2013-03-11 17:16:57 -
ACC.13 Presentation Features Unprecedented Data on Nearly 5,000 Patients,
Including "All Comers," from Global RESOLUTE Clinical Program
SAN FRANCISCO -- March 11, 2013 -- Cardiologists at ACC.13 learned today that
patients with coronary artery disease who received a Resolute drