Carolyn Y.
Johnson November 16, 2019 at 1:00 p.m. CST
Some of the most
common invasive heart procedures in America are no better at preventing heart
attacks and death in patients with stable heart disease than pills and
lifestyle improvements alone, according to a massive federally funded study designed to resolve a
long-standing controversy in cardiology.
Researchers found
that invasive procedures to unclog blocked arteries — in most cases, the
insertion of a stent, a tiny mesh tube that props open a blood vessel after
artery-clearing angioplasty — were measurably better than pills at reducing
patients’ chest pain during exercise. But the study, called ISCHEMIA, found no
difference in a constellation of major heart-disease outcomes, including
cardiac death, heart attacks, heart-related hospitalizations and resuscitation
after cardiac arrest. There was no benefit to an invasive strategy in people
without chest pain.
Overall, the keenly anticipated ISCHEMIA study results
suggest that invasive procedures, stents and bypass surgery, should be used
more sparingly in patients with stable heart disease and the decision to use
them should be less rushed, experts said.
The $100 million
trial, presented Saturday at the annual meeting of the American Heart
Association ahead of publication in a peer-reviewed journal, is the latest
entry into a long and contentious argument over how to treat artery blockages,
one that has pitted powerful factions of American heart specialists against
each other. It echoes a similar study 12 years ago that was critiqued by
interventional cardiologists, the doctors performing the invasive procedures.
“This is a milestone
study that people will talk about and write about for years to come,” said
Elliott Antman, a cardiologist at Brigham and Women’s Hospital who was not
involved in the study and praised it for the wealth of information gathered and
the rigor and sophistication of the analyses.
“The ISCHEMIA trial
shows that an early invasive approach does not protect patients against death
or the overall chance of a heart attack, but does effectively relieve chest
pain — the more chest pain a patient has, the more likely they are to benefit,”
Antman said.
The ability to
implant stents using a catheter inserted through blood vessels in the arm or
groin has transformed cardiology over the past three decades. Stents have been
clearly demonstrated to save lives in people who are suffering from a heart
attack.
But as heart
medicines such as statins have improved, there has been active debate about
whether stents and other invasive procedures are more effective for people who
aren’t in the throes of a heart attack but have stable heart disease —
generally defined as having clogged arteries, sometimes accompanied by chest
pain, or angina, when they exert themselves.
A major study more than a decade ago
found stents didn’t work better than drugs, but it triggered criticism, and
proper use of stents has become one of the most heated debates in medicine — in
part because so much is at stake. Coronary heart disease affects 17.6 million
Americans; companies that make stents are multibillion-dollar enterprises; the
procedures are a major income stream to interventional cardiologists and
hospitals; and many people who have stents credit their good health to the
procedure.
“If you go to major medical centers that do
these procedures, you really talk to anyone, and they say after a very abnormal
stress test there is a rush to schedule a cardiac catheterization because
people have been afraid they’re at imminent risk of heart attack or sudden
death,” said Judith Hochman, senior associate dean for clinical sciences at New
York University Grossman School of Medicine and a leader of the trial. The new
results show there’s “absolutely no risk in trying medicines, and seeing if the
patient gets better — maybe they’ll become angina-free, and if not then they
have to make a decision, do they want to take medications and have angina some
of the time” or have a more invasive procedure.
Kirk Garratt, past
president of the Society for Cardiovascular Angiography and Interventions, said
the results were unsurprising and were in line with current practice.
“I think that most
interventional cardiologists in America today don’t offer angioplasty to
patients unless they can point at a specific benefit the patient will receive
from that treatment,” Garratt said.
The new study was
designed to finally settle the question of whether stents are better for
patients with stable heart disease — and some physicians said it could change
how tens of thousands of people are treated in hospitals, transform how
cardiologists talk with patients about their options and save hundreds of
millions of dollars in health-care spending each year.
