ARRIVE II registry demonstrates low 2.5 percent TAXUS-related re-intervention rate in complex lesions
14 März 2006 - 4:36PM
PR Newswire (US)
Six-month results are consistent with ARRIVE I data VANCOUVER,
March 14 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ: ANPI; TSX: ANP) today announced that its corporate partner
Boston Scientific Corporation ("BSC") has announced preliminary
six-month results from its ARRIVE II registry, confirming the
safety of the TAXUS(R) Express(2)(TM) coronary stent system in
"real-world" patients. ARRIVE II expands on the ARRIVE I registry
by studying more than 5,000 consecutively enrolled patients across
53 sites in the U.S., including patients with complex lesions (65
percent), multiple stents (38 percent) and diabetes (32 percent).
BSC made the announcement at the i2 Summit held in conjunction with
the annual American College of Cardiology Scientific Session in
Atlanta. "The ARRIVE II six-month data is very impressive,
especially in light of the high percentage of complex lesions and
patients," said John M. Lasala, M.D., Ph.D., of Barnes-Jewish
Hospital and Washington University School of Medicine in St. Louis,
and the study's Co-Principal Investigator. "The diabetic subset
data is particularly notable, showing lower re-intervention rates
than the study's broader patient population. The results are very
consistent with six-month data from ARRIVE I, further supporting
the outstanding performance of the TAXUS stent system in
challenging lesions and high-risk patients." The ARRIVE II registry
completed enrollment in October 2005 with a total of 5,007
patients. Preliminary clinical findings were collected for the
first 4,057 patients (81 percent) enrolled through May 2005.
Complete six-month data on all patients will be available in May
2006. ARRIVE II six-month findings demonstrated an overall
TAXUS-related major cardiac event rate of 3.6 percent, including
cardiac death (0.7 percent), myocardial infarction (1.2 percent),
and TAXUS-related re-intervention of the target vessel (2.5
percent). This compares favorably with six-month ARRIVE I results,
which showed an excellent overall TAXUS-related major cardiac event
rate of 4.4 percent and a re-intervention rate of 3.1 percent. The
ARRIVE II registry reported a low stent thrombosis rate of 1.1
percent, which is consistent with safety data from other DES
registries. The diabetic sub-population analysis demonstrated
positive results, showing an overall TAXUS-related major cardiac
event rate of 3.3 percent and a re-intervention rate of 1.9
percent. Diabetic patients are generally considered more likely
than non-diabetic patients to require repeat procedures due to a
higher incidence of restenosis following angioplasty and stenting.
The consecutive enrollment design of ARRIVE II yielded a very
diverse and high-risk patient population involving patients with
acute myocardial infarction (13.5 percent), multi-vessel stenting
(15 percent), stenting of grafts (6.4 percent), small vessels with
RVD less than 2.5 mm (3.1 percent), long lesions greater than 20 mm
(20.5 percent) and stenting of in-stent restenotic lesions (5.9
percent). The high percentage of community-based hospitals enlisted
in the study also contributed to a wide range of physician
experiences and hospital capabilities, which better reflect
"real-world" conditions. BSC acquired worldwide exclusive rights
from Angiotech to use paclitaxel to coat its coronary stent
products and has co-exclusive rights to other vascular and
non-vascular products. About Angiotech Pharmaceuticals
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty
pharmaceutical company pioneering the combination of pharmaceutical
compounds with medical devices and biomaterials to both create
novel solutions for poorly addressed disease states and improve
surgical outcomes. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ: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 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. FOR ADDITIONAL
INFORMATION: --------------------------- Analysts and Investors:
Rui Avelar, Chief Medical Officer Angiotech Pharmaceuticals, Inc.
(604) 221-7676 ext 6933 Media: Colleen Beauregard Waggener Edstrom
Bioscience (503) 443-7863, Email: DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Analysts and Investors: Rui Avelar,
Chief Medical Officer, Angiotech Pharmaceuticals, Inc., (604)
221-7676 ext 6933; Media: Colleen Beauregard, Waggener Edstrom
Bioscience, (503) 443-7863, Email:
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