Stents Can Kill

Now-epidemic chronic disease destroys blood vessels, usually slowly, and just a bit at a time.

Stents are "tubes" placed inside infected blood vessels - to create a mechanical support for destroyed areas.

Sounds like a miracle of modern science, right? But no...

A leading U.S. cardiologist called on Friday for a sweeping study to evaluate the risks of potentially fatal blood clots related to devices that are widely used to treat blocked heart arteries. ...Nearly 6 million heart patients worldwide have received a so-called drug-eluting stent, a tiny wire mesh tube that is covered with a drug that reduces scar formation and keeps vessels from reclosing.

But there has been a growing body of evidence that this newer generation of stents, compared with the bare metal variety, may cause blood clots to form long after implantation. Known as late-stent thrombosis, the risks were the center of debate at a cardiology meeting earlier this week in Barcelona.

"No one has done the right kind of long-term study," he said, adding that patients should be followed for three or four years instead 9 months. "How else will we answer the question?" ...Dr. Mark Ricciardi, director of interventional cardiology at the University of New Mexico Health Sciences Center, was supportive of such a study saying drug-coated stents may have been embraced a bit too eagerly. ..."If we haven't learned that we need to wait for long-term data, we should have learned it now," Ricciardi told Reuters."

Top US cardiologist seeks sweeping stent study

Sick people tend to be desperate - and desperate people make great guinea pigs.

Enough. Time to treat patients like people, NOT guinea pigs.

And time to treat the causes, NOT the symptoms.



.

Considering the shear number of individuals who receive this treatment everyday, compounded by the fact that your source doesn't cite any real number just a "growing body of evidence", I think this is more alarmist crap.

Sorry, but this is just alarmist.

Mariella

Originally posted by bsl4doc

Sorry, but this is just alarmist.

Not at all.

The Cleveland Clinic is one the leading medical centers in the USA, and Dr. Stephen Nissen is head of cardiovascular medicine at the Clinic.

"Late-stent thrombosis" is a well known risk associated with drug-eluting stents - the risks were the center of debate at a cardiology meeting earlier this week in Barcelona.

FYI - I refused to allow a stent placement prescribed in 2003 based on earlier reports. And I am NOT sorry.


.

I honestly don't mind at all if a patient refuses a stent, it is their right to do so. However, quoting an obscure risk attached to a very common precedure is indeed alarmist. There will always be a few doctors who will go against this new method or that one. It's a common trend in modern medicine; old doctors prefer old methods, and feel any risk is unacceptable, despite the risk attached to any other treatment.

Let's face it, anytime you put anything in the human body, especially in the circulatory system, you are facing the possible risk of problems. Is it nice to think about what COULD happen due to a stent? No, of course no. However, what are the alternatives? Sure, in your case, you came out fine. There are many others in worse condition.

Mariella

I realize that this is merely anecdotal, but I have to dissent, based on purely personal experience.

I had a massive heart attack 3 years ago. My cardiologist says that I was a candidate for a quintuple bypass. Instead, I was implanted with five drug-eluting stents; one on the day of my heart attack, four more ten days later. I was released from the hospital within 48 hours of my attack. I was able to walk 6 blocks in 100 degree summer heat the day after I got home (gotta have my funny pages!). Ten days later I was re-admitted for cardiac catheterization to implant the remaining four stents. I was released the next morning.

Now granted, I was lucky enough to have my procedures at one of the five best cardiac-care facilities in the US. And I was prescribed Plavix (to reduce the possibility of clots) for a year following the procedure.

My point is that I've never had any problem with thrombosis of any kind: perhaps I'm just lucky. Perhaps its because of the follow-up treatment and care I've received. Either way, IMO the reduced trauma and rapid recovery made possible by stents far out-weighs the risks associated with them. Add to the equation the known risks, including death, associated with major surgery, such as bypass surgery, and the conclusion is clear to me; go with the stent whenever possible.

the reduced trauma and rapid recovery

THIS IS KEY!

