WEDNESDAY, Feb. 13 (HealthDay News) -- Drug-coated stents
haven't worked well for blocked leg arteries, but German doctors
are reporting good initial results with drug-coated balloons, which
are inserted at the end of catheters and are inflated to reopen the
arteries.
Catheters whose balloons were coated with paclitaxel, one of the
drugs commonly used for coronary artery stents, were better at
keeping leg arteries open than conventional balloon catheters, said
the study by researchers at the Eberhard-Karls University in
Tuebingen.
Only two of the 48 persons with what is formally known as
peripheral artery disease (PAD) who were treated with the coated
balloons required second procedures to reopen arteries in the
following six months, compared to 20 of the 54 people treated with
conventional catheters, the report said.
The difference was evident after two years, when 28 of the 54
people treated with conventional balloons required reopening
procedures, compared to seven of the 48 patients treated with
coated catheters. Over that period, the drug-treated arteries
remained more open than those treated with conventional
devices.
No benefit was seen in a third group of patients who were
treated with conventional catheters and had paclitaxel dripped into
their arteries.
The average age of the study participants was 68; 24 percent
were smokers, and 49 percent had diabetes.
The findings are published in the Feb. 14 issue of the
New England Journal of Medicine.
"This is a really promising initial look at this technology,"
said Dr. Daniel Clair, chair of vascular surgery at the Cleveland
Clinic. "It is very promising, but we need more data."
Drug-coated stents are not used routinely in the United States
for PAD, Clair said. Two trials for PAD done in Europe showed
initial advantages of drug-coated stents over the bare-metal kind,
he said, but the differences had disappeared after two years, and a
number of the stents implanted in leg arteries had fractured, he
said.
Several aspects of the German trial raise questions, Clair
added. The blockages treated in the study were relatively small,
averaging 7.5 centimeters (about 3 inches), Clair noted, while the
femoral artery, which is most often affected by PAD, is about 16
inches long.
"I would love to see this kind of trial done in the United
States with longer lesions," Clair said.
That thought was echoed by Dr. Issam Moussa, director of
endovascular services at New York Presbyterian/Weill Cornell
Medical Center in New York City.
"This is obviously very promising, but my initial impression is
that this is too good to be true," Moussa said. Drug-coated
balloons have been tried for coronary arteries without success, he
said, "because not much of the drug goes into the artery wall. My
skepticism comes from that biological aspect."
But that view is balanced by "kind of an optimistic
perspective," Moussa said. "If this [the German finding] really
works, it would be a really big breakthrough. We should design a
really big trial with hundreds of patients and more complicated
lesions using this device to see if we can replicate the German
results."
The German researchers got financial support for their study
from a number of drug companies, including stent manufacturers.
More information
For more on PAD, consult the
U.S. National Library of Medicine.
