had dropped because of recent studies. Should I have to take 6 times the amount of Plavix for six stents for six lifetimes or just six years or 6 months after each new addittion. Who can call for an investigation? Who will? Who should? Score another for big business and the purchase of a government for sale to the highest bidders. Conficts of interest clearly present at every level and yet few havce the guts to print the facts. Meanwhile the body count continues to rise as they now are forced to either blame the clotting on the patient via non-compliance or some kind of kinda Plavix deficiency none mentioned prior. They certainly cant blame it on the greedy "off lable docs that turned sick folks into stent puppets as they got nearly 3x the $$$ for "Off lable us" the problem here is that no oone is accountable and those whom might otherwise hold them accountable are also covering there respective tails while also reaping the rewards of a blind eye when asked. FDA. Fraudulent and Deceptive Administration. [Editor's note: this post has been edited for length]
Mike S., "former stent puppet", Florida, USA, January 30, 2007

• Tom -- you're right on with your observation, and this was the concern expressed by several of the FDA panel members during Day #2 of the December session, one of whom was Dr. Steve Nissen, head cardiologist at the Cleveland Clinic. The problem lies in the fact that there are not sufficient data tracking this problem to make pronouncements one way or the other. But since there were some studies that seemed to indicate longer term Plavix and aspirin were beneficial, this led to the recent joint recommendation by all the medical organizations involved that dual antiplatelet therapy (aspirin plus Plavix or Ticlid) be continued for one year, and more, if the patient is a low-risk for bleeding complications. Another problem is that the exact cause (or more likely causes) of very late stent thrombosis are not completely clear. Cessation of antiplatelet therapy seems to be one. But a stent that was not optimally placed to begin with may be another. Possibly a hypersensitivity reaction to the stent polymer might be another. Dr. Eric Topol (also on the FDA panel) theorized that there may be a certain genetic predisposition to platelet activation which would put that group more at risk -- but that would require DNA testing of hundreds of patients who have experienced stent thrombosis. Late stent thrombosis does occur in a very small number of patients and if you are taking antiplatelet therapy, the risk should be reduced. As for requesting open heart bypass surgery to lessen the risk -- the risk involved in such an operation may be greater than what you're trying to avoid. But these are questions for your cardiologist and/or cardiac surgeon.
Angioplasty.Org Staff, Angioplasty.Org, January 28, 2007

• We continue to hear that clot risk from DES stents is "only about one out of 200 to 250 patients who have received DES stents, and therefore the problem is not epidemic. But according to the Cleveland Clinic's Feb. 2007 newsletter, at the December FDA hearing, evidence was presented that "...the worst consequences of delayed clotting were most likely to occur in patients with complicated heart disease, requiring several stents that overlap, or branch out from an intersection of arteries". Doesn't this mean that serious risk from clotting among DES stent patients with complicated heart disease, such as myself, run a much higher than 1 in 200 risk of clot problems later, and therefore we should not be lumped in with statistics calculated from DES patients as a whole? Perhaps our risk is 1 in 100 or 1 in 50? For those of us in this more dangerous category, should we not consider requesting open heart-bypass surgery to lessen our risk?
Tom T., Arizona, USA, January 25, 2007

