TAXUS(R) stents demonstrate excellent efficacy and safety in studies presented at TCT 2006
27 Oktober 2006 - 12:05AM
PR Newswire (US)
Independent meta-analysis and real-world registries prove to be
strong votes of confidence for TAXUS(R) VANCOUVER, Oct. 26
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global specialty
pharmaceutical and medical device company, reports that research
presented this week at the Transcatheter Cardiovascular
Therapeutics (TCT) conference, the world's largest interventional
vascular medicine meeting, further supports the safety and efficacy
of Drug Eluting Stents and in particular TAXUS(R)
paclitaxel-eluting coronary stent systems. "We welcome the results
of the independent meta-analysis and the real-world registries,"
said William Hunter, MD, President and CEO of Angiotech
Pharmaceuticals, developer of the paclitaxel-eluting technology
along with partner Boston Scientific. "These results show the TAXUS
paclitaxel-eluting stent systems perform exceptionally well in both
clinical trial and real-world patient populations, with superior
efficacy and low complication rates." A new, independent study
conducted by the Cardiovascular Research Foundation confirming that
the TAXUS paclitaxel-eluting coronary stent is safe and effective
was presented at TCT on Tuesday, October 24, 2006. Martin B. Leon,
M.D., founder of the Cardiovascular Research Foundation and
Professor of Medicine, Columbia University Medical Center in New
York presented the independent meta-analysis of 3,506 patients from
the TAXUS I, II, IV, V and VI clinical trials. For the TAXUS stent:
- The rate of freedom from stent thrombosis at up to four years was
98.7 percent (1.3 percent thrombosis rate), compared to a 99.1
percent rate of freedom from stent thrombosis (0.9 percent stent
thrombosis rate) in the bare-metal control group. - This
meta-analysis showed a small but statistically significant (0.40
percent, p=0.033) increase in the incidence of stent thrombosis
after one year for the TAXUS stent as compared to the bare- metal
control stent. However, there was no corresponding increase in
death or myocardial infarction (MI). - The results for up to four
years follow-up also showed a trend toward a lower rate of
all-cause death, as well as the combination all-cause death or
Q-wave MI, for the TAXUS stent compared to its bare-metal control.
Despite the 0.4 percent increase in late-stent thrombosis, the
all-cause death rate at up to four years was 6.4 percent for the
TAXUS stent compared to 7.0 percent for bare-metal (a statistically
non-significant decrease). "This data should be tremendously
reassuring for patients and physicians," said Dr. Hunter. "In a
nutshell, it means that compared with a bare metal stent, patients
who receive a TAXUS stent have roughly half the chance of
restenosis, and an equal or lower chance of death or having a
myocardial infarction after four years." Positive results also
reported for TAXUS(R) Liberte(TM) stent direct stenting
Twelve-month follow-up data from TAXUS ATLAS, the pivotal clinical
trial evaluating the TAXUS(R) Liberte(TM) paclitaxel-eluting stent
system, was reported by investigator Mark Turco, M.D., Director of
the Center for Cardiac and Vascular Research, Washington Adventist
Hospital, and co-principal investigator of the trial. The data
demonstrated that the safety and efficacy benefits associated with
the TAXUS Liberte Stent System at nine months were maintained at 12
months in workhorse lesions. While identical inclusion and
exclusion criteria were used for both the TAXUS Liberte stent and
the TAXUS(R) Express(TM) stent historical control group, more
complex lesions were treated with the TAXUS Liberte stent than with
the TAXUS Express stent. Despite this difference, the study
reported comparable results in clinical outcomes between both
groups. The study reported a low 12-month overall cardiac death
rate of 0.8 percent for the TAXUS Liberte stent, as compared to 1.0
percent for the control group (P=0.62). The study also reported an
overall myocardial infarction (MI) rate of 4.0 percent for the
TAXUS Liberte stent group, as compared to 3.9 percent for the
control group (P=0.89). The overall rate of stent thrombosis at 12
