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Patients
with Drug-Coated Stent Implants have lower
risk of Heart Attack and Death
Newswise — Heart disease patients 65 and
older who receive stents coated with
medicine to prevent blockages are more
likely to survive and less likely to suffer
a heart attack than people fitted with
stents not coated with medication, according
to a new study supported by HHS’ Agency for
Healthcare Research and Quality and the
American College of Cardiology’s National
Cardiovascular Data Registry.
The comparative effectiveness study of
262,700 Medicare patients who received
stents – spring-like tubes to keep heart
vessels open – is the largest ever to
compare drug-coated stents with bare metal
ones.
A team of researchers from Duke University,
AHRQ and Kaiser Permanente found that,
compared with patients who received bare
metal stents, those fitted with stents
coated with medication, called drug-eluting
stents, had an 18 percent better survival
rate over the 30-month study period and were
16 percent less likely to suffer a heart
attack.
“The findings provide important new evidence
for decision making by heart disease
patients and their physicians,” said AHRQ
Director Carolyn M. Clancy, M.D.
“These results should help resolve many
lingering questions regarding the safety of
drug-eluting stents in recent years.”
HHS’ Food and Drug Administration approved
two stents coated with drugs in 2003 and
2004, but then issued precautionary
advisories in 2006 after receiving scattered
reports of blood clot formation, or
thrombosis, and deaths. Subsequent clinical
trials and other studies produced
conflicting results.
The researchers in the AHRQ-funded study
found that 16.5 percent of the patients
implanted with bare metal stents died within
30 months of implantation, compared with
13.5 percent of those with drug-eluting
stents, after adjusting for population
differences.
They also found that 8.9 percent of the
patients with bare metal stents suffered
heart attacks during the period, compared
with 7.5 percent of those with drug-eluting
stents – a 16 percent higher rate.
The researchers further found that patients
fitted with drug-eluting stents in 2005 and
2006 had a lower risk of death than those
given the stents in 2004.
“Some previous studies have suggested that
drug-eluting stents are associated with an
excess long-term death rate, whereas others
have not,” said the study’s lead author,
Pamela S. Douglas, M.D., Geller professor of
medicine at Duke University.
The researchers found no significant
differences in the percentages of
drug-eluting and bare metal stent patients
who required a repeat angioplasty or
coronary artery bypass graft surgery
(roughly 23 percent) and in the percentages
of patients who suffered strokes or major
bleeding (about 3 percent and 3.5 percent,
respectively).
The results were not affected by age,
gender, race, ethnicity or other factors.
According to AHRQ’s Art Sedrakyan, M.D.,
Ph.D., a co-author of the study, the better
outcomes found for patients with
drug-eluting stents may be at least
partially explained because those patients
are required to take blood-thinning drugs,
such as clopidogrel, for a long time after
their procedure.
Patients who receive bare metal stents are
usually prescribed blood-thinner medications
for a shorter period of time and may take
them less often.
In addition, patients with drug-eluting
stents may visit their doctors more often
after hospital discharge and may receive
prescriptions for drugs and therapies to
lower their cholesterol levels and manage
other heart conditions more often than
patients who received bare metal stents.
The researchers based their study on data
from the American College of Cardiology’s
National Cardiovascular Data Registry on
patients who underwent angioplasty with
drug-eluting or bare metal stent
implantation at 650 hospitals, together with
Medicare national claims data to capture
post-hospital discharge information.
The authors call for longer follow-up
studies to further support the study’s
results and to confirm the possible effects
of post-implantation treatment with
blood-thinning drugs such as clopidogrel.
For more information about AHRQ's Effective
Health Care Program and the DEcIDE Network,
visit the Effective Health Care Web site at
http://effectivehealthcare.ahrq.gov.
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