Boston Scientific Corporation (NYSE: BSX) today announced preliminary six-month results from Phase I of its global OLYMPIA registry, supporting the safety and efficacy of the TAXUS(R) Liberte(TM) coronary stent system(1) in real-world patients. The results were announced at the SOLACI (Sociedad Latino Americana de Cardiologia Intervencionista) Congress in Porto Alegre, Brazil.
Phase I of the global OLYMPIA registry included 529 patients from seven countries(2) in which TAXUS Liberte has already been approved. The Phase I enrollment comprised diverse and high-risk populations, including patients with complex lesions or clinical characteristics (57.0 percent), multi-vessel disease (49.1 percent), prior myocardial infarction (45.9 percent) and diabetes (49.9 percent).
"The OLYMPIA Phase I six-month data are very impressive and show consistency with results from other TAXUS clinical trials and registries," said Waqar H. Ahmed, M.D., M.S., FACC, at King Fahed Armed Forces Hospital in Jeddah, Saudi Arabia, and the Principal Investigator for the first Phase of the OLYMPIA registry. "The data further support the strong performance of the TAXUS Liberte coronary stent system in challenging lesions and high-risk patients."
"The initial results from OLYMPIA build on the unparalleled rigor of the TAXUS clinical program and provide us with positive, consistent clinical outcomes data among patients with complex lesions or characteristics," said Jeff Goodman, President of Boston Scientific International. "As the second-generation platform for our TAXUS stent system, the Liberte stent is designed to improve deliverability and conformability to challenging lesions and demonstrates Boston Scientific's commitment to providing new and innovative treatment options."
OLYMPIA Phase I six-month findings demonstrated an overall TAXUS-related major cardiac event rate of 2.3 percent, including cardiac death (0.8 percent), myocardial infarction (1.3 percent), and TAXUS-related re-intervention of the target vessel (1.3 percent). The OLYMPIA Phase I registry reported a low stent thrombosis rate of 1.5 percent, which is consistent with safety data from other DES registries.
The multi-phased OLYMPIA registry plans to enroll up to 35,000 patients from more than 600 centers in 70 countries and is designed to analyze real-world clinical outcomes data for Boston Scientific's next-generation TAXUS Liberte paclitaxel-eluting stent system in the treatment of patients with coronary artery 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: http://www.bostonscientific.com.