Boston Scientific Highlights TAXUS, PROMUS Clinical Data at TCT 2009
September 17, 2009 – Boston Scientific Corp. announced its schedule of the company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, Sept. 21-25, in San Francisco.
"We look forward to the presentation of additional clinical data reinforcing the safety, efficacy and deliverability of our two distinct drug-eluting stent (DES) platforms -- TAXUS and PROMUS," said Donald S. Baim, M.D., executive vice president, chief medical and scientific officer at Boston Scientific. "We also anticipate positive three-year data from the TAXUS ATLAS trials, assessing the performance of our second-generation TAXUS Liberte Atom and Long Stents in patients with small vessels and long lesions. Boston Scientific is the only company to offer FDA-approved 2.25 mm diameter and 38 mm length drug-eluting stents."
All events are held at the Moscone Center.
Monday, Sept. 21
• PROMUS and TAXUS Express Stents – Gregg W. Stone, M.D., will present three-year data from the SPIRIT III Clinical Trial during a Drug-Eluting Stent Summit at 5:43 p.m. in room 104. SPIRIT III is a randomized, noninferiority trial of 1,002 patients treated with the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. The company plans to issue a press release at this time.
Tuesday, September 22
• TAXUS ATLAS Small Vessel, Long Lesion and Direct Stenting studies – Mark A. Turco, M.D., coprincipal investigator of the TAXUS ATLAS trials, will present three-year data from the TAXUS ATLAS Small Vessel and TAXUS ATLAS Long Lesion trials in a poster session beginning at 8 a.m. in Hall D. Results will assess the long-term benefit of the TAXUS Liberte Atom 2.25 mm stent in small vessels and the TAXUS Liberte Long 38 mm stent in long lesions. The same poster session will feature three-year data from the TAXUS ATLAS Direct Stent trial presented by John A. Ormiston, M.D. TAXUS ATLAS is a global, multicenter, single-arm study designed to demonstrate that the TAXUS Liberte Stent is noninferior in safety and efficacy to the TAXUS Express Stent. The company plans to issue a press release at this time.
• SYNTAX Study data – Several oral abstracts on multivessel disease revascularization featuring analysis from the landmark SYNTAX trial will be presented in room 131 from 10 a.m. to noon. Ted Feldman, M.D., will present an analysis of outcomes after repeat revascularization from the SYNTAX trial. Patrick W. Serruys, M.D., will present a new assessment of the reproducibility of the SYNTAX Score, a novel angiographic tool used to measure the complexity of coronary artery disease. Michael J. Mack, M.D., will present an analysis of stroke occurring in SYNTAX patients. SYNTAX is the first randomized, controlled clinical trial comparing percutaneous coronary intervention using drug-eluting stents to coronary artery bypass graft surgery in patients with left main and/or three-vessel disease.
Wednesday, September 23
• PROMUS and TAXUS Express Stents – Dr. Stone will present one-year results from the SPIRIT IV Clinical Trial at 11 a.m., during a Late-Breaking Trials session in the Esplanade Ballroom. SPIRIT IV is a prospective, single-blinded, multicenter clinical trial with 3,690 patients randomized 2:1 to the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. The primary end point is the rate of ischemia-driven target lesion failure at one year. The company plans to issue a press release at this time.
Friday, September 25
• HORIZONS-AMI Two-Year Data – Dr. Stone will present two-year data from the HORIZONS-AMI clinical trial at 11:30 a.m., during a Late-Breaking Trials session in the Esplanade Ballroom. HORIZONS-AMI 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.
Boston Scientific will present its latest cardiovascular products at booth 716 in the exhibition hall, including the TAXUS Liberte Atom and TAXUS Liberte Long Paclitaxel-Eluting Coronary Stent Systems, and the iLab System 2.0 Software upgrade. The company will also feature emerging DES innovations, including the platinum-chromium Element Stent platform and new bioabsorbable coating technologies.
TAXUS, Express, Express2, Liberte, Atom, PROMUS and Element are trademarks of Boston Scientific Corporation or its affiliates. XIENCE V is a trademark of Abbott Laboratories group of companies. The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The SPIRIT Clinical Program is sponsored by Abbott. The TAXUS Express Stent was the control in the SPIRIT III and SPIRIT IV clinical trials.
In the United States, the TAXUS Element Stent and PROMUS Element Stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
The safety and effectiveness of the TAXUS Stents has not been established in direct stenting procedures, in patients with an acute myocardial infarction, or 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: www.bostonscientific.com