Favorable outcomes seen
following angioplasty with drug-eluting stents for lower-risk patients
with left main coronary artery disease
Heart bypass surgery is considered the gold
standard for most patients with left main coronary artery disease,
one of the most serious types of heart disease and one that affects
thousands. But a new UCLA study reports favorable long-term outcomes
for lower-risk patients with this condition who underwent angioplasty
with medication-coated stents, rather than bypass surgery.
Published in the June issue of the journal Catheterization and
Cardiovascular Interventions, the study found that for patients
with left main coronary artery disease who had normal artery function,
the more minimally invasive procedure may be a safe and effective
option.
"This is one of the first studies assessing the long-term
outcomes of this procedure in lower-risk patients," said Dr.
Michael Lee, an assistant professor of cardiology at the David Geffen
School of Medicine at UCLA.
According to Lee, current national guidelines recommend angioplasty
with stenting only for patients who are poor candidates for surgery.
He said that this may change in the future, if more studies like
this one demonstrate the procedure's effectiveness in a wider range
of patients.
Researchers reviewed data, taken from an international registry,
on 221 patients who had left main coronary artery disease with normal
artery function. All patients had undergone angioplasty with drug-eluted
stents between 2002 and 2009 at one of four institutions. The average
patient age was 68, and the majority were male.
Patients sought angioplasty with stenting instead of surgery for
a number of reasons, including high surgical risk due to health
issues like chronic obstructive pulmonary disease or a severely
calcified artery, older age, or a preference for the more minimally
invasive procedure.
"The study provided a window into "real-world" experience
and is reflective of what is seen in everyday clinical practice,"
Lee said.
In examining 30-day outcomes for patients in the study group, the
team found no reports of cardiac death, stroke, restenosis or blood
clots forming related to the stent. Seven patients (3 percent) experienced
a mild myocardial infarction that can occur during the procedure.
According to Lee, these are mild events with little long-term clinical
impact.
Follow-up angiographs were available for 136 (62 percent) of the
patients, which helped further track their heart health status.
At one year, the cumulative event-free survival rate for cardiac
death was 97.7 percent, and the event-free rate for artery restenosis
was 92.9 percent.
Over the course of the study, 22 patients needed to be retreated
due to the artery restenosis, and this occurred mostly in the first
year. Of those patients, 14 underwent a repeat angioplasty and eight
had bypass surgery.
"Our analysis found that the short-term outcomes were excellent,"
he said. "Patients who survived after the first year had very
good long-term survival and a low incidence of retreatment."
At nearly four years, the event-free survival rate for cardiac
death was 95.5 percent, and the event-free rate for restenosis was
88.9 percent. Twenty of the 221 patients had died and nine deaths
were cardiac-related.
"We found that this procedure had a low overall risk profile
and may prove to be a viable alternative for this patient group,"
Lee said.
Lee added that the next step would be a clinical trial comparing
angioplasty with drug-eluting stents to coronary bypass surgery
in this lower-risk patient population.
The study took place at four hospitals; they were located in Los
Angeles and Santa Barbara in the U.S., and in Turin and Padua in
Italy. The type of drug-eluting stents used in the study was at
the discretion of the interventional cardiologist.
No outside funding was used in the study.
Additional study authors include Dr. Tae Yang of the division of
cardiology at Ronald Reagan UCLA Medical Center; Dr. Giuseppe Biondi-Zoccai,
Dr. Dario Sillano, Dr. Enrico Cerrato and Dr. Imad Sheiban of the
division of cardiology at the University of Turin-San Giovanni Battista
"Molinette" Hospital in Turin; Dr. Giuseppe Tarantini
and Dr. Jola Xhaxho of the department of cardiac, thoracic and vascular
sciences at the University of Padova Medical Center in Padua; and
Dr. Joseph Aragon of the division of cardiology at Santa Barbara
Cottage Hospital in Santa Barbara.
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