April-September
2007 Archives:
September 3, 2007 -- 3:38PM EDT
"England swings like a pendulum do"
The pendulum here is not the one that Roger
Miller sang about in 1966, but rather, if you don't mind a major
gear-shift, the one that Dr. Kirk Garratt of Lenox
Hill Heart and Vascular Institute discussed with me recently
-- namely the use of drug-eluting stents vs. bare metal stents.
(I'll explain what England has to do with it later on, as well
as gear-shifts.) Dr. Garratt told me that he felt the pendulum
had swung too far in the direction away from drug-eluting stents
(DES).
In 2004, DES were the darling of interventional
cardiologists: these new devices were going to change the way interventions
were done because they overcame the bug-a-boo of restenosis. DES
became one of the fastest adoptions of a new technology ever and
in the U.S. virtually replaced the older bare metal stent overnight.
Swing pendulum swing!
Everything was going along fine until the small
but potentially catastrophic incidence of late stent thrombosis came
to the forefront, most publicly one year ago at the European Congress
of Cardiology. Was it a big problem? There was much heated debate,
scary headlines and the convening of a 2-day FDA stent safety panel
in December. At that panel, Dr. Lars Wallentin presented the SCAAR
registry data from Sweden which concluded a 0.5%-1% increased
risk of death or heart attack from drug-eluting stents per
year, starting after 6 months.
Swing back pendulum! In just 6 months, the stent
device industry experienced a thrombosis of their own: drug-eluting
stent use in the U.S. had dropped from 90% to 70%. (In Sweden, DES
use hovers around 20%.)
Now, yesterday in fact, longer follow-up and greater
numbers have significantly
revised the latest SCAAR registry data -- new conclusions have
just been presented at this year's ESC and guess what? No discernible
difference between DES and bare metal has been found in terms of
higher risk of death and MI! The disparity seen at 1-year disappeared
after 3 and 4 years, as the patients with bare metal stents caught
up, and as cardiologists, concerned over stent thrombosis, began
selecting patients more carefully and prescribing antiplatelet therapy
for a longer duration.
(This trend of catch-up and evening out, by the
way, was one which was vociferously advocated by Marty Leon and Gregg
Stone at last year's TCT meeting. They were right.)
Various studies have also been presented showing
long-term safety for the Taxus and Cypher stents. And Medtronic's
Endeavor and Abbott's Xience second generation DES are expected to
hit the U.S. market in the next year.
Stand clear. Pendulum about to swing back.
While many may seem astonished at the 360 that's
occurred, the reasons are not that complicated and were totally predictable.
In fact we at Angioplasty.Org have been writing about these factors
for the past year. Immediately after last year's ESC, in the midst
of the scare
dreadlines from the press and the antidotal "they're okay,
really" messages from the device industry, we posted a "Stent
Advisory for Patients" to help our very concerned readers
understand and make intelligent decisions.
In our
exclusive interview with Dr. Antonio Colombo, he compared drug-eluting
stents to a high performance race car:
It’s like if you were driving a faster
car. If you know what you’re doing, it’s fine. But
it’s more prone to make a mistake if you’re not very
careful.
We would add that you also need to know where you
can drive it safely, how long the trip is going to take, and make
sure to check the oil regularly.
Cutting to the chase, DES work great, but they
require at least a year or two of dual antiplatelet therapy (clopidogrel
and aspirin) to prevent thrombosis. This is not a plus for patients
who need or are likely to need surgery in that year. Also not a plus
for patients who are at high risk for bleeding. Or for patients who
might be allergic to the stent, the polymer, the drug, or Plavix.
Similarly, cardiologists need to take care in placing
the stents accurately and expanding them fully -- something Dr. Colombo
and others discuss at length and why they use Intravascular
Ultrasound (IVUS) to guide them in these decisions.
Finally, there are patient populations who don't
really see a large benefits from DES: those with large diameter arteries,
for example.
In contrast, narrow arteries, bifurcation lesions,
diabetics -- those at higher risk for restenosis, can benefit widely
from the use of drug-eluting stent technology, since these devices
can reduce the repeat procedures that have been necessary in the
past, eliminating the risks inherent in any additional medical procedures
and, saving the cost of repeat procedures.
Which brings me to England. The
National Institute for Health and Clinical Excellence (NICE
-- or as British cardiologists are now calling it, not-NICE) has
recommended that the British Health Service cease reimbursing the
use of DES because they are not cost-effective. Comments from the
public on this proposal just closed last week and the decision
as to whether to follow NICE's guidelines is imminent. Given the
somewhat different news coming out of the ESC, perhaps England
will also swing like the pendulum do, and deep-six this recommendation
-- something strongly
urged by cardiologists not only in Britain, but all around
the world.
June 8, 2007 -- 7:14PM EDT
Consumer Retorts
The magazine that tells you the best dishwasher
to buy, which toaster gives you that nice overall even brown crispness,
or which SUV is most likely to roll-over on a sharp turn, has
now entered the cath lab. The Editors (and the experts they
have consulted) are recommending against getting angioplasty, except
in certain very specific cases, like a few hours after a heart
attack (my recommendation: don't wait -- get that angioplasty now!
WHILE you're having the heart attack!!).
CR also thinks that multislice CT angiography
is "seldom worthwhile"; their number one recommendation: "In
general, don't bother with CT angiography." You might think
that this recommendation might slightly upset the 3,400 members
of the Society of Cardiovascular Computed Tomography (SCCT) --
and it did. The CR piece was published online last week, but had
been published in print back in March -- and the SCCT leadership
wrote a
strongly worded critique, taking Consumer Reports to task for
maligning this new and valuable test. For example, CR mistook a
CT angiogram for a Calcium Scoring test.
Well this new online version corrected that one
error, but left in a slew of others. You can read all about it in today's
feature on Angioplasty.Org.
April 19, 2007 -- 12:26pm EDT
Banned in Boston
In today's news from theheart.org,
Shelley Wood reports that the Boston-based New
England Journal of Medicine has banned Marty Leon from its
panel of peer-reviewers, and furthermore will not be inviting Dr.
Leon, one of the highest profile interventional cardiologists in
the world, to write reviews or editorials for the Journal for
a period of five years.
This action was taken in response to Leon's alleged
breaking of the press embargo around the COURAGE trial, which was
scheduled to be presented on Tuesday morning, March 27, at this year's
American College of Cardiology annual meeting in New Orleans -- and
simultaneously published online by the New England Journal. The five-year
COURAGE trial studied whether angioplasty/stents added to medical
therapy provided any additional benefit in reducing death and heart
attack in stable patients.
In the weeks leading up to the ACC, the trial had
been the subject of much press hype and statements from non-interventional
cardiologists that, if the results showed no benefit for stents over
drug therapy, it would "shake the foundations of interventional
cardiology" -- a throwing down of the gauntlet to stent-evangelists
like Marty Leon, one of the builders of that foundation.
As for the embargo, the Thursday before the ACC
began, the NEJM gave the results of the COURAGE trial to all health
reporters, this one included, so that we could prepare our stories.
We were allowed to reveal those results to anyone we interviewed
for an article. We just weren't supposed to publish or discuss the
results in public until Tuesday morning.
Fast forward to Sunday night the 25th at the Hilton
New Orleans Riverside hotel. The first two days of ACC presentations
and PowerPoints were now over and many interventionalists were attending
a free reception (food with open bar) and an evening "satellite
symposium" about drug-eluting stents, sponsored by Boston Scientific.
The final speaker was Marty Leon.
As Keith Winstein reported two
hours later in the Wall Street Journal's Health Blog:
Leon...tipped the audience of several hundred
doctors to the embargoed conclusions of the Courage trial about
stents...adding that he had reviewed the Courage study after
it was submitted to a medical journal. "It was rigged to
fail, and it did," he said...."There's going to be
an onslaught.... A lot of people have been taking shots at us,
and we need to go on the offense for a while."
Boom. The Battle of New Orleans had begun. Or was
it just "Marty Gras"? In any case, the whiff
of grapeshot wafted across Convention Center Boulevard. Monday
morning's WSJ ran a more detailed story. The embargo was broken.
ACC and NEJM leadership was furious. They hastily scheduled a press
conference and made the following statement:
At 1 p.m. Central time on Monday, the American
College of Cardiology lifted the media embargo on the COURAGE
trial that was to be presented on Tuesday. The decision was made
after the College discovered that information related to the
study’s results was released Sunday evening and that information
was made public in a media article.... We are extremely disappointed
that this individual or individuals released this information,
betraying the confidentiality of the scholarly process and the
professional integrity of the scientific community. The American
College of Cardiology will be considering strong sanctions against
the individual or individuals involved.
Boom. Boom.
Dr. William Boden, lead author of the COURAGE trial,
was very disappointed at having to scurry around and not present
the results of his five-year's worth of arduous study at the appointed
time and place.
Now, not quite four weeks later, the New England
Journal of Medicine has levied its penalty -- the ACC has yet to
announce what, if any, sanctions it will take.
As for Dr. Leon, he has denied breaking the embargo,
saying that his comments had been misunderstood, taken out of context
by a journalist, that he didn't reveal any results, that he was talking
to a room of cardiologists and did not know who was in the audience.
And as for Keith Winstein, the Wall Street Journal
reporter, the NEJM stated that it did not have a problem with his
article, because he was only reporting on the embargo break. Winstein
reported to us receiving a similar sentiment from Steve Nissen, president
of the ACC.
This incident, however, has a bit more back story
-- which I'll be discussing in short order.
April 7, 2007 -- 6:36pm EDT
New York Times: Angioplasty AND Drugs Are
Important
Gina Kolata's must-read entry in the New
York Times health series "Six Killers" is in tomorrow's
paper (on Easter Sunday?) and it's an important piece. Published
online today, "Lessons
of Heart Disease, Learned and Ignored", is a welcome
addition to the many flawed articles that have hit the popular
press in the past two weeks since the results of the COURAGE
trial were announced.
Instead of pumping a false comparison about how "drugs
are better than stents", or vice-versa, Kolata's piece is not
only totally accurate, but a much-needed correction, showing both
the importance of compliance with prescribed heart medications, and how
angioplasty can literally stop a heart attack in its tracks and save
a life.
One of our fears at Angioplasty.Org, one shared
by most interventional cardiologists I've spoken to in the last week,
is that the onslaught of anti-stent press would send a message to
the public that angioplasty doesn't work. Forbes magazine even ran
a headline, "Stent
Shocker: They Don't Stop Heart Attacks" -- total crap! They
do! And Ms. Kolata's article describes just how they do in a very
compelling story.
BOTH drug and stents are important therapies. The
real problem is that they are unfortunately not being delivered to
a majority of the people who need them most -- which is the subject
of our
latest analysis of the COURAGE trial results.
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