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Stents and bypass surgery are no more

effective than drugs for stable heart disease,


highly anticipated trial results show
Ningsih Ridwan
Dr. Zakaria Mustari, Sp.PD
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

“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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

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.
Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show “ Washington Post”

“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.

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