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(Full text of a statement. Contact details below.)
NATICK, Mass., Aug 31 /PRNewswire-AsiaNet/ - Boston Scientific Corporation (NYSE: BSX) announced today that enrollment has exceeded 13,000 patients in the TAXUS OLYMPIA registry, designed to confirm the safety and performance of the Company's second-generation drug-eluting coronary stent (DES), TAXUS(R) Liberte(TM)(1), in a real-world setting. OLYMPIA is the world's largest DES registry to date and plans to enroll up to 27,000 patients treated for complex coronary lesions, at more than 500 centers worldwide.
"The advent of the TAXUS Liberte stent system has raised the bar in terms of the performance of DES since it provides physicians with the increased flexibility and deliverability they need to treat complex coronary artery blockages," said Martyn Thomas, M.D., F.E.S.C., Director of Invasive Cardiology, Kings College Hospital, London, UK and one of the coordinating investigators of the registry. "We look forward to seeing how these improved features will be reflected in the near- and long-term clinical outcomes to be obtained from the OLYMPIA registry."
The multi-center, prospective, observational OLYMPIA registry will evaluate a variety of safety and performance measures, including the rate of repeat procedures (target lesion revascularization, or TLR), major adverse cardiac events such as heart attack (myocardial infarction) and death, and in-stent thrombosis. Additionally, sub-analyses on complex patient groups such as diabetics, patients with multi-vessel disease, in-stent re-blockages (restenosis) or a prior history of heart attack will be performed.
"The OLYMPIA registry is the first to specifically document the real-world outcomes in patients treated with a next-generation DES such as Boston Scientific's TAXUS Liberte stent," said Jeff Goodman, President, Boston Scientific International. "OLYMPIA will provide some of the most comprehensive real-world data for DES use in treating coronary artery disease. We expect the results will further support the safety and performance of the TAXUS Liberte stent system in complex lesions and complex patients."
The OLYMPIA registry is enrolling patients in multiple phases, corresponding to the commercial introduction of the TAXUS Liberte stent system in different regions of the world. The initial, transitional phase enrolled 529 patients from a limited number of international markets in which TAXUS Liberte stent is already commercially available. The six-month results from Phase I were presented at the SOLACI 2006 Congress in Porto Alegre, Brazil and showed a low overall TAXUS-related major cardiac event rate of 2.3 percent. Additional data will be presented at the European Society of Cardiology/World Congress of Cardiology 2006 in Barcelona, Spain.
"Phase I showed that 50 percent of the patients included were diabetic," stated Waqar H. Ahmed, M.D., M.S., FACC, at King Fahed Armed Forces Hospital in Jeddah, Saudi Arabia, coordinating ...
Source: HighBeam Research, LARGEST DRUG-ELUTING STENT REGISTRY REACHES HALFWAY POINT.