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6/11/04 - 10/11/04, New Orleans, LA
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Scientific Sessions, the largest cardiovascular meeting
in the world, is being held in New Orleans Nov. 6–10.
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DURHAM, N.C. -- While the placement of stents in newly
reopened coronary arteries has been shown to reduce the need for
repeat angioplasty procedures, researchers from the Duke
Clinical Research Institute have found that stents have no
impact on mortality over the long term.
In the largest such analysis of its kind, the Duke
researchers said their findings have important economic and
clinical implications for physicians who are deciding whether
their heart patients should receive coronary artery bypass
surgery, or less-invasive angioplasty, which includes the
placement of a stent.
Stents, which were introduced in the U.S. in 1994, are tiny
mesh tubes that are inserted at the site of a blockage in a
coronary artery that has been opened during balloon angioplasty.
The procedure seeks to prevent the artery from becoming blocked
again, a process known as restenosis. These blockages, caused by
atherosclerotic plaque, can starve the heart of oxygen-rich
blood and lead to a heart attack.
Duke cardiologist David Kandzari, M.D., who presented the
results of the Duke analysis Nov.7, 2004, at the American Heart
Association's annual scientific sessions in New Orleans, said
the findings on mortality rates should also be expected to hold
true for the latest generation of drug-eluting stents. These
stents, which were introduced in 2003, are coated with a drug
that keeps blood clots from forming inside them.
"We have found in our long-term analysis that stents do
provide a significant early and sustained reduction in the need
for subsequent procedures to re-open the treated artery,"
Kandzari said. "However, we also found that stents do not have
any influence on long-term survival.
"Since earlier studies have shown that new drug-eluting
stents can lessen the incidence of restenosis, we would expect
the need for repeat procedures to decline even more as these
stents become more widely used," Kandzari continued. "While
earlier trials of drug-eluting stents have demonstrated a
significant reduction in repeat procedures, they still have
shown no differences in mortality compared with more
conventional stents."
Specifically, the researchers found that over the average
seven-year follow-up period of their study, 19 percent of
patients who received a stent needed another revascularization
procedure in the treated artery, compared to 27 percent for
those who did not receive a stent. However, the long-term
mortality rate for those receiving a stent was 19.9 percent vs.
20.4 percent for those who did not, a disparity which did not
statistically differ.
For their analysis, the researchers consulted the Duke
Database for Cardiovascular Disease, which keeps detailed
clinical data on all heart patients receiving treatment at Duke.
The researchers identified 1,288 matched pairs of patients who
underwent either balloon angioplasty alone or stenting -- yet
all had a similar likelihood of receiving a stent based on their
clinical and demographic characteristics.
The patients, 63 percent of whom were male and who had an
average age of 59 years, were treated between 1994 and 2002. One
in four was diabetic, and one in four had suffered a previous
heart attack.
"This study, based as it is on a real-world population of
patients, tells us that stents do not save lives, though they do
have a profound effect on avoiding repeat procedures," Kandzari
said. "We've know that restenosis has never been scientifically
associated with increased mortality, but it has been associated
with an increased need for revascularization and with a
reduction in symptoms such as chest pain."
Given these findings, Kandzari said physicians treating their
heart patients should not automatically assume that placing a
stent, whether the original bare-metal type or the newer
drug-eluting version, will be the end of treatment.
"Many physicians will successfully place a stent and think
that's it," Kandzari continued. "The bigger issue is that many
of these physicians should also then be prescribing drugs that
have a clearly demonstrated beneficial effect on long-term
mortality."
Kandzari plans to follow up this study with a similar
analysis of the effects of the drug-eluting stents on mortality.
Also, the team plans to measure any differences in the quality
of life of these patients.
"As we take on more and more difficult and complicated cases
in the catheterization lab, we should take a step back to see if
there are certain instances when bypass surgery may be the best
option," Kandzari said. "There is the temptation out there to
just place stents in all patients, no matter what. In some prior
trials, the difference in outcome between angioplasty and
surgery patients was driven by restenosis, not by differences in
mortality.
"However, in the era of conventional stenting, we knew that
there we still some instances in which bypass surgery might
provide an incremental survival benefit," Kandzari said. "Before
routinely placing drug-eluting stents in similar patients, these
findings underscore the need for systematic evaluation of
drug-eluting stents in these types of patients."
Patients with left main coronary artery disease, for example,
appear to fare better with bypass surgery than with angioplasty
and stents. Previous study has also suggested this may be true
for diabetic heart patients with extensive disease, who appear
to benefit the most from bypass surgery, Kandzari said.
"Appropriately, a trial is forthcoming to compare treatment
with drug-eluting stents with bypass surgery in diabetic
patients," he said.
The study was supported by the Cordis Corp., Miami Lakes,
Fla., which develops stents. Kandzari has no financial interest
in Cordis.
Other members of the Duke team were Robert Tuttle, M.D.,
James Zidar, M.D., and James Jollis, M.D.
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Sources
American Heart Association - scientific sessions - 6/11/04 - 10/11/04, New Orleans, LA Legal Disclaimer
The materials presented here were prepared by independent authors
under the editorial supervision of The Doctors Lounge, and do not represent a
publication of the American Heart Association. These
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The material presented here does not reflect the views of The Doctors
Lounge or
the companies providing unrestricted educational grants. These materials
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Copyright © 2004 The Doctors Lounge.
| Article reviewed by: |
Dr. Tamer Fouad, M.D.
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