The reason we use these stents now is that they are less invasive, allow for faster recovery, and reduce the trauma the body must recover from.

Thank you!

Mariella

I don't know. If I had the choice between drug coated Stents and Multip-Bypass surgury, I would go with the Stents without even thinking about it. What is the survival rate of Bypass surgeries these days anyway? What is the Recovery times?

While I don't agree with the title of this thread (because I haven't seen any claim by any source that these stents are killing anybody), I'd like to point out that soficrow's original posting, and the quote by Dr. Ricciardi, no where suggest you should have bypass surgery instead of a stent - when a stent will fix the problem. The point (obfuscated by the misleading title) was that this is yet another example of the medical community deciding to collect long-term research data on the public, versus collecting it in a controlled research effort with a small volunteer research group.

The issue is - are the mesh stents causing a problem the metal stents did not? And why didn't they research that issue prior to sticking them in a huge number of the general populace? More and more this "research on the general populace" is happening in the medical community - with drugs, apparatuses, procedures.

Originally posted by Valhall
While I don't agree with the title of this thread (because I haven't seen any claim by any source that these stents are killing anybody), I'd like to point out that soficrow's original posting, and the quote by Dr. Ricciardi, no where suggest you should have bypass surgery instead of a stent - when a stent will fix the problem. The point (obfuscated by the misleading title) was that this is yet another example of the medical community deciding to collect long-term research data on the public, versus collecting it in a controlled research effort with a small volunteer research group.

The issue is - are the mesh stents causing a problem the metal stents did not? And why didn't they research that issue prior to sticking them in a huge number of the general populace? More and more this "research on the general populace" is happening in the medical community - with drugs, apparatuses, procedures.

What you don't seem to understand is that before any treatment or procedure is used on the any patient, it DOES undergo research in small volunteer groups. Several times. There will always be things that come up after approval, however. Do you think the makers of aspirin knew it would world well against heart disease? No. But did you voice concern when doctors started using it for that purpose?

Mariella

Strange, I thought the issue was drug coated stents vs. the traditional non-drug coated stents.


IMO behind the scenes it seems to be a large but simple struggle for dominance of the market, particularly between Johnson & Johnson, and Boston Scientific.


www.ptca.org...
www.ptca.org...://www.ptca.org/news/2006/0904.html

Originally posted by bsl4doc

What you don't seem to understand is that before any treatment or procedure is used on the any patient, it DOES undergo research in small volunteer groups. Several times. There will always be things that come up after approval, however. Do you think the makers of aspirin knew it would world well against heart disease? No. But did you voice concern when doctors started using it for that purpose?

Mariella

uhhh...while I AM older than you, I'm not THAT old. Further to it - what kind of strawman's argument is that???

"we've always been treating you like lab rats! so what's the problem?"

Originally posted by Valhall

Originally posted by bsl4doc

What you don't seem to understand is that before any treatment or procedure is used on the any patient, it DOES undergo research in small volunteer groups. Several times. There will always be things that come up after approval, however. Do you think the makers of aspirin knew it would world well against heart disease? No. But did you voice concern when doctors started using it for that purpose?

Mariella

uhhh...while I AM older than you, I'm not THAT old. Further to it - what kind of strawman's argument is that???

"we've always been treating you like lab rats! so what's the problem?"

Hmm, I don't believe that's what I said. Perhaps you should re-read my post. What I DID say was that this method has gone through several studies before being introduced to teaching hospitals, where most newer treatments are used first. Of course, there will always be new things discovered about a treatment once it's widely used. My example of aspirin is one of these. We had no clue that it could be used to reduce the risk of heart disease until a fortuitous incident occured and the connection was made. If you don't like the risk of modern medicine, don't go to the doctor. Just keep using homemade remedies which often don't cure anything or simply compound the condition. Sorry =(.

Mariella

Well my mother just have one of those procedures to repair one of her hart arteries is only been 5 months since the procedure. She went in for one procedure and end up in the operating room when her test show that she had clogged artery.

She wasn't given a choice it was that or the possibility of facing death.

