Boston Scientific announces two-year follow-up data from TAXUS IV clinical trial
29 September 2004 - 6:20PM
PR Newswire (US)
Boston Scientific announces two-year follow-up data from TAXUS IV
clinical trial - Benefits maintained at two years - VANCOUVER, BC
and WASHINGTON, DC, Sept. 29 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate
partner, Boston Scientific ("Boston"), today announced two-year
follow-up data from its TAXUS IV clinical trial. The benefits
reported at 12 months -- for patients who received a
paclitaxel-eluting stent compared to patients who received a
bare-metal stent -- were maintained at two years. Boston Scientific
made the announcement at the annual Transcatheter Cardiovascular
Therapeutics symposium in Washington, D.C. Boston reported that the
results support safety and efficacy, as demonstrated by low rates
of target lesion revascularization (retreatment rate, or TLR) that
were maintained at two years. The TAXUS group reported a 5.6
percent (36/645) TLR rate compared with 17.5 percent (112/640) in
the control group. The follow-up rate at two years was outstanding
with 97 percent of patients returning. The rate of patients living
free of TLR events was 94.4 percent at two years for the TAXUS
group, as compared to 82.6 percent for the control group. Boston's
results for diabetic patients (including oral and insulin-requiring
diabetics) in the TAXUS group also showed that benefits were
maintained at two years. The TLR rate for diabetics was 8.0 percent
(12/150) compared to 22.0 percent (35/159) in the control group.
Diabetic patients are more likely than non-diabetic patients to
experience restenosis following angioplasty and stenting with
bare-metal stents, and may stand to benefit substantially from
drug-eluting stent technology. Diabetic patients are expected to
represent approximately 40 percent of coronary interventions. "The
TAXUS IV results at two years are exceptional and support the
long-lasting safety and efficacy of paclitaxel-eluting stent
technology," said Gregg W. Stone, M.D., the study's Principal
Investigator and Professor of Medicine, Columbia University Medical
Center in New York. "These outcomes establish the durability of the
TAXUS stent in a broad range of complex patients and blockages,
representing a true medical advance. At two-year follow-up, the
incremental benefits of having received the TAXUS stent system
rather than a bare-metal stent continue to increase with no
evidence of late catch-up apparent." TAXUS IV is a randomized,
double-blind pivotal trial designed to assess the safety and
efficacy of a paclitaxel-eluting coronary stent system in reducing
restenosis in de novo lesions 10 - 28 mm in length and 2.5 - 3.75
mm in diameter. The study, which enrolled 1,326 patients at 73
sites in the United States, is using Boston Scientific's TAXUS(TM)
Express(TM) coronary stent system. This system is built on the
Express(TM) coronary stent system, which offers excellent
deliverability to the treatment site and superb conformability to
the vessel wall. Boston Scientific has acquired worldwide
co-exclusive rights from Angiotech to use paclitaxel to coat its
coronary stent products and other vascular and non-vascular
products. Vancouver-based Angiotech Pharmaceuticals, Inc., a
specialty pharmaceutical company focusing on drug-coated medical
devices and biomaterials, is dedicated to enhancing the performance
of medical devices and biomaterials through the innovative uses of
pharmacotherapeutics. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please
visit our website at http://www.angiotech.com/. CONTACTS: Todd
Young, Angiotech Pharmaceuticals (Analysts & Investors), (604)
221-7676 ext 6933; Rui Avelar, Angiotech Pharmaceuticals, Inc.
(Analysts), (604) 221-7676 ext 6996; Eric Starkman, Starkman &
Associates (Media), (212) 252-8545 ext 12 Statements contained
herein that are not based on historical or current fact, including
without limitation statements containing the words "anticipates,"
"believes," "may," "continue," "estimate," "expects," "may" and
"will" and words of similar import, constitute "forward-looking
statements" within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. 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. Such factors include, among others, the following:
general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
competition; changes in business strategy or development plans; the
ability to attract and retain qualified personnel; existing
governmental regulations and changes in, or the failure to comply
with, governmental regulations; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
or the Canadian securities regulators. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements. DATASOURCE:
Angiotech Pharmaceuticals, Inc. CONTACT: Todd Young, Angiotech
Pharmaceuticals (Analysts & Investors), (604) 221-7676 ext
6933; Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts), (604)
221-7676 ext 6996; Eric Starkman, Starkman & Associates
(Media), (212) 252-8545 ext 12
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