http://www.nytimes.com/2002/11/20/health/20HEAR.html

Device May Make Angioplasty Safer Than Surgery
By LAWRENCE K. ALTMAN


CHICAGO, Nov. 19 � An experimental filter makes the artery-clearing
procedure called angioplasty safer than standard surgery for
preventing tens of thousands of strokes caused by clogged arteries in
the neck, a new study suggests.
For decades, doctors have performed the surgery � carotid
endarterectomy � with the aim of cutting open the affected arteries
to remove fatty deposits before they can lead to a stroke. In part
because the deposits can dislodge during surgery to cause a stroke
and in part because the operation leaves a long scar, many doctors
have looked to angioplasty instead.
But angioplasty � in which a wire is inserted into an artery in the
thigh and threaded through other arteries to reach the blocked area
in the neck � can also cause the particles to dislodge. 
In the new study, reported at the annual meeting of the American
Heart Association here today, a tiny filter was used to trap the
particles. It helped cut the incidence of strokes and other serious
complications after 30 days by half, as compared with patients who
underwent the standard operation without the filter.
If the new findings hold up in further testing, use of the filter may
make angioplasty a preferred procedure among many of the estimated
200,000 Americans who undergo carotid artery surgery each year, said
Dr. Jay S. Yadav of the Cleveland Clinic, who led the study.
Particles that break away from the buildup of fatty deposits in the
carotids are a leading cause of the 730,000 strokes that occur in
this country each year.
"It's a watershed event," Dr. Yadav said, adding that it was the
first time a less invasive procedure had been shown superior to
surgery in cardiovascular disease.
Dr. Donald La Van of the University of Pennsylvania, who was not
involved in the study, said it would indeed be a watershed event if
the carotid arteries remained open over a longer period of time.
Information on how the patients did after one year will be reported
next spring, Dr. Yadav said.
In the study, involving 307 patients at 29 hospitals in the United
States, 9 of the 156 angioplasty patients who received the filters,
or 5.8 percent, died or had a nonfatal stroke or heart attack within
30 days, compared with 19 of 151, or 12.6 percent, who had surgery.
The study was financed by Cordis, a subsidiary of Johnson & Johnson,
which makes the experimental filter device, called the AngioGuard.
The AngioGuard is like an umbrella. Doctors guide it along the wire
from the thigh artery to the carotid artery and open it at the
desired site. There it takes the shape of a basket that catches
dislodged particles.
After inflating a balloon to open the clogged artery � just as
doctors do in angioplasty to open up blocked arteries in the heart �
doctors insert a tiny metal tube called a stent to help keep the
artery open. The carotid stent is made of flexible nickel and
titanium so it can change shape as the artery pulses.
After a neurologist examines the patient, the doctors collapse the
filter and carefully remove it. Translucent whitish particles are
found in about 80 percent of the filters, and the particles usually
cover about half the filter surface, Dr. Yadav said.
But in 5 percent to 10 percent of patients, the filter becomes so
clogged that it slows blood flow to the brain. When that happens,
doctors have to speed up the procedure to prevent brain damage, Dr.
Yadav said.
The researchers have not been able to determine which patients are
most likely to be included in the 5-to-10-percent group.
Because new fatty deposits and tissue can form on the stents and then
block a repaired artery, researchers have reported significant
progress in reducing the frequency of such complications by coating
the tubes with various drugs. But Dr. Yadav said the role of coated
stents in carotid angioplasty was not known.




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