• It's been a few months since I've had time to read and comment on the Forum. It's Rosanne, from Stoneham, Ma. 55 year old non smoking female who underwent stent procedure in Oct. 2005. I get so frustrated with the "cough" we all experience from Lisinopril,as in my situation, if NOT for the CVS pharmacist I would not have known what was causing my cough. I was miserable.(I still wonder why my cardiologist did not tell me about this side effect)....Once I stopped the Lisinopril the cough disappeared completely. I have found that whenever I get a cold or the FLU, the cough comes back as if I were taking that drug again. I've just recovered from 4 weeks of being bed ridden with a cold, fever, cough from the Flu...(and I had the FLU shot).. I am happy to report that taking Plavix every other day after I passed my one year anniversary of my Taxus Stent, October 2006(having 99% and 60% blockage)my nose bleeds have almost completely stopped. I have since had another stress test as I continued to have pain in my chest. I am still not able to lie on my left side, as I experience pressure and shortness of breath. As you know I have ITP (platelet dysfunction), making hematomas more frequent for me. My question tonite is this: I bumped my left arm two weeks ago. A small black and blue remained for some time. I noticed the other nite while showering that I have a "lump" or "knot" in the place where the black and blue once was. Is this an inside hematoma or should I be concerned and call my doctor? My life with angina and my DES has changed in ways NO ONE can understand or at least will try to understand. The comfort I receive in reading what my fellow patients feel is worth more than I can say. I keep all of you in my prayers. Yes, we need to "live our lives"..but the uncertainty and worrying is a NATURAL feeling for anyone post stent procedure. I am now taking Protonix 2x a day for the "heartburn" they say I suffer while I was experiencing chest pains and did not know what "heartburn" was. I can only relate it to the drug in the stent and whatever I was eating (ice cream maybe) after 8 p.m. I've had to cease my love for ice cream. My blood pressure continues to be 134/94. My doctor gave me a fluid pill to take but it made me dizzy so I stopped. I take Tiazac for my BP, 2 Protonix, Lipitor, Plavix, a baby aspirin and an Iron pill as my iron level is low. I cannot seem to get my good cholesterol up and was wondering if that new pill Caduet would be of some help for me. I will discuss this with my cardiologist soon. Thanks again for my time . I apologize for my lengthy email, but I've been sick over a month and obviously have MISSED voicing my concerns... God Bless!
Rosanne G., Stoneham Massachusetts, USA, January 23, 2007

• High I'm Keith a former homebuilder,Father and part time bodybuilder. I wasn't doing good with my workouts and thought I would go get checked, the doctor said I needed a stent, so that was better then open heart at least I could continue to work and maybe compete in bodybuilding. The Dr. said for me to take my meds. for eight months so I did , went back for my checkup and he said I was doing Great and he would see me in about twenty years. I was a happy camper, on with my work and bodybuilding for two years, then one day in the middle of my workout my chest felt funny so I said I will do my chest exercise the next day, and about ten minutes later it felt like some one punched me in the chest with a hammer handle. I got to the hospital and they said I had an MI and after that I found it was a clot in my stent,and Rick said the rest. But do we go on with our lives and hope it won't happen again and pay out the A**, or do we all get together and demand to be helped or at least supported for being Guinea pigs. After all we really didn't get to choose.
Keith L. McCauley, unemployed father, Worden, Montana, USA, January 18, 2007

• Dan, you're very welcome. Your cough might be due to lisinopril which is an ACE inhibitor. A known side-effect of ACE inhibitors is a cough. If it continues, call your cardiologist and see if he might recommend something else (we're assuming this is to control your blood pressure -- possibly a different drug class, like calcium channel blockers, would work).
Angioplasty.Org Staff, Angioplasty.Org, January 9, 2007

• Thank you for your answer in my last posting. It's good to have someone that understands what we are going thru to talk with. I had two Taxus Express2 stents inserted into the same vessel the night of my heart attack last Dec. 30th. The following Feb. I had a third Taxus inserted into the other side of the heart into an 85% blockage. It seems like a few months later, I developed a minor sore throat that comes and goes with a non-productive cough at times. Yesterday, I coughed a couple of times and produced blood both times - approx a table spoon each time. I've coughed a few times today with no blood. I do have the sensation of my throat closing off a little and wonder if this is anything to really worry about since I am on generic Plavix (Clopidogrel). I am also taking simvastatin, toprol xl and lisinopril as well as 325mg aspirin - vitamins - and fish oil. Could this be a indication of an allergy to a medication. (I've never been allergic to any medications but of course I've never been on these before.) Thanks again
Dan R., Indiana, USA, January 9, 2007

• Dan, the major downside of Plavix and aspirin, other than economic (Plavix costs $4/day) is the bleeding risk, or the occasional person who is allergic to Plavix. But there also are benefits to Plavix, above and beyond the antiplatelet action around the stent (in fact, the use of Plavix after stenting is technically "off-label" for the drug itself). If you are at low risk for bleeding complications, and you don't have any adverse reactions to Plavix, then there's not much on the downside. As I have written elsewhere, during the FDA meeting, panel member and highly-regarded interventional cardiologist Dr. Christopher White strongly voiced the opinion that the labeling for Plavix need not be changed from the current 3-6 months. When asked by Panel chair Dr. William Maisel, "Dr. White, if you had a DES and no bleeding risk, how long would you take Plavix?" Without hesitation, Dr. White responded, "Indefinitely!" and the room rippled with laughter. Also, you are right that if you need surgery, you'll have to stop. But discuss this at the time with your interventional cardiologist and surgeon -- you don't necessarily have to go off completely, and should be able to stay on aspirin. This also depends on how long since the stent was implanted. The problem is we don't know why some stents don't completely heal in some people and we don't have a simple way of telling if they have or not.
Angioplasty.Org Staff, Angioplasty.Org, January 8, 2007

