Five-Year Data From Taxus II Clinical Trial Highlights Safety and Efficacy of Taxus(R) Stent Compared to Bare-Metal Stent
"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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This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements may be identified by words like "anticipate," "expect," "project,""believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates usinginformation available to us at the time and are not intended to be guaranteesof future events or performance. These forward-looking statements include,among other things, statements regarding clinical trials, product performance,competitive offerings, procedural volume, overall market size and our marketposition. If our underlying assumptions turn out to be incorrect, or ifcertain risks or uncertainties materialize, actual results could varymaterially from the expectations
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