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February
16,
2010 -- 10:55pm EST
Stents Downgraded by Wall Street
Journal: If Only It Were That Simple
 A broad-based critique, claiming overuse of
heart stents and angioplasty, was published as a major
feature in Thursday's Wall Street Journal. Clocking
in at just under 2,000 words, Keith J. Winstein's article, "A
Simple Health-Care Fix Fizzles Out", time-travels back three
years to look at the COURAGE trial and
how it has
affected (or
not) the treatment of patients with "stable coronary artery disease".
(For a refresher on COURAGE, read Angioplasty.Org's
2007 report).
The main thesis of Winstein's piece is that
the use of stents, after an initial drop of 13% right
after COURAGE was published,
is now back
to pre-COURAGE levels. With the subtitle, "Why
Health Policies Can Fail to Keep Up With Key Medical Findings",
the WSJ article questions this rebound in stent use, which it
characterizes as a "lucrative treatment"
that can be "ineffective"
and "unnecessary", and discusses the resistance to the COURAGE
results from both the interventional cardiology community and
the medical device manufacturers. (Gee...and I always thought
the WSJ was a
"friend" to business and industry.) The article also discusses
how reimbursement policies currently favor stenting over medical therapy.
WSJ Simplifies Study Results by Ignoring Key
Issues
Although the impact of the article may have been
lessened somewhat when Bill
Clinton was treated successfully with two stents only hours after
the WSJ hit the street, there's no question that the COURAGE study
(along with other similar trials, such as
the recent BARI 2D)
raises important issues, but the WSJ piece leaves out some important
points and, well, here's a sample of the opening graphs:
It sounds like such a simple concept: Study
different medical treatments and figure out which delivers
the best results at the cheapest cost, giving patients the
most effective care.... Yet, an examination of one of the best-known
examples of a comparative-effectiveness analysis shows how
complicated such a seemingly straightforward idea can get.
The study, known as "Courage" (sic)...shook the
world of cardiology. It found that the most common heart surgery—a
$15,000 procedure that unclogs arteries using a small scaffold
or stent—usually yields no additional benefit when used
with a cocktail of generic drugs in patients suffering from
chronic chest pain
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The words that jump out at me
are "simple" and "straightforward" -- because the
diagnosis and treatment of coronary artery disease are neither.
It may be comforting to view
medicine through the eyes of an engineer or programmer, where you
define a problem, create a fix, test it and implement it. But figuring
out how to diagnose and treat a specific patient involves juggling
multiple moving targets while keeping on top of the latest research,
findings and available tools: it's what good doctors do.
Also Winstein's choice of the phrase "no additional benefit"
is not accurate. The COURAGE study concluded that the addition of
stenting "did not reduce the risk of death, myocardial infarction,
or other major cardiovascular events." In fact, the Quality of Life
portion of COURAGE showed that patients who received stents felt
better (less
pain) than the patients on OMT. That would definitely be a "benefit".
So here are a few facts and
findings that may mess up this "simple concept" and show it to
be a bit less than straightforward:
Comparison About More Than Just
Drugs vs. Stents
COURAGE was not simply about "generic drug cocktails"
vs. stents; it was about Optimal Medical Therapy (OMT) alone vs.
OMT with the addition of stents. OMT is defined
as a combination of "intensive medical therapy, a reduction of
risk factors, and lifestyle intervention (diet, regular exercise,
and smoking cessation)."
Patients
on OMT took 8-10 or more pills daily. They also were counseled about
lifestyle changes, given support to lose weight, to exercise, to
stop smoking -- none of these changes, as many of us know, are easy
to accomplish; These patients got a type of personalized care that
unfortunately is not readily available to many. In the "real
world" studies
have shown 40-50% compliance
with diet,
exercise, etc. -- in COURAGE compliance was boosted to 80-90% --
but can this be extrapolated to real-life? If insurers actually paid
for these types of full-blown support services for weight-loss,
exercise and smoking cessation (and they should!) -- what would
that additional cost be for all "stable" heart patients?
