Medicated stents are bad news

[Gaby]

One of the unwritten rules in Modern Medicine is always to give a prescription for a new drug quickly, before all its side effects have come to the surface, or at least so it seems to be. Everybody knows about the evilness of pharmaceutical corporations and the policies of FDA, this section is full of examples.

It is as if somehow, somewhere, someone has convinced enough people that taking a certain drug is the only way to heal from a certain disease. And someone has, of course, also failed to alert a lot of people to the side effects of these drugs. Certain side effects are kept sort of silent to the public in general... The specific point in case I'm talking about are the medicated stents used in heart diseases as a treatment for the pandemic syndrome of coronary artery disease, which of course had brought lots of money to pharmaceutical corporations as it is one of the diseases per excellence of this self service third density world.

Background

Coronary artery disease (CAD) is a condition where the inside of the artery is narrowed by a buildup of atherosclerotic plaque resulting in a reduction in blood flow that deprives the heart muscle of oxygen causing symptoms. A heart attack occurs when the blockage suddenly increases or when strenuous exercise is attempted. The causes of CAD are multifactorial, and I guess we could include several nonaknowledged causes by the scientifical community as we had seen several times in the past that for apparently no reason someone involved in something "interesting" suddenly dies of a heart attack.

In any case, when its already way too late, as in "sudden death", "heart attack", "unstable angina"(someone with chest pain at rest, he or she generally is aware it is bad enough so as to die from that...) there are life saving procedures and one of them are interventional procedures (Percutaneous coronary intervention (PCI))

Interventional procedures are nonsurgical procedures used to treat blocked coronary arteries and increase blood flow to the heart. These interventions include the insertion of stents "- metallic spring-like implants" that greatly reduced the problem of abrupt closure and the need for emergency surgery. More recently, stents coated with drugs (drug-eluting stents) modify the healing process and reduce the incidence of restenosis or reclosure. They bring down risk of artery re-blockage (restenosis) from about 25 per cent to less than 10 per cent (or so it is said). There is always the possibility that papers with the best results get picked up for publications or so I will dare to say...

The concern

There are 6 million people around the world with drug eluting stents (DES). And for quite some time there have been some concerns about these stents but this is kept somehow kind of silent. Doing a quick search on the internet, I found an article of HindustanTimes.com:

Medicated stents are bad news

By HT
Tuesday September 5, 11:33 AM

Drug-coated stents used to prop open blocked arteries may cause potentially fatal blood clots in rare cases, said experts at the World Cardiology Congress (WCC) in Barcelona. Safety concerns were raised when a Swiss-Dutch study presented at the WCC said recipients of drug-coated stents were at increased risk of potentially-fatal thrombosis (blood clots).
[...]

This is not the first time the drug-coated stents have come under a shadow: In 2003, the US Food and Drug Administration issued a warning after receiving more than 290 reports of blood clots in Cypher patients, with more than 60 deaths associated to the device. The Taxus stent has been linked to a life-threatening mechanical defect that caused three deaths and several complications, which has resulted in a recall of over 100000 of the medical devices.The FDA, however, did not ask for drug-covered stents to be withdrawn.

Notice how it says "rare cases". I think it is slightly more than "rare" as we will see...

Anyway, so the subject was brought in a Congress in Barcelona and it had sparkled a lot of rationalizations and debates among the scientifical community. I have an article with some interesting points that I marked in bold; other "strange" words are generally the names given by the companies to their medicated stents, according to their generation; and MI is myocardial infarction AKA heart attack, and Q-wave MI denotes the most severe form of myocardial infarction.

Via heartwire:

Studies linking drug-eluting stents to increased mortality/MI spark impassioned pleas for reason and calls for calm

September 3, 2006

Shelley Wood

Barcelona, Spain - Many attendees of the World Congress of Cardiology 2006 had quit the conference center for sunshine and sangria by the time Drs Edoardo Camenzind (University Hospital Geneva, Switzerland) and Alain J Nordmann (University Hospital Basel, Switzerland) took the stage Sunday evening with the final presentation of the hotline session, stunning the remaining audience members with evidence of increased death in patients randomized to drug-eluting stents (DES) within the trial programs that secured approval for the devices in the first place.

