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) Express2(R) Stent System
NATICK, Mass. and BARCELONA, Spain, May 19 /PRNewswire-FirstCall/ -- Boston
Scientific Corporation (NYSE: BSX) today announced positive outcomes from a
substudy of patients with left main coronary disease who were treated with the
TAXUS(R) Express2(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 <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 <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 <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 Express2 Stent System have not been
established in patients with left main or three-vessel disease.
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:
www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements may be identified by words like "anticipate," "expect," "project,"
"believe," "plan," "estimate," "intend" and similar words. These
forward-looking statements are based on our beliefs, assumptions and estimates
using information available to us at the time and are not intended to be
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include, among other things, statements regarding clinical trials, regulatory
approvals, competitive offerings and product performance. If our underlying
assumptions turn out to be incorrect, or if certain risks or uncertainties
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factors, in some cases, have affected and in the future (together with other
factors) could affect our ability to implement our business strategy and may
cause actual results to differ materially from those contemplated by the
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cautioned not to place undue reliance on any of our forward-looking
statements.
Factors that may cause such differences include, among other things: future
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description of these and other important risks and uncertainties that may
affect our future operations, see Part I, Item 1A- Risk Factors in our most
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applicable to all forward-looking statements contained in this document.
CONTACT: Paul Donovan
508-650-8541 (office)
508-667-5165 (mobile)
Media Relations
Boston Scientific Corporation
Natacha Gassenbach (onsite at PCR)
508-250-9348 (mobile)
33 1 6 08 97 70 36 (mobile)
Media Relations
Boston Scientific Corporation
Larry Neumann
508-650-8696 (office)
Investor Relations
Boston Scientific Corporation
SOURCE Boston Scientific Corporation
Media Relations, Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165
(mobile), or Natacha Gassenbach (onsite at PCR), +1-508-250-9348 (mobile),
+33-1-6-08-97-70-36 (mobile), or Investor Relations, Larry Neumann,
+1-508-650-8696 (office), all of Boston Scientific Corporation
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