Stents Can Kill

www.jvir.org...

A high technical success rate (97%) and low complication rate were observed. Exercise performance and health-related QOL results improved significantly after stent placement.

ats.ctsnetjournals.org...

Our experience provides some evidence that early mortality of life-threatening acute type B aortic dissection may be reduced by emergency endovascular stent grafting and that this form of treatment is a promising therapeutic option.

Two peer-reviewed medical journals articles I found after a brief PubMed search. Can you provide the same, or are you just depending on non-peer reviewed, unscientific news sites?

~Mariella

mod edit to use "ex" tags instead of "quote" tags
Quote Reference.


[edit on 20-11-2006 by sanctum]

bsdoc - this thread is chock full of medical references. Feel free to check back.

Your references failed to address the critical question - when are stents appropriate?

This thread is about the appropriate use of stents. There are 2 main points about inappropriate stent use:

1. Inappropriate use of stents can be dangerous, and sometimes, deadly.

2. Stenting often is unnecessary, with NO medical benefit, meaning patients are exposed to unnecessary risk for the privilege of throwing about $10,000 down the toilet.


.

1. Inappropriate use of stents can be dangerous, and sometimes, deadly.

Inappropriate use of anything can be potentially deadly. Most doctors (I say most because there are always those who temper their judgement with $$, but I feel they are in the minority, despite your undocumented claims to the contrary) use their best judgement when choosing a treatment plan. What one doctor feels should be stented, another my not, just as some doctors treat cancer more aggressively than others. Doctors always inform their patients of the inherent risks and cannot perform anything without consent, unless in an emergent situation.

Originally posted by bsl4doc

1. Inappropriate use of stents can be dangerous, and sometimes, deadly.

...Most doctors (I say most because there are always those who temper their judgement with $$, but I feel they are in the minority, despite your undocumented claims to the contrary)

Erm.

This issue is the headlines because:

1. The European Union and US are considering new stent safety guidelines - as we speak.

This is a hot political topic - with vested interests and serious money on the table.

But you probably know that, don't you?


2. Stents are big business - and now are used almost routinely, and often, inappropriately.

Doctors Rethink Widespread Use of Heart Stents

The medical community is having second thoughts about stents. ...stents are a big business, generating $6 billion a year in sales for their makers and thousands of dollars in fees for each procedure performed by the specialists implanting them.

...But now ...some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

3. There is no transparency, accountability or independent analysis of trial data for medical devices like stents.

4. There are safer, less invasive alternatives.

Stem Cell Experiment Yields Heart Valves

Scientists for the first time have grown human heart valves using stem cells from the fluid that cushions babies in the womb, offering an approach that may be used to repair defective hearts.

The idea is to create new valves in the laboratory while a pregnancy progresses and have them ready to implant in a baby with heart defects after it is born.

The Swiss experiment follows recent successes at growing bladders and blood vessels and suggests that people may one day be able to grow their own replacement heart parts, in some cases, even before they are born.

I am interested in this topic because stenting is the only treatment available to me at this juncture - as an experimental procedure - and I know it's inappropriate.

I know several other people who have FMD, as I do, and allowed stent implantation - they all have had serious problems with restenosis.

Pathology of in-stent restenosis.

The process of in-stent restenosis parallels wound healing responses. Stent deployment results in early thrombus deposition and acute inflammation, granulation tissue development, and ultimately smooth muscle cell proliferation and extracellular matrix synthesis. The severity of arterial injury during stent placement correlates with increased inflammation and late neointimal growth. These pathological findings provide useful targets for therapies aimed at reducing the incidence of in-stent restenosis.

Stents are permanent - once implanted they can't be removed. So restenosis involves complex, invasive and risky "stent cleaning" procedures - or full-out vascular surgery to remove the stented section of the artery.

Most vascular diseases are systemic - so stenting does NOT address the underlying problem. Stents only treat a small, limited area - and leave the rest.

Stents are NOT for everyone - the studies show they likely are most useful as an emergency intervention in life threatening situations when other therapies do not work.

The push to use stents as a standard therapy for vascular disease results from a marketing strategy, NOT medical evidence that stents are generally safe and universally effective.



More Background:

Angioplasty and Stenting Useless, Possibly Dangerous, 12 Hours After Heart Attack

Opening a blocked artery with balloons and stents can be lifesaving in the early hours after a heart attack, but a new study concludes that it often does no good if the heart attack occurred three or more days before. ...The new study “should change practice, and I believe it will,” said Dr. Judith S. Hochman, director of the cardiovascular clinical research center at New York University medical school, and leader of the study, which included 2,166 patients at 217 hospitals in the United States and other countries.

