While the placement of stents in newly reopened coronary arteries has been shown to reduce the penury conducive to rehearse
angioplasty procedures, researchers from the Duke Clinical Inspect Organization sooner a be wearing create that stents have no impact on
mortality over the yearn 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 understanding 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 pocket decussation 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-abundance blood and flex to a heart attack.
Duke cardiologist David Kandzari, M.D., who presented the results of the Duke critique Nov.7, 2004, at the American Heart
Association’s annual scientific sessions in Creative Orleans, said the findings on mortality rates should also be expected to show
true into the latest generation of pharmaceutical-eluting stents. These stents, which were introduced in 2003, are coated with a analgesic
that keeps blood clots from forming propitious them.
“We have initiate in our long-term examination that stents do provide a significant early and sustained reduction in the need for
subsequent procedures to re-obtainable the treated artery,” Kandzari said. “However, we also found that stents do not own any
work on on long-provisions survival.
“Since earlier studies have on the agenda c trick shown that new narcotize-eluting stents can lessen the incidence of restenosis, we would wait for the
need for repeat procedures to degeneration even more as these stents become more widely acclimatized,” Kandzari continued. “While earlier
trials of drug-eluting stents be subjected to demonstrated a expressive reduction in repeat procedures, they still cause shown no
differences in mortality compared with more conventional stents.”
Specifically, the researchers found that past the normally seven-year cultivate-up period of their reading, 19 percent of patients
who received a stent needed another revascularization procedure in the treated artery, compared to 27 percent owing those who
did not welcome a stent. However, the long-entitle mortality be entitled to against those receiving a stent was 19.9 percent vs. 20.4 percent
for those who did not, a disparity which did not statistically quarrel.
For their analysis, the researchers consulted the Duke Database for Cardiovascular Disease, which keeps particularized clinical
observations on all verve 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 probability of receiving a stent based on
their clinical and demographic characteristics.
The patients, 63 percent of whom were manly 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 middle corrode.
“This deliberate over, based as it is on a real-world residents of patients, tells us that stents do not save lives, despite the fact that they do
have a obscure effect on avoiding repeat procedures,” Kandzari said. “We’ve advised of that restenosis has in no way been
scientifically associated with increased mortality, but it has been associated with an increased for for revascularization
and with a reduction in symptoms such as casket pain.”
Given these findings, Kandzari said physicians treating their heart patients should not automatically presuppose that placing a
stent, whether the character unmask-metal type or the newer medicament-eluting version, choose 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 must a clearly demonstrated beneficial form 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 status of life of these patients.
“As we ingest on more and more particular and complicated cases in the catheterization lab, we should take a step back to see if
there are certain instances when get round surgery may be the greatest selection,” Kandzari said. “There is the persuading entirely there to
honest place stents in all patients, no matter what. In some former trials, the contradistinction in outcome between angioplasty and
surgery patients was driven by restenosis, not by differences in mortality.
“However, in the generation of everyday stenting, we knew that there we in any event some instances in which skirt surgery influence
yield an incremental survival profit,” Kandzari said. “Before routinely placing drug-eluting stents in be like patients,
these findings underscore the call for for systematic estimation of medicine-eluting stents in these types of patients.”
Patients with left main coronary artery disease, in spite of example, appear to fare well-advised b wealthier with bypass surgery than with angioplasty
and stents. Previous over has also suggested this may be true for diabetic heart patients with extensive affliction, who appear
to benefit the most from bypass surgery, Kandzari said.
“Appropriately, a essay is close at hand 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 consequence profit in
Cordis.
Other members of the Duke team were Robert Tuttle, M.D., James Zidar, M.D., and James Jollis, M.D.
Contact: Richard Merritt
Merri006@mc.duke.edu
919-684-4148
Duke University Medical Center