• First, thank you for a site that allows us to voice our opinions, fears and anger and know that there are others out there that are going through the same thing. I do have one question and that is what are the negatives about being left on Plavix or the generic for 'the rest of my life'? I understand that if you have to have any type of surgery you have to quit the Plavix and aspirin at least a week in advance (is this putting the gun to your head and hoping there aren't any bullets in it?). I hope to have some information on this subject so that I can help my Dr. make the right decision for me and so that he can't come back later and say 'you asked to be left on the Plavix for life, now you take responsibility for my prior actions'.
Dan R., Indiana, USA, January 8, 2007

• Reading some of the comments here can be upsetting -- there is a lot of anger and fear out there -- some of it is caused by the over-sensationalizing of this issue by some of the media ("Tiny Time Bombs Ticking in Your Heart") but some of it is caused by the lack of substantive patient education on this issue -- something we tried to bring to the attention of the FDA and the device manufacturers who attended the FDA Panel.

Val from Texas, I definitely can hear where you are coming from -- but to set the record straight, stents have been around a long time, and drug-eluting stents were tested in the lab, in cadavers and in animals before they were used in humans. And they are not lethal weapons -- it is very important to keep perspective and this is a complex problem. First of all, the frequency of late stent thrombosis is very low. So low that a "statistical significance" was not seen until very recently. As many physicians have stated, the older bare metal stents have a much higher restenosis (reblockage) rate, and that's not benign. Up to a third of patients whose arteries reblock learn about it because they wind up hospitalized with a heart attack or other problem. So drug-eluting stents were invented to reduce that risk -- and they have done so -- yet there is this other problem now surfacing (because it is such a low frequency event, it was not discernable until there were very large populations to study). But there are many many patients who have benefitted from this technology.

Does that mean there's no problem? Of course not. One result of this controversy is already happening -- doctors are now thinking twice about using drug-eluting stents in certain patients. They want to make sure the patient will comply with Plavix and aspirin therapy (shown to reduce the stent thrombosis problem significantly), to make sure they can afford it, to make sure they are the best candidates, that they are at risk for restenosis in the first place (if the restenosis rate of bare metal stents is 20%, which means 80% of those stents DON'T restensose). For example, with some larger arteries, the difference in restenosis rates between bare metal and DES is minimal, so why use a DES? Also CABG is not really the gold standard in many cases (in severe diffuse triple vessel disease, it is) -- but why have your chest cracked open to fix a singe blocked vessel, when it can be done in less than an hour via angioplasty? Finally, re: the class action suits to have these stents removed, they can't be removed because they become part of the arterial wall. We've seen ads by lawyers promising patients that they can sue the companies to pay for taking these stents out. Not true!

Barry, "on-label" means the use of a single drug-eluting stent in a simple single vessel, one that is "de novo" (not previously treated). That's what was looked at in the clinical trials and the data for that population satisfied even the biggest critics on the FDA Panel -- drug-eluting stents are safe when used "on-label". "Off-label" means any other use, multiple stents in one vessel, or multiple vessels, or used to fix a previously blocked stent, and several other indications. In these cases, the panel concluded that there is just not enough data to say there is no increased risk, because there has not been sufficient follow-up. This is not saying that there is a significantly greater risk, just that whether there is or not can't be known right now. There definitely is a small risk. So caution is advised and hopefully cardiologists out there are hearing this cautionary note. Read our "Patient Advisory" for more information and the comments of some leading doctors.
Angioplasty.Org Staff, Angioplasty.Org, January 7, 2007