Stents have been increasingly used in people with clogged arteries who are not having heart attacks, but some studies suggest that those patients would be better off taking drugs to reduce cholesterol, inflammation and clotting. The reasoning is that artery disease tends to be systemic and extensive, but stents can treat it only in tiny spots.

***

A standard treatment for heart artery blockages has now been shown to increase the risk of fatal blood clots. ...Drug coated stents, which are little mesh tubes used to prop open clogged heart arteries, are used in more than 90 percent of stent procedures. (BUT)... The evidence suggests drug-eluting stents may be beneficial in only a third of patients. Some experts believe they should be used primarily in small blood vessels, where the risk of restenosis is greatest.

"We sort of can't just stent everyone with a drug eluting stent with impunity like we thought," Dr. Finkielstein said, "that being said, there is going to be a high risk patient who will benefit from drug eluting stents, certainly the technology is good and we just need to find which patients would benefit."

The stent market is worth more than $5 billion a year. Coated stents cost around three times more than bare metal ones.

***

The FDA said today it will hold a special meeting of a device advisory committee to assess new data about "small but significant" increases in the rates of death and myocardial infarction among patients treated with drug-eluting coronary stents.

...the FDA said that for "thousands of patients each year, these devices have resulted in a significant reduction in the need of second procedures to treat restenosis." An estimated one million drug-eluting stents have been implanted in patients in the United States.

***

The safety of drug-eluting stents in patients with coronary artery disease has been called into question following the presentation of 2 independent meta-analyses here at the European Society of Cardiology World Congress of Cardiology (WCC). ... The studies, which were reported at a Hotline session on September 3rd, sparked alarm and controversy by suggesting that drug-eluting stents carry a higher risk of death and myocardial infarction (MI) than traditional bare-metal stents. ...the new studies, which pooled data from randomized controlled trials involving first-generation sirolimus- or paclitaxel-coated stents, revealed increased rates of stent thrombosis leading to death or Q-wave MI, as well as increased rates of non-cardiac death.

Edoardo Camenzind, MD, cardiologist, University Hospital, Geneva, Switzerland, and colleagues found that rates of death or MI during extended follow-up were 30% to 40% higher in patients who received the Cypher sirolimus-coated stent than in those with bare-metal stents. ...Dr. Camenzind's analysis evaluated data from the Randomized Study with the Sirolimus-eluting Velocity Balloon-Expandable Stent, Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS), European-SIRIUS, and Canadian-SIRIUS studies. Data were analyzed at 4 different time points for each type of stent.

In a second study, Alain Nordmann, MD, clinical epidemiologist, Basel Institute for Clinical Epidemiology, University Hospital, Basel, Switzerland, and colleagues combined data from 17 trials of drug-eluting stents with follow-up periods of 1 to 4 years. ...Dr. Nordmann's analysis found a greater than 2-fold increase in the rate of non-cardiac death in patients who received sirolimus-coated stents versus controls. Causes of death included cancer, stroke, and lung disease.

Studies Link Drug-Eluting Stents With Death, Myocardial Infarction: Presented at WCC

Also see: 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?

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



[edit on 19-11-2006 by soficrow]

I agree that there needs to be more transparency in the American medical institution, however, I STRONGLY disagree with you that there is some more effective, safer alternative, or that all or even most stent patients have complications.

All you have done is provide evidence that there are still problems with the new stents and that new guidelines need to be put in place, which is what is currently going on. I see no reason stents should be removed altogether. I think that they, like ANY OTHER NEW MEDICATION/TREATMENT/TECHNIQUE, can only be studied and evaluated once in use. We have no way of testing these tools except during real life clinical situations. No dummy, simulator, animal test, etc. can safely predict every situation, every biochemistry, and every complication that may arise.Until we meet these problems head on and reevaluate the treatment's usage, there will always be high numbers of complications.

You have EVERY RIGHT to refuse to accept this treatment, and I applaud you for being educated on your own medical risk profile. If the alternatives sound reasonable and safe to you, go for it. On the other hand, if those fail, stents may become a more viable option for you. Any doctor will tell you that the least invasive, but still viable, method is always preferred, especially if you are advanced in age (which you may or may not be, I don't know), so if you have a noninvasive option and are not in critical need of a stent, I say go for the less invasive treatment.

