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Clinical Data Reinforce Safety and Efficacy of Boston Scientific's Two Drug- Eluting Stent Platforms
Date:3/29/2009

s regarding the difference between paclitaxel and other 'olimus stents in diabetic populations. Results from the TAXUS ATLAS trials with Boston Scientific's second-generation TAXUS Liberte(R) Stent yielded comparable efficacy and safety in diabetic and non-diabetic patients. These data were used to support the CE Mark approval of a diabetic indication for TAXUS Liberte in Europe."

Three-year data from the SPIRIT II Trial demonstrated that overall Major Adverse Cardiac Events (MACE), a composite endpoint, favored the PROMUS (XIENCE V) Stent compared to the TAXUS Stent (6.4% vs. 14.9% respectively, p=0.029), while the individual components of Myocardial Infarction (MI) and Ischemia-Driven Target Lesion Revascularization (ID-TLR) were not significantly different (MI: 3.3% vs. 6.8%, p=0.20; ID-TLR: 4.2% vs. 9.4%, p=0.092). The third MACE component, cardiac death, favored the PROMUS (XIENCE V) Stent (0.5% [n=1] vs. 4.2% [n=3], p=0.024). No corresponding difference in death was seen in the two-year data of the larger, subsequent SPIRIT III study (2.0% vs. 2.5%, p=0.59). Low and comparable rates of stent thrombosis were sustained at three years for PROMUS (XIENCE V) and TAXUS patients per the Academic Research Consortium (ARC) definite/probable definition (0.9% vs. 2.8%, p=0.27).

"We are pleased with the performance of our two key drug-eluting stents in these studies and with the continued progress in our pipeline," said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. "Our second-generation TAXUS Liberte Stent launched earlier this month in Japan, and we look forward to introducing our third-generation Element(TM) Stent on both drug platforms. Patient enrollment in the PLATINUM clinical trial to evaluate the PROMUS Element Stent is ahead of plan, while the PERSEUS trial, designed to study the TAXUS Element Stent, has completed enrollment. Both Element(TM) stents are
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SOURCE Boston Scientific Corporation
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