Angiotech partner announces start of enrollment in groundbreaking clinical trial comparing drug-eluting stents to cardiac surger
12 April 2005 - 6:26PM
PR Newswire (US)
Angiotech partner announces start of enrollment in groundbreaking
clinical trial comparing drug-eluting stents to cardiac surgery -
SYNTAX Trial Will Study Most Complex Patient Subsets VANCOUVER,
April 12 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate partner Boston
Scientific Corporation ("BSC") today announced that enrollment has
begun in its clinical trial known as SYNTAX, which will compare the
performance of drug-eluting stents with cardiac surgery in the most
complex patient subsets: those with coronary artery disease in all
three coronary arteries, in the left main coronary artery, or both.
This randomized, controlled clinical trial is designed to compare
12-month outcomes of percutaneous coronary intervention (PCI) using
the BSC's TAXUS(R) Express2(TM) paclitaxel-eluting coronary stent
system with coronary artery bypass graft (CABG) treatment. SYNTAX
is a multi-center, prospective trial that will involve over 4,200
patients at up to 90 sites in Europe and the United States. In
recent years, the outcomes and risks of both CABG and less-invasive
PCI treatments have been substantially improved through new
treatment strategies, patient monitoring and technologies such as
drug-eluting stents. Previous studies comparing CABG and PCI using
bare-metal or drug-eluting stents have been limited to highly
selected patient populations. For the most severe form of coronary
artery disease involving all three coronary arteries, the left main
artery, or both, the optimal treatment strategy remains
undetermined. The SYNTAX trial uses an innovative enrollment
methodology that enrolls consecutive patients without significant
exclusion criteria. Based on an initial assessment, the treating
cardiothoracic surgeon and interventional cardiologist will jointly
decide whether a patient meets the eligibility requirements for
both treatment approaches (CABG and PCI). Patients who are eligible
for both treatment options will be enrolled in the randomized arm
comparing CABG to PCI, which will include approximately 1,500
patients. Patients determined to be eligible for only one treatment
option will be enrolled in one of two "nested" registries tracking
either CABG or PCI, which will include approximately 2,750 patients
combined. Results from the randomized arm will help compare CABG to
PCI in treating patients eligible for both treatment options. The
primary endpoint is the 12-month major adverse cardiac and cerebral
event (MACCE) rate, which includes death, myocardial infarction,
repeat revascularization and stroke. The nested registries will
define profiles of patients eligible for only one of the treatment
options. The trial's Principal Investigators are Professor
Friedrich Mohr, M.D., Program Director of the Heart
Center/Cardiothoracic Surgery, University of Leipzig, Germany and
Professor Patrick Serruys, M.D., Ph.D., Chief of Interventional
Cardiology, Thoraxcenter-Erasmus University Rotterdam, The
Netherlands. Marie-Claude Morice, M.D., Head of Cardiology,
Institut Hospitalier Jacques Cartier in Massy, France enrolled the
first patient in the SYNTAX randomized cohort on April 5, along
with Arnaud Farge, M.D., the surgical co-principal investigator at
the Institute. Other sites are scheduled to enroll patients in the
coming weeks. "The drug-eluting stent revolution has led us to the
point where a randomized comparison of the TAXUS system with
surgery in the highest-risk patients is critical," said Dr. Morice.
"The results of this study may profoundly change the practice of
medicine. I am proud that the Institut Jacques Cartier is the first
to enroll a patient in this groundbreaking trial." 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. 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 dramatically 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," "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. 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 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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