Many Stent Procedures Unnecessary
Heart Drugs Just as Good at Preventing Heart Attacks, Death in Some People, Study Shows
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Stent Patients as Likely to Die, Have Heart Attack continued...
Then, about half the participants also underwent angioplasty, usually with
Over the next five years, 19% of those in both groups died or had a heart
attack. Similar numbers of people in both groups -- about 12% -- were
hospitalized for heart problems.
However, there were some benefits to angioplasty. People who had the
procedure were 40% less likely to need another procedure to open up blocked
heart arteries. And, particularly in the first two years, they reported better
quality of life and less frequent episodes of chest pain.
But over time, some of the differences started to dissipate. By five years
later, 74% of people who had angioplasty were angina-free vs. 72% of those who
got drugs alone, a difference so small it could be due to chance.
Results Stun Medical Community
Boden notes that COURAGE is "the first properly-sized study to answer
the question of whether angioplasty and stents reduce the risk of death and
heart attacks in people with stable coronary artery disease."
The results came as a shock to many in the cardiology community -- even to
the researchers themselves.
"The study was designed with the hypothesis that the combination of
angioplasty and optimal medical therapy would be superior," Boden says.
"But the results do not support its benefit in reducing heart attacks and
death when used as an initial management strategy."
So why would so many doctors recommend a costly procedure without strong
evidence it works?
The average cost of having an angioplasty was $38,000 in 2003, according to
the American Heart Association.
Nissen thinks it’s because “it seems so intuitively obvious: If you open up
a block artery, you’ll fix the problem.”
American Heart Association President Raymond J. Gibbons, MD, chief of
cardiology at the Mayo Clinic, adds that there’s a financial incentive for
doctors. "People get paid for how many procedures they do," he tells
But this study "clearly shows there is no advantage to PCI [percutaneous
coronary intervention, or angioplasty] as an initial strategy. It’s
unnecessary," Gibbons says. "Angioplasty should be reserved for
patients [who can’t be helped] by medical therapy."
Adds Nissen, "This study will change a lot of thinking. The benefits of
angioplasty in people with stable chest pain is very modest, at most. It should
be reserved for patients for intolerable symptoms."
But many doctors who perform angioplasties say the procedure’s proven
benefits in relieving angina, or chest pain, is getting lost in the
Donald Baim, MD, chief medical officer of Boston Scientific, a manufacturer
of drug-eluting stents, says, "COURAGE is not a catastrophic failure. [It
shows that angioplasty plus stents] improves symptoms."
Marty Leon, MD, of Columbia University Medical Center, says, "There are
so many deep flaws in the way this study was executed and planned. It was
rigged to fail," and it did. "This study should not affect
Boden says the criticism is unfounded, pointing out that the researchers
purposely studied people at medium to high risk of having a heart attack or
dying -- "the very people you would expect to benefit most from the