Stopping stent restenosis

[johnnybgood75]

Hi. My wife has had 3 angioplasties, the 1st in 2001, the second in 2008 and the last this year (2009). The procedure in 2008 resulted in restenosis of a stent and caused her to return in 2009. It seems that restenosis is occurring again as her chest pain is beginning to return.

We have already modified our diet and lifestyle and feel that apart from the issue of restenosis we probably have the heart disease under control.

Does anyone know of any way to stop or reverse restenosis which has already begun in a stented artery? We would like to find some way to do this so as to avoid the trauma of another invasive angioplasty or bypass surgery.

Thanks,

Johnny

[oldie]

when your angiogram showed a 100% block of your Lad and 72% of circonflex, did the doctor say you needed a stent and you said NO , I'll follow the medication route?

[erijon]

Sorry, no doctors on this board. You need to post your question on the expert forum. It can be difficult to get in as they only take 2 questions each day, but keep trying as slots open up by time zone so if you don't get in now, you may later on.

Check your inbox.


Good luck!

Jon.

[claraleite]

One year ago, my husband underwent a stent implant surgery because he had a abdomen aortic aneurism. RIGHTafter the surgery however, he had intense back pains, and the ct scans and mris lab technicians only would say that he had a worn out spine disk. Today my husband went to see a pain management doctor, because the pain has been so umbearable. But this new doctor after studying his case, required a new MRI immediatelly, because he fears that the stent might be the cause for the pain, and there could be a leak in the aorta. What we understand is that the stent ws placed in a way that has been causing pain on his back.  I feel deceived by the doctor who operated on him, because he never mentioned that the reason for this horrible pain could be the stent implant. Instead he made us believe that it could be just because the patient's getting over 60's, and the back disks could start degenerating. The fact is my husband never had a back pain before the stent implant.He will go do the MRI tonight, but i'm aprehensive, could you please let us know what's the things we could be up against?!


thanks
clara

[erijon]

One last thought, didn't really read your post completely, but here's something you should ask your doctor about. Krill is not advised in people using blood thinning  drugs or anticoagulants. People taking blood thinners (anticoagulant or anti-platelet medication), such as aspirin, warfarin (Coumadin), heparin, clopidogrel (Plavix), non-steroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Motrin, Advil), naproxen (Naprosyn, Aleve) should only use krill oil under a physician's supervision.

The Krill may be making the symptoms from the Plavix worse.

Just a thought,

Jon

[erijon]

I understand your point that not all people respond the same to all meds, that's a fact. It is important to remember that these meds do help many, including myself.

I have read some of Dr. Mercola's (corrected spelling) theories and he really isn't saying anything new or revolutionary. Also, I am always suspicious of doctors that sell their own supplements on their website. I don't think he should be encouraging individuals to start supplements without knowing a little more about the individual's history. He can certainly make suggestions and question conventional thinking, but his website is really little more than just another supplement sales site.

Jon

[lmyrna]

Ken, I can tell you from first hand experience that statins cause not only muscle pain and weakness but also memory loss and confusion.  My cardio even said that in some, it can cause amnesia that doesn't alway come back.  I got to where I could hardly walk or write because my muscles were so weak plus, I could hardly remember my name.  He took me off the statin and put me on 2 grams of Krill.  I have only been on it for a couple of weeks so I'm not sure if it is working or not.  Also, I am very sensitive to medications of all kinds.  The Plavix is making me so tired and just a general feeling of malaise.  All people do not get the reactions but some do.  Do a little research yourself instead of asking someone to back up what they are saying.  Dr. Mercolla has a website devoted to scientific studies on all the medications.  Whatever, it is rude to tell someone they don't know what they are talking about when obviously, you do not either.

[kenkeith]

QUOTE: "Cardiologists on the one hand are still concerned how many patients are dying when taken off plavix, stent manufacturers on the other hand are saying "oh come on its not really that bad, we have some numbers here to prove it". So, who do you believe?

You believe an independant study that has a large sample of the population studied for an appropriate period of time.  What is your source regarding complaints by doctors regarding patient deaths?  What is the source the manufacturers (stent) have numbers disproving?  I don't believe there are statistics or any collation of data that has been published regarding complaints by doctors, and of course the manufacturers' response can be predicted.  Several months ago I quoted a source and posted that stated DES demand has slacked off and BMS sales have increased.  

QUOTE: "Well not too long ago, someone came to this forum asking if their pacemaker could have developed a fault. I was attacked by certain individuals for even suggesting they can have faults. I tried to give my experience in the electronics industry but was accused of being a liar. So, I am just 'proving' pacemakers can and do develop faults. If ones name is marred or one is accused, one has the right to prove their innocence".

I remember that thread, and if I remember correctly the discussion related to a newly installed pacemaker and the inference was that the statistics for failure were quite high.  
The subject of quality control, batch processing, and statistical analysis significally lowered the outrages high statistics of mechanical failure that you quoted.  There can be a batch that is high statistic probability of being defective but the associated problem is corrected.  You were not attacked; it seemed did not understand the manufacturing process.  There was no evaluation of problems with the battery, adjustments, not properly installed, etc.QUOTE:"Again, put into layman terms, does the percentage really mean a thing? One hospital for a procedure quoted me 20% risk, another 1%. That's a massive difference isnt it?"  

>>>To properly evaluate a surgeon, the number of successes is usually in thousands establishing no problem for a thousand like kind operations.  One hundred time does not provide an adequate measurement.  

Before there can be meaning for a statistical evaluation , all elements or factors need to be identical ......forgive the cliche, apples to oranges.  Who would go to a hospital that had 20% failure rate, the reason is obvious as the percentage of failures indicate.  The risks involved should be represented in a graphic bell curve, and an inference that the patient is within the bell curve, and the patient is a random selection.

Regarding airplanes there can be a probable statistical assessment when parts should be replaced, most effective time for proper maintenance, and when the plane should be retired. There is a record of maintenance and problems...it would be very bad policy not to maintain a record.  

[ed34]

"some studies I've read show numbers as high as 3%"

Again, put into layman terms, does the percentage really mean a thing? One hospital for a procedure quoted me 20% risk, another 1%. That's a massive difference isnt it?
Let's look at risks. If a surgeon is repeating a procedure he has performed 100's of times and never had a failure, his risk will be very low. If a surgeon has performed 2 procedures and one has failed, his risk will be much higher. Just like when we board a plane, we have no idea of how many problems it has encountered or how old it is. We have no idea of the experience of the pilot, we simply board the plane and grip onto statistics. If we knew the plane had suffered 20 in flight problems in the last month and the pilot was not very experienced, we MIGHT think twice and demand another flight. Before ANY cardiologist touches me, I always as how long they have been qualified and how many of these procedures has he done and how many have failed. I then ask his personal opinion off the record. This has more impact on reassurance and knowing you've made the right choice. When I asked a cardiologist how the heck he managed to establish a risk factor of 20% he didn't answer me. Another Cardiologist at the same hospital said he probably didn't feel confident, have the experience or even want to attempt it. Why not just say that? That made me feel the procedure would be too risky anywhere when it wasn't. It's false information killing my hopes.
Perhaps some doctors do accurately calculate the risk factor, but unless you have the absolute best cardiologist for that particular procedure, I fail to see how it can ever be accurate?
Another way to look at it is this. Imagine you want a Cardiologist to rotablate a particularly large blockage which is on a curve. Your cardiologist has never attempted this and is very much against attempting it. Will he give you the true risk factor which experienced cardiologists will give? or will he try to deter you from the procedure in favour of something else, such as a bypass? I have recently learned that the best cardiologists work in research/teaching hospitals. My usual consultant was taught by the cardiologist who did my last procedure and he in turn teaches other cardiologists at two hospitals.

[erijon]

Understand your point, but by your thinking we should be holding the medical community responsible for the risk involved in a angiogram as well. We should also be warning everyone about the risk and forcing change on the system. We both know that any procedure like this is going to have a risk and it is not practical to think it can be eliminated.

As far as the pacemakers go, it's the same thing. For the most part they are very reliable and according to what I read last night, the trend over the past 8 years shows a great improvement in the number of defects, the lowest number I saw was 1.37 per thousand compared to 12.04 per thousand 15 years ago. If I needed one I would want my doctor to explain the risk to me and do the procedure because lets face it, no cardiologist is going to implant a pacemaker on a whim, it generally needs to be done to preserve life and that trumps the 1.37 in 1,000 risk any day, everytime. So to me, to point out the flaws in pacemakers after the fact is really not our place. I know this is a forum and people come here for answers, but despite what we think, we're not experts and should not be making these kinds of statements. I know my doctor has done considerably more research on statins than I have (if that's possible) and I trust his judgement. I choose to leave it at that.  I have been called naive over this position but please understand that I have looked at the data myself and I had a choice to agree with my doctor or find another if we disagreed. Again, we can all throw studies out there, but how many people on this forum are really educated to the point they can accurately interpret them? You have more knowledge than most and probably are able to pull more from a study than the average individual on the forum, but giving that information to some one that does not have the ability to fully understand what they are reading as well as the consequences is not always a good thing.

Anyways, I respect your opinion, this is just mine.

[ed34]

Well not too long ago, someone came to this forum asking if their pacemaker could have developed a fault. I was attacked by certain individuals for even suggesting they can have faults. I tried to give my experience in the electronics industry but was accused of being a liar. So, I am just 'proving' pacemakers can and do develop faults. If ones name is marred or one is accused, one has the right to prove their innocence.

The negative side of things creates improvements. If drug companies fed people with medication that killed 1%, and didn't try to research for improvements, we would never improve. That's why stents were developed, to reduce risks and make recovery faster. To have to open a chest to bypass a single blockage was really unnecessary. So without the negatives, how can you ever create a path for the future.
It's like saying if a child keeps tripping over your shoes and banging their head, you would never move those shoes. Do we simply tell the child not to complain about the negatives. We are always making improvements on the negatives to make the world a healthier and safer place. As adults we are the same as children, we learn from mistakes and hopefully improve them. Sure, many times we have no other option, but hopefully we eventually do. We also have to try and make sure the right decisions are made, such as the shoes being put in a safe place and not just moved to another hazardous location. How can we ever learn without looking at the negatives?
This was the case with the pacemaker. I felt it very possible it could have been faulty, but to tell someone its virtually impossible is nothing short of ridiculous.

[erijon]

I've been watching this post and have not really been too interested in posting as I just don't have enough first hand knowledge to go toe to toe. Having said that, I'll throw my two cents worth in now.

What gets lost in posts like this are the people that benefit from these treatment's, statins and implanted devices. Respectfully Ed, I can (and have :) ) gone post for post, study for study on these topics. We have been through this many times and you all know where I stand. Here's how I feel, you can always come up with negatives, side effects, worst cast scenarios and past problems with any treatment out there. I don't see any negligence or recklessness in the current medical protocol when it comes to these treatments. What no one mentions are the thousands upon thousands of people that have benefited from these treatments compared to the small percentage that had adverse results. How many lives have statins saved? How many people would be worse off if they did not have this option? Would you say that people who need implanted devices should decide against it due to the small percentage of failures? Bottom line is that some people NEED these treatments to survive and to minimize their safety only raises anxiety, after all what choice do some people have? It's like having an angiogram as you have required in the past. There is a risk, I can post study after study to point out the risk, some studies I've read show numbers as high as 3%, but how would say no to a cardiologist in the ER when requesting an angiogram?

These treatments are necessary and have a definite benefit. There are risks to anything, but to always look at the negative side of things is not realistic. Be informed, do the research, make your decision but when we post we should be looking at the benefit as well.

