Five-Year Data From Taxus II Clinical Trial Highlights Safety and Efficacy of TaxusÂ® Stent Compared to Bare-Metal Stent
TAXUSÂ® Stent shows no additional very late stent thrombosis
NATICK, Mass. and VIENNA, Austria
NATICK, Mass. and VIENNA, Austria, Sept. 4 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced five-year and final results from its TAXUS II clinical trial, demonstrating continued long-term safety and efficacy for the TAXUSÂ® paclitaxel-eluting stent system. Among the findings, the TAXUS stent showed no additional stent thrombosis between years four and five, while the bare-metal control experienced one stent thrombosis during this same period. This marks the third consecutive year of TAXUS II follow-up with no stent thrombosis seen in the TAXUS stent patient group. The Company made the announcement at the annual European Society of Cardiology 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 very late 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 this trial, the data revealed that the TAXUS paclitaxel-eluting stent maintained its efficacy benefits and had no thrombosis between years four and five while the bare-metal control had one additional thrombosis. These results warrant important consideration and possible further study if seen as an indication of longer term trends."
The efficacy advantage of the TAXUS Stent seen at six months was maintained through the five years following stent implantation, with the commercialized slow-release (SR) version of the TAXUS Stent reducing Target Lesion Revascularization (TLR) by 44 percent versus bare-metal stents (TAXUS SR 10.3%, BMS 18.4%, p=0.0003). Safety of the TAXUS stent was also maintained with Major Adverse Cardiac Events (MACE) for the TAXUS SR stent showing a 35 percent reduction over the bare-metal control stent (TAXUS SR 20.4%, BMS 27.6%, p=0.01). The overall myocardial infarction (MI) rate for the TAXUS SR stent was 4.7 percent as compared to 7.1 in the bare-metal group (TAXUS SR 4.7%, BMS 7.1%, p=NS).
"We are pleased that the TAXUS II results continue to support the proven safety and efficacy profile of the TAXUS paclitaxel-eluting stent system and that the benefits of the TAXUS Stent are maintained over the long term," said Jeff Goodman, President of Boston Scientific International. "The TAXUS II five-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 patients in 15 countries designed to evaluate the safety and efficacy of a TAXUS paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations.
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/.
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CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation