Long Term Data Presented at ESC 2010 Further Support the Benefit of TheSirolimus Drug-Eluting Stent Compared to The ENDEAVOR(R) Zotarolimus-Eluting Stent in Important High-Risk Subgroups
STOCKHOLM, September 2, 2010/PRNewswire/ --
- Additional Analysis of 18 Month Data of the SORT OUT III Trial
Provides Detail on Safety and Efficacy Outcomes in Patients With
Diabetes, Acute Coronary Syndrome, or Treatment of Multiple
Lesions
Three new analyses of subgroups from the SORT OUT III study
presented at the European Society of Cardiology (ESC) meeting in
Stockholm, Sweden, provide additional detail on longer-term
follow-up subgroup safety and efficacy outcomes in the SORT OUT III
trial in three high-risk subgroups (diabetes, acute coronary
syndrome and multiple lesion). These important data add detail to
those already published in the March 2010 issue of The Lancet on
the clinical outcomes for the primary endpoint in the total
population and in multiple subgroups at 9 months follow-up and on
clinical outcomes at 18 month follow up of the randomized
comparison of the CYPHER(R) Stent and the Endeavor(R) Stent.
The initial results of the SORT OUT III study were published in
the Lancet and showed significantly reduced adverse events at 9 and
18 months for the CYPHER(R) Sirolimus-eluting Coronary Stent over
Medtronic's Endeavor(R) Stent in an unselected group of 2,332
patients undergoing coronary intervention in real world clinical
practice. The authors reported that subgroup analysis of the
primary endpoint of 9-month Major Adverse Cardiac Events (MACE,
defined as a composite of cardiac death, myocardial infarction
[MI], or target vessel revascularization [TVR]) were also
consistent across all subgroups.
The new data from ESC provide important additional information
on longer-term outcomes at 18 months in three key groups of
patients that are at higher risk of adverse events when undergoing
coronary intervention, namely patients with diabetes, acute
coronary syndromes, and treatment of multiple lesions. These data
confirm that the significant reductions in major adverse events in
these subgroups seen at 9 months with the CYPHER Stent compared to
the ENDEAVOR Stent were sustained through 18 months of follow-up
and provide important details of how the components of MACE (death,
MI, and TVR) contribute to the reduction in major adverse
events.
Among the high-risk diabetic patient population in SORT OUT III,
the incidence of MACE at 18 months was significantly reduced by 74%
with CYPHER vs. ENDEAVOR (4.8% in the CYPHER Stent group vs. 18.3%
in the Endeavor(R) Stent group; hazard ratio 4.05; 95% confidence
intervals: 1.86-8.82). This difference was driven by statistically
significant reductions in death, MI, TVR and TLR favoring the
CYPHER Stent. In the CYPHER Stent group, the incidence of MACE was
also significantly reduced by 46% compared to the ENDEAVOR Stent in
patients without diabetes (4.5% in the CYPHER Stent group vs. 8.3%
in the ENDEAVOR Stent group; hazard ratio 1.87, 95% confidence
intervals: 1.30-2.69).
Among patients with acute coronary syndrome in SORT OUT III
(defined as patients with unstable angina or myocardial
infarction), the incidence of MACE at 18 months was significantly
reduced by 43% with CYPHER vs. ENDEAVOR (5.0% in the CYPHER Stent
group vs. 8.7% in the Endeavor(R) Stent group; hazard ratio 1.78;
95% confidence intervals: 1.10-2.88). This difference was driven by
a statistically significant reduction in TLR and TVR favoring the
CYPHER stent. In the CYPHER Stent group the incidence of MACE was
also significantly reduced by 60% compared to the ENDEAVOR Stent in
patients with stable angina (4.2% in the CYPHER Stent group vs.
10.4% in the ENDEAVOR Stent group; hazard ratio 2.53, 95%
confidence intervals: 1.60-4.02).
Finally, among the high-risk group treated for disease in
multiple lesions in SORT OUT III, the incidence of MACE at 18
months was significantly reduced by 80% with CYPHER vs. ENDEAVOR
(2.6% in the CYPHER Stent group vs. 13.2% in the Endeavor(R) Stent
group; hazard ratio 5.29; 95% confidence intervals: 2.59-10.8).
This difference was driven by statistically significant reductions
in death, MI, and TVR favoring the CYPHER Stent. In the CYPHER
Stent group the incidence of MACE was also significantly reduced by
35% compared to the ENDEAVOR Stent in patients treated for disease
in one lesion (5.4% in the CYPHER Stent group vs. 8.3% in the
ENDEAVOR Stent group; hazard ratio 1.55, 95% confidence intervals:
1.06-2.27).
"The SORT OUT III subgroup analyses further support significant
safety and efficacy differences between the CYPHER(R) Stent and the
Endeavor(R) Stent," said Campbell Rogers, M.D., Chief Scientific
Officer and Head, Global Research and Development, Cordis
Corporation and concludes, "In these data sets, risks of adverse
events are up to five-fold higher with the Endeavor(R) Stent than
with the CYPHER(R) Stent in patients with other complications like
diabetes that are described in these data."
Notes to Editors:
About CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide
to treat approximately three million patients with coronary artery
disease. The safety and efficacy of the device is supported by a
robust clinical trial program that includes more than 70 studies
that examine the performance of the CYPHER(R) Stent in a broad
range of patients.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson &
Johnson company, has been a worldwide leader in the development and
manufacture of interventional vascular technology. Through the
company's innovation, research and development, Cordis partners
with interventional cardiologists worldwide to treat millions of
patients who suffer from vascular disease.
*Cordis Corporation has entered into an exclusive worldwide
license with Wyeth for the localized delivery of sirolimus in
certain fields of use, including delivery via vascular stenting.
Sirolimus, the active drug released for the stent, is marketed by
Wyeth Pharmaceuticals, a division of Wyeth, under the name
Rapamune(R). Rapamune is a trademark of Wyeth
Pharmaceuticals.
**The third party trademarks used herein are trademarks of their
respective owners.
Source: Cordis Corporation
Contact: Name Ulrike Domany, Director Public Affairs &
Communication, (o) +43-1-36-025-310, (m) +43-664-83-504-83
Posted: September 2010