Or if you want I can go back to posting study results and links :)

Just my opinion, stepping off the soap box now.............

[ed34]

More reliable pacemakers which undergo strict testing....

http://www.leighday.co.uk/news/news-archive/ela-medical-pacemaker-claims-settled

http://www.schmidtandclark.com/defective-pacemakers#{height:449,id:43778}

http://guidantlawsuit.lawinfo.com/

http://www.medlawlegalteam.com/defibrillator_malfunction.html

http://www.yourlawyer.com/topics/overview/Medtronic-Pacemaker-Sigma-or-Kappa

There are many many more, its unbelievable. If they go through vigorous testing, I fail to see how so many flaws are ending up inside patients.

[ed34]

In 2001 the FDA pressurised the Bayer pharmaceutical company to withdraw the cholesterol lowering drug cerivastatin from the market. This was because 31 people had died of a muscle disorder, rhabdomyolysis from taking this drug.
Other Statin manufacturers quickly added health warnings to all their products which were not there before. Now all Statin drugs have warnings about muscle pains and if you feel these symptoms, get to your GP. They also now state memory loss can be an issue. According to the FDA medwatch, over 3300 cases of statin-associated rhabdomyolysis were reported between January 1, 1990, and March 31, 2002.
Dr. Gregg C. Fonarow, UCLA professoer of cardiology, was recently quoted as saying between 2% and 8% of statin patients report muscle pain.
A 2008 study of in vitro muscle cells exposed to simvastatin found that at a dose equivalent to 40 mg/day, new muscle cell growth was reduced by 50%. While this does not translate directly to how statins work inside the body, it does provide scientists proof that statins directly affect muscles.
Nerve damage is a real issue....
http://www.sciencedaily.com/releases/2002/05/020514075710.htm
P. Michael Ho, MD, PhD and John S. Rumsfeld, MD, PhD of the Denver VA Medical Center in Colorado and colleagues studied a group of 3,137 patients with ACS discharged from 127 Veterans Affairs hospitals with an average follow-up of six months after cessation of clopidogrel. Approximately half of the patients were treated with medical therapy only and half with angioplasty/stents. 17% of those on the medical therapy group died or had a heart attack in this period, but almost two-thirds of those events occurred in the first 90 days. A similar pattern was seen in the angioplasty/stent cohort. Heart attacks are caused by sudden blood clots in the coronary artery which cut off the blood supply to the heart.

[cowboyz321]

feeling light pressure onleft side of chest . .stented area . .moreso with exersize . .stents are two @ 2years . .one coated . .one not.  last stress test way okay last year . . last 3 weeks i started to notice a location of dull pressure.  will see my cardio guy asap will keep you updated !  tx for your time

[kenkeith]

As usual all fluff and no substance.  Where are your sources for the rambling rhetoric.  

[ed34]

It all depends on who you choose to believe. If you look at many of the research studies, they have been funded by , yes you guessed it, the Stent manufactures. Why? because cardiologists start making noises about how they are losing their patients, fatally, and so the stent companies have to invent some research to please the FDA. Cardiologists on the one hand are still concerned how many patients are dying when taken off plavix, stent manufacturers on the other hand are saying "oh come on its not really that bad, we have some numbers here to prove it". So, who do you believe?
Its the same as patients suffering discomfort all over the world from medication side effects, wondering why they have this pain, that twinge, this itch. Medicine companies spend a fortune on research and keep saying the side effects are next to none. I believe a few years ago the FDA removed a statin drug from the market, yet the company still claimed it was perfectly safe.
We are all under the umbrella of uncertainty and with two different stories, someone has to be telling us lies. I know, let's flip a coin.

