NATICK, Mass. and SAN FRANCISCO, Sept. 23 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today welcomed one-year data from the SPIRIT IV clinical trial comparing the XIENCE V((R)) (PROMUS((R))) Everolimus-Eluting Coronary Stent System to the TAXUS((R)) Express2(TM) Paclitaxel-Eluting Coronary Stent System. The results support the benefits of paclitaxel-eluting stents in diabetic patients. The trial enrolled 3,690 patients, including 1,140 diabetics, the largest diabetic subset ever studied in a drug-eluting stent clinical trial.
The SPIRIT IV results were presented at the 21(st) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium by Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital, and Principal Investigator of the trial.
The TLF rates for diabetic patients at one year were 6.4% for the XIENCE V (PROMUS) Stent and 6.9% for the TAXUS Express Stent (p=0.80). For diabetic patients requiring insulin, the TLF rates were 8.0% for the XIENCE V (PROMUS) Stent and 7.0% for the TAXUS Express Stent (p=0.83).
The results showed the trial met its endpoint of TLF non-inferiority with rates of 4.2% for the XIENCE V (PROMUS) Stent and 6.8% for the TAXUS Express Stent (p<0.0001). Contributing to this result was a significant difference in TLR (2.5% for XIENCE V (PROMUS) versus 4.6% for TAXUS Express, p<0.001), including a large subgroup of patients (n=1,352) with vessels smaller than or equal to 2.75 mm. As announced yesterday, the TAXUS ATLAS Small Vessel Trial reported a statistically significant reduction in the rate of TLR in small vessels treated with the 2.25 mm diameter TAXUS Liberte Atom(TM) Stent compared to the older 2.25 mm diameter TAXUS Express Atom Stent.
“We are pleased that our thinner-strut TAXUS Liberte Stent has proved so appealing to clinicians as a replacement for the TAXUS Express Stent,” said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. “We continue to be the only manufacturer offering both everolimus- and paclitaxel-based drug-eluting stent platforms, and we look forward to introducing our upcoming family of platinum chromium Element(TM) Stents, which will be offered in everolimus, paclitaxel and bare-metal versions.”
The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. SPIRIT IV is sponsored by Abbott. TAXUS, TAXUS Express2, Express, Liberte, PROMUS and Element are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.
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.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements 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 using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, regulatory approvals, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Boston Scientific Corporation