months for the TAXUS Liberte stent group was 0.9 percent, as
compared to 0.7 percent for the control group (P=0.63). The TAXUS
ATLAS trial reported an overall target vessel revascularization
(TVR) rate of 9.2 percent for the TAXUS Liberte stent group, as
compared to 8.9 percent for the control group (P=0.83) at 12
months. "The TAXUS ATLAS Workhorse trial results are extremely
compelling and the data from the TAXUS Liberte stent in this study
suggest safety and efficacy comparable to the TAXUS Express stent
in the treatment of coronary artery disease," said Dr. Turco. "We
are also seeing significant advantages in the deliverability and
conformability of the more flexible TAXUS Liberte stent as compared
to the TAXUS Express stent." TAXUS ATLAS DIRECT STENT clinical
trial also reported positive results Nine-month data was presented
from the TAXUS ATLAS DIRECT STENT clinical trial. The TAXUS ATLAS
DIRECT STENT trial is a 247-patient, global, multi-center,
single-arm study of the TAXUS Liberte paclitaxel-eluting coronary
stent system for the treatment of patients with de novo coronary
artery lesions using the direct stenting (no balloon pre-dilatation
of the vessel prior to stenting) deployment technique. The study
assessed the safety of direct stenting compared to placement of a
stent using balloon pre-dilatation. The control arm for the trial
is the angiographic cohort of the TAXUS ATLAS WORKHORSE clinical
trial, which mandated pre-dilatation. Although the TAXUS ATLAS and
TAXUS ATLAS DIRECT trial had the same inclusion and exclusion
criteria, simpler lesions were selected for the direct stent group.
"We saw significantly less target lesion revascularization (TLR),
target vessel revascularization (TVR) and major adverse cardiac
events (MACE) rates for the direct stent group as compared to the
pre-dilatation control group," said John Ormiston, M.D.,
co-principal investigator of both the TAXUS ATLAS DIRECT STENT
trial and the TAXUS ATLAS WORKHORSE study, and Interventional
Cardiologist, Mercy Hospital and Green Lane Cardiovascular Unit,
Auckland, New Zealand. "Overall, the trial suggests that the direct
stenting method using the TAXUS Liberte stent is as safe and
effective as stenting with pre-dilatation." The study reported a
success rate of 97.6 percent for delivery of the TAXUS Liberte
stent by direct stenting, and a shorter procedure time for patients
assigned to receive intravascular ultrasound during the index
procedure. The study reported a low nine-month overall cardiac
death rate of 0.8 percent for the direct stent group, as compared
to 1.3 percent for the control group (P=0.73). The study also
reported an overall myocardial infarction (MI) rate of 4.5 percent
for the direct stent group, as compared to 4.3 percent for the
control group (P=0.87). The rate of stent thrombosis for the direct
stent group was 0 percent, as compared to 0.9 percent for the
control group (P=0.33). The rate of target vessel revascularization
was 5.0 percent for the direct stent group, as compared to 11.2
percent for the control group (P=0.0056). The rate of MACE was 9.1
for the direct stent group, as compared to 14.7 for the control
group (P=0.0307). The rate of target lesion revascularization was
2.9 percent for the direct stent group, as compared to 7.8 percent
for the control (P=0.0087). Data in complex patients and lesions
from OLYMPIA Registry support safety and efficacy of TAXUS Liberte
stent system Results of the global TAXUS OLYMPIA registry,
supporting the safety and efficacy of the TAXUS Liberte coronary
stent system in real-world patients were also presented by Martyn
Thomas, M.D., F.R.C.P., King's College Hospital, London, United
Kingdom. This included 12-month data from the 529 patients in Phase
I of the multi-phased registry and preliminary six-month data from
the first 2,066 patients in Phase III. Both Phase I and Phase III
patients exhibited a broad range of lesion and procedural
complexity, reflecting "real world" usage patterns seen in everyday
clinical practices. Population characteristics included a high
proportion of diabetics (50 percent in Phase I, 32 percent in Phase
III), multi-vessel disease (49 percent in Phase I, 59 percent in
