Drug-coated stents widely used for unapproved conditions

[Guest guest]

Drug-coated stents widely used for unapproved conditions

_http://www.naturalnews.com/022852.html_

(http://www.naturalnews.com/022852.html)

 

 

NaturalNews) Doctors have been widely prescribing drug-coated heart stents

for uses not approved by the FDA, according to two studies recently published

in the Journal of the American Medical Association.

 

Stents are wire-mesh tubes that are widely used to prop open heart valves to

prevent them from collapsing due to cardiovascular disease. They are often

used in conjunction with medical procedures such as angioplasty.

 

In 2004, three years ago, the FDA approved stents coated with medication

that makes blood vessels less likely to close again. They do this by

suppressing

the immune response that may stimulate growth of smooth muscle tissue in the

stented area. Because of the effectiveness of this treatment in preventing

restenosis (reclosing of the blood vessel), the new stents immediately became

wildly popular with _doctors_ (http://www.naturalnews.com/doctors.html) . By

2006, 90 percent of all stents being prescribed were of the drug-coated

variety, a market of $6 billion.

 

According to the two new studies, in the rush to adopt the new devices,

doctors ended up prescribing them for conditions for which they were not

approved

and their safety or effectiveness had not been tested. The studies found

that approximately 50 percent of the coated stents installed in 2004 and 2005

were prescribed for unapproved health conditions.

 

The use of _drug-coated stents_

(http://www.naturalnews.com/drug-coated_stents.html) dropped off slightly last

fall, after they were found to increase

the chance of deadly _blood clots_ (http://www.naturalnews.com/blood_clots.html)

.. However, 70 percent of the stents prescribed are still drug-coated.

 

One of the new studies, which looked at 5,541 patients, found that patients

treated with drug-coated stents had their risk of blood clots, heart attack

and death more than doubled. Because the overall complication rate was only

2.5 percent even in sicker patients, however, the researchers pronounced the

devices safe.

 

The authors of the second study, which looked at 3,323 patients, disagreed.

 

" Clinicians should be cautious about extrapolating the benefits of

drug-eluting stents over bare metal stents, " they said.

 

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[Guest guest]

, surpriseshan2

wrote:

>

> Drug-coated stents widely used for unapproved conditions

> _http://www.naturalnews.com/022852.html_

[...]

> One of the new studies, which looked at 5,541 patients, found that

patients

> treated with drug-coated stents had their risk of blood clots, heart

attack

> and death more than doubled. Because the overall complication rate

was only

> 2.5 percent even in sicker patients, however, the researchers

pronounced the

> devices safe.[...]

 

That is a huge silent scandal in cardiovascular health, it is a " killer "

stent/therapy for severe coronary disease and corporations are getting

away with it. They have, of course, failed to alert a lot of people o

of these drug coated stents complications. People with the stents have

to stick to powerful blood thinners to make their blood flow smooth

enough through the stent, unless they want to take their chances... Some

did and the consequences show up above too... sudden death, and heart

attack if you are more lucky... It's unbelievable.

 

By October 2006, there were 6 million people around the world with drug

eluting stents (DES)(drug coated stents). And for quite some time there

have been some concerns about these stents but this is kept somehow kind

of silent, with sporadic concerns like the one raised now. I kept the

next article from HindustanTimes.com in my archives, it was posted in

, but the link is no longer available there (why I'm not

surprised...) :

 

 

Medicated stents are bad news

<http://in.news./060905/32/679t0.html/>

 

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 already know...

 

Anyway, so the subject was brought in a Congress in Barcelona in 2006

and it had sparkled a lot of rationalizations and debates among the

scientific community. I have an old article with some interesting

points that I marked in bold; other " strange " words are generally the

names given by the companies to their drug coated 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 <http://www.theheart.org/index.do/> :

 

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, " 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, "

Yusuf stated. " We therefore need a thoughtful and selective approach to

PCI, complementing full medical therapy. . . . 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 (and heart surgery) are life saving therapies and period, that

is, for those situations when you are one breath away from death and

absolutely every other therapy failed, as chronic diseases are best

treated with alternative therapies. Its definitely better to use a

bare stent, without any kind of drug on it. The following quote stands

out " 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 " .

 

A corporative/man made disease. There are millions of people with drug

coated stents in the world, and counting... Sure it made someone a

billionaire and that someone is getting away with the crime, yet again.

 

 

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