~Mariella

Originally posted by bsl4doc

I agree that there needs to be more transparency in the American medical institution,

But not the EU? ...The issue is transparency of research results from international manufacturers.

I see no reason stents should be removed altogether.

No one is saying that they should be.

The line was, "Put on the brakes, don't step on the gas."

Stents went from obscurity to mass-use in a few short years - with no transparency or sharing of data. There were and are significant problems arising from inappropriate use.

The big brouhaha is about protecting a $6 BILLION industry - not patients' rights to appropriate care.

I think that they, like ANY OTHER NEW MEDICATION/TREATMENT/TECHNIQUE, can only be studied and evaluated once in use. ...Until we meet these problems head on and reevaluate the treatment's usage, there will always be high numbers of complications.

You are advocating the use of patients as guinea pigs. I don't support that.

Please read the PubMed article on restenosis linked above. FYI - The restenosis "problem" can be "predicted" by a few protein tests. Which are NOT routine because the underlying 'vascular' disease is epidemic, and the tests are positive too often.




.

You are advocating the use of patients as guinea pigs. I don't support that.

Then you must be against nearly all modern medical procedures/treatments. Every drug and procedure undergoes human clinical trials, i.e. guinea pigs. We are unable to predict the biochemical effects somethinge ill have under EVERY CIRCUMSTANCE in the human body except by testing in said human body.

I personally think that the main flaw with experimental testing of drugs and procedures is that they are conducted on white males, most often. Their biochemistry will differ from mine, yours, etc etc.

Please read the PubMed article on restenosis linked above. FYI - The restenosis "problem" can be "predicted" by a few protein tests. Which are NOT routine because the underlying 'vascular' disease is epidemic, and the tests are positive too often.

Granted, that one issue can sometimes be predicted by the protein assay analysis, but there are many complications with stents, as well as other commonplace procedures which have no testing available. Sorry, there just isn't a test for everything, and if we ran every test possible, you would be bitching about how much it costs to get anything done =(. We walk a thin line between safety and cost, unfortunately, which I think is a horrible thing to do.

Again -

The real issue here is that stents went from obscurity to mass-use in a few short years - with no transparency or sharing of data. There were and are significant problems arising from inappropriate use.

The big brouhaha is about protecting a $6 BILLION industry - not patients' rights to appropriate care.

The FDA and EU are considering new stent guidelines - to protect patients.

That's not a bad thing, imo.

Originally posted by soficrow
Again -

The real issue here is that stents went from obscurity to mass-use in a few short years - with no transparency or sharing of data. There were and are significant problems arising from inappropriate use.

The big brouhaha is about protecting a $6 BILLION industry - not patients' rights to appropriate care.

Money makes the world go 'round, unfortunately. As much as you or I dislike it, capitalism is ehre to stay and will always influence nearly every aspect of human existence, from how many children you have, to what medical treatment you receive, to what neighborhood you live in. It's sad, and I dislike it, but you can't revolutionize the system when it seems most people are ok with it =(.

[quote[The FDA and EU are considering new stent guidelines - to protect patients.

And? I was under the impression that this is what you wanted? I think it's a move in the right direction, personally.

~Mariella

This thread is about the dangers of inappropriate stenting, not the pros and cons of "capitalism."

As I pointed out and clarified:

The FDA and EU are considering new stent guidelines - to protect patients.

That's not a bad thing, imo.

...I certainly hope everyone can see past the marketing campaigns, and the people who push the marketing propaganda for questionable purposes.

Originally posted by soficrow
This thread is about the dangers of inappropriate stenting, not the pros and cons of "capitalism."

As I pointed out and clarified:

The FDA and EU are considering new stent guidelines - to protect patients.

That's not a bad thing, imo.

...I certainly hope everyone can see past the marketing campaigns, and the people who push the marketing propaganda for questionable purposes.

If they guidelines are being redrawn...where is the issue? I don't see what you're getting at. Yes, there was probably an excess of stents being implanted, but now the procedure, having been studied for some time in the medical community, is being examined and altered, just like any other process in medicine. Again, what exactly do you have a problem with?

Originally posted by bsl4doc

Again, what exactly do you have a problem with?

Please, read the posts for more information.

And please, stop trying to derail this thread.

Your sympathies with industry are obvious, and you appear intent on to sabotaging fruitful discussion and the open sharing of information. If that is not your intent, you might consider changing your tactics.


.