Both of the meta-analyses combined all of the Cordis/J&J-sponsored Cypher randomized trials, as well as the Boston Scientific-sponsored Taxus program: one found an increased incidence of death and Q-wave MI with the Cypher stent and a trend toward increased death/Q-wave-MI with the Taxus, while the second found no differences in cardiac mortality but an increase in noncardiac mortality, again with the Cypher stent.

The separate presentations, which shared a single hotline slot-necessitating rushed synopses on the part of the presenters-spurred discussant Dr Salim Yusuf (McMaster University, Hamilton, ON) to deliver a thundering indictment of what he later described to the press as an "epidemic of madness" over misuse of PCI for stable angina in general and drug-eluting stents specifically.

"As clinicians we seem to have lost our clinical judgment, let alone our ability to view data and evidence," Yusuf stated. "We therefore need a thoughtful and selective approach to PCI, complementing full medical therapy. . . . The whole field of angioplasty has been led astray by a preoccupation with restenosis, for which study after study has shown has no prognostic value. We're chasing problems that are iatrogenic that naturally would not exist in people. We've had a perverse financial incentive on the practice of cardiology. It is time to stop and reevaluate."

Two meta-analyses draw on company-sponsored trials

Camenzind's meta-analysis was based on two separate analyses of the sirolimus and paclitaxel data. In the first, the investigators examined death and Q-wave MI in the published or presented papers, pooling them by time of follow-up. From eight to nine months of follow-up, out to one, two, and three years of follow-up, death/MI rates increased at rates that ranged from 30% to 40% higher in the Cypher-treated patients than those of the bare-metal-stent controls. A similar trend was seen, over time, for the paclitaxel-eluting stent, but here the relative difference between the Taxus and the bare-metal stent was only about 5% difference over the three years of follow-up.

In the second analysis, all of the randomized trials within each stent's program were stratified by last follow-up data. In this analysis, serious adverse events in sirolimus were 6.3% compared with 3.9% in the bare-metal-stent group (p=0.03) and in the paclitaxel trials were 2.6% vs 2.3% (p=NS).

"We conclude that death and Q-wave MI [as the] clinical presentation of stent thrombosis have a higher incidence in first-generation DES as compared with bare-metal controls," Camenzind stated. "Excess events appear to occur with both types of stents, although the magnitude seems to be higher with sirolimus. A risk/benefit analysis of systematic use of first-generation drug-eluting stents is warranted."

Nordmann's findings, while raising the specter of increased deaths, actually clashed somewhat with those of Camenzind. Nordmann et al combined data from 17 randomized controlled trials of paclitaxel- or sirolimus-eluting stents to evaluate total mortality, cardiac mortality, and noncardiac mortality. While total mortality at one year trended toward a benefit of DES, at two, three, and four years the investigators saw a trend toward increased mortality with DES. For cardiac mortality, however, there was no statistically significant difference between DES and bare-metal stents or for either sirolimus- or paclitaxel-eluting stent compared with bare-metal stents. Most striking, however, was the data for noncardiac deaths, which at two and three years pointed to an association between sirolimus stent implantation and increased noncardiac mortality. Separate analyses identified these deaths as cancer, stroke, or lung disease.

"DES for the treatment of coronary artery disease do not reduce mortality when compared with bare-metal stents," Nordmann concluded. "Preliminary evidence suggests that sirolimus but not paclitaxel may lead to an increase in noncardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving DES are mandatory to determine safety of patients receiving these devices."


Impassioned calls for a fresh look at DES, without industry involvement

To the press, Nordmann pointed out that obtaining raw data on mortality from the stent manufacturers had been "extremely difficult," highlighting the need for non-company-sponsored, large randomized clinical trials with ample follow-up.

At the very least, said Yusuf, large registries should be mandated to track adverse events in DES recipients. But Yusuf also made a plea to the major cardiovascular organizations to step up and revisit not only the use of DES but the role of PCI in the treatment of stable, non-drug-refractory angina. And to be clear, he added, PCI and drug-eluting stents play a key role in the treatment of unstable angina and acute coronary syndrome-it is as a treatment for stable angina to treat non-life-threatening restenosis that Yusuf singles out as a "myth" and a "man-made disease."

As for the meta-analyses themselves, Yusuf stated: "These new studies raise concern. I do not believe these trials are convincing, but they are disconcerting given that we have no data that this procedure is useful. There is a significant excess in noncardiac deaths, and we need to find out if this is real."

