Recently FDA-Approved, Novel Heart Device Shows Consistently Low
Event Rates Across Broad Spectrum of Coronary Artery Disease Patients,
Including Those with Diabetes
CHICAGO--(BUSINESS WIRE)--Mar. 24, 2012--
According to new clinical data presented today at ACC.12 –– the 61st
Annual Scientific Session & Expo of the American College of Cardiology
(ACC) –– the Resolute drug-eluting stent (DES) from Medtronic, Inc.
(NYSE: MDT) maintains a powerful and persistent treatment effect for a
wide variety of patients with coronary artery disease, including those
with diabetes mellitus, through two years of follow-up.
The latest data on this novel heart stent, which received approval from
the U.S. Food and Drug Administration (FDA) last month with a
first-of-its-kind indication for the treatment of coronary artery
disease in patients with diabetes mellitus, come from the RESOLUTE US
clinical study and two pooled analyses of the entire Resolute clinical
program –– one on safety measures for all patients (RESOLUTE Pooled
Safety), the other for all patients with diabetes (RESOLUTE Pooled
Diabetes).
Highlights of the two-year data include low rates of target lesion
failure (TLF), target lesion revascularization (TLR) and
definite/probable stent thrombosis (def/prob ST).
Laura Mauri, M.D., of Harvard Clinical Research Institute and Brigham
and Women’s Hospital in Boston, presented the two-year results from
RESOLUTE US; Jorge Belardi, M.D., of the Cardiovascular Institute of
Buenos Aires in Argentina, the two-year update for RESOLUTE Pooled
Safety; and Alan Yeung, M.D., of the Stanford University School of
Medicine in Palo Alto, the two-year update for RESOLUTE Pooled Diabetes.
“What’s particularly striking about the two-year outcomes from the
Resolute clinical program is the device’s consistently strong
performance and low event rates in such a wide variety and high number
of patients,” explained Dr. Mauri, a national co-principal investigator
of RESOLUTE US like Dr. Yeung and Martin Leon, M.D., of the
Cardiovascular Research Foundation and NewYork-Presbyterian
Hospital/Columbia University Medical Center in New York. “The Resolute
DES yields excellent outcomes in patients with and without diabetes
mellitus, and that’s a factor of significant clinical relevance given
the large number of diabetes patients that undergo percutaneous coronary
intervention each year. Its safety and efficacy data at two years of
patient follow-up continue to impress.”
RESOLUTE US
RESOLUTE US enrolled 1,402 patients across 128 U.S.-based clinical trial
sites. The two-year results among 1,359 patients include low rates of
TLF (7.3%), clinically-driven TLR (4.3%), and def/prob ST (0.2%).
These powerful clinical results were achieved despite 34 percent of the
patients having diabetes mellitus, which typically drives higher event
rates. Among the 474 patients with diabetes in RESOLUTE US, the Resolute
DES showed consistently low two-year rates of TLF (8.9%) and
clinically-driven TLR (5.7%) and no def/prob ST (0.0%).
Pooled Analyses
The global RESOLUTE clinical program consisted of a large randomized
controlled trial and a series of confirmatory single-arm studies
involving nearly 250 sites in 32 countries. In total, the program
enrolled 5,130 patients who received a Resolute DES; about one third
(n=1,535) of these patients had diabetes, a proportion that mirrors the
U.S. patient mix for percutaneous coronary intervention (PCI).
For the pooled analyses related to safety and diabetes presented today
at ACC.12, two-year data on more than 5,000 patients from the RESOLUTE
program who received a Resolute DES were included. Individual trials,
while powered for many composite endpoints, are often underpowered to
show real differences for low-frequency but clinically important adverse
events such as ST.
The two-year update to RESOLUTE Pooled Safety showed very low rates of
clinically-driven TLR (4.7%) and def/prob ST (0.9%), despite 46 percent
of the patients in the RESOLUTE program being considered complex1.
The two-year update to RESOLUTE Pooled Diabetes, which presents clinical
outcomes in patients with and without diabetes who received a Resolute
DES, shows consistently low event rates out to two years despite the
higher-risk nature of the diabetes patient population. For example, the
update presents clinically-driven TLR and def/prob ST rates for the
standard-risk diabetes patients, a cohort pre-specified for analysis by
the FDA in order to obtain the device’s diabetes indication.
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Dataset
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Patients with Diabetes
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Patients without Diabetes
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RESOLUTE Pooled
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Standard-Risk Cohort (N=2,781)
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(N=878)
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(N=1,903)
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-- clinically-driven TLR
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4.8%
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3.4%
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-- def/prob ST
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0.3%
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0.4%
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In collaboration with leading clinicians, researchers and scientists,
Medtronic offers the broadest range of innovative medical technology for
the interventional and surgical treatment of cardiovascular disease and
cardiac arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers and
providers 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 periodic reports on file with the
Securities and Exchange Commission. Actual results may differ materially
from anticipated results.
1 Complex patient definition: bifurcation, bypass grafts,
ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal
insufficiency or failure (creatinine >140 µmol/L), lesion length >27 mm,
>1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI =
0). Only R-AC and R-INT included complex patients.
Source: Medtronic, Inc.
Medtronic, Inc.
Joe McGrath
Public Relations
612-819-6421
or
Jeff
Warren
Investor Relations
763-505-2696