• Some days when I think about it, I wonder if today is the day when it happens! However, I am told by my cardiologist that he will be keeping me on Plavix and aspirin 325 for the foreseeable future or until some development in the science offers another course of therapy. I pray, try not to worry, and follow directions of a guy I believe to be a superior cardiologist. That's all I can do. By the way, what does: "off-label" and "on-label" mean in this discussion?
Barry B., New Jersey, USA, December 28, 2006

To Debbie: Please, tell me where you live. You can reach me at jvaljon1@aol.com. If you live in TX I can give you the name of the Doctor who is taking care of my husband. This doctor, who is very compassionate, said that my husband probably has to take Plavix "for the rest of his life". In other words, he'd have no difficulty prescribing the Plavix as needed to your husband, either, because for sure with the stents, they do need the Plavix for life OR until the tissue overgrows the stent. Because only a thin line of cells is needed to cover the stent, there's no sure way to tell if/when, this happens in any particular person. Only if you know for sure that the stent has been completely overgrown would it be at all safe to discontinue the Plavix. This is because the overgrowth would be endothelial tissue--the innermost lining of any artery--and that would prevent clots from forming. But there's no way right now to tell if that thin lining of cells has completely covered a stent. Why?

Because from what I understand--and I hope that someone can come along who knows different, to contradict me--if they can--stents were never tested on animals before being put into people. In other words, we and our loved ones ARE THE TEST SUBJECTS. Words cannot express the betrayal that patients feel toward the FDA, for cynically allowing this to happen--nor the betrayal that we feel toward the doctors who TOOK MONEY to implant these things and then leave patients hanging with their lives in the balance if they don't take their Plavix, which many of them cannot afford to do if their insurance says: "Sorry--we can't prescribe over the original 3- or 6- or 18-month period". Because the Plavix demand and the Plavix price are both so high, and thus so intertwined that to leave patients hanging is tantamount to a death sentence for many of them, Debbie, there are now also legal class-action lawsuits starting up which demand removal of stents and placement of CABG grafts--the gold standard, which of course is being ignored in favor of these untested but most lucrative (to the insurance co's, who then do not have to cover the far more expensive but way safer CABG procedure), in-artery devices).

I will tell you the name of our doctor if you want it. If you live in TX. If not, try to find a doctor in your area who would not mind prescribing Plavix for a longer term. You can use WebMD and this message site, this looks like a pretty decent one, for locating such a doctor. Best of luck, Debbie. I feel that any doctor who keeps shoving these things into people should have his/her license permanently yanked. The general run of cardiac patients have never given their doctors permission to use them as guinea pigs in this way. That's why, in addition to finding a doctor who will prescribe Plavix for life, I feel that it's also important to find and join one of the class-action lawsuits against these things.

And, by the way--there may be a political solution to all this pain and suffering, both stent-related and otherwise: If enough so-called 'bleeding heart' (and today's current stent usage gives that phrase a whole new meaning, doesn't it?) DEMOCRATS are elected to both Houses, to form a MEANINGFUL MAJORITY, and then a Democrat president is elected, this country will be able to implement its own rules and bring itself back to where it's serving us again, instead of its now-corporate bosses. Because the last time that Democrats were all in the majority, the FDA was fully funded and animal testing was the Phase IV of the FDA approval ladder--not, us!

I mean, whatever happened to the first line of the Oath of Medicine: "First, Do No Harm"?????

People should also know that Canada's a good option. Recently (probably in fear because of the approaching election) the House voted to resume letting low-priced Canadian drug imports into America resume, so people could maybe get their Plavix (generic--clopidrogel) and not have to choose between risking clots and/or feeding their kids. It took me a long time to vote Democrat because I've always voted Republican before, but I realize that these are the people who let this horror happen and I don't think they should ever be allowed to have any kind of political life at all. In fact, anyone who had a hand in cutting FDA funding I believe should be in jail for a good long time, for endangering the public like they did. But that's just me. Sorry for the harangue/diatribe. But I've been horrified now for four months, and am trying to shepherd my husband around his risks. Luckily I know a couple of ways that might help--MIGHT, cause I can't really know, can I? Nevertheless, in the absence of all actual help, one has to try what one can....
Val Fitzgerald, Spouse of Cypher stent-implanted person, Grand Prairie, TX, USA, December 27, 2006