Pausing to assure a tittering audience that he was dead serious in his comments, Yusuf added, "I call on the ESC to [convene] a balanced and independent working group, and not just of interventionalists. Certainly you can bring them in, but also noninterventionalists, health economists, patient representatives, and government representatives, and have a committee to find out what the real role of PCI is, of these stents, and keep industry out of it."

Camenzind, for his part, stopped short of denying a role for drug-eluting stents, insisting that his study, and his misgivings, apply only to the two first-generation drug-eluting stents. "We need stents that can control restenosis, that don't totally abolish the healing process but that are able to control it."

Third study also sparks debate

Yet another study, presented earlier in the day by Dr Peter Wenaweser (Thorax Center, Rotterdam, the Netherlands) also highlighted the stent thrombosis risk with DES. In the study, Wenaweser and colleagues examined rates of early and late stent thrombosis in patients enrolled in the SIRTAX and Post-SIRTAX registries in Bern and the RESEARCH and T-SEARCH registries in Rotterdam, between April 2002 and December 2005. In Bern, patients received clopidogrel and aspirin for three to six months, while in Rotterdam, patients received dual antiplatelet therapy for three to 12 months. Only angiographically documented stent thromboses were included in the analysis.

In all, 152 stent thromboses occurred in 8146 patients. The cumulative incidence of stent thrombosis was 2.9%, yielding a rate of 1.3 per 100 patient-years. The rate of stent thrombosis was 1.2% at 30 days, 1.7 at one year, 2.3 at two years, and 2.9% at three years, "an almost linear increase of 0.6% per year between 30 days and three years," Wenaweser commented.

In interviews with heartwire, experts tried to put the findings in perspective, offering the oft-repeated calls for longer clopidogrel duration. Dr Antonio Colombo's group (Columbus Hospital, Milan, Italy) has a forthcoming paper examining rates of stent thrombosis in patients who quit dual antiplatelet therapy at one year, compared with patients who stayed on the drug out to three years.

"I think all of the presentations are pointing to the fact that stent thrombosis is there and needs a solution," Colombo told heartwire. "It exists, but it's not terrifying. My problem with this issue is that we did not use bare-metal stents in situations where we now use DES, so I doubt we can do a fair comparison of stent thrombosis between DES and bare-metal stents."

Stents are for life saving procedures and period. I would certainly prefer a bare stent, without any kind of drug on it. The following quote is useful "stents play a key role in the treatment of unstable angina and acute coronary syndrome-it is as a treatment for stable angina to treat non-life-threatening restenosis that Yusuf singles out as a "myth" and a "man-made disease".

I hope this was useful for someone. I mean, there are 6 million people with medicated stents in the world, and counting...

 

[Beau]

Thanks, this was useful for me.
My father has a stent in his heart, put in over ten years ago. I would be interested in finding out if it was a drug-coated stent.

 

[Gaby]

Thanks, this was useful for me.
My father has a stent in his heart, put in over ten years ago. I would be interested in finding out if it was a drug-coated stent.

If it was over 10 years ago it must be a stent without drugs. :)

Now they are making even new generations of stents claiming to deal with the problems of the medicated ones...

 

[Gaby]

I encourage those of you at risk for cardiovascular disease and/or who have had a family member with a cardiovascular event to revise my first post carefully.

The industry has had a huge impact in how cardiovascular disease is managed.

The first post is 10 years old when I was still practicing heart surgery. It is even more valid today because that knowledge got buried.

Stents and bypass heart surgery are best reserved for life saving procedures: heart attack and unstable angina that doesn't respond to medical treatment. A "preventive" stent for something like stable angina (where chest pain eases with rest) is a iatrogenic diagnosis and treatment.

As quoted in the above thread:

PCI and drug-eluting stents play a key role in the treatment of unstable angina and acute coronary syndrome-it is as a treatment for stable angina to treat non-life-threatening restenosis that Yusuf singles out as a "myth" and a "man-made disease."

In short, it is a procedure best left for the emergency room situation.

Even in the emergency room situation and where there is a clear indication, cardiologists are tempted to re-open everything they see even when only one artery might have needed treatment.

Arteries are very delicate things. Re-opening with angioplasty and leaving stents - a foreign material - should be left for the very last option.

