UPDATE: Abbott Stent Tops Boston Sci Devices In 2 Studies
23 Septiembre 2009 - 4:19PM
Noticias Dow Jones
One-year data from two studies showed an Abbott Laboratories
(ABT) heart stent outperformed both newer and older versions of
Boston Scientific Corp. (BSX) devices by leading to lower rates of
serious events, adding to evidence that has helped make Abbott's
stent a market leader.
When it came to a subgroup of diabetic patients, however, the
3,690-patient, Abbott-sponsored "Spirit IV" trial showed similar
performance between the Abbott and older Boston Scientific stents.
This sets the table for Boston Scientific to defend its turf among
a big patient group it has targeted.
Data from Spirit IV and the other trial, called "Compare," were
released Wednesday at the Transcatheter Cardiovascular Therapeutics
conference in San Francisco.
The devices at issue are drug-coated stents, which prop open
clogged heart arteries and use medication to combat renarrowing.
They make up a roughly $4 billion global market where Abbott and
Boston Scientific are big competitors.
The companies also share some business because Boston Scientific
sells the Abbott-made Xience device under a different name and a
profit-sharing deal. Because of that arrangement, good data for
Xience can help or hurt Boston Scientific depending on how it
affects sales of its different stents.
Spirit IV showed Xience topping Taxus Express, an older device
Boston Scientific has essentially replaced with a new version
called Taxus Liberte. Boston Scientific argued that Liberte is
better than the older stents on certain fronts; data released on
Tuesday showed benefits for Liberte in small arteries and long
areas needing treatment, for example.
But Abbott believes Spirit IV results remain relevant because
the Boston Scientific stents are similar. Abbott's case was
bolstered by the single-hospital, 1,800-patient Compare study from
the Netherlands that represented the first big match-up between
Xience and Liberte, and similarly showed better Xience
performance.
Whether stent-implanting doctors will shift business due to the
two studies, which Abbott believes is possible, remains to be seen.
Cardiologist Gregg Stone, Spirit IV's main investigator, said
Wednesday that he views Xience as the top stent for nondiabetics.
He serves on both Abbott and Boston Scientific advisory boards.
Spirit IV included twice as many patients with Xience devices as
Taxus Express stents. The main measurement was a combination of
death from heart events, heart attacks linked to the problem
artery, and retreatment of the problem area due to restricted blood
flow. On this composite measurement, known as target lesion
failure, the rate at one year for Xience patients was 4.2%, while
it was 6.8% with Taxus Express.
On the specific measure of retreatment in the problem area, the
rate was 2.5% with Xience and 4.6% with Taxus Express. Notably,
this study didn't include routine patient follow-up with angiogram
imaging tests - doctors believe this can fuel repeat procedures due
to narrowing they see, but isn't causing discomfort.
The study also showed a lower rate of rare but dangerous
stent-related clots, which are a closely watched complication, with
the Xience device at one year.
Compare's main goal, meantime, was to track a combination of
serious events including death, nonfatal heart attacks and
retreatment of the previously treated artery. On this measure, the
rate for Xience at one year was 6.2%, compared with a 9.1% rate for
Taxus Liberte.
Unlike clinical trials that hand-pick patients and may omit
certain complications, Compare tracked patients with a variety of
"real-world" problems.
Xience's dominance in Wednesday's data stopped when it came to
diabetics, who tend to have smaller vessels that are prone to
re-clogging.
Among diabetic patients in Spirit IV, who made up nearly
one-third of the study, the rates of events were similar between
Xience and Taxus Express despite the Xience advantages among
nondiabetics.
That study "actually supports Boston Scientific in relation to
the diabetic outcome, even though we're using our last-generation
stent," said Keith Dawkins, the associate chief medical officer at
Boston Scientific, in an interview. The company said late Wednesday
it was reviewing the results from Compare.
Stone, a professor of medicine at Columbia University Medical
Center, said outcomes for diabetics can still be improved and
should be an area of focus for future drugs and stents.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com