1/3rd of Patients Given "Drugs Only" Switched
to Stents
While it is true that there were no statistically significant
differences between the two groups in terms of death and heart attack,
fully 1/3 of the patients who
started with medical therapy crossed-over to stenting, mainly for
symptom relief (the BARI 2D trial experienced a similar cross-over
rate of over 40%). In other words, someone thought stenting was beneficial!
Study included only Bare Metal Stents
Drug-eluting stents were not
even approved until the final 6 months of COURAGE, so less than 3% of patients
received them; 97% received the older bare
metal
variety.
Drug-eluting
stents
significantly
reduce
restenosis
(reblocking of the artery). Studies have shown that about 1/3 of the time,
restenosis manifests as a heart attack. So would the results of COURAGE have
favored stenting if drug-eluting stents were used?
Very Limited Patient Selection -- 90% of
Candidates Rejected
90% of the patients initially screened for COURAGE were
not enrolled in the trial (i.e. they did not fit the study's definitions
of
"stable angina"). A 90% exclusion rate is fairly high and critics
of COURAGE point to this to show that the patient population was
not what cardiologists encounter in their day-to-day practice.
Pre-Testing No Simple Solution Either
The WSJ article also makes a case for more pre-testing
of patients before a stent is decided upon. According to the AHA/ACC/SCAI
Guidelines, this is the way it's s'posed to be. But
studies have shown that up to 50% of patients getting a diagnostic
angiogram have not had a nuclear stress test. There are reasons.
Because of previous diagnostics and/or clear symptoms, there may
be no question that the patient has coronary artery disease (Bill
Clinton did not need to undergo a stress test last week). Another
confounder is that nuclear stress tests
show a relatively large number of false positives or equivocal results,
so those patients are sent to the cath lab for a diagnostic angiogram
-- yet 37% of patients
who get diagnostic caths show no coronary
artery disease. And the
scenario of someone dying of a heart attack the day after a negative
stress
test is oft-quoted
(the tragic case of Tim Russert, for example). Moreover, many imaging
experts believe that Cardiac CT is a better, more
accurate test for the presence of coronary artery disease -- yet
its use is
being restricted by insurers and Medicare as being overused (not
true) and unsafe (also not true -- properly done, the radiation
from a Cardiac CT scan is less than that from a standard nuclear
stress test). The testing/decision tree for patients with chest pain
definitely needs updating.
Guidelines Plus Individualized Medicine -- More Effective
than One Size Fits All!
Certainly, some sort of decision-making, and discussion
with the patient, before choosing stenting as the treatment is essential.
And treatment with medical therapy and lifestyle change should be
the first line. These
are the guidelines agreed upon by the professional cardiology societies.
What we really need is better patient and professional
education, and a system that supports patient self-care, which might
increase implementation
of these guidelines. But making that happen is a hard sell -- probably
because it doesn't immediately make or save anyone money (take it
from those of
us in the education business!).
The take-away from COURAGE is that, in this very specific
low risk patient population, stenting can be safely deferred,
to see if OMT can provide a less invasive, less costly benefit.
The downside for patients, however, is if insurers
take some of these concepts and use them to deny care. In an interesting
experiment,
Blue Cross/Blue
Shield in some parts of New York is requiring "stable patients"
to do 12 weeks of medical therapy before they will cover a stent
procedure. I only wonder if the type of COURAGE-level support
will be there for them. I also wonder how the type of patient that
would be in the COURAGE cross-over-to-stenting group will fare. Will
they have to suffer angina for weeks before their procedure can be
covered by insurance?
Finally, there is a strong movement in medicine today
towards individualized treatment. As more is learned of genetic markers,
cytochromes, etc.
it may be that "one size fits all" treatment will disappear.
This concept has been discussed at length by many cardiologists,
most directly by Dr. Eric Topol regarding optimal duration of antiplatelet
therapy. (Read his exclusive
interview on Angioplasty.Org)
So the fear of using results from a study of a very particular
hand-picked although large patient population to mandate (and possibly
limit)
care for a broad population of heart patients, is a bit disconcerting.
Remember too that in all of this, we are only discussing
those patients with "chronic stable angina", a condition which
itself many have trouble defining. Not in dispute are patients with
more serious coronary artery disease, especially those in the midst
of a heart attack. They are, without any question, best served by
reopening the arteries, whether via bypass surgery or angioplasty.
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