If you are going to receive medicated stents, know that you can't just drop the blood thinner medication prescribed either otherwise you run a high risk for a fatal event. A foreign material of that kind in your arteries is certainly more thrombotic than any arterial sub-occlusion. It doesn't help that the stents are placed in the most vital arteries of your heart either.

This is a topic very hard to navigate for the average folk, but know that anti-inflammatory dietary choices and measures will go a very long way in avoiding an unpleasant situation.

 

[ashu]

Wow fascinating reading Gaby thank you. A co-worker revealed that he had a stent put in also (+10 years ago) and he mentioned it was laced with medication? But did not say with what - nor did I question. He is also on drugs for life and seems to be content with that. Not to mention he always looks pretty inflamed whenever I see him (like he has just finished a marathon).

The concern

There are 6 million people around the world with drug eluting stents (DES). And for quite some time there have been some concerns about these stents but this is kept somehow kind of silent.

I recall the co-worker saying that the place where he went to have his stent put in was like a conveyer belt operation – there were loads of people one after the other getting it put in - which when thinking about it is quite scary :O

 

[Lilou]

I recall the co-worker saying that the place where he went to have his stent put in was like a conveyer belt operation – there were loads of people one after the other getting it put in - which when thinking about it is quite scary :O

That is scary!! When my husband had his heart trouble, we avoided the hospital here in the USA and instead sent him overseas for treatment. They used a chemical cocktail to dissolve his blockages. I do not know the medicines they used, but he took them for about 2 weeks. When they went in again, all the blockages on his left side were gone, and those remaining on the right side were less than 20% - so they were able to manually remove those and he avoided a stent!

Stents are a big money maker for hospitals, so it seems they are installing them in people routinely, whether they really need them or not!
I found this link that is very useful for alternatives to heart surgery http://www.heartprotect.com/

 

[Gaby]

Stents are a big money maker for hospitals, so it seems they are installing them in people routinely, whether they really need them or not!

Exactly!!

As it says in the link provided above: Bypass Surgery And Angioplasty Are Rarely Needed.

 

[Ollie]

...
I found this link that is very useful for alternatives to heart surgery http://www.heartprotect.com/

Thank you Lilou, the link was very helpful.

 

[Gaby]

A co-worker revealed that he had a stent put in also (+10 years ago) and he mentioned it was laced with medication? But did not say with what - nor did I question. He is also on drugs for life and seems to be content with that. Not to mention he always looks pretty inflamed whenever I see him (like he has just finished a marathon).

I modified the first post to highlight the following:

Most striking, however, was the data for noncardiac deaths, which at two and three years pointed to an association between sirolimus stent implantation and increased noncardiac mortality. Separate analyses identified these deaths as cancer, stroke, or lung disease. [...]

The rate of stent thrombosis was 1.2% at 30 days, 1.7 at one year, 2.3 at two years, and 2.9% at three years, "an almost linear increase of 0.6% per year between 30 days and three years,"

Nowadays, a potent anti-platelet blood thinner combined with aspirin is suggested for one year. After one year, usually only aspirin is continued indefinitely. But according to the above data, the risk of thrombosis rises with time!

It is crazy. I think that maintaining a good diet, supplementation and a regular detox program would go a long way for those who already have medicated stents. But the thrombotic capacity of these stents is such that the person has to adhere to the prescribed potent blood thinner for the recommended time... Otherwise the person risks a fatal event.

I have not found any research to guarantee the needed anti-platelet activity from a natural source within the context of a medicated stent. The potent anti-platelet blood thinner drug blocks platelet capacity by 70-80%. What in nature can do that? This without considering the potency of aspirin which also needs to be factored in into the equation. Despite the claims of this or that in nature to be an excellent blood thinner, I have not come across with any scientific data that will report an 80% blocking platelet activity on top of aspirin's blood thinning effect. The best data available seems to be for Omega 3s, but at best it blocks platelet activity by 20% with the doses used in the studies. We don't know if a higher dose could reach higher blocking capacity.

Perhaps with the help of an anti-inflammatory lifestyle + diet + supplements, the stent would be covered with a more physiological inner lining that would decrease the chance of thrombosis with time though.

 

[MusicMan]

Stents are a big money maker for hospitals, so it seems they are installing them in people routinely, whether they really need them or not!

