SYNTAX substudy shows positive outcomes for left main patients treated with TAXUS(R) Express(2)(R) Stent System
19 Mai 2009 - 11:38PM
PR Newswire (US)
VANCOUVER, May 19 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today
announced that its corporate partner, Boston Scientific Corporation
(NYSE:BSX) has reported positive outcomes from a substudy of
patients with left main coronary disease who were treated with the
TAXUS(R) Express(2)(R) Paclitaxel-Eluting Coronary Stent System.
SYNTAX-LE MANS is a substudy of the landmark SYNTAX trial, the
first randomized, controlled clinical trial to compare percutaneous
coronary intervention (PCI) using the TAXUS Stent to coronary
artery bypass graft (CABG) surgery in patients with left main
disease and/or significant narrowing of all three coronary arteries
(three-vessel disease). The substudy data were presented by A.
Pieter Kappetein, M.D., Ph.D., at the annual EuroPCR Scientific
Program in Barcelona. SYNTAX-LE MANS compares late angiographic and
clinical outcomes in 263 patients with left main disease (149
treated with the TAXUS Stent and 114 treated with CABG). It is
designed to assess 15-month patency (vessel openness) and the
safety of stents and grafts in this high-risk population; it
includes separate primary endpoints for each treatment arm. For PCI
patients, the primary endpoint is the rate of long-term patency
(defined here as (less than)50% stenosis) of the treated lesion
sites. For CABG patients, the primary endpoint is the ratio of
obstructed/occluded grafts (defined here as (greater than or equal
to)50% stenosis) to total placed grafts. Results were presented
separately for each group, and no formal statistical inferences
between the two groups were made due to the different primary
endpoints. Results were also broken out by left main lesion
location, including distal and non-distal. For those patients
receiving a TAXUS Stent, the patency rate for the treated lesion
was 92 percent. Restenosis was more common with distal lesions (90%
patency) compared with non-distal lesions (98% patency). Reported
in-stent late loss was low at 0.2 mm for non-distal lesions. The
reported 15-month MACCE rate (all-cause death, stroke, myocardial
infarction and revascularization) for the TAXUS Stent patients was
13 percent, driven primarily by a nine percent repeat
revascularization rate. For CABG patients, the overall
obstruction/occlusion ratio at 15 months was 16 percent, with six
percent of grafts obstructed in the range of (greater than or equal
to)50% to (less than)100%, and 10 percent of grafts occluded 100%.
On a per patient basis, the obstruction/occlusion ratio was 27
percent, with nine percent of patients having a graft obstructed in
the (greater than or equal to)50% to (less than)100% range and 18
percent of patients having a graft occluded 100%. The reported
MACCE rate for CABG patients at 15 months was nine percent. "The
data announced today from SYNTAX-LE MANS will offer important
insights for doctors as they evaluate treatment options for
challenging left main patients," said Keith Dawkins, M.D.,
Associate Chief Medical Officer of Boston Scientific. "We are
encouraged by the high stent patency rate at 15 months, which
increases our confidence in the application of PCI in this
high-risk population. The results support previously announced
outcomes with PCI and CABG in patients with left main disease." The
safety and effectiveness of the TAXUS Express(2) Stent System have
not been established in patients with left main or three-vessel
disease. Forward Looking Statements --------------------------
Statements contained in this press release that are not based on
historical fact, including without limitation statements containing
the words "believes," "may," "plans," "will," "estimates,"
"continues," "anticipates," "intends," "expects" and similar
expressions, constitute "forward-looking statements" within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995 and "forward-looking information" within the meaning of
applicable Canadian securities laws. All such statements are made
pursuant to the "safe harbor" provisions of applicable securities
legislation. Forward-looking statements may involve, but are not
limited to, comments with respect to our objectives and priorities
for 2009 and beyond, our strategies or future actions, our targets,
expectations for our financial condition and the results of, or
outlook for, our operations, research, development, product and
drug development. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause the
actual results, events or developments to be materially different
from any future results, events or developments expressed or
implied by such forward-looking statements. Many such risks,
uncertainties and other factors are taken into account as part of
our assumptions underlying these forward-looking statements and
include, among others, the following: general economic and business
conditions, both nationally and in the regions in which we operate;
market demand; technological changes that could impact our existing
products or our ability to develop and commercialize future
products; competition; existing governmental regulations and
changes in, or the failure to comply with, governmental
regulations; adverse results or unexpected delays in pre-clinical
and clinical product development processes; adverse findings
related to the safety and/or efficacy of our products or products
sold by our partners; decisions, and the timing of decisions, made
by health regulatory agencies regarding approval of our technology
and products; the requirement for substantial funding to conduct
research and development and to expand manufacturing and
commercialization activities or consummate acquisitions; and any
other factors that may affect performance. In addition, our
business is subject to certain operating risks that may cause the
actual results expressed or implied by the forward-looking
statements in this press release to differ materially from our
actual results. These operating risks include: our ability to
attract and retain qualified personnel; our ability to successfully
complete pre-clinical and clinical development of our products;
changes in business strategy or development plans; our failure to
obtain patent protection for discoveries; loss of patent protection
resulting from third party challenges to our patents;
commercialization limitations imposed by patents owned or
controlled by third parties; our ability to obtain rights to
technology from licensors; liability for patent claims and other
claims asserted against us; our ability to obtain and enforce
timely patent and other intellectual property protection for our
technology and products; the ability to enter into, and to
maintain, corporate alliances relating to the development and
commercialization of our technology and products; market acceptance
of our technology and products; our ability to successfully
manufacture, market and sell our products; the continued
availability of capital to finance our activities; and any other
factors referenced in our other filings with the Securities and
Exchange Commission ("SEC") and applicable Canadian regulatory
authorities. For a more thorough discussion of the risks associated
with our business, see the "Risk Factors" section in our annual
report for the year ended December 31, 2008 filed with the SEC on
Form 10-K, and our quarterly report for the three months ended
March 31, 2009 filed with the SEC on Form 10-Q. Given these
uncertainties, assumptions and risk factors, readers are cautioned
not to place undue reliance on such forward-looking statements.
Except as required by law, we disclaim any obligation to update any
such factors or to publicly announce the result of any revisions to
any of the forward-looking statements contained in this press
release to reflect future results, events or developments. About
Angiotech Pharmaceuticals Angiotech Pharmaceuticals, Inc. is a
global specialty pharmaceutical and medical device company with
over 1,500 dedicated employees. Angiotech discovers, develops and
markets innovative treatment solutions for diseases or
complications associated with medical device implants, surgical
interventions and acute injury. To find out more about Angiotech
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. DATASOURCE: Angiotech Pharmaceuticals,
Inc. CONTACT: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,
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