TUESDAY, Jan. 18 (HealthDay News) -- Stents, already used to
open clogged heart arteries, might have another use: clearing
arterial blockages in the brain after traditional stroke treatments
fail.
In new research involving 19 stroke patients, doctors say this
experimental application appears nearly full-proof in unblocking
brain arteries in patients for whom other clot-removal methods
didn't work.
"The bottom line is that stroke is a deadly condition," said study lead author Dr. Italo Linfante, director of endovascular neurosurgery and interventional neuroradiology at the Baptist Cardiac and Vascular Institute in Miami. "Up to 10 years ago it was a death sentence. Yet now if you go to the hospital early enough with a stroke there are several ways to be treated."
Current treatments are 60 percent successful, he noted, "so we
are always looking to develop better and better weapons, and
pushing the limits to fix it. And with stents we are reaching 95
percent, in terms of successfully opening up the arteries."
Linfante and his team are slated to present their findings this
week in Miami at the International Symposium on Endovascular
Therapy (ISET).
Stroke is the third leading cause of death in the United States
today. Ischemic strokes, caused by blood clots, are the more common
type of stroke. Hemorrhagic stroke, the other type, occurs when a
blood vessel ruptures and bleeds into the brain.
Before participating in the study, none of the patients had
benefited from standard treatments used to remove arterial
blockages in the brain. These blockages reduce normal blood flow
and raise the risk for death and disability. Standard treatments
range from clot-dissolving drugs to procedures aimed at suctioning
out blockages.
By inserting stents -- tiny metal mesh tubes -- into blocked
cranial arteries, the study team was able to open up arterial
passages in 18 of the 19 patients, amounting to a 95 percent
success rate.
Twelve of the patients (63 percent) had minimal or no side
effects, and five patients (26 percent) ultimately died from a
major stroke, according to the researchers.
Yet they concluded that 80 percent to 90 percent of the stroke
patients would have become severely disabled and/or died if such
stents had not been used to restore normal blood flow.
Linfante said that while the results of his investigation must
be viewed as preliminary, he's "very confident" that further
research will prove that stents are an effective intervention for
stroke patients. Clinical trials are needed, he said.
"In the U.S. today, stents are only FDA-approved for use in the heart," he added. "But so far, the results with stroke patients are unbelievably positive." Stents for stroke have already been tested in clinical trials in Europe, he explained, noting that "they have seen the same success we have seen."
So, Linfante said, "here we're trying to move ahead as quickly
as possible to do more research using them with stroke patients in
large clinical trials. And we hope that, for the general public, we
will see it approved for this use within the next two or three
years."
Dr. Richard B. Libman is chief of the division of vascular
neurology with the Harvey Cushing Institutes of Neuroscience at
North Shore-Long Island Jewish Health System in Great Neck, N.Y. He
called the new findings "extremely encouraging" but also urged
caution.
"There have been similar small studies already published giving quite similar results," he noted. "But they all involve a very small series of patients, which makes it a little hard to interpret. Not only that, but there is no comparison control group. And that's one of the weaknesses of all device trials in stroke that have been published so far, because the FDA does not have the same stringent requirements for the approval of mechanical devices as they do for medications."
"Having said that, this type of approach is innovative, aggressive, and very promising," Libman added, "and definitely demonstrates the need for large trials with an appropriate control group if possible."
It should be noted that studies presented at meetings typically
do not undergo the rigorous checks that precede publication in
scientific journals.
In a second study, also slated for presentation at the ISET
meeting, researchers from the Stanford University School of
Medicine report that drug-coated stents may provide long-term
relief for patients with clogged leg arteries typical of peripheral
artery disease (PAD).
Two years after stents coated with the drug paclitaxel were
inserted in nearly 280 patients, the investigators found that
three-quarters of the leg arteries remained open, and the
post-procedure survival rate among such patients approached 87
percent. Compared with bare-metal stents, the drug-coated stents
performed significantly better in this regard, the researchers
found.
More information
For more on stents, visit the
American Heart Association.