Medtronic Stent Successfully Treats Long Lesions And Small Vessels, Two Characteristics Typical Of Patients With Diabetes, In Multiple Studies New Data from RESOLUTE Clinical Program Show Strong Performance in Complex Subsets
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October 23, 2012 -- Minneapolis and Miami -- For the treatment of long lesions and
small vessels –– two challenging characteristics of coronary artery disease commonly
found in patients with diabetes –– the Resolute drug-eluting stent from Medtronic, Inc.
(NYSE: MDT) delivered successful clinical results, according to new data presented at
the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Ronald Caputo, MD |
"The Resolute stent continues to provide consistent and favorable clinical results," said
Ronald Caputo, M.D., director of cardiac services and cardiology research at St. Joseph's
Hospital in Syracuse, N.Y. "Patients with long lesions and small vessels are among the
most difficult to treat, and for those who also have diabetes it can be even more
challenging."
Long Lesions (One-Year Follow-Up)
For the long-lesion cohort, data on 222 patients from the RESOLUTE US and
RESOLUTE Asia clinical studies who received a 38 mm Resolute stent for the treatment
of coronary lesions less than or equal to 35 mm in length showed a one-year target
lesion failure (TLF) rate of 5.4 percent, with low rates of clinical events and no instances
of late stent thrombosis (0.0 percent). (Target lesion failure is a composite endpoint that
includes clinically-driven target lesion revascularization, cardiac death and target-vessel
myocardial infarction.) The 38 mm Resolute stent is not currently available for
commercial distribution in the United States.
This pre-specified analysis contributes to Medtronic's submission to the U.S. Food and
Drug Administration (FDA) for approval of the 38 mm Resolute Integrity drug-eluting
stent, a length for this device that is considered investigational in the United States. The
company's approval application for the 38 mm stent is currently under review by the
FDA. Core sizes of the Resolute Integrity stent received FDA approval in February.
Of the patients in this cohort, nearly 38 percent had diabetes mellitus, and their results
were similar to the patients without diabetes. For the diabetes patients, the one-year
TLF rate was 6.0 percent, with similarly low clinical event rates and no instances of stent
thrombosis (0.0 percent). Additionally, the one-year rate of clinically-driven target
lesion revascularization in the diabetes patients was a low 2.4 percent. (Target lesion
revascularization means a repeat procedure was clinically necessary to treat the
narrowed arterial segment again.)
Small Vessels (Two-Year Follow-Up)
For the small-vessel cohort, data on 1,956 patients were pooled from the RESOLUTE,
RESOLUTE All Comers, RESOLUTE International, RESOLUTE US and RESOLUTE
Japan clinical studies who received a Resolute stent for the treatment of coronary
lesions of no greater than 2.5 mm in diameter.
The data on patients with small vessels from these studies showed a two-year TLF rate
of 10.1 percent, similar to the 3,174 patients in these same studies with larger vessels (8.7
percent, p=0.53). They also showed low rates of clinical events and stent thrombosis for
both groups at two years, with no statistical differences between the two.
Of the patients in this cohort, more than one-third had diabetes mellitus, and their
results were similar to those without diabetes. For the 672 diabetes patients, the two-year
TLF rate was 11.2 percent; for the 1,284 patients without diabetes, it was 9.6
percent (p=0.28). Two-year rates of clinically-driven target lesion revascularization were
also very similar for the two groups: 6.3 percent for patients with diabetes; 4.8 percent
for patients without diabetes (p=0.19). In addition, the two-year rates of stent
thrombosis were low and also similar: 0.9 percent for diabetes patients; 0.8 percent for
non-diabetes patients (p=0.73).
Dr. Caputo is an investigator in RESOLUTE US and presented the small vessel data.
Shirish Hiremath, M.D., director of the cardiac catheterization laboratory at Ruby Hall
Clinic in Pune, India, is an investigator in RESOLUTE Asia and presented the long
lesion data.
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.
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.
Source: Medtronic,
Inc.
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