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Safety and Efficacy of Drug-Eluting Stents Reaffirmed in New England Journal of Medicine Articles and Editorial

Natick, Massachusetts (ots/PRNewswire)

Boston Scientific
Corporation (NYSE: BSX) today welcomed the results of two studies and
an editorial published in today's edition of The New England Journal
of Medicine (NEJM), all of which reaffirmed the safety and efficacy
of drug-eluting stents.
Commenting on the editorial and articles describing results of two
randomized clinical trials, PASSION and TYPHOON, the company stated:
"We welcome the conclusion of The New England Journal of Medicine
that drug-eluting stents are a safe and effective therapy, with lower
retreatment rates than bare-metal stents. Patients who have suffered
acute myocardial infarction (AMI, or a serious heart attack) are
among the most complex and difficult groups to treat[1]. In The
PASSION trial, the lower rates of cardiac death and recurrent heart
attack for the TAXUS(TM)  stent as compared to the bare-metal control
stent -- and a particularly low retreatment rate of 5.3 percent --
reinforce the exceptional safety and efficacy of the TAXUS
drug-eluting stent."
"[T]he data from these two trials indicate that drug-eluting
stents can be used safely in the setting of primary PCI [percutaneous
coronary intervention] and are likely to reduce the need for repeated
revascularization," NEJM wrote in its editorial. The editorial also
cautioned that "[i]t would be dangerous to conclude from these data
that one drug-eluting stent is better than the other in primary PCI,
since direct comparisons of the two stents for this indication are
not available." The editorial noted that the retreatment rates for
the TAXUS stent in the PASSION study and for the Cypher(TM) stent in
the TYPHOON study were "remarkably similar" at 5.3 percent and 5.6
percent, respectively. As indicated by the editor, differences in
study design, definitions of endpoints and study conduct did not
allow any side-by-side comparisons for the two different DES
technologies in this clinical setting.
The PASSION trial showed that in AMI patients, the TAXUS stent
achieved reductions in cardiac death (3.9 percent for the TAXUS stent
versus 6.2 percent for the bare-metal control), target lesion
revascularization, or retreatment rate (5.3 percent for the TAXUS
stent versus 7.8 percent for bare metal) and reinfarction, or repeat
heart attack (1.7 percent for the TAXUS stent versus 2.0 percent for
bare metal). While not adequately powered to provide statistical
significance, this study supports the safety and efficacy of the
TAXUS stent technology in AMI. Boston Scientific is currently
providing financial support for a randomized, controlled clinical
trial designed to compare TAXUS stents to bare-metal stents in AMI
patients. The 3,400-patient definitive HORIZONS AMI trial is powered
to confirm the benefits of the TAXUS stent in AMI.
In the PASSION trial, the rate of angiographically confirmed stent
thrombosis for the TAXUS stent (1.0 percent) was low and no different
from the bare-metal control stent.
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.
This press release contains forward-looking statements. Boston
Scientific wishes to caution the reader of this press release that
actual results may differ from those discussed in the forward-looking
statements and may be adversely affected by, among other things,
risks associated with new product development and commercialization,
clinical trials, intellectual property, regulatory approvals,
competitive offerings, integration of acquired companies, Boston
Scientific's overall business strategy, and other factors described
in Boston Scientific's filings with the Securities and Exchange
Commission.
[1] The TAXUS stent is not approved for treatment of AMI in the
United States. It is approved for treatment of AMI in Europe.

Contact:

CONTACT: Geraldine Varoqui, Boston Scientific PR Manager
International, Tel: +49-2102-489-461, varoquig@bsci.com OR Tracy
Paul, BSC press office, Tel: +44-20-7413-3101,
tpaul@medicalknowledgegroup.com

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