Exactly!!

As it says in the link provided above: Bypass Surgery And Angioplasty Are Rarely Needed.

Well, that was an eye-opener!
I'll keep that in mind when I get checked out on Monday.
Thanks, Gaby.

 

[Darek]

I just remembered something. Maybe there's another alternative way to clean your arteries?

https://www.sott.net/article/246004-Can-Pomegranate-Keep-You-From-Going-Under-The-Knife

A remarkable study, published in the journal Clinical Nutrition, took 10 patients with atherosclerosis and measured their carotid arteries before and after one year of supplementing their diet with pomegranate juice. After one year, the plaque clogging their carotid arteries was reduced by up to 30%, while the control group's blockages increased by 9% - effectively reversing the disease process by up to 39% within one year. Additional "side benefits" included a 130% increase in their antioxidant status, with LDL susceptibility to oxidation (it is far more important to maintain the quality of the LDL, i.e. keep it from getting damaged, than to nit-pick about the "right number") being reduced 59%. Finally, systolic blood pressure was reduced 21% within the first year. Wow, right? But it only gets better....

 

[happyliza]

Thank you so much for this thread regarding stents Gaby. This has been a vital place in my research against the Red Flags I got when mum said her consultant said she has only 6 months to live last week unless she has a stent in her blocked heart valve! She cannot have an anaesthetic and had already had to undergo terribly painful and invasive tests! The worst being a camera in her hand going up to her heart with not even any local or painkillers.

Of course my sister believes the doctors implicitly and said "I was there, I heard what the consultants said and even saw the scans!' The problem was that she ended my call saying my autistic niece had another of her many 'meltdowns' on hearing the discussion of me presenting the safer options!

I am pleased to note that Dr Howard H Wayne from Heartprotect.com also published a book :

How to Protect Your Heart from Your Doctor Paperback – 1 Feb. 1995​

Which is only available from the USA. I have asked my daughter to order it for my mum so she is able to personally research and make her own decisions on her treatment.
Meanwhile, I am looking into where in the UK - around Berkshire we can find a therapy centre for mum to attend. I will ask her to obtain all the test results from the consultants - which they never furnish patients with strangely!
So far I have only found one place : Benefits of EECP

Enhanced External CounterPulsation
Available at The Dove Clinic
This section contains a summary of some of the key trials published in peer-reviewed medical journals, and begins with a summary of the International EECP Patient Registry of over 5000 patients, which provides data demonstrating therapeutic outcomes and duration of benefit, and the CCS functional class system.
The Canadian Cardiovascular Society Functional Classification of Angina
The table below outlines a scoring system to grade the severity of symptoms suffered by people with angina. If you have angina you may wish to look at the table below to grade your symptoms of angina against the classes I (mild) to IV (severe).
Data gathered by International EECP Patient Registry of over 5,000 patients (see IEPR study below) showed

• after 24 months follow up 31% of patients recorded being angina free compared to 0% at the start of the study.
• 82% of patients improved after EECP by one or more CCS class
• 43.9% of patients improved after EECP by two or more CCS classes
• Benefits were sustained over the 24 month follow up, the table below summarises the data:

I am not sure if this is the best option - or if they offer a full care system. I will try to speak with the clinic today as well as ask Dr Howard Wayne clinic if they can recommend anywhere in the uk. Fingers crossed.

Edit: Forgot to mention that naturally I have the added burden of 'killing' my mum if anything happens by going against mainstream in my siblings minds!!

 

[Redrock12]

Thanks for this thread sister Gaby. It explains why you recommended the protocol that you did for my heart. I had what the docs called a bare metal stent inserted, so I'm hoping it wasn't a medicated stent. I now have four stents in my heart's blood vessels, three of them inserted in 2011. At that time, I refused the statin meds, in fact all the prescribed meds,which really upset my family physician. And I cancelled two appointments with the operating surgeon owing to hazardous winter road conditions (He was really upset but tough toe nails, it's my body). But up until the most recent attack, I experienced no issues with my heart. However, I am taking the doctor-prescribed meds, as well as the supplements you recommended (red yeast rice and CoQ10), as well as D3, zinc, potassium iodide, ascorbic acid, and liquid ionic magnesium.
What a blessing you are to the Fellowship, with your knowledge and training, all freely given.