Angiotech partner announces positive results from its TAXUS VI drug-eluting stent trial
25 Mai 2004 - 6:47PM
PR Newswire (US)
Angiotech partner announces positive results from its TAXUS VI
drug-eluting stent trial Results support safety and efficacy of
moderate-release formulation in high-risk patients, including long
lesions with overlapping stents, small vessels and diabetics
VANCOUVER, May 25 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP), a specialty
pharmaceutical company focusing on drug-coated medical devices and
biomaterials, today reported that its corporate partner, Boston
Scientific Corp. announced nine-month results from its TAXUS VI
clinical trial. The trial enrolled 448 patients at 44 sites in
Europe, assessing the safety and efficacy of a moderate-release
formulation paclitaxel-eluting stent in high-risk patients,
including long lesions with overlapping stents, small vessels and
diabetics. Boston made the announcement at the annual Paris Course
on Revascularization, the largest interventional cardiology
conference in Europe. The randomized, double-blind trial is
designed to assess a moderate- release paclitaxel-eluting coronary
stent system in reducing restenosis in long de novo lesions (18 -
40 mm in length and 2.5 - 3.75 mm in diameter). The study is using
Boston Scientific's TAXUS(TM) Express(TM) coronary stent system.
"These remarkable results provide strong support for the safety and
efficacy of polymer-based delivery of paclitaxel in treating
coronary artery disease in complex cases," said Jim Tobin,
President and Chief Executive Officer of Boston Scientific.
"Today's data is consistent with earlier TAXUS trials, supporting
the conclusion that the moderate-release formulation is as safe and
effective as the slow-release formulation. The TAXUS VI outcomes
demonstrate reductions in TVR, TLR and binary restenosis similar to
those trials, but in higher-risk patients. We are pleased that even
in this challenging patient group, the TAXUS stent system proved
particularly effective in diabetic patients. When comparing TAXUS
VI to other TAXUS trials, it is important to keep in mind that
TAXUS VI represents a much higher bar. For example, the average
lesion length in TAXUS IV was approximately 13 mm, while in TAXUS
VI it was approximately 21 mm. TAXUS VI had the longest mean lesion
length and the highest-risk patient population of any drug-eluting
stent trial to date, yet the results were still outstanding."
Revascularization rates ----------------------- The study's primary
endpoint was target vessel revascularization (symptom-driven repeat
revascularization of the target vessel, or TVR). The TVR rate of
9.1 percent in the TAXUS group was significantly lower than the
control group rate of 19.4 percent (P(equal sign)0.0027). The study
reported a target lesion revascularization (TLR) rate of 6.8
percent in the TAXUS group compared with 18.9 percent in the
control group (P(equal sign)0.0001). TLR - or retreatment rate - is
one of the most important indicators of the performance of
drug-eluting stent technology. Safety ------ The results supported
safety as demonstrated by low rates of Major Adverse Cardiac Events
(MACE), which include death, myocardial infarction (MI; Q-wave and
non-Q-wave) and TVR. The study reported a 16.4 percent MACE rate at
nine months in the TAXUS group compared with 22.5 percent in the
control group. This reduction was due to the lower TLR rate in the
TAXUS group compared with the control group. In addition, stent
thrombosis rates in the TAXUS group were low (0.5 percent or 1/219
patients) compared to the control group (1.3 percent or 3/227
patients) (p(equal sign)0.62), indicating comparable safety of
drug-eluting stents and bare metal stents. Efficacy -------- The
study reported an in-segment (stented vessel segment plus 5 mm
beyond each end of the stent) binary restenosis rate of 12.4
percent in the TAXUS group compared with 35.7 percent in the
control group (P(equal sign) less than 0.0001) (binary restenosis
is defined as 50 percent or greater vessel re-occlusion). The study
reported an in-stent binary restenosis rate of 9.1 percent in the
TAXUS group compared with 32.9 percent in the control group
(P(equal sign) less than 0.0001). In addition, the study found
significant improvements in the more sensitive, quantitative
angiographic measurements (in-segment, in-stent and at the edges),
such as in-segment percent diameter stenosis (30.4 percent in the
TAXUS group versus 45.4 percent in the control group, P(equal sign)
less than 0.0001), in-segment minimum lumen diameter (1.97 mm in
the TAXUS group versus 1.51 mm in the control group; P(equal
sign)0.0001) and in-segment late lumen loss (0.24 mm in the TAXUS
group versus 0.66 mm in the control group; P(equal sign) less than
0.0001). Diabetic patients ----------------- The diabetic
population in the TAXUS group reported an in-segment binary
restenosis rate of 10.8 percent compared with 47.6 percent in the
control group (P(equal sign)0.0005). Binary restenosis in the TAXUS
group diabetic population was comparable to that of non-diabetic
patients in the TAXUS group. Medically treated diabetic patients
represent approximately 20 percent of the overall patient
population in the study. The TLR rate for the medically treated
diabetic sub-population of the TAXUS group was 2.6 percent compared
with 22 percent in the control group (P(equal sign)0.0103).
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. In addition to the improved
restenosis rates, marked improvement in late loss was also seen in
the diabetic population of the TAXUS group compared to the bare
metal stent control group (0.19 mm versus 0.81 mm; P(equal sign)
less than 0.0001). Diabetic patients are expected to represent
approximately 40 percent of coronary interventions. "These findings
represent further evidence that the TAXUS system is effective in
treating de novo coronary artery disease across a wide range of
patients," said Professor Eberhard Grube, M.D., Chief of
Cardiology/Angiology at the Heart Center in Siegburg, Germany, and
Co-Principal Investigator of the TAXUS VI trial. "Not only did the
trial meet its primary endpoint of TVR, but the low reintervention
and restenosis rates are particularly noteworthy given the average
lesion length of more than 20 mm in this study." "The low MACE, TVR
and stent thrombosis rates seen in TAXUS VI demonstrate that the
TAXUS stent system is safe and effective using the moderate-release
formulation," said Keith Dawkins, M.D., Consultant Cardiologist,
Wessex Cardiothoracic Centre Southampton University Hospital,
Southampton, England, and Co-Principal Investigator of the TAXUS VI
trial. "This outcome is especially significant given the
higher-risk patient population studied in the trial. More
importantly, it helps prove that TAXUS is safe in both slow- and
moderate-release formulations." The TAXUS technology is Boston
Scientific's proprietary polymer-based, paclitaxel-eluting stent
system for reducing coronary restenosis, the growth of neointimal
tissue within an artery after angioplasty and stenting. Boston
Scientific launched the TAXUS(TM) Express(2)(TM) paclitaxel-eluting
coronary stent system in Europe and other international markets in
February 2003 and in the United States in March 2004. Today Boston
Scientific is the global leader in the drug-eluting coronary stent
market. 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/. 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:ANPI)(TSE:ANP), please visit our website at
http://www.angiotech.com/. 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," 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
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uncertainties and other factors that may cause the actual results,
events or developments to be materially different from any future
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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
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other claims asserted against the Company; and other factors
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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. FOR ADDITIONAL INFORMATION:
--------------------------- Analysts: Rui Avelar, Angiotech
Pharmaceuticals, Inc. (604) 221-7676 ext 6996 Investors: Ian
Harper, Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6933
Media: Eric Starkman, Starkman & Associates (212) 252-8545 ext
12 DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: Analysts:
Rui Avelar, Angiotech Pharmaceuticals, Inc., (604) 221-7676 ext
6996; Investors: Ian Harper, Angiotech Pharmaceuticals, Inc., (604)
221-7676 ext 6933; Media: Eric Starkman, Starkman & Associates,
(212) 252-8545 ext 12
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