Boston Scientific Promus and Taxus Stents Continue Strong Performance in Safety and Efficacy Measures
NATICK, Mass., and WASHINGTON, October 22, 2007 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today welcomed results from the SPIRIT III Clinical Trial, which continue to support the proven safety and efficacy of the market-leading TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System and add to the growing body of strong clinical evidence for the XIENCE(TM) V (PROMUS(TM)) Everolimus Eluting Coronary Stent System. An analysis of the data was presented by Gregg W. Stone, M.D., of Medical Center and the Cardiovascular Research Foundation in New York, and the Principal Investigator of the SPIRIT III Trial, during a late- breaking trial session at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
One-year results from the SPIRIT III trial included an updated analysis of 1,002 patients with coronary artery disease treated with either the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. Ischemia-driven target lesion revascularization (TLR) for 669 patients treated with the XIENCE V (PROMUS) Stent changed from 2.6% to 3.3% between nine months and one year, while for the 333 patients treated with the TAXUS Stent, TLR changed from 5.0% to 5.6% during the same time period, still failing to reach statistical significance (p=0.09). Target vessel revascularization (TVR) at one year was also similar, with 6.1% for PROMUS and 7.5% for TAXUS (p=0.41).
The overall MACE (Major Adverse Cardiac Events) rate (defined as cardiac death, myocardial infarction (heart attack, or MI) or ischemia-driven TLR) through one year was 5.8% for the XIENCE V (PROMUS) Stent and 9.9% for the TAXUS Stent (p=0.01), reflecting an increased number of small (non-Q wave) MIs at the time of the procedure (2.5% vs. 3.8%).
Subset analysis showed especially strong performance of the TAXUS Stent in diabetic patients with MACE rates remaining low at 4.7%, while MACE rates increased in the XIENCE V (PROMUS) Stent to 8.8%. In long lesions (lesion length>13.2 mm), MACE was 7.7% for the XIENCE V (PROMUS) Stent and 8.0% for the TAXUS Stent; in small vessels (RVD< / =2.775 mm), 6.1% for the XIENCE V (PROMUS) Stent and 12.1% for the TAXUS Stent*.
Stent thrombosis rates through one year were also low for both the TAXUS Stent (0.6%, 0.6%) and the XIENCE V (PROMUS) Stent (0.8%, 1.1%), using protocol and ARC definitions, respectively.
"The SPIRIT III one-year data reaffirms the proven long-term outcomes of the TAXUS Stent," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We look forward to launching the PROMUS Stent in the U.S., which will complement our paclitaxel-eluting TAXUS Stent by offering physicians a deliverable Olimus option."
The PROMUS Stent has CE Mark approval and is distributed in most European countries and other international markets. The PROMUS Stent is an investigational device in the U.S. and not yet approved for sale. It is currently under FDA review with an anticipated U.S. launch in 2008. The safety and efficacy of the TAXUS Express2 Stent System have not been established in patients with diabetes, long lesions and small vessels.
SPIRIT is sponsored by Abbott. TAXUS, Express2 and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.
*Subsets were not designed for statistical comparisons and demonstrated the above observational results.
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: www.bostonscientific.com.
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CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Dan Brennan 508-650-8538 (office) 617-459-2703 (mobile) Investor Relations Boston Scientific Corporation
CONTACT: Media, Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165(mobile), or Investors, Dan Brennan, +1-508-650-8538 (office),+1-617-459-2703 (mobile), both of Boston Scientific Corporation
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Posted: October 2007