NATICK, Mass., Nov. 29 /PRNewswire-AsiaNet/ –
- Trends Favour Boston Scientific’s TAXUS Stent Over J&J’s Cypher in Interim
9-Month Data From Largest Independent DES Registry in US
Boston Scientific Corporation (NYSE: BSX) welcomed interim results from the
independent, multicentre STENT registry that further demonstrate the efficacy
and safety of Boston Scientific’s TAXUS(TM) Express2(TM) paclitaxel-eluting
coronary stent system among real-world patients with blocked coronary arteries.
An analysis of data on patients who have completed 9-months of follow-up to
date revealed a numerical trend favouring the TAXUS stent over Johnson &
Johnson’s Cypher(R) sirolimus-eluting stent system in reducing major adverse
cardiovascular events (MACE) and target vessel revascularization (TVR).
STENT (Strategic Transcatheter Evaluation of New Therapies) is the first
US, multicentre, prospective registry initiated to evaluate the long-term
efficacy and safety of paclitaxel- and sirolimus-eluting coronary stents among
real-world patients and in 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 9 months. When you adjust the two groups to
account for the higher complexity level of the TAXUS stent arm, results favour
the TAXUS stent, but without statistically significant differences between the
two stents."
Eight coronary interventional centres across the US are participating in
the registry, which will enrol 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 9
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.
The late clinical outcomes trend is numerically in favour 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-centre trials conducted in
Europe, interim data from STENT suggest that paclitaxel- and sirolimus-eluting
stents are either equal or show a trend favouring 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.
SOURCE Boston Scientific Corporation
/CONTACT: Maren Koban of BSC press office, +44-20-7973-4497,
mkoban@hillandknowlton.com; or Natacha Gassenbach of Boston Scientific
Corporation, mobile: +33-6-08-97-70-36 /
/Web Site: http://www.bostonscientific.com /
(BSX)
November 29, 2005
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