• I thought I was alone on his journey! I had a 'major cardiac event' on Dec. 30, 05. That evening I was in surgery having two Taxus Express2 stents inserted. In Feb 06 I had a third Taxus placed for a 85% blockage. I am on Plavix and 325mg aspirin daily (which I haven't missed any doses to date). Now I am reading all of this negative news about the stents and wonder if I will still be alive in three years. The articles that I have read all use a three year evaluation between the bare metal stents and the medicated stent. Is there an average life expectancy after having the stents? I feel my Dr. has dropped me since I will see his nurse practitioner in May 07. It's like, you have the stents now get on with your life. How do I deal with the fear and anger? Is there a pill for that also? I don't know whom to talk to that can understand where I am coming from.....
R.H., Indiana, USA, December 23, 2006

• I would just like to let your readers know that the stent problem is just as bad over here in the UK. I had three bare metal stents placed just over two years ago nobody told us about the problems with them, even with type two diabetes (i.e. blocking) now i need to have a new one and there are trying to put the des version in, not a lot of chance off that happening, i have had constant nerve/pain in my chest ever since the stents were placed and the doctors over here can not sort it out. I was healthier prior to the stents being placed. Why they carry on with this treatment when they know its faulty i do not know, I am just glad they are not plane makers
J.L., United Kingdom, December 23, 2006

• You know the hard thing is you don't hear from your cardiologist to warn you that your life may be in danger however small it may be. I have a TAXUS Express2 MONORAIL 2.5x16mm at my R-PDA. Talk about being responsible. One has to read about it himself to find out what is going on about what your doctor has treated you with!
Raj, Georgia, USA, December 19, 2006

• I have 7 Des Taxus stents. 2 were put in 12-14-05 a tear happened -- they put in two more on 12-21-05. I had another pain in 5-28-06 and they put in 3 more. At no time did any one tell me about these.Or tell me to sign a trial use. I just thought it was what was used nothing new. Guess what a surprise I'm feeling right now. Still no one has told me anything thank god for this site I found by chance After seeing something on tv.
Mike H., West Virginia, USA, December 18, 2006

• Tom -- The 1 in 200 figure derives from an estimated 0.5% greater incidence of late stent thrombosis from DES over bare-metal stents -- across the board -- as reported in the recent flurry of data.
Angioplasty.Org Staff, Angioplasty.Org, December 18, 2006

• I am so glad to see public patient input at the FDA panel session re; drug eluting stent safety. I would guess that many of us who have had adverse reactions following surgery -preceded by the withdrawal of Plavix- are being ignored by the stent manufacturers.
Jack Munroe, Retired, Savannah, Ga., December 16, 2006

• In your response to Jose, you said that the blood clot problem experienced after 6 months seems to occur only in more complex or "off label" cases. Possibly one in 200. And that if all patients took their dual antiplatelet meds this number may be smaller. Is this 1 in 200 an estimate derived from all who have received DES stents, or just from those who have received "off label" DES stents, in which case the odds are somewhat greater than 1 in 200 for that sub-group?
Thomas T., Arizona, USA, December 14, 2006

• Jose and others, please read our "Patient Advisory" in the right-hand column, which was written two months ago and is still what physicians are saying. To put the problem in perspective, remember, this is a very infrequent occurrence. The device aren't "defective", but they seem to cause a slightly greater-than-normal incidence of blood clots after 6 months, and then only in more complex or "off label" cases. Possibly one in 200. And if all patients took their dual antiplatelet meds (Plavix and aspirin) this number may be smaller. So don't panic. That being said, it is very important to stay on your meds to minimize this risk.
Angioplasty.Org Staff, Angioplasty.Org, December 13, 2006

• i am 31 years old and a father of (3) beautiful boys ages 12,8,2 back in july of this year i suffered a massive heart attack. i had a stent implanted and then on to recovery doing cardiac rehab, month later had a icd implanted. and now i really thought that i was on the road to recovery but then yesterday i saw on tv about the problems with stents. and to be honest i'm so scared of losing my life. now I'm wondering why the products weren't pulled when they started to have the problems instead let thousand of people get these implants and why aren't the doctors who implant them trying to do immediate follow ups i know its a lot but that way patients that have received these implants wont feel like they were just left out in the cold because that's the way i feel. not knowing of the progress that the stent is making or if its just making matters worst. its really sad that people like my self have to wait for clinical trials and test just to hear that everything is okay why don't we start worrying about the people that already have them and how anything can be done to prevent such a thing and for our minds can be put at ease because theirs going to be a lot of sleepless nights for now on so please help us get better not worst we don't want to die because of the information and studies. now remember i have a beautiful wife and 3 boys that i don't want to leave
Jose F., USA, December 13, 2006

