Assunto: The TAXUS(TM) Stent System Shows
Excellent Results in Small Vessels
09 de fevereiro de 2006 14:20 HORALOCAL
The TAXUS(TM) Stent System Shows Excellent
Results in Small Vessels
PARIS, France, Feb. 9 /PRNewswire/ -- Boston
Scientific announced that the data from its
TAXUS Clinical Trial Program, including the Meta
Analysis, shows excellent efficacy and safety in
treatment of small vessels (<2.5mm diameter).(1)
The large-scale, Johnson & Johnson-sponsored
REALITY study (n=1,353 across 88 centers
worldwide) directly compared the TAXUS(TM) and
Cypher(TM)(x) Stent systems in small arteries.
The REALITY study confirmed the excellent
clinical outcomes with the TAXUS(TM) Stent
system in small vessels.(2)
Recently, the
de-facto single-centre ISAR SMART study compared
Taxus(TM) and Cypher(TM) Stent systems in small
vessels, which included patients with arteries
similar in size to REALITY but in less complex
lesions. This study, conducted by Professor
Adnan Kastrati from the German Heart Centre,
Technical University, Munich, Germany, failed to
prove non-inferiority of the TAXUS(TM) versus
the Cypher Stents system in small vessels.(3)
Dr. Donald Baim, Brigham and Women's Hospital,
Boston, MA, commented that the data from the
small ISAR SMART study is at odds with the large
body of evidence from the TAXUS Clinical Trial
program including those data from the small
vessel meta-analysis. Dr. Baim further suggested
that we should therefore temper the ISAR SMART
findings, in which routine angiographic
follow-up led to an unheard of 100% rate of
conversion from angiographic restenosis to
target lesion revascularization, in the TAXUS
arm. "This pattern suggests that the 'occulo-stenotic
reflex' was at play, compared to the usual
picture of a 50% conversion rate," said Dr. Baim.
According to the evidence-based medicine
clinical trial scoring system available on
http://TCTmd.com, the ISAR SMART study scores
only 3 out of 10 points and its outcomes should
therefore not be used to direct clinical
practice.(4) Prof. Sigmund Silber, author of the
scoring system and Chairperson of the European
PCI guidelines said, "ISAR SMART study does not
have a primary clinical endpoint, is a de-facto
single-center experience without validation from
an external, independent core catheter lab. Thus
it is attributed a low score according to the
scoring system."
Jeff Goodman, President,
International for Boston Scientific commented, "The
TAXUS(TM) Stent system has excellent outcomes in
small vessels based on the rich body of evidence
from the TAXUS(TM) Clinical Trial Program. The
clinical outcomes in small vessels from the
SIRIUS (xx) trial suggest some shortcomings with
the Cypher(TM) Stent in small vessels.(5) "
Coronary Artery Disease is the major cause of
premature death and disability in the Western
world and most European countries. It is
currently responsible for approximately 16
million deaths yearly, which represents
one-third of global deaths, a burden predicted
to significantly rise to 37% by 2020.(6) Small
vessel disease accounts for nearly 40% (7) of
CAD and its treatment with bare metal stents has
been particularly difficult due to problems with
reclogging of the arteries.
Boston Scientific
is a worldwide developer, manufacturer and
marketer of medical devices whose products are
used in a broad range of interventional medical
specialties. For more information, please visit:
http://www.bostonscientific.com .
REFERENCES:
1) TAXUS meta-analysis II, IV, V, VI presented
by G. Stone at
ACC 2005
2) REALITY study presented by M.C. Morice at ACC
2005
3) ISAR SMART is an independent study conducted
by Pr Kastrati /
Mehilli J, Dibra A, Kastrati A et al. Eur Heart
J 2006; online.
4) Silber Score on tctmd.com.
5) SIRIUS 2.25mm -- Long data abstract by
Jeffrey W. Moses at TCT
2005
6) http://www.medscape.com/viewarticle/480730
7) Morice MC. Stenting for small coronary
vessels. J Invasive
Cardiol 2003;15:377-379.
x) Cypher is a registered trademark of J&J
Cordis
xx) SIRIUS is a trial by J&J, Cordis
SOURCE Boston Scientific International
02/09/2006
CONTACT: Geraldine Varoqui, PR Manager
International of Boston
Scientific, +49-2102-489-461, varoquig@bsci.com,
or Maren Koban of
BSC press office, +44(0)20-7973-4497, mkoban@hillandknowlton.com
Web site: http://TCTmd.com
http://www.bostonscientific.com
http://www.medscape.com/viewarticle/480730
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