SYNTAX substudy shows positive outcomes for left main patients treated with TAXUS(R)...
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SYNTAX substudy shows positive outcomes for left main patients treated with
TAXUS(R) Express(2)(R) Stent System
VANCOUVER, May 19 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc.
(NASDAQ: ANPI, TSX: ANP) today announced that its corporate partner, Boston
Scientific Corporation (NYSE: BSX) has reported positive outcomes from a
substudy of patients with left main coronary disease who were treated with the
TAXUS(R) Express(2)(R) Paclitaxel-Eluting Coronary Stent System. SYNTAX-LE
MANS is a substudy of the landmark SYNTAX trial, the first randomized,
controlled clinical trial to compare percutaneous coronary intervention (PCI)
using the TAXUS Stent to coronary artery bypass graft (CABG) surgery in
patients with left main disease and/or significant narrowing of all three
coronary arteries (three-vessel disease). The substudy data were presented by
A. Pieter Kappetein, M.D., Ph.D., at the annual EuroPCR Scientific Program in
Barcelona.
SYNTAX-LE MANS compares late angiographic and clinical outcomes in 263
patients with left main disease (149 treated with the TAXUS Stent and 114
treated with CABG). It is designed to assess 15-month patency (vessel
openness) and the safety of stents and grafts in this high-risk population; it
includes separate primary endpoints for each treatment arm. For PCI patients,
the primary endpoint is the rate of long-term patency (defined here as (less
than)50% stenosis) of the treated lesion sites. For CABG patients, the primary
endpoint is the ratio of obstructed/occluded grafts (defined here as (greater
than or equal to)50% stenosis) to total placed grafts. Results were presented
separately for each group, and no formal statistical inferences between the
two groups were made due to the different primary endpoints. Results were also
broken out by left main lesion location, including distal and non-distal.
For those patients receiving a TAXUS Stent, the patency rate for the treated
lesion was 92 percent. Restenosis was more common with distal lesions (90%
patency) compared with non-distal lesions (98% patency). Reported in-stent
late loss was low at 0.2 mm for non-distal lesions. The reported 15-month
MACCE rate (all-cause death, stroke, myocardial infarction and
revascularization) for the TAXUS Stent patients was 13 percent, driven
primarily by a nine percent repeat revascularization rate.
For CABG patients, the overall obstruction/occlusion ratio at 15 months was 16
percent, with six percent of grafts obstructed in the range of (greater than
or equal to)50% to (less than)100%, and 10 percent of grafts occluded 100%. On
a per patient basis, the obstruction/occlusion ratio was 27 percent, with nine
percent of patients having a graft obstructed in the (greater than or equal
to)50% to (less than)100% range and 18 percent of patients having a graft
occluded 100%. The reported MACCE rate for CABG patients at 15 months was nine
percent.
"The data announced today from SYNTAX-LE MANS will offer important insights
for doctors as they evaluate treatment options for challenging left main
patients," said Keith Dawkins, M.D., Associate Chief Medical Officer of Boston
Scientific. "We are encouraged by the high stent patency rate at 15 months,
which increases our confidence in the application of PCI in this high-risk
population. The results support previously announced outcomes with PCI and
CABG in patients with left main disease."
The safety and effectiveness of the TAXUS Express(2) Stent System have not
been established in patients with left main or three-vessel disease.
Forward Looking Statements
--------------------------
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others, the following: general economic and business conditions, both
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other filings with the Securities and Exchange Commission ("SEC") and
applicable Canadian regulatory authorities. For a more thorough discussion of
the risks associated with our business, see the "Risk Factors" section in our
annual report for the year ended December 31, 2008 filed with the SEC on Form
10-K, and our quarterly report for the three months ended March 31, 2009 filed
with the SEC on Form 10-Q.
Given these uncertainties, assumptions and risk factors, readers are cautioned
not to place undue reliance on such forward-looking statements. Except as
required by law, 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 press release to reflect future results, events
or developments.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and
medical device company with 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 (NASDAQ: ANPI, TSX: ANP),
please visit our website at www.angiotech.com.
SOURCE Angiotech Pharmaceuticals, Inc.
DeDe Sheel, Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (415) 293-4412, dede.sheel@fdashtonpartners.com
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