Boston Scientific to Release Broad Range of Clinical Trial Data on the Performance of Taxus Coronary Stent Systems at TCT 2008
NATICK, Mass., October 10, 2008 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) twentieth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 12 to 17 in Washington, D.C.
Boston Scientific will be announcing a wide range of safety and efficacy data on its TAXUS(R) Express2(TM) and second-generation TAXUS(R) Liberte(R) Paclitaxel-Eluting Coronary Stent Systems, including 12-month subset data on patients with left main (LM) and three-vessel disease (3VD) from the SYNTAX trial, which compares percutaneous coronary intervention (PCI) using the TAXUS Express2 Stent System to coronary artery bypass graft (CABG) surgery in these most complex patient groups. In addition, the Company will present two-year results from the ARRIVE diabetic subset analysis (TAXUS Express Stent), three-year data from the ATLAS Workhorse and Direct Stenting trials and two-year ATLAS data on small vessels and long lesions (TAXUS Liberte Stent).
"We are pleased to be announcing new subset data on left main and three-vessel disease patients from the landmark SYNTAX study, the only randomized trial of its kind to provide physicians with critical data on the performance of drug-eluting stents (DES) in these very difficult patient populations," said Keith D. Dawkins, M.D., Senior Vice President and Associate Chief Medical Officer at Boston Scientific. "We also plan to present additional detail on the SYNTAX Score -- a new scientific measure for anatomical complexity designed to provide guidance to physicians is assessing treatment options for LM and 3VD patients."
Schedule of Events Sunday, October 12 (all times are ET)
-- TAXUS ATLAS Workhorse, Direct Stenting, Small Vessel and Long Lesion studies. Three-year data from the TAXUS ATLAS Workhorse study and two-year data from the TAXUS ATLAS Direct Stent study will be presented by the study's co-principal investigator Mark A. Turco, M.D., in an e-poster session titled "TAXUS ATLAS and TAXUS ATLAS DIRECT STENT Trials: Durable Effectiveness of the TAXUS Liberte Stent and Long-Term Benefit of Direct Stenting". In addition, two-year data from the TAXUS ATLAS Small Vessel and Long Lesion studies will be presented by John A. Ormiston, M.D., in an e-poster session titled "Durable Benefit of TAXUS Liberte vs. TAXUS Express in Small Vessels and Long Lesions in the TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION Trials". TAXUS ATLAS is a global, multi-center, single-arm study designed to demonstrate that the TAXUS Liberte Stent is non-inferior in safety and efficacy to the TAXUS Express Stent. The Company plans to issue a press release at this time.
-- TAXUS ARRIVE diabetic data. A diabetic sub-group analysis from the TAXUS ARRIVE registry will be presented by John M. Lasala, M.D., PhD, in an e-poster session titled "TAXUS Mitigates the Effect of Diabetes on Restenosis Independent of Patient Risk Profile: Two-Year Results from the TAXUS ARRIVE Program". The ARRIVE program is designed to collect and analyze "real-world" safety and clinical outcomes data from the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in the treatment of patients with coronary artery disease. The Company plans to issue a press release at this time.
Tuesday, October 14
-- SYNTAX Study subset data. The latest 12-month outcomes subset data from the SYNTAX trial will be presented by Principal Investigators Patrick W. Serruys, M.D., Ph.D., and Friedrich W. Mohr, M.D., beginning at 11:10 a.m. in the Main Arena of the Washington Convention Center. Dr. Serruys will present a Featured Lecture on "Revascularization in Patients with Unprotected Left Main Coronary Artery Disease," while Dr. Mohr will present on "Revascularization in Patients with Triple Vessel Coronary Artery Disease." SYNTAX is the first randomized, controlled clinical trial comparing PCI using drug-eluting stents to CABG in patients with left main and/or three-vessel disease. The Company plans to issue a press release at this time. Dr. Serruys will present additional details on the SYNTAX Score during his Featured Lecture as well as during Tuesday's Focus on SYNTAX Sessions in a presentation titled "SYNTAX Score: Methodology and Importance."
-- Focus on SYNTAX. From 2:00 -- 6:00 p.m., a series of focus sessions titled "Revascularization for Left Main and Triple-Vessel Disease: Focus on SYNTAX" will take place in Room 147AB. Details on the topics and presenters can be found in the official TCT program.
-- Symposium on SYNTAX Trial Data. From 8:00 -- 10:00 p.m., the Company will sponsor a symposium entitled "The SYNTAX Trial: Understanding the Data in Complex Anatomies and Advanced Disease," chaired by Dr. Serruys in the Grand Ballroom of the Renaissance Hotel. The symposium will offer an overview of the latest SYNTAX trial data and feature a panel discussion on subset case presentations for patients with multi-vessel disease and left main disease. The symposium will include panel members Ted E. Feldman, M.D., Michael J. Mack, M.D., Martin B. Leon, M.D., and Friedrich W. Mohr, M.D. A reception will be held prior to the symposium at 7:00 p.m.
Wednesday, October 15
-- OLYMPIA High-Risk Subgroups. One-year results from Intercontinental and European Launch Phases of the global OLYMPIA registry will be presented in an oral abstract session by Waqar H. Ahmed, M.D., M.S., FACC, at 8:41 a.m., in Room 145AB. OLYMPIA is the world's largest prospective, multi-center, multi-phased registry for a single drug-eluting stent. The registry is designed to analyze real-world clinical outcomes data for Boston Scientific's second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System. Results from more than 22,000 patients will focus on safety and efficacy, and will highlight outcomes within high-risk lesion subgroups and patients with serious co-morbid conditions. The Company plans to issue a press release at this time.
-- HORIZONS AMI data. At 11:00 a.m., Gregg W. Stone, M.D., will present data from the featured trial of the day "HORIZONS AMI: A Prospective Randomized Trial of Paclitaxel-Eluting Stents vs. Bare-Metal Stents in Patients with Acute ST-Segment Elevation Myocardial Infarction" in the Main Arena. The HORIZONS AMI trial is a randomized, controlled clinical trial designed to compare TAXUS stents to bare-metal stents in 3,400 AMI (acute myocardial infarction) patients. The Company plans to issue a press release at this time.
-- SYNTAX Sessions. From 10:15 a.m. -- 12:30 p.m., an additional series of sessions moderated by Dean J. Kereiakes, M.D., and Craig R. Smith, M.D., titled "Coronary Artery Disease I: Revascularization Controversies" will occur in Room 206. Details on the topics and presenters can be found in the official TCT program.
Boston Scientific will present its latest innovations at booth 814 on Level 2 of the Exhibition Hall, including the TAXUS(R) Express2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent System, which recently became the only DES approved by the FDA for use in vessels as small as 2.25 mm in diameter.
The safety and effectiveness of the TAXUS Express Stent has not been established in patients with left main, three vessel disease, or an acute MI. In the U.S., the TAXUS Liberte Stent is an investigational device and is not available for sale.
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.
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CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
CONTACT: Paul Donovan, Media Relations, +1-508-650-8541, mobile+1-508-667-5165, or Larry Neumann, Investor Relations, +1-508-650-8696,both of Boston Scientific Corporation
Web site: http://www.bostonscientific.com/
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Posted: October 2008