The only thing that I am aware of is that my sister that also works in the medical field told me that my mothers chances of survival after the procedure is about 5 years taken into consideration that her hart is in bad shape.

Something that she very nicely told me over dinner.

I am still trying to digest that bit of information. But I wonder if she was talking abou the procedure been of short term or is about her hart.



[edit on 14-9-2006 by marg6043]

I have to agree with those who think our trial periods aren't long enough. For example, Prozac only was tried on a small group for 6 weeks! It usually takes that long to see the full effect of any anti-depressant. I do think they're using us as guinea pigs. Stents can be miraculous, but they can also kill. I have some personal experience with it. Several years ago, I worked at a plant that made stents. THe entire facility was nuts. It was all about the bottom line, nothing more. They workers were poorly paid, management could care less about any employee concerns, etc. IOW, things were pretty haphazard and careless. There have been lawsuits against stent makers.

While I was working there, my dad died of a faulty stent. He was my birth father, I didn't meet him until the last 10 years of his life. I loved him very much, he was veery dear to me and I took his death very hard. In addition, I had to go out of town to go to his funeral. I was out from work 5 days without pay. He was only 61 he should have lived much longer. Oddly enough, when I came back they fired me for being out too long, that's the kind of company they were. Shortly afterwards I began to hear about faulty stents and lawsuits.

Anyway, my point is that it DOES happen.

.


makeitso observes:

IMO behind the scenes it seems to be a large but simple struggle for dominance of the market, particularly between Johnson & Johnson, and Boston Scientific.

www.ptca.org...
www.ptca.org...://www.ptca.org/news/2006/0904.html

makeitso - close, but no cigar.

The real issue here is about transparency, accountability and independent analysis of trial data for medical devices.

At present, there is no transparency, accountability or independent analysis of trial data for medical devices.

Medical devices makers are under pressure to give more access to data from their clinical trials, following controversy over the long-term safety of drug-coated stents. ...Top heart experts, meeting in Barcelona, urged firms to follow the lead of the pharmaceutical industry and make available details of their studies in order to allow independent analysis.

Drugmakers agreed last year to release details of all trials on medicines, apart from those in initial Phase I development, after allegations they sometimes suppressed damaging results.

Devices companies have, as yet, given no such undertaking.

Device firms urged to match pharma on transparency

IMO - the need for transparency, accountability and independent analysis is self-evident, self-explanatory and downright effing obvious.

The link above no longer works. Here's another:

NEW LINK

Bhadihar - as this quote clarifies, drug-eluting stents are a great product for the right patient.

"Today, there's more data that says (the incidence of blood clots) is a risk. The best thing for doctors to do is to tap on the brakes, not hit the accelerator," Ricciardi said. "I don't think this is the nail in the coffin for this technology, but it needs to be studied more. It's a great product for the right patient."

Val and Mariella - When drug-eluting stents create blood clots, the resulting thrombosis can kill. The title is not alarmist, nor is it inaccurate.

One of the primary issues IMO, is that these stents are being foisted on patients with vascular diseases like FMD - which respond well and best to angioplasty. Meaning that stents are neither indicated nor required. But they are being implanted anyway. Just to "expand the market."

Stents are indicated for obstructive vascular diseases like atherosclerosis, and when angioplasty loses patency. Stents are not indicated for vascular diseases like FMD, which are obliterative as well as obstructive.

The makers of drug-eluting stents are pushing too many windows, IMO.


IMO - this is yet another illustration showing that the blockbuster one-size-fits-all approach to treatment does not work. Everyone is different, and has different medical needs.

But industry is concerned with "market dominance" - not patients - or appropriate medical care. So people die.



More Coverage

Physicians want transparency as Guidant lawsuits grow

...Guidant Maker CEO Resigns; Shares Rise

Medical Device Firms Need More Data Transparency

EU Commission launches revision of the Medical Device Directives

Are hospitals next in line?

Government investigators probing relationships between physicians, devicemakers may soon train sights on hospitals. Hospitals could soon find themselves facing legal heat stemming from schemes in which they may have been the victims.