You want to see why a drug eluting stent is a good thing??

well..... you said i was just spouting an opinion...so heres a good long hard medical perspective at why they are a good idea.

www.cardiology.utmb.edu...
(yes its a while back but its still valid)
Go to page 60 .... 30 patients is a good sized study group...and 6 months is a fair amount of time for complications (if any to develope).... seems fair to me so far... then keep reading to see that some trials are using over ONE THOUSAND people to test saftey......

Sofi, I'm sorry, but you are entitled to your opinion, how ever alarmist it may be, but the truth of the matter is, stents save lives.

You made a choice, which you are entitled to, but i'm sure glad I am nothing to do whith health care in the USA - You want to be looked after in a capitalist society, yet bitch and moan when a company tries to save lives and make a dollar at the same time...... I pity the American health care Professionals I really do. Damned if you do, damned if you don't.... (you think this stuff grows on trees or some thing? You as a country won't support a nationalised health care system (too communist...) and yet, you moan when people need to make money from some thing and yet have tried damn hard to save lives.......

Originally posted by soficrow

Originally posted by bsl4doc

Again, what exactly do you have a problem with?

Please, read the posts for more information.

And please, stop trying to derail this thread.

Your sympathies with industry are obvious, and you appear intent on to sabotaging fruitful discussion and the open sharing of information. If that is not your intent, you might consider changing your tactics.


.

Sooo...by disagreeing with you, having credible sources, and personal, as well as professional experience in the medical field...I am "sympathizing with industry"? You know I work in a social medical system, right? What industry would I be sympathizing with?

Perhaps you should take a deep breath and try to suppress your McCarthy-esque accusations?

~Mariella

.

Please. Stay on topic or don't post here.



.

Originally posted by D4rk Kn1ght

Sofi, I'm sorry, but you are entitled to your opinion, how ever alarmist it may be, but the truth of the matter is, stents save lives.

Used at the right time, for the right reason, yes stents do save lives.

Used inapproproately, stents kill.

The stent industry grew by leaps and bounds over the past few years - now it's worth over $6 Billion.

Unfortunately, that growth and those profits accrued by using stents inappropriately.

You want to be looked after in a capitalist society, yet bitch and moan when a company tries to save lives and make a dollar at the same time......

How dare you presume to know my wishes or desires?

How dare you misrepresent my work in such a way?


The issue is that stents are being marketing aggressively, used inappropriately - and are killing people because of that abuse.


Are you saying people ought to happily give their lives so their local stent salesmen can meet his quota?

Are you saying people ought to happily give their lives so their local stent salesmen can meet his quota?

The "stent salesman" doesn't prescribe the treatment, and believe it or not, most doctors are not out to screw you. I know that comes as a shock to you, but a great majority of doctors like seeing their patient live, not flounder in an ineffective treatment profile.

Perhaps you could come down off of your pedestal and see that doctors aren't angels of death in white coats?

~Mariella

[edit on 11/21/2006 by bsl4doc]

Originally posted by bsl4doc

Are you saying people ought to happily give their lives so their local stent salesmen can meet his quota?

The "stent salesman" doesn't prescribe the treatment, and believe it or not, most doctors are not out to screw you.

Perhaps you could come down off of your pedestal and see that doctors aren't angels of death in white coats?

Your defense of the stent industry here reads like Dr. Fred Singer's defense of the tobacco and oil industries.



The issue is that stents are being marketing aggressively, used inappropriately - and are killing people because of that abuse.

Stents are NOT for everyone - studies show they likely are most useful as an emergency intervention in life threatening situations when other therapies do not work.

The push to use stents as a standard therapy for vascular disease results from a marketing strategy, NOT medical evidence that stents are generally safe and universally effective.

Stents went from obscurity to mass-use in a few short years - with no transparency or sharing of data. There is no transparency, accountability or independent analysis of trial data for medical devices like stents.

Now, the evidence is piling up - there were and are significant problems arising from inappropriate stent use. The line is, "Put on the brakes, don't step on the gas."


You focus on protecting a $6 BILLION industry - not patients' rights to appropriate care.


Unlike you, some doctors are having second thoughts about stents - because of the new data.

Doctors Rethink Widespread Use of Heart Stents

. ...stents are a big business, generating $6 billion a year in sales for their makers and thousands of dollars in fees for each procedure performed by the specialists implanting them.

...some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

Quite simply - stents are not for everyone. But they are marketed as if they are, and have been used as if they are.

People have died as a result of this marketing campaign. Unless someone puts on the brakes, more people will die, needlessly. Others will just waste their money on unnecessary, risky surgery - money better spent elsewhere.








