|
Answers
to Top Ten Questions About Stents and Angioplasty vs. Drug Therapy
COURAGE Trial Results
Breed Public Confusion
|
 |
March 28, 2007 --The
highly-anticipated results of a study comparing heart stents
and angioplasty to drug treatment that were released Tuesday have
set off a media firestorm of misinterpretation, causing confusion
for
patients
and
physicians.
The five-year COURAGE study, presented at the
annual meeting of the American College of Cardiology (ACC) in New
Orleans, looked at 2,287 heart
patients
who
suffer
from chest
pain (angina) but who are otherwise considered low-risk for heart
attack, and concluded that the addition of angioplasty and stenting
to optimal drug
therapy
resulted
in no significant reduction in heart attack or death.
Headlines,
such as "Stents'
heart value in doubt" (UPI) and "Heart
Attack Study Casts Doubt On Routine Use of Angioplasty" (Washington
Post) imply that this study demonstrates
stents are not an effective heart therapy.
One group of leading cardiologists added to this
impression
with
bold public statements: Dr. Steven Nissen, immediate
past-president
of
the ACC called the study a "blockbuster" and AHA president
Dr. Raymond Gibbons said the study shows that "hundreds
of thousands of Americans with stable angina who received coronary
stents
did not need them". Others disagreed: leading interventionalist
Dr. Martin Leon proclaimed that the study was "rigged to fail".
Dr. Eric Topol, a leading cardiologist, whose efforts led to
the
Vioxx recall, told theheart.org, "COURAGE really
does not present anything new...there is no surprise with this
trial."
A balanced interpretation came from
Dr. Gregory Dehmer, president of a leading professional organization,
the Society for Cardiovascular Angiography and Interventions (SCAI),
who told Angioplasty.Org that
the study was not "a
huge revelation, but more a penetrating glimpse at the obvious." The
SCAI itself issued a press release, stating it was unlikely that
the study
results
would alter the approach for treating patients with chronic
stable angina.
To cut
through this confusion, following are answers
to the
"Top Ten" key
questions from consumers that media reports on the COURAGE Trial
have raised:
- Can angioplasty and
stenting save lives? In the case of a
heart attack, angioplasty
definitely saves lives -- many studies have
proven this; the COURAGE trial does not apply to
patients
who are having a heart attack;
- Do stents have proven value? COURAGE
also does not apply to patients with advanced disease
who
are at
risk
for heart attack (Acute
Coronary Syndrome) -- angioplasty and stenting
have been proven to be a significant therapy for
these patients;
- Will this trial
change medical practice? The
results of COURAGE are not revolutionary, but instead
are consistent
with current practice guidelines
from all major professional groups (AHA/ACC/SCAI) that
recommend using angioplasty and stenting only after
medical therapy
has proven
inadequate;
- Were the patients in this
trial at risk for heart attack? Patients
with chronic stable angina are, in fact, at low
risk
for death
or
heart attack --
stents in these patients are not intended to prevent
death, but to relieve pain and improve quality
of life.
- Should people with chronic
stable angina get stents? Angioplasty is still a proven
treatment option for
those whose "quality
of life" (angina
or activity level) is not improved by medical therapy,
or
for those patients who do not tolerate the side effects
of medical therapy;
- Do
stents and angioplasty make people feel better? This
initial report did show that the scores for physical
limitation, angina frequency, and
quality of life were significantly better for
patients in the angioplasty group; in fact, 1/3
of the patients in the medications-only group switched
over
to angioplasty during
the course
of the trial because
their angina was not relieved by medication alone;
- Are stents safe? In
this trial, angioplasty and stenting proved to be as
safe as medical therapy;
- Do drugs or stents
cure heart patients? Coronary
artery disease is a chronic condition -- lifestyle
changes, medications, stents are
ways of managing the
disease and relieving symptoms, but they do not "cure"
the disease;
- Did all the patients in
this study experience relief of chest pain? No.
In the COURAGE study neither therapy completely eliminated
angina
for more than a
quarter
of the patients.
- Have patients with stable
angina been given stents unnecessarily? Under
current practice guidelines, it is recommended
that patients with stable angina first be given a
trial
of
medical therapy, along with lifestyle changes and
risk factor
reduction. They are candidates for stents if
they continue to experience
problems. What is unknown
is how often these guidelines have not been followed,
and whether cardiologists have in fact recommended stents
as a first treatment option for this patient population.
There is significant controversy as to how often this occurs.
Estimates of how many angioplasty procedures are
done in patients with
stable coronary artery disease range from
25% to 85%.
|
|
This study comes on the heels of others that
have raised concern about rare but life-threatening blood clots
(late stent thrombosis)
in
patients
who have received
drug-eluting stents (virtually all of the patients
in the COURAGE trial received the older bare metal stents). In light
of the media coverage of the drug-eluting stent problems, Dr. Lloyd
Klein of Rush Heart Institute in Chicago and an editor of the
Journal of Invasive Cardiology expressed concern:
"I'm very worried that the same thing
will happen with COURAGE -- that
in the
rush
to present
something that is new,
and
which is
different...that it will
be done in an exaggerated
way in
which it would appear that therefore having intervention under
any circumstance
is unnecessary if you have stable angina.... I just don't
want to see patients who really could be helped by the procedure
walk away from it and say, 'Oh I just heard this study
and angioplasty doesn't help.' That would be a bad thing."
"What
all of these studies highlight is the importance of careful patient
selection
and
the need to involve patients in deciding
among treatment options," says Angioplasty.Org editor Burt
Cohen.
"This study will certainly give a heads
up to any cardiologists who are not following guidelines and who
are intervening with stents before discussing medication options
with low risk
patients. Also, I think confusion comes because
some cardiologists may not
make
it
clear
to stable,
low
risk heart
patients
that
intervention is an option in an effort to make them feel better,
not a life-saving necessity," Cohen states.
"It seems to
be common
sense
that chest pain must mean you are at risk for
a heart attack and that
opening up a narrowing in an artery will prevent a heart
attack. But the science of heart disease is more complex than this.
I'm
not sure the profession has done a great job of making this clear
to consumers and informing them about the pros and cons of treatment
options."
|