Legal experts say that scenario might result from ongoing government investigations into relations between medical devicemakers and their physician clients. For four years, federal prosecutors have scrutinized the sales and marketing practices of devicemakers similarly to the way they have investigated those activities at pharmaceutical manufacturers before them. U.S. attorneys in Boston; Los Angeles; Newark, N.J.; and Philadelphia have sent civil and, in some cases, criminal subpoenas to at least a dozen producers of cardiac and orthopedic devices.

Web 2.0 pay for play: payola, or transparency? (Blog - but well written with good links and references.)

msnbc.msn.com...

Abbott Laboratories

Thrombosis News: Links to Pro and Con Coverage on Drug-Eluting Stents


.

But why would a doctor choose to use this over angioplasty if he felt the patient really needed angioplasty? You're the one that always says my profession does everything for money, and surely an angioplasty would brnig in more cash, no?

Mariella

Originally posted by bsl4doc
But why would a doctor choose to use this over angioplasty if he felt the patient really needed angioplasty? You're the one that always says my profession does everything for money, and surely an angioplasty would brnig in more cash, no?

Mariella

Gawd no. We're talking junkets and conferences (free vacations), more perks and lots of actual cash. Never mind a piece of the action, like shares in the manufacturing company. Happens all the time.

This is BIG business, with BIG payoffs.


These two links give a broad overview of how the more common kickback schemes are structured:

Are hospitals next in line?

Web 2.0 pay for play: payola, or transparency?


...About a year ago I did some quick research on a doctor (and his procedure) that was being promoted in one of my FMD support groups - and found out he had been thrown out of a California Medical University for 'study fraud', and that he owned million$ of dollars worth of shares in the device he was promoting.

...I'll see if I can find that file, to illustrate how nasty the situation really is.


.

I had a heart attack in 2002 at 31 years of age. I am 6'4, 210 lbs and it great health. However, stress folks is a killer. I lost my father, a marriage, a home and a child in the course of 6 months. It was devastating and it hit me hard.

I was given the choice of the conventional and the newer stent and went with the newer. I had 90 % blockage in one artery and after it was 'cleaned(angio)', the stent was inserted. I was out of the hospital in 2 days, and playing football at the beach with my son in a week. It was only then that I noticed that I did tire faster before the operation.

Bottom line is, it has helped me, and I have had no side effects. I was given excellent information while in the hospital to also help me with my decision. Remember a few years ago when eggs were bad and then they were good and then they were bad...Doctors treat patients now, they do not cure them.

Also, in these tests, you would be amazed at the things people will eat and how they will not excercise once they have a procedure that saved their life. Oh those lazy Americans.

.

Certainly some people benefit from drug-eluting stents. But many do not.

Some people benefit from insulin too. Does that mean every patient should get insulin? Or that everyone should get the same amount? Without monitoring glucose levels and the dose?

Again - one size does NOT fit all. Especially in medicine - and whether you're talkin drugs or devices.


.
sp

[edit on 15-9-2006 by soficrow]

Originally posted by bsl4doc
But why would a doctor choose to use this over angioplasty if he felt the patient really needed angioplasty? You're the one that always says my profession does everything for money, and surely an angioplasty would brnig in more cash, no?

Mariella

Angioplasty is an interventional treatment that will open blocked arteries (typically only increasing the available flow). The procedures usually leaves the vessel in a weakened state (blood vessels are active structures in the body, constricting and dilating according to physiological needs). A stent will "shore up" a weakened and vulnerable area, and the eluting medication can prevent infection and/or clotting. The vessel over time will grow over the stent, leaving a slightly constricted, but patent vessel.

Originally posted by soficrow
FYI - I refused to allow a stent placement prescribed in 2003 based on earlier reports. And I am NOT sorry.

If stents are not for you, so be it... To condemn them is nothing short of irresponsible. Thousands upon thousands of lives are saved each year through these procedures.

[edit on 15/9/2006 by Mirthful Me]