The ATLAS trial is a global, multicenter pivotal study designed to support U.S. Food and Drug Administration approval of the TAXUS Liberté stent system. It is assessing the safety and efficacy of a slow-release dose formulation paclitaxel-eluting TAXUS Liberté stent system for the treatment of coronary artery disease. ATLAS compares the TAXUS Liberté system to a matched control group from the TAXUS IV and V trials made up of patients with the TAXUS Express2 system. The results presented include 871 patients at 61 sites in the United States, Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan. The primary endpoint for the study is target vessel revascularization at nine months. In addition to the ATLAS trial, the TAXUS Liberté program includes several expansion studies for long lesion stenting, small vessel stenting and direct stenting of coronary lesions.
The ATLAS clinical trial results support safety, as demonstrated by a low overall MACE (Major Adverse Cardiac Events) rate. Thirty-day MACE was 3.3 percent in Group X and 2.8 percent in Group Y (the study remains blinded through the primary endpoint at nine months). Cardiac deaths were 0.2 percent in both groups. The overall myocardial infarction (MI) rate was 3.0 percent in Group X and 2.6 percent in Group Y. The overall target vessel revascularization (TVR) rate was 0.4 percent in Group X and 0.2 percent in Group Y. Stent thromboses were also low, with a rate of 0.5 percent in Group X and 0.2 percent in Group Y.
"The ATLAS clinical trial data gives us our first look at the safety profile of the next-generation TAXUS Liberté stent system for the treatment of coronary artery disease and the early results are positive," said Mark A. Turco, M.D., F.A.C.C., Director, Center for Cardiac and Vascular Research, Washington Adventist Hospital, and Co-Principal Investigator for the ATLAS study. "I have found the Liberté stent platform to be a significant step forward in deliverability and conformability, particularly in the most challenging lesions. It is my hope that we will also demonstrate in the ATLAS program that the homogenous stent architecture of the Liberté stent will further optimize drug delivery."
"The ATLAS results mark yet another chapter in the remarkable story of the TAXUS stent system as a revolutionary treatment for coronary artery disease," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "This positive early data supports the continued safety of Boston Scientific's combination of paclitaxel and our proprietary Translute™ polymer. As the next generation to our market-leading TAXUS Express2 system, TAXUS Liberté combines the proven benefits of our technology with best-in-class deliverability in even the most complex patient cases."
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.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.