[edit on 21-11-2006 by soficrow]

My nutritional doctor says that the American Medical Association and the pharmaceutical companies are in bed with one another.

After reading through this debate, I see more evidence to support that statement.

Stents or no stents. Drugs or no drugs.

Any method to amend cardio-vascular disease which does not involve surgery and/or drugs is the more progressive and intelligent approach

I could care less about the profit margin of doctors, surgeons, and drug companies.

Many people agree with this stance.

Months ago I attended a nutritional seminar in Maryland that was conducted by one of the better nutritional companies - Natures Sunshine Products. What I mean by the word better is that they carefully monitor their supplements to ensure that they are of the highest purity. In contrast, when you get vitamins from convenience stores and supermarkets they generally have many fillers and chemicals in them. Which means that one has to do some research and be discriminating, as well as pay a little more, in order to get quality supplements that do only good.

A Simple Lesson In Prevention & Treatment

In that NSP seminar they cited a nutritional study whereby a group of pigs were fed Krispy Kreme Donuts. Being very fatty, this led the pigs to having their arteries clogged.

They then had the pigs ingest high-grade Omega-3 supplements, which is essentially distilled fish oil.

The end result?

The Omega-3 literally unclogged their arteries.

No surgery, no stents, no angioplasty, and no drugs

Want to prevent and/or treat heart disease?

Get off the drug treadmill and starting taking care of your body.

Lose the unnecessary weight through proper diet (which does not mean starving oneself), eat right, and start taking upscale vitamin supplments - like high-grade Omega-3 and/or Omega 3-6-9, as well as Vitamin E, Coral Calcium and Ester-C (among others).

Also, end all dairy, alcohol, non-organic meats, all pork products, and butter consumption in one's diet. Eat lots of fresh vegetables daily. Avoid iceberg lettuce (as it has zero nutritional value), and have a green powder shake daily - like this one.

A daily pro-biotic supplment - like this - as well as a good digestive aid with every meal - like this - is also a wise move.

Leave the surgery and drugs to those who allow greedy doctors and drug companies to take control of their lives and to use them as guinea pigs for long-term medical experiments.

The issue is that stents are being marketing aggressively, used inappropriately - and are killing people because of that abuse.

Which is why the guidelines are being redrawn.

Stents are NOT for everyone - studies show they likely are most useful as an emergency intervention in life threatening situations when other therapies do not work.

Again, this is something we can only learn through their use, and this attitude will most likely be reflected in the new guidelines.

Stents went from obscurity to mass-use in a few short years - with no transparency or sharing of data. There is no transparency, accountability or independent analysis of trial data for medical devices like stents.

A lot of new treatments go from limited to massive use in short spans of time. Tylenol, penicillin, etc. etc. . All have their side effects, all are capable of killing, all must be reviewed and have guidelines set after much trial and error.

You focus on protecting a $6 BILLION industry - not patients' rights to appropriate care.

When did I do this? I said that I'm happy the guidelines are being changed, that I support a noninvasive alternative when possible, and that there should be more transparency. Are you perhaps confusing me with the voices in your head that you argue with?

Unlike you, some doctors are having second thoughts about stents - because of the new data.

See above statement.

...some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

So can McDonald's food, and they advertise more viciously and more widely than any pharmaceutical company. Why aren't you taking on them, as well?

Quite simply - stents are not for everyone. But they are marketed as if they are, and have been used as if they are.

you're right, they have been. And now that we have more data and the guidelines are being redrawn, they won't be.

People have died as a result of this marketing campaign. Unless someone puts on the brakes, more people will die, needlessly. Others will just waste their money on unnecessary, risky surgery - money better spent elsewhere.

Oh please, don't give me this "martyr for the cause" crap. Based on your history posting here, you just want one more issue that you think is a jab in the side of the modern medical establishment.

You just can't seem to accept that something proactive is already being done, that is, changing the guidelines. Sure, the stents aren't for everyone, I absolutely agree. I also agree that doctors were overzealous in their use. But you know what? Doctors are human. When we are given studies and such that seem reputable and the results seem to be there, we go with what appears to be the best current option. Now that more real time data is available, we are able to see that stents are not always the best plan of attack, and wil adjust accordingly.

Medicine changes and mutates just like any other field: there are always alterationg in treatment plans, methods of testing, etc. If you are not willing to accept a few missteps in order to make large strides, so be it. I'm just glad you aren't the one making the calls =(.




~Mariella