• All your responses are verification that, as Rick said, there is a massive disconnect out there between what patients need to know and what they are told (or not told). Thank you all for writing in. Lynn, "on-label" use is for "improving luminal diameter for the treatment of de novo (new) lesions < 28 mm in length in native coronary arteries > 2.5 to < 3.75 mm in diameter for the Taxus -- the Cypher label is similar. Any other use (multiple arteries, overlapping stents, treatment of a previously stented artery that has reblocked) are technically "off-label", and this is where there have been seen slightlly less good outcomes. It is unknown whether the less good outcomes are due to the stent itself, or to the fact that the situation is already more complex. 60-70% of all procedures are done "off-label" -- these are done at the discretion of the physician. The FDA doesn't regulate "off-label" use. Confused? You've got company.
Angioplasty.Org Staff, Angioplasty.Org, December 13, 2006

• How true this is. It does seem like we are left out there w/o support. I now have 7 stents-5 DES. What does off label mean exactly? Any answer would be appreciated.
Lynn J., South Carolina, USA, December 13, 2006

• Hi, my name is Sheryl and I just finished reading Rick Dulin's story regarding the DES Stent. It was a real deja vu. I just read the same article that he was referring to on MSNBC a couple of weeks ago. I had the same concerns. I called my family doctor, who then said that she doesn't know enough about the stents and I should call my cardiologist. I then called his office, which was closed for that week. Meanwhile, I was so concerned about what I had read that little else was on my mind daily. I then wrote an email to Dr. Oz (from XM radio, Oprah & Friends) the Heart Specialist, concerning this article. I spoke to Dr. Oz a couple of days later and asked him this question and he basically said that I need to be on Plavix indefinitely. I then told him that I was on Plavix for the six months that my doctor had prescribed and haven't been on it since August of this year. He said I was to treat this as an emergency and call the doctor's office and tell them I would like a prescription for Plavix. I then called the Cardiologists office and spoke to the woman who answered the phone and told her what Dr. Oz had said. She then began to say that she never heard that and that she would talk to the doctor and call me back. She then called me back about 2 minutes later and said, "oh yes, I guess the new guidelines say that you should be on Plavix indefinitely". I was stunned. I was thinking that if I hadn't called and found all this out somehow on my own, that I would have never received this information from the doctor. These doctors need to be accountable to their patients, not just place the stent and then see you later. I believe that they have a responsibility to inform all patients after the fact, when they receive these new guidelines, this should be passed on to the patient. Not just tell the ones that ask. I think this is horrible to think that doctors don't feel a responsibility after the patient has the stent in place. This should be part of the guidelines also, that the doctors keep the patients as informed as they are ASAP. They do not realize the fear that people like me live with every day, worrying about this device that THEY put into me. The doctors need to be accountable. I just wanted to let you know that there is lots of us out there in the same boat. Thanks for listening.
Sheryl, USA, December 12, 2006

• AMEN to everything RIck Dulin has said. In my work as an artist-in-residence for Smith Farm Center for Healing and the Arts at Howard University Hospital, I have witnessed firsthand the necessity of having patient education and support services that meet the patient and his/her family/friends at their level of understanding. This means that the healthcare industry and government regulators must invest in culturally appropriate patient education that incorporates a wide range of literacy levels.
Ananda Kiamsha Madelyn Leeke, USA, December 12, 2006

• My husband had a medicated stent implanted in Jan/06 (Cypher). This was his 4th heart procedure (2 bypasses and 2 different stents). He's 60 years old, diabetic, hypertensive, CAD and a type A personality !!! His Dr. told him to get on Plavix 75 mg for 6 months. Then discontinue it. Today, we contacted his physician to see if we should re-start the Plavix (no answer yet). We're both extremely concerned. As I understand the news- Plavix (or some blood thinner) should be taken
at least 1 year (or longer). Am I right??? Good Luck to you.
Debbie, USA, December 11, 2006

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