Lower Re-Intervention Rates for the TAXUS Stent in Diabetic Patients
NATICK, Mass. and CHICAGO, Nov. 20 /Xinhua-PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) today welcomed a presentation by Joost
Daemen, M.D., and Patrick Serruys, M.D., entitled "The Long Term Efficacy of
Sirolimus-eluting (SES) and Paclitaxel-eluting stents (PES) as Compared to
Bare-Metal Stents (BMS) in Patients With Diabetes Mellitus." Data were
presented from the T-SEARCH/RESEARCH registry, a 708-patient, real-world
registry managed from the Thoraxcenter, Erasmus University Medical Center in
Rotterdam, The Netherlands. The presentation reports that the TAXUS(TM) stent
(PES) exhibited a lower re-intervention rate and equal or lower instances of
death or heart attack than the Cypher(TM) stent (SES) and bare-metal stents
(BMS). The data were presented at the annual American Heart Association (AHA)
Scientific Sessions in Chicago.
The presentation reported two-year results, which trended in favor of the
TAXUS stent compared to the Cypher stent and BMS in both target vessel
revascularization (TVR) and major adverse cardiac events (MACE) rates. The
TVR rate for the TAXUS stent was 9.7 percent compared to 15.3 percent for the
Cypher stent (p=0.06) and 19.5 percent for BMS (p=0.0034). Rates of TVR for
the Cypher stent and BMS were comparable (p=0.97). The study also reported
rates of MACE with the TAXUS stent of 21.2 percent compared to 28.9 percent
for the Cypher stent (p=0.058 PES vs. SES) and 29.7 percent for BMS (p=0.04
PES vs. BMS). The presenter concluded that the MACE data showed no benefit to
SES as compared to BMS in the study’s patient population, and that there was
a trend toward better TVR outcomes with PES.
Two-year cumulative incidence of mortality was comparable among the three
stent groups, with rates of 11.5 percent for the TAXUS stent, 13.3 percent
for the Cypher stent and 9.8 percent for BMS. The two-year stent thrombosis
rate for the TAXUS stent was lower than that of the Cypher stent (2.4 percent
versus 4.4 percent), however, the difference was not statistically
significant (p=0.29). Stent thrombosis for BMS was 0.8 percent, which was not
significantly different from TAXUS (p=0.18). Stent thrombosis for Cypher at
two years was significantly higher compared to BMS (p=0.015).
"This study provides further insight into the strong performance of the
TAXUS stent in diabetic patients and adds to the growing body of TAXUS stent
data in this difficult-to-treat patient population," said Paul LaViolette,
Chief Operating Officer of Boston Scientific. "These results are particularly
compelling because they represent patients with multiple complexities, the
kind physicians treat every day in real-world settings. We are also pleased
that the data demonstrated that the safety profile of the TAXUS stent was
comparable to -- or better than -- that of bare-metal stents."
Diabetic patients generally have more long-term complications than
interventional cardiology patients as a whole, making results in diabetic
patients with heart disease worthy of note when evaluating overall stent
performance. The important and growing diabetic patient subset accounts for
approximately one-quarter of all coronary interventional procedures worldwide
(1).
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devises 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. Boston Scientific
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 new product
development and commercialization, clinical trials, intellectual property,
regulatory approvals, competitive offerings, Boston Scientific’s over all
business strategy, and other factors described in Boston Scientific’s
filings with the Securities and Exchange Commission.
(1) Kereiakes DJ and Young JJ. Percutaneous coronary
revascularization of diabetic patients in the era of
drug-eluting stents. Rev Cariovasc Med 2005: 6 (suppl 1): S48-S58
