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HORIZONS AMI Trial Demonstrates Superior Outcomes with TAXUS® Drug-Eluting Stents in Heart Attack Patients
Landmark trial provides new insight for physicians
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October 15, 2008 / Natick, MA and Washington, DC -- Boston Scientific Corporation (NYSE: BSX) today announced results from an analysis of the HORIZONS AMI trial. The HORIZONS AMI trial, sponsored by the Cardiovascular Research Foundation (CRF) with research grant support from Boston Scientific and The Medicines Company (NASDAQ: MDCO) is designed to determine the safety and efficacy of the TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System compared to bare-metal stenting in patients experiencing an acute myocardial infarction (AMI), commonly referred to as a heart attack. With 3,006 patients enrolled globally, the HORIZONS AMI trial will provide the medical community with critical data from one of the largest randomized clinical trials ever performed in patients with heart attacks. Heart attack patients are often treated with bare-metal stents and are a more complicated patient population at higher risk of death. Analysis of the data was presented at CRF's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
Gregg
W. Stone, MD |
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"In the HORIZONS AMI trial,
the outcomes provide definitive evidence that, in patients with
AMI, drug-eluting stents were superior in efficacy to bare-metal
stents and had a comparable safety profile at one year," said
Gregg W. Stone, M.D., CRF Chairman, Professor of Medicine and
the Director of Research and Education at the Center for Interventional
Vascular Therapy at New York Presbyterian-Hospital/Columbia University
Medical Center and Principal Investigator of the HORIZONS AMI
trial.
"Outcomes from prior registry studies of drug-eluting stents
compared to bare-metal stents in AMI patients have been conflicting;
this is the first prospective, large, international randomized
clinical trial and provides conclusive evidence on this subject," continued
Dr. Stone. |
"The
findings from the HORIZONS AMI trial will have a major impact on how decisions
are made regarding drug-eluting and bare-metal stents in the highest risk patients
in this trial, those in the early hours of a heart attack. This study removes
much of the uncertainty and concern about the efficacy and safety of drug-eluting
stents in this clinical setting. Moreover, all of the patients in this trial
will be followed for five years to ensure that these favorable results are maintained."
One-year results showed comparable overall safety outcomes (death, stroke, myocardial
infarction or stent thrombosis) between the two treatment groups (8.0 percent
for the Express® bare-metal stent versus 8.1 percent for the TAXUS Express® Stent,
p=0.92). There was a statistically significant 41 percent reduction in revascularization
in the TAXUS Express group (7.5 percent for the Express Stent versus 4.5 percent
for the TAXUS Express Stent, p=0.002).
"Our investments in drug-eluting stent clinical trials are designed to provide the medical community with relevant data they can use in combination with their own clinical judgment to decide optimal treatment strategies for patients," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "The
HORIZONS trial provides valuable insight into the benefits of the TAXUS Express
Stent in a high-risk patient population."
The safety and effectiveness of the TAXUS Express Stent has not been established in patients with AMI.
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/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934. Forward-looking statements
may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and
similar words. These forward-looking statements are based on our beliefs, assumptions
and estimates using information available to us at the time and are not intended
to be guarantees of future events or performance. These forward-looking statements
include, among other things, statements regarding clinical trials, regulatory
approvals, competitive offerings, product performance and our market position.
If our underlying assumptions turn out to be incorrect, or if certain risks or
uncertainties materialize, actual results could vary materially from the expectations
and projections expressed or implied by our forward-looking statements. These
factors, in some cases, have affected and in the future (together with other
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cause actual results to differ materially from those contemplated by the statements
expressed in this press release. As a result, readers are cautioned not to place
undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A -- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A -- Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific Corporation
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