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.
For more on PAD, consult the U.S. National Library of Medicine.
SOURCES: Daniel Clair, M.D., chair of vascular surgery, Cleveland Clinic; Issam Moussa, M.D., director of endovascular services, New York Presbyterian/Weill Cornell Medical Center, New York City; Feb. 14, 2008, Ne
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