2013-03-04 15:10:16 -
Interruption or Discontinuation After One Month Following Implant Procedure
'Low and No Increased Risk' of Stent Thrombosis at One Year in Clinical Studies
MINNEAPOLIS -- March 4, 2013 -- Of relevance to the clinical practice of
interventional cardiology, Medtronic, Inc. (NYSE: MDT) announced today that it
has received regulatory approval to update the CE (Conformité Européenne) mark
labeling for the Resolute Integrity drug-eluting stent with new information on
one month of dual antiplatelet therapy (DAPT), the shortest minimum duration
referenced on the label for any device of its kind.
labeling states: "One year data from the RESOLUTE Clinical Program
indicates low stent thrombosis rates for those who interrupted or discontinued
DAPT any time after one month. While physicians should continue to adhere to
current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or
discontinue DAPT medication one month or more after stent implantation are
considered at low risk and showed no increased risk for stent thrombosis."
This labeling update applies to product distributed in countries that accept the
CE mark. It does not apply to product distributed beyond these countries,
including the United States.
Dual antiplatelet therapy -- the combination of acetylsalicylic acid (ASA) and a
thienopyridine like clopidogrel -- reduces the risk of stent thrombosis, the
formation of a blood clot inside the stented arterial segment; but long-term use
of antiplatelet agents increases the risk of bleeding complications. Balancing
these risks remains a challenge.
Dual antiplatelet therapy guidelines for patients who receive a drug-eluting
stent differ by geographic region, but generally recommend daily compliance for
six to 12 months.
For a variety of reasons, however, some patients interrupt or discontinue their
DAPT early, which raises safety concerns.
"An independent analysis of data on nearly 5,000 patients from the global
RESOLUTE Clinical Program who received a Resolute drug-eluting stent shows that
the greatest risk of stent thrombosis due to DAPT interruption is within the
first 30 days of the implant procedure," explained Prof. Sigmund Silber, M.D.,
director of the Heart Centre at the Isar in Munich, Germany. "It also shows that
DAPT interruption after 30 days is associated with a low risk of stent
thrombosis and no increased risk for cardiac death or target vessel myocardial
Prof. Silber, a member of the ESC 2010 guidelines committee for myocardial
revascularization, presented this analysis at TCT 2012, which took place in
Miami in October. Ajay Kirtane, M.D., an interventional cardiologist at NewYork-
Presbyterian Hospital/Columbia University Medical Center, plans to present
additional analysis during ACC.13, which is scheduled to take place in San
Francisco from March 9-11.
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
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
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Source: Medtronic, Inc. via Thomson Reuters ONE