WEDNESDAY, Jan. 22, 2014 (HealthDay News) -- Drug-coated
"scaffolds" that are placed in the arteries and then melt away over
time could offer a new treatment for people with painfully clogged
leg arteries, an early study suggests.
Researchers found that the experimental devices eased leg pain
in 35 patients with peripheral artery disease. People with the
condition have artery-clogging "plaques" impeding blood flow to the
legs. Before treatment, 57 percent of the patients had severe pain
when they walked; one month after treatment, none of them did.
The findings, scheduled for presentation Wednesday at the
International Symposium on Endovascular Therapy, in Miami, should
be considered preliminary until published in a peer-reviewed
And experts cautioned that it's not clear how these devices
compare with the current treatment for more severe cases of
peripheral artery disease -- namely, traditional metal stents.
The new devices are similar to stents, according to background
information included in the study. In both cases, the implants are
threaded into a blocked artery through a catheter. Once there, they
prop open the vessel and slowly release medication designed to
reduce inflammation and prevent the artery from narrowing
But unlike stents, which remain in the artery, the scaffolds
eventually disappear, the researchers said. They're made of
polylactide, a biodegradable material that's already used in
The idea is to leave behind a normally functioning blood vessel
and avoid some of the long-term complications that can arise with
stents, said Dr. Johannes Lammer, the lead researcher on the
One problem with stents is that they can irritate and inflame
the artery lining, causing the vessel to narrow again -- a
condition doctors call "restenosis." Also, Lammer said, stents in
leg arteries can break because leg arteries, unlike heart arteries,
are under significant pressure from everyday movements.
Additionally, if a patient eventually needs bypass surgery to
restore better blood flow to the legs, stents can interfere with
the procedure, Lammer said.
Dr. Angel Caldera, an interventional cardiologist at Scott &
White Memorial Hospital in Round Rock, Texas, said it's best if
there is no device in the arteries.
Caldera, who was not involved in the study, agreed that the
dissolving scaffolds have potentially important advantages. But
they remain to be proven, he stressed.
"This study is a feasibility and safety trial," Caldera said. "All we can say is, 'Yes, we can do this, and it appears to be safe.' Is this going to be better than what we have now? It's way too early to tell."
Still, Caldera called the preliminary findings "encouraging,"
and said it's "exciting" to see new technology being developed for
treatment of peripheral artery disease.
Abbott Laboratories, which funded the study, already has a
similar scaffold device approved in Europe and parts of Asia and
Latin America for treating blocked heart arteries. Trials aimed at
approval in the United States are under way.
For the current study, Lammer and his colleagues at the Medical
University of Vienna, in Austria, implanted the devices in 35
patients with a single blockage in a leg artery.
Before the procedure, 57 percent of the patients had severe leg
pain when they walked, according to the researchers. Over the next
six months, that dropped to zero. The percentage with moderate pain
dipped from 34 percent to 9 percent.
By month six, two-thirds of the patients were pain-free, and the
rest had only mild symptoms.
Both Lammer and Caldera said plenty of questions remain. The
current study will follow the patients for three years to see how
they fare in the long term.
Lammer said a trial that compares the dissolving scaffolds with
standard stents is still needed. A big question is whether the
newer devices really do curb the risk of restenosis, he said.
Dr. Alex Powell is medical director of interventional radiology
at Baptist Cardiac and Vascular Institute in Miami. He said:
"Long-term data is necessary before labeling a procedure a success.
Walking will always be the most important component of [peripheral
artery disease] therapy. No medication or procedure will ever take
away the benefits of a walking program."
For now, stents seem to help many people with more severe
peripheral artery disease. In another study on the agenda at the
endovascular meeting, researchers followed 250 stent patients for
three years. At that point, 73 percent of treated arteries were
still open and, on average, the patients were still walking farther
and faster than they had before treatment.
Peripheral artery disease affects an estimated 8 million people
in the United States. The same health problems that contribute to
heart disease can also feed peripheral artery disease, including
diabetes, smoking, high blood pressure and high cholesterol.
Often, Caldera said, peripheral artery disease can be managed by
reining in those risk factors and getting moderate exercise. Stents
and bypass surgery are reserved for more severe cases.
"What's most important," Caldera said, "is smoking cessation and controlling diabetes, high cholesterol and high blood pressure so you never get to the point of needing stents."
The American Heart Association has more on
peripheral artery disease.
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