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

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

September 15, 2006

    NATICK, Mass., Sept. 15 /Xinhua-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.

    For more information, please contact:

     Geraldine Varoqui
     Boston Scientific PR Manager International
     Tel:   [phone]
     Email: [e-mail] 

     Tracy Paul
     BSC press office
     Tel:   [phone]
     Email: [e-mail] 

SOURCE  Boston Scientific Corporation