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Medtronic's Endeavor
Stent Continues to Demonstrate Compelling and Consistent Long-Term
Clinical Results
Independent Analysis of
Large and Comprehensive ENDEAVOR Program Shows Remarkably Durable
Safety and Efficacy at Five Years of Follow Up in Coronary Artery
Disease Patients
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Medtronic's
Endeavor®
Zotarolimus-Eluting
Stent |
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March 14, 2010 --
Minneapolis, MN and Atlanta, GA -- The consistency and quality of the long-term
clinical results for the Endeavor® drug-eluting stent (DES)
from Medtronic, Inc. continue to distinguish it as a
treatment for coronary artery disease, according to newly released
data.
Five-year findings from the comprehensive ENDEAVOR program were
released today at ACC.10, the American College of Cardiology's
59th Scientific Session. The E-Pooled analysis -- which now includes
five-year data from the ENDEAVOR I (E-I), ENDEAVOR II (E-II),
E-II Continued Access (CA), and ENDEAVOR III (E-III) clinical
studies, and three-year data from the ENDEAVOR IV (E-IV) and
ENDEAVOR Pharmacokinetics (E-PK) clinical studies -- demonstrates
striking consistency in clinical results across multiple studies.
Notable findings include a very low rate of late repeat revascularization
events and a paucity of very late stent thrombotic events with
8,799 patient-years of follow up. |
"The consistency of results across these well conducted clinical trials is remarkable," said Dr. David Kandzari, director of interventional cardiology research at Scripps Clinic in La Jolla, Calif., and co-principal investigator of E-III and E-IV. "The
Endeavor stent has demonstrated a very compelling safety and efficacy
profile wherein there is a very low likelihood that patients treated
with the Endeavor stent will experience late stent clotting or the
need for a repeat procedure beyond the first year of follow up."
The E-Pooled analysis includes patients who were treated with the Endeavor DES in E-I, E-PK, E-II, E-II CA, E-III and E-IV; it uses the Medtronic Driver(R) bare-metal stent (BMS) control arm of E-II as a comparator. The following table shows rates of major adverse cardiac events (MACE), all-cause mortality, cardiac death/myocardial infarction (CD/MI), target lesion revascularization (TLR), and definite and probable stent thrombosis (ST) as defined by the Academic Research Consortium (ARC).
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E-Pooled Analysis at Five Years of Patient Follow Up
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| Event |
Endeavor DES
n=2,132 |
Driver BMS
n=596 |
P-value |
|
| MACE* |
14.3% |
24.4% |
<0.001 |
| All-cause mortality |
6.1% |
7.6% |
0.206 |
| Cardiac Death / Myocardial Infarction |
5.2% |
8.4% |
0.003 |
| Target Lesion Revascularization (TLR) |
7.0% |
16.5% |
<0.001 |
| Stent Thrombosis (ARC def/prob) |
0.8% |
1.7% |
0.051 |
| Very Late (>1 yr) Stent Thrombosis |
0.2% |
0.4% |
0.460 |
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* MACE is a composite endpoint comprised of all-cause mortality,
MI,
emergent CABG and TLR |
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Of particular relevance are the longitudinal safety results,
including the low rates of Cardiac Death / Myocardial Infarction (CD/MI) and
Stent Thrombosis (ST),
which
are achieved against a background of only 39 percent and 8 percent of Endeavor
patients being maintained on dual-antiplatelet therapy at one year and five years
of follow-up, respectively.
The E-Pooled analysis includes clinical data on more than 2,100 Endeavor patients from six rigorously conducted clinical trials distinguished by 100 percent patient monitoring, 100 percent source data verification and independent, blinded event adjudication performed at the Harvard Clinical Research Institute.
Included in this analysis -- and also released today at
ACC.10 -- are the final five-year results from the ENDEAVOR III randomized controlled
trial comparing the Endeavor DES to the Cypher® DES (from Johnson & Johnson's
Cordis Corp.) with a primary angiographic endpoint of late lumen loss at eight
months.
E-III five-year results show low rates of MACE, TLR and ST for Endeavor patients which are consistent with the E-Pooled analysis. They also reveal statistically significant difference in rates of CD/MI as well as a trend toward lower MACE in favor of the Endeavor DES.
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ENDEAVOR III at Five Years of Patient Follow
Up
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| Event |
Endeavor
ZES |
Cypher
SES |
P-value |
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| MACE* |
13.6% |
21.8% |
0.054 |
| Cardiac Death / Myocardial Infarction |
1.3% |
6.5% |
0.003 |
| Stent Thrombosis (ARC def/prob/poss) |
1.0% |
3.7% |
0.079 |
| Target Lesion Revascularization (TLR) |
8.0% |
6.5% |
0.547 |
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* MACE is a composite endpoint comprised of all-cause
mortality, MI,
emergent CABG and TLR |
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Importantly, E-III five-year outcomes confirm the phenomena of late catch-up in TLR with the Cypher DES: From years 1--5 of follow up, the data show a TLR increase of 86 percent with the Cypher DES compared to 21 percent with the Endeavor stent. This difference in TLR rates after the first year of patient follow up in E-III drives similar overall TLR rates at five years. Additionally, MACE increased in the Cypher patients by 173 percent compared to 74 percent in the Endeavor patients.
While the observed increase in late clinical events with the Cypher DES are intriguing and consistent with other recent trials, E-III is not designed or powered to detect differences in clinical events. The definitive study comparing the Endeavor DES to the Cypher DES is PROTECT, the largest randomized stent trial of its kind, with independent and blinded clinical events adjudication and data safety monitoring committees. With 8,800 patients, PROTECT is designed to evaluate whether the Endeavor stent protects against late stent thrombosis and results in fewer deaths and MIs at three years of follow-up. Enrollment in the PROTECT study was completed in December 2008.
Medtronic CardioVascular is committed to advancing the treatment of coronary, peripheral, aortic and structural heart disease through collaboration with leading clinicians, researchers and scientists worldwide.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology -- alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's Annual Report on Form 10-K for the year ended
April 24, 2009. Actual results may differ materially from anticipated results.
Source: Medtronic,
Inc.
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