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GROUNDBREAKING VA RESEARCH SHOWS DRUGS AS
EFFECTIVE AS ARTERIAL STENTS -- Researchers'
findings expected to shake up heart-treatment
field,
where angioplasty has become widely used.
Story here...
http://www.contracostatimes.com/
mld/cctimes/news/nation/16980166.htm
Story below:
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Drugs as effective as stents, study says
Researchers' findings expected to shake up
heart-treatment field, where angioplasty has become widely used
By Thomas H. Maugh II and Daniel Costello
LOS ANGELES TIMES
For patients with clogged arteries who have not yet had a heart attack,
the widely used surgical treatment of balloon angioplasty with the
insertion of a stent is no better than conventional drug treatment,
researchers said Monday
In a study of more than 2,000 patients, those receiving only drug
therapy had the same number of heart attacks, strokes and deaths as
those who received the drugs and underwent artery-opening angioplasty,
researchers from the Department of Veterans Affairs told a meeting of
the American College of Cardiology.
The only difference was a slight improvement in quality of life for
those receiving angioplasty because of fewer chest pains, known as
angina.
The findings deal a blow to the stent industry, which sells an estimated
$3.2 billion worth of stents each year in the United States.
As many as 65 percent of the estimated 1 million stenting procedures
performed each year occur in such patients at a cost of about $40,000
per surgery.
"This is good news for patients and physicians," said Dr. William Boden
of the University of Buffalo School of Medicine, who led the study.
In the rush to perform angioplasty, the effectiveness of drug treatment
"was lost in the shuffle. It was considered old-fashioned, ho-hum. Now
we can say to physicians ... you are not putting patients in harm's way.
That is something we didn't know before."
"These findings are pretty explosive," said Steven Nissen, president of
the American College of Cardiology. "I think this is going to shake
things up pretty significantly."
Experts cautioned that the results do not apply to patients who have
suffered a heart attack because of a blockage in the coronary artery.
Numerous studies have shown that angioplasty is the gold standard for
such patients, and physicians urge that it be implemented as soon as
possible to re-open the artery and restore blood flow to the heart.
But in nonemergency situations, the drugs act fast enough to forestall
the need for angioplasty.
Stent makers said the study provided little new information, did not
include the newest generation of drug-eluting stents and did not address
the key issue of whether stents prevent the need for further
angioplasties.
They also argued that the device's greatest benefit is improving quality
of life.
The study, also published online Monday by the New England Journal of
Medicine, is the first large analysis examining its value for those with
what is known as stable disease.
The study, called the Courage Trial, enrolled 2,287 patients at 15
Veterans Administration medical centers and another 35 hospitals in the
United States and Canada.
It was sponsored primarily by the VA and the Canadian Institutes of
Health Research. Many of the researchers involved have received
consulting and lecture fees from major drug companies.
All the patients had at least a 70 percent blockage of their coronary
artery and chest pains several times per week. Most also had high
cholesterol and high blood pressure, and many had diabetes.
"This is a moderate- to high-risk group of patients," Boden said. "We
wanted to give angioplasty the best possible chance to show a benefit."
All of the patients were placed on multiple medications, including
beta-blockers, ACE inhibitors and diuretics to lower blood pressure,
statins to decrease cholesterol and blood thinners to prevent clots.
The drug treatments typically costs about $1,500 a year, according to
the American Heart Association.
The patients also were counseled about lifestyle programs for smoking
cessation, increased exercise and a better diet.
Half the patients also underwent angioplasty, and many of them received
a stent -- a wire-mesh tube inserted into the artery to hold it open
after the balloon is withdrawn. The balloon and the stent are threaded
into the coronary artery through a small incision in the groin.
After an average of 4.6 years of monitoring, there were 211 deaths,
heart attacks or strokes in the group receiving angioplasty and 202 in
the group receiving only drug therapy.
The only difference between the two groups was that angioplasty patients
had fewer symptoms of angina -- although even that difference was not as
large as had been expected.
After three years, 67 percent of those in the angioplasty group were
free of angina, compared with 62 percent in the medication-only group,
according to the study.
Stent makers tended to scoff at the study. Dr. Donald Baim of Boston
Scientific Corp. argued that the results "don't really tell us much that
we didn't already know."
Some cardiologists who specialize in the procedures also argued that the
study did not focus on the sickest patients who are most likely to
benefit and that the main purpose of angioplasty in many is to alleviate
chest pain, not to prevent heart attacks.
"I don't think this is going to cause any huge paradigm shift," said
Gregory Dehmer, president of the Society for Cardiovascular Angiography
and Interventions. "This study was limited to a fairly select group of
patients with very stable symptoms."
Some Wall Street analysts agreed about the study's limited impact, but
only because they don't anticipate it will depress sales any more than
they've fallen already.
Sales of stents have been declining since last year over concerns that
deadly clots might form around a small percentage of the most popular
devices after they are implanted and that bypass surgery might have a
significant survival advantage over stents in some patients.
Analysts say cardiologists are more reticent about recommending the
procedure.
Washington Post contributed to this story.
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Larry Scott --
