Medtronic, Inc. : American College of Cardiology Journal Publishes Outcomes of
Diabetes Patients Treated with Medtronic's Resolute Stent
Implanted Medical Device for Coronary Artery Disease Performed As Well
In Study Subjects With Diabetes Who Were Not Taking Insulin As In Those
MINNEAPOLIS -- April 15, 2013 -- The current issue of JACC: Cardiovascular
Interventions, a peer-reviewed journal published by the American College of
Cardiology, includes an article that describes how the Resolute Integrity
drug-eluting stent from Medtronic, Inc. (NYSE: MDT) became the first and only
device of its kind to be approved by the U.S. Food and Drug Administration
(FDA) with a specific indication for treating the coronary artery disease of
patients with diabetes mellitus.
A common comorbidity of coronary artery disease, diabetes affects
approximately one-third of patients who receive coronary stents and
historically has been associated with adverse clinical outcomes. New research
presented in the journal article, however, shows that treatment with the
Resolute drug-eluting stent led to similarly positive outcomes for diabetes
patients who were not taking insulin and for patients without diabetes. It was
sponsored by Medtronic.
Titled "Clinical Outcome of Patients With and Without Diabetes Mellitus After
Percutaneous Coronary Intervention with the Resolute Zotarolimus-Eluting
Stent" (R-ZES), the article presents the results of two separate analyses of
patient-level data from the global RESOLUTE clinical program, which enrolled a
total of 5,130 patients who received a Resolute drug-eluting stent as
participants in one of five studies conducted in the United States and
The authors' conclusions state: "The R-ZES is safe and effective in patients
with diabetes. Long-term clinical data of patients with non-insulin-treated
diabetes are equivalent to patients without diabetes. Patients with
insulin-treated diabetes remain a higher risk subset."
Two Analyses, Similar Findings
One analysis reported in the article evaluated the performance of the device
in the 878 standard-risk diabetes patients who received it. Prospectively
determined in conjunction with the FDA, it set a 12-month target vessel
failure (TVF) rate of 14.5 percent as a performance goal.
The actual rate of TVF at 12 months among these standard-risk diabetes
patients was significantly lower at 7.8 percent (p<0.001), demonstrating
superiority of the Resolute drug-eluting stent over first-generation devices
in this patient subset. The results of this analysis led to FDA approval of a
unique diabetes indication for the Resolute Integrity drug-eluting stent in
This analysis also found low and comparable rates of target lesion failure
(TLF) at two years in the patients with non-insulin-treated diabetes when
compared to the patients without diabetes (8.0% vs. 7.1%). In addition, it
found a predictably higher two-year TLF rate in the patients with
insulin-treated diabetes (13.7%).
(Target vessel failure is a composite endpoint that includes cardiac death,
myocardial infarction and revascularization attributable to any part of the
stented vessel; target lesion failure includes the same components, but only
as attributable to the stented segment of the vessel.)
Another analysis reported in the article evaluated the cumulative incidence of
TLF at two years for all 5,130 patients, many of whom had complex coronary
For this analysis, the patients were first divided into two groups: those with
diabetes (1,535; 30%) and those without diabetes (3,595; 70%). The diabetes
patients were then divided into two groups: those who were taking insulin
(455; 30%) and those who were not taking insulin (1,080; 70%).
This analysis yielded a similar finding. Specifically, it found low and
comparable two-year rates of TLF in patients with non-insulin-treated diabetes
and patients without diabetes (8.9% vs. 8.4%) -- and a predictably higher rate
of TLF at two years in patients with insulin-treated diabetes (16.7%).
"These two analyses offer interventional cardiologists worldwide increased
confidence when making treatment decisions about the coronary artery disease
of patients with diabetes mellitus, who have historically experienced worse
clinical outcomes following coronary stent procedures," said lead author Prof.
Dr. Sigmund Silber, director of the Heart Center at the Isar in Munich,
The strong performance of the Resolute drug-eluting stent in patients with
diabetes -- both in clinical studies and real-world clinical practice --
advances the growing body of evidence that warranted the device's unique
diabetes indication in the United States.
In collaboration with leading clinicians, researchers and scientists
worldwide, 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 around the world.
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
- end -
This announcement is distributed by Thomson Reuters on behalf of Thomson
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE
Press spacebar to pause and continue. Press esc to stop.