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Taxus VI Clinical Trial Demonstrates Positive Long-Term Outcomes,for Moderate-Release Paclitaxel-Eluting Stent at Four Years

ntrolled study of 446 patients at 44 international sites is designed to assess the TAXUS moderate-release paclitaxel-eluting coronary stent system in reducing restenosis in high-risk patients, including de novo lesions with overlapping stents, lesions 26 mm or greater in length and small vessels. Lesion size ranged from 18 - 40 mm in length and 2.5 - 3.75 mm in diameter. TAXUS VI is the first randomized, controlled clinical trial to demonstrate durability of drug-eluting stents in complex lesions at four years. Follow-up included 98 percent of the patients enrolled at four years.

The study's results demonstrate a continued significant reduction in target lesion revascularization (TLR, or retreatment rate) as compared to the bare-metal stent control group at four years. The four-year TLR rate was 12.9 percent for the TAXUS Stent group, as compared with 21.4 percent for the control group (P=0.0082 (only two TLR events were reported between three and four years for the TAXUS Stent group)). The rate of patients living free of TLR events was 87.1 percent at four years for the TAXUS Stent group, as compared to 78.6 percent for the bare-metal stent control group.

The four-year results for TAXUS VI support long-term safety with the increased levels of paclitaxel in the moderate-release formulation used in the study. Even with an in vitro dosing rate 8-10 times greater than the commercialized slow-release formulation, no compromise in safety was observed. The TAXUS Stent group continues to report no new stent thrombosis after two years with a low 2.4 percent cardiac death rate.

Boston Scientific launched the slow-release formulation TAXUS Express2 paclitaxel-eluting coronary stent system in Europe and other international markets in 2003 and in the United States in 2004. The Company launched the slow-release formulation TAXUS(R) Liberte(TM) paclitaxel-eluting coronary stent system in Europe and other international markets in 2005. The TAXUS Express modera
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