TAXUS® Stent Demonstrates Excellent Efficacy and Safety in Independent 'STENT' Registry
Trends favor Boston Scientific's TAXUS stent over J&J's Cypher in interim nine-month
data
from largest independent DES registry in U.S.
NATICK, Mass., Oct. 25 -- Boston Scientific Corporation (NYSE: BSX - News)
today welcomed interim results from the independent, multicenter STENT registry
that further demonstrate the efficacy and safety of Boston Scientific's TAXUS® Express2™
paclitaxel-eluting coronary stent system among real-world patients with blocked
coronary arteries. An analysis of data on patients who have completed nine months
of follow-up to date revealed a numerical trend favoring the TAXUS stent over
Johnson & Johnson's Cypher® sirolimus-eluting stent system in reducing major
adverse cardiovascular events (MACE) and target vessel revascularization (TVR).
The interim results were presented at the annual Transcatheter Cardiovascular
Therapeutics (TCT) symposium in Washington, D.C.
STENT (Strategic Transcatheter Evaluation of New Therapies) is the first U.S., multicenter, prospective registry initiated to evaluate the long-term efficacy and safety of paclitaxel- and sirolimus-eluting coronary stents among real-world patients and clinical situations. Charles Simonton, M.D., is chairman of the executive steering committee for the STENT group.
"The present study shows that TAXUS stents are being implanted in patients who are slightly older, have higher lesion risk and somewhat smaller vessels than patients receiving Cypher stents," said Dr. Simonton. "Based on data collected so far, paclitaxel- and sirolimus-eluting stents demonstrate similar efficacy and safety overall at nine months. When you adjust the two groups to account for the higher complexity level of the TAXUS stent arm, results favor the TAXUS stent, but without statistically significant differences between the two stents."
Eight coronary interventional centers across the United States are participating in the registry, which will enroll more than 8,000 patients, the largest population in any study of its kind. A total of 3,758 patients receiving either the TAXUS stent (1,476) or the Cypher stent (2,282) had completed nine months of follow up at the time of the interim analysis. The majority of baseline characteristics were similar among the two treatment groups, although TAXUS stent patients tended to be slightly older with more acute coronary syndrome, slightly smaller vessel diameters and higher ACC lesion risk scores. Late clinical outcomes trend numerically in favor of paclitaxel as compared to sirolimus, including death (2.1 vs. 2.7), myocardial infarction (1.8 vs. 2.2), TVR (3.4 vs. 4.2), and MACE (6.8 vs. 7.9). In addition, both the TAXUS and Cypher stents showed low rates of thrombosis that are consistent with results seen in bare-metal stents.
"In contrast to some of the smaller, single-center trials conducted in Europe, interim data from STENT suggest that paclitaxel- and sirolimus-eluting stents are either equal or show a trend favoring the TAXUS stent," said Hank Kucheman, President of Boston Scientific's Interventional Cardiology business. "Most importantly, the results confirm what we have seen again and again in randomized clinical trials like TAXUS II, IV and V, and in registries like ARRIVE: the TAXUS Express2 stent system performs well in real-world patient populations. We look forward to seeing the full results next year."
Additional data from STENT are scheduled to be presented at the American College of Cardiology conference in 2006, with the final analysis slated for presentation at TCT 2006.
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.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.
CONTACT:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
Source: Boston Scientific Corporation
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