"Do Heart Stent Procedures Work for Angina Chest Pain?"
Angioplasty and stents for non-emergency
coronary artery disease is one of the most
common invasive procedures performed in the United States.
Though it appeared to offer immediate relief
of angina chest pain in stable patients with coronary artery disease,
it didn’t actually translate into a lower risk of heart attack or death.
This is because the atherosclerotic plaques that narrow blood flow
tend not to be the ones that burst and kill you.
But hey, symptom control is important—
that’s much of what we do in medicine.
But cardiology has a bad track record when it comes to
performing procedures that don’t actually end up helping at all.
Case in point: internal mammary artery ligation.
Though it didn’t make much anatomical sense,
why tying off arteries to the chest wall and breast
would somehow improve coronary artery circulation,
it worked like a charm.
Immediate improvement in 95% of hundreds of patients.
Could it have been just some elaborate placebo effect,
and they were cutting into people for nothing?
There’s only one way to find out. You cut into people for nothing.
They randomized people to get the actual surgery or a fake surgery
where they cut you open and get to the last step
but don’t actually tie off those arteries.
And … the patients who underwent the fake surgery
experienced the same relief. Check out the testimonials.
“[I]mmediately, I felt better.”
“ ...95 percent better.”
“No chest trouble even with exercise.”
“ ... I’m cured!”
And these are all people who got the sham surgery.
So, it was just the extravagant placebo effect.
Think about it. Some frightened, poorly-informed man
with angina chest pain, winding himself tighter and tighter,
sensitizing himself to every twinge of chest discomfort,
who then comes into the environment of a great medical center
and a powerful, positive, paternalistic personality
and hears how great it’s going to be,
goes through the whole operation
and leaves a new man with his trademark scar.
One sham patient was actually cured though.
“The patient is optimistic and says he feels much better.”
Office note the next day: patient dropped dead.
So hey, no more chest pain!
This has happened over and over. I’ve got an idea!
How about we burn holes into the heart muscle with lasers
to create channels for blood flow.
Worked great, until it was proven that it doesn’t work at all.
Cutting the nerves to your kidneys was heralded as a cure
for hard-to-treat high blood pressure until...
sham surgery proved the procedure itself was a sham.
The necessity for placebo-controlled trials has been rediscovered
several times in cardiology, typically to considerable surprise.
Before they are debunked, often the therapy is thought to be
so beneficial that a placebo-controlled trial
is deemed unnecessary and perhaps even unethical.
That was the case with stents.
Hundreds of thousands of angioplasties and stents
are done every year, yet placebo-controlled trials
had never been done. Why?
Because cardiologists were so unquestionably sure that it worked
that it would be unethical to perform a fake procedure
to prove something we already know is true.
When patients are aware that they have had a stent,
they have a clear reduction in angina and improved quality of life.
But what if they weren’t aware? Would it still work?
Enter the ORBITA trial.
After all, anti-angina medication is only taken seriously
if there is blinded evidence of a symptom relief against a placebo pill;
so, why not pit stents against a placebo procedure.
In both groups, doctors threaded a catheter
through the groin or wrist of the patient,
and with X-ray guidance, go up to the blocked artery,
and then either inserted a stent or just pulled the catheter back out.
They had problems even getting the study funded.
They were told we already know the answer to this question—
of course, stents work— and that’s even what
the researchers themselves thought.
They were interventional cardiologists themselves.
They just wanted to prove it. Boy, were they surprised.
Even in patients with severe coronary artery narrowing,
angioplasty and stents did not increase exercise time
more than the fake procedure.
“Unbelievable” read the New York Times headline,
remarking that the results “stunned leading cardiologists
by countering decades of clinical experience.”
In response to the blowback, the researchers wrote that
they sympathize with everyone’s shock and disbelief.
Yes, we could have tried to spin it somehow,
but they had a duty to preserve scientific integrity.
While some commended them for challenging the existing dogma
around a procedure that has become so routine, ingrained,
and profitable, others questioned their ethics.
After all, four patients in the placebo group had complications
from the guide wire insertion and required emergency measures
to seal the tear they made in the artery.
There were also three major bleeding events in the placebo group;
so, they suffered risks without even a chance of benefit.
But “[f]ar from demonstrating the risks of sham-controlled trials,
this demonstrates exactly what patients are being
subjected to on a routine basis” for nothing.
Those few complications in the trial are dwarfed
by the thousands that have been killed
or maimed by the procedure over the years.
You want unethical? How about the fact that an invasive procedure
has been performed on millions of people
before it was actually ever put to the test?
Maybe we should consider the absence, not the presence,
of sham control trials to be the greater injustice.
When a former FDA commissioner was asked at
the American Heart Association meeting whether sham controls
should be required for the approval of all devices,
he replied, "Do you want to get the truth or not?"