Phase III), small vessels (40 percent in Phase I and Phase III),
and complex lesions (defined as B2/C, 48 percent in Phase I, 60
percent in Phase III). OLYMPIA Phase I 12-month findings
demonstrated an overall TAXUS Liberte stent-related cardiac event
rate of 3.7 percent, including myocardial infarction (1.4 percent),
and TAXUS Liberte stent-related re-intervention of the target
vessel (1.9 percent). Overall cardiac death was 1.5 percent. Phase
III six-month results showed an overall TAXUS Liberte stent-related
cardiac event rate of 3.0 percent, including myocardial infarction
(0.9 percent), and TAXUS Liberte stent-related re-intervention of
the target vessel (1.8 percent). Overall cardiac death was 0.9
percent. Phase I OLYMPIA data reported one additional stent
thrombosis from six months to one year, with an overall stent
thrombosis rate of 1.7 percent at 12 months. Phase III results
demonstrated a stent thrombosis rate of 0.5 percent out to six
months. Stent thrombosis rates for both Phases are consistent with
safety data from other Drug Eluting Stent registries. Low rates of
TAXUS Liberte stent-related cardiac events and TAXUS Liberte
stent-related re-interventions were also reported in high-risk
patient subsets, including diabetics, multiple stents, long lesions
and small vessels, and were consistent with overall rates. These
patient subsets are typically considered to be at high risk for
bare-metal stenting. "The OLYMPIA data from Phases I and III are
extremely positive, especially given the high degree of patient and
procedural complexity," said Dr. Thomas, the principal investigator
for the OLYMPIA registry. "The results show consistency with other
TAXUS clinical trials and registries, and build on the strong
performance of the TAXUS coronary stent systems in complex lesions.
The TAXUS Liberte stent is proving to offer a significant advance
in design and deliverability and is a welcome addition to our
available treatment options for coronary artery disease." About
Angiotech Pharmaceuticals Angiotech Pharmaceuticals, Inc. is a
global specialty pharmaceutical and medical device company with 14
facilities in 6 countries and 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 Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. TAXUS(R) is a registered trademark of
Boston Scientific Corporation (BSC). Liberte(TM) and EXPRESS(TM)
are trademarks of BSC. BSC acquired worldwide exclusive rights from
Angiotech to use paclitaxel in connection with its coronary stent
products and has co-exclusive rights to certain other vascular and
non-vascular products. Note on 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," "estimate,"
"continue," "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 constitute "forward-looking information" within the
meaning of applicable Canadian securities laws. All such statements
are made pursuant to the "safe harbour" provisions of applicable
securities legislation. Forward-looking statements involve known
and unknown risks, uncertainties, assumptions 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. Factors taken into account as part of our assumptions
underlying these forward-looking statements include, among others,
the factors referenced in our annual information form and other
filings with the applicable Canadian securities regulatory
authorities or the Securities and Exchange Commission; 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 report to differ materially from our actual
results. Given these uncertainties, assumptions and risk factors,
readers are cautioned not to place undue reliance on such
forward-looking statements. 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 report to reflect future results, events or developments.
CONTACT: FOR ADDITIONAL INFORMATION: Analysts and Investors: Janet
Craig, Angiotech Pharmaceuticals, Inc., (416) 997-9006; Media:
Charles Muggeridge, (416) 720-4741; Leslie Wood, (416) 400-1831
DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: FOR ADDITIONAL
INFORMATION: Analysts and Investors: Janet Craig, Angiotech
Pharmaceuticals, Inc., (416) 997-9006; Media: Charles Muggeridge,
(416) 720-4741; Leslie Wood, (416) 400-1831
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