NATICK, Mass. and VIENNA, Austria, Sept. 4 Boston Scientific Corporation (NYSE: BSX) today announced five-year and finalresults from its TAXUS II clinical trial, demonstrating continued long-termsafety and efficacy for the TAXUS(R) paclitaxel-eluting stent system. Amongthe findings, the TAXUS stent showed no additional stent thrombosis betweenyears four and five, while the bare-metal control experienced one stentthrombosis during this same period. This marks the third consecutive year ofTAXUS II follow-up with no stent thrombosis seen in the TAXUS stent patientgroup. The Company made the announcement at the annual European Society ofCardiology Congress in Vienna, Austria.
"Long-term results from TAXUS II reinforce the safety of paclitaxel-eluting stent technology and provide encouraging data regarding late and verylate stent thrombosis out to five years," said Prof. Sigmund Silber, M.D.,F.A.C.C., F.E.S.C., who presented the TAXUS II results at ESC 2007. "In thistrial, the data revealed that the TAXUS paclitaxel-eluting stent maintainedits efficacy benefits and had no thrombosis between years four and five whilethe bare-metal control had one additional thrombosis. These results warrantimportant consideration and possible further study if seen as an indication oflonger term trends."
The efficacy advantage of the TAXUS Stent seen at six months wasmaintained through the five years following stent implantation, with thecommercialized slow-release (SR) version of the TAXUS Stent reducing TargetLesion Revascularization (TLR) by 44 percent versus bare-metal stents (TAXUSSR 10.3%, BMS 18.4%, p=0.0003). Safety of the TAXUS stent was also maintainedwith Major Adverse Cardiac Events (MACE) for the TAXUS SR stent showing a 35percent reduction over the bare-metal control stent (TAXUS SR 20.4%, BMS27.6%, p=0.01). The overall myocardial infarction (MI) rate for the TAXUS SRstent was 4.7 percent as compared to 7.1 in the bare-metal group (TAXUS SR4.7%, BMS 7.1%, p=NS).
"We are pleased that the TAXUS II results continue to support the provensafety and efficacy profile of the TAXUS paclitaxel-eluting stent system andthat the benefits of the TAXUS Stent are maintained over the long term," saidJeff Goodman, President of Boston Scientific International. "The TAXUS IIfive-year data shows continued durability with low rates of MI and TLR,demonstrating the long-term therapeutic advantage of TAXUS."
TAXUS II is a randomized, double-blind, controlled study of 536 patientsin 15 countries designed to evaluate the safety and efficacy of a TAXUSpaclitaxel-eluting coronary stent, in which two sequential cohorts of patientswith standard risk, de novo coronary artery lesions were treated withdifferent dose formulations.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visitwww.bostonscientific.com.
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