About 500,000 heart
stent procedures are performed each year in the United States, and the
researchers estimate that about a fifth of those are for people with stable
heart disease. Of those, about a quarter — or an estimated 23,000 procedures —
are for people without any chest pain. If just those procedures are avoided,
researchers estimated, it could save about $570 million each year. But the
researchers think that is a conservative estimate, and that as doctors and
patients discuss options, even more procedures might be delayed or skipped
depending on each patient’s circumstances, preferences and activity level.
Doctors “have very
strong emotional beliefs, and they’ve been practicing in a way that sends these
patients straight to the cath lab for generations, and that’s not going to
change overnight,” said John Spertus, a cardiologist at St. Luke’s Mid America
Heart Institute and one of the study leaders. “I think it’s incredibly
important in this era where we’re trying to improve the value of health care,
improve patients’ outcomes at a lower cost."
The debate over the
trial’s results began before it even finished. More than a year ago, there
were fierce social media debates and critiques in the pages of medical journals.
Critics compared a change to the trial’s design to moving the goal posts midway
through and worried that it would make the results of the trial hard to
interpret. The leaders of the trial fired back that the change was part of the
original trial design.
A year ago, one of
the trial leaders, Sripal Bangalore of New York University Langone Health, said
in an interview that researchers spent considerable time trying to decide how
to respond to critiques and misinformation on Twitter — while still carrying
out the trial.
“What we felt is that
it was different, unprecedented in a way, because the trial is not complete.
Nobody knows the results,” Bangalore said.
Now the debate can
begin about the evidence. More than 5,000 patients with moderate to severe
stable heart disease from 320 sites in 37 countries were randomly assigned
after a stress test indicated heart disease. They received either medical therapy
and lifestyle counseling alone, or medicine plus stents or bypass surgery.
There was a slight shift in the two groups’ experience of a composite of five
disease-related events over the course of the trial: In the first year, people
who received an invasive strategy were at slightly higher risk of heart attacks
than those on medicine alone. By the end of the trial at four years, they were
at a slightly lower risk of heart attacks. The researchers found that this did
not lead to a significant difference between the overall rates of clinical
events between the two groups, but Garratt pointed to this decreased risk as an
important and significant result. The Ischemia investigators hope to follow the
patients for another five years.
The new study, Antman
said, will give patients and doctors a solid framework to discuss the benefits
and risks. For example, an elderly patient with stable heart disease who isn’t
very active but suffers some chest pain may decide on drug therapy. A younger
patient who has more frequent chest pain that impedes active daily life could
opt for an invasive strategy.
“I, as a clinician,
would feel comfortable advising my patient not to undergo the invasive strategy
if the angina was absent or controlled, or it was tolerated. I would feel okay
— sometimes you struggle with that decision,” said Alice Jacobs, professor of
medicine at Boston University School of Medicine, who was not involved in the
study.
Barry Brady, 69, of
Hollister, Calif., had few qualms about signing up for the trial and was glad
to find himself in the group receiving medical therapy. Brady suffered a heart
attack in 2008 and received four stents that saved his life. In 2016, he went
to his doctor feeling lethargic and weak. A cardiology work-up showed his blood
pressure and cholesterol were dangerously high, and an echocardiogram (EKG)
“didn’t show up so well,” Brady recalled.
Brady was assigned to
the arm that received optimal medical therapy, plus help making lifestyle
changes. After changing to a mostly vegan diet, taking a regimen of pills and
continuing with exercise, including using an elliptical machine three times a
week and golfing, he said he feels much better — and is glad to have avoided
more extreme interventions.
“It’s so invasive, to
me, that I just didn’t feel like going through that again,” Brady said. “I
thought if I could just do it by the diet, medication and exercise, that would
be so much better.”
He has been able to
hike in Bryce Canyon National Park in Utah and take a golfing trip to Hawaii,
and said that while the changes to diet took some discipline, they were
relatively easy given the benefits he’s felt in his energy levels.
“We want patients to
understand that it’s okay to pause and it’s not urgent that they have a
procedure,” said David Maron, director of preventive cardiology at Stanford
University, one of the study’s leaders. “It’s important for physicians to
understand how symptomatic a patient is — and what is it worth to the patient
to go ahead and have a procedure.”
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