[cblmn7]

thank you it gives me a little beter understanding. just so many medical opinions on this it confuses me

[kenkeith]

QUOTE: "Too fast for most patients to even realise something has gone wrong and fatalaties have occurrred. Many Cardiologists still argue that patients who receive DES should stay on Plavix indefinitely until these problems are more understood and addressed.
Oh and how quickly can clotting block an artery when Plavix is stopped? in a matter of several minutes, it's that quick".
>>>>> I don't believe half what you state in your post, but do you mind providing source for the above, and i will go from there.  I have asked for a source in other postings,  and you fail to provide, so I'm beginning to believe you are making up information.

[kenkeith]

QUOTE: "my cardiogist told me im on plavix and asprin for the rest of my life. how come if after a year thedrug in the des is gone. just wondering. i have been told by 3 different drs that i have too".    

The easy answer is the doctor believes the risk of excessive bleeding doesn't outweigh the risk of cardiovscular event. Tests are continuing regarding restenosis, clots, etc. with the last test there were some agreement to discontinue Plavix after a year or so as that period of time seems to be the most vulnerable for blood clots...maybe longer for diabetics. The following governemnt trial study indicates a higher risk for a heart attack if Plavix is discontinued.

"A recent trial government trials that shows after clopidogrel (plavix) discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation".

For referrence:

NCT00590174 on 2008_01_09
ClinicalTrials Identifier: NCT00590174
Updated: 2008_01_09
Descriptive Information
Brief title Clopidogrel Use and Long-Term Safety After Drug-Eluting Stents Implantation

Official title Evaluation of the Long-Term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events

Trial study:
The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Detailed description:
Instructions for the use of drug-eluting stents (DES)commercially available in the worldwide specify treatment with clopidogrel for at least 3 months (for sirolimus-coated stents) or 6 months (for paclitaxel-coated stents) after implantation. Premature discontinuation of this minimum antiplatelet therapy has been associated with stent thrombosis. However, studies of late thrombosis events among patients with a drug-eluting stent have cast doubt on whether the recommended regimens are sufficient. An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation.
Therefore, this study is designed to evaluate the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation.


  

                        


            
    
  

[cblmn7]

my cardiogist told me im on plavix and asprin for the rest of my life. how come if after a year thedrug in the des is gone. just wondering. i have been told by 3 different drs that i have too.

[kenkeith]

QUOTE: "Too fast for most patients to even realise something has gone wrong and fatalaties have occurrred. Many Cardiologists still argue that patients who receive DES should stay on Plavix indefinitely until these problems are more understood and addressed.
Oh and how quickly can clotting block an artery when Plavix is stopped? in a matter of several minutes, it's that quick".
>>>>> I don't believe half what you state in your post, but do you mind providing source for the above, and i will go from there.  I have asked for a source in other postings,  and you fail to provide, so I'm beginning to believe you are making up information.

Yes, we know there are biodegradable stents in the future or so they say.  Also, a stent platform such as a bifurgation stent.  That is a new chapter so lets focus on the present and you can start by supplying your source for your rhetoric.

[ed34]

Well not quite the end. All this worry about clotting and restenosis should be a thing of the past by now. Where are the third generation stents?
Aren't we supposed to have bioresorbable stents by now? These sit in a vessel and slowly dissolve harmlessly away, leaving a perfectly healed and healthy artery. No clot problems, no restenosis problems. No worries about the artery collapsing.
I thought they were going to be introduced by 2009?

[kenkeith]

QUOTE: "When Plavix is stopped, the surface of the stent can still be too rough and clotting will form."  

>>>>>Clotting forms when there is a rupture of the soft plaque within the lining of the vessel into the lumen, and other causes given below. A rough area does not cause a clot...it causes plaque due to shear stress, blood flow turbulence and gradient pressures of an uneven surface.

I stated on this forum and I don't see any changes except may be the delivery system..
by kenkeith, Aug 29, 2008 03:58PM
To: omi123
For a perspective when a stent is placed in a blood vessel, new tissue grows inside the stent, covering the struts of the stent. Initially, this new tissue consists of healthy cells from the lining of the arterial wall (endothelium). This is a favorable effect because development of normal lining over the stent allows blood to flow smoothly over the stented area without shear stress, etc. Later, scar tissue may form UNDERNEATH the new healthy lining.

In about 25% of patients, the growth of scar tissue underneath the lining of the artery may be so thick that it can obstruct the blood flow and produce an important blockage. In-stent restenosis is typically seen 3 to 6 months after the procedure; after 12 months have passed uneventfully, it is rare.  
___________________________________________

Some injury almost always occurs to the artery  during stent placement. This can trigger a healing process where scar tissue collects on the inside of the stent, making the stented vessel narrow again. It is most likely to occur in SMALL vessels, LONG stents and in people with diabetes. Most DES elute their drug in the first three months, which is the period when scar tissue typically forms in bare metal stents.

Drug "eluting" stents have now been developed to STOP  the growth of the scar tissue. They use a small amount of immunosuppressive drug loaded on to the stent to prevent vascular smooth muscle cells dividing and proliferating the neointima..

The thrombosis is controlled using anti-platelet therapy. However, BMS are not immune from restenosis, primarily by neointimal (thin covering over the intima) HYPERPLASIA is caused from the ripping of the vessel during balloon expansion and exposure of the vessel’s smooth muscle cells (this causes blood clots, not an irregular surface).

While DES significantly reduce restenosis compared to BMS rates, studies found DES have increased rates of late-stent thrombosis, believed to be caused by the drug delivery polymer irritating the vessel. The rate of thrombosis is below 1 percent, but this finding prompted the American College of Cardiology to post guidelines suggesting 12 months of anti-platelet therapy after DES implantation (another cause for clots).

Although stents provide a less invasive method of treatment or repair as opposed to surgery, they do possess one major disadvantage. As the area around the stent heals, the scar tissue that accumulates often invades the area held open by the stent and causes the area to occlude with scar tissue. This process is called reactive fibrosis . Oftentimes, in these cases, smaller stents are placed inside the original larger stents in order to open up a stent occluded with scar tissue

For a statistic,.... now most people, approximately two thirds, will get a thin little scar or scab inside the artery, and that heals the artery very nicely. But approximately a third of patients will have an excessive amount of scar or scab form, given the size of the artery, because these arteries are actually quite small, and that will gradually re-narrow the artery within the first six or twelve months, and that's what is called  re-stenosis.
Risk for blood clots (not irregular surface!).  we know that the likelihood of the arteries re-narrowing after drug-eluting stents are much less than after bare metal stents, but these are very potent compounds, and sometimes they cause the artery to heal to a minimal degree. And, as a result, occasionally blood clots can form on drug-coated stents.

The end! :)

[ed34]

Bare metal stents have more cases of restenosis than drug eluting stents, but there is a very big difference, one which is of huge concern. When a bare metal stent develops restenosis (if it is going to), it starts soon after the stent is inserted. However, the beauty is, it happens gradually and the patient notices degredation in their health. This is enough to usually save the patient from a heart attack because they reattend hospital.
Drug eluting stents are not so kind. It seems that as long as Plavix is taken, then the stent 'usually' remains clear. However, it is very difficult for the body to grow new Lumen tissue through the stent because the coating seems to inhibit this. The coating was designed to stop scar tissue forming but it also stop natural tissue growing. When Plavix is stopped, the surface of the stent can still be too rough and clotting will form. Now, the biggest problem with DES is that restenosis is not gradual, it is very fast indeed. Too fast for most patients to even realise something has gone wrong and fatalaties have occurrred. Many Cardiologists still argue that patients who receive DES should stay on Plavix indefinitely until these problems are more understood and addressed.
Oh and how quickly can clotting block an artery when Plavix is stopped? in a matter of several minutes, it's that quick.
I shudder now, knowing I stopped Plavix last year and have a DES. Thankfully my last angiogram showed it fully patent. In a way, I feel safe being back on Plavix again now.