Journal of American College of Cardiology Article Reports Fewer Repeat Procedures...

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Mon May 11, 2009 8:30am EDT

Journal of American College of Cardiology Article Reports Fewer Repeat
Procedures With Boston Scientific's TAXUS(R) Liberte(R) Stent

Authors identify important differences between drug-eluting stent brands

NATICK, Mass., May 11 /PRNewswire-FirstCall/ -- Boston Scientific Corporation
(NYSE: BSX) today welcomed the publication of an article in the current
edition of the Journal of American College of Cardiology (JACC) reviewing data
on more than 19,000 patients from the Swedish national registry who were
evaluated for restenosis, or the re-narrowing of arteries after percutaneous
coronary intervention (PCI).  The article reported that patients who received
a TAXUS(R) Liberte(R) Paclitaxel-Eluting Stent had numerically lower
incidences of repeat procedures to treat restenosis at two years as compared
to patients treated with 'olimus-based drug-eluting stents (DES), including
Cordis' Cypher(R) Stent and Medtronic's Endeavor(R) Stent.  In the patients
with diabetes, the TAXUS Liberte Stent demonstrated a statistically
significant lower restenosis rate compared to the Endeavor Stent, which had
more than two times the risk of repeat procedures. 

The Swedish Coronary Angiography and Angioplasty Registry holds data on all
patients undergoing PCI in Sweden.  The objective of this independent study
was to evaluate restenosis rates of drug-eluting stents in patients with and
without diabetes in a real-world setting.  The JACC article reported that both
the TAXUS Liberte Stent and Boston Scientific's first-generation DES -- the
TAXUS(R) Express(R) Stent -- were the only stents in the study showing no
increased risk of restenosis for patients with diabetes as compared to those
without diabetes.  Both the Cypher Stent and Endeavor Stent showed significant
increased risk of restenosis in patients with diabetes.  In addition, the
study showed that the TAXUS Liberte Stent had an approximately 23 percent
lower restenosis rate at two years compared to the prior-generation TAXUS
Express Stent.  The authors concluded that "There seem to be important
differences between different brands of DES."(1)

"The results of this study are noteworthy for TAXUS Liberte, which compared
favorably in rates of repeat procedures to both 'olimus stents," said Donald
S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. 
"The findings presented in the article are consistent with our own clinical
trial observations, including recently published ARRIVE and ATLAS data, and
may reflect the different mechanism of action for paclitaxel compared to the
'olimus agents used in the other drug-eluting stents.  The newer and
thinner-strut TAXUS Liberte Stent performed better than the TAXUS Express
Stent in reducing restenosis." 

The Swedish registry study included four DES brands: TAXUS Liberte, TAXUS
Express, Cypher and Endeavor.  In total, the registry included 35,478 DES
implants during 22,962 procedures in 19,004 patients, with 1,807 restenoses
reported over a mean 29-month follow-up period.  For the entire study
population, the repeat revascularization rate per stent was 3.5 percent after
one year and 4.9 percent after two years.  Overall, the adjusted risk of
restenosis was 1.23 times higher in patients with diabetes than in patients
without diabetes.  In patients with diabetes, restenosis was higher in the
non-TAXUS Stents.  The sirolimus-eluting Cypher Stent and the
zotorolimus-eluting Endeavor Stent had higher restenosis rates in patients
with diabetes compared with those in patients without diabetes (1.25 times and
1.77 times, respectively).  

"The Swedish study shows there are significant distinctions among available
DES, as well as differences between first- and second-generation products,"
said Hank Kucheman, Senior Vice President and Group President, Cardiovascular
for Boston Scientific.  "Our two-drug strategy has allowed us to maintain our
global DES leadership position by offering the next-generation TAXUS Liberte
Stent as well as the PROMUS(R) Everolimus-Eluting Coronary Stent.  We look
forward to introducing our third-generation Element(TM) Stent on both drug
platforms later this year in CE Mark countries."

TAXUS Stents have been evaluated by the industry's most extensive randomized,
controlled clinical trial program, with follow-up to five years in some cases.
 These trial results have been supplemented by data on more than 35,000
patients enrolled in post-approval registries.  To date, approximately 11
million Boston Scientific stents have been implanted globally, making them the
world's most frequently used stents. 
 
The TAXUS Liberte Paclitaxel-Eluting Coronary Stent System received U.S. Food
and Drug Administration approval in October 2008, and received European CE
Mark approval for use in patients with diabetes in December 2007.  In the
United States, the TAXUS Stents are not specifically indicated for use in
patients with diabetes. 

The PROMUS Stent is a private-labeled XIENCE V(R) Everolimus-Eluting Coronary
Stent System manufactured by Abbott and distributed by Boston Scientific. 
XIENCE V is a trademark of the Abbott Laboratories group of companies.  Cypher
is a trademark of Cordis Corporation.  Endeavor is a trademark of Medtronic
Vascular, Inc.

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:
www.bostonscientific.com.   
(1) (J Am Coll Cardiol 2009;53:1660-7)


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    CONTACT:  Paul Donovan
              508-650-8541 (office)
              508-667-5165 (mobile)
              Media Relations
              Boston Scientific Corporation

              Larry Neumann
              508-650-8696 (office)
              Investor Relations
              Boston Scientific Corporation


SOURCE  Boston Scientific Corporation

Media Relations, Paul Donovan, +1-508-650-8541, or mobile, +1-508-667-5165, or
Investor Relations, Larry Neumann, +1-508-650-8696, both of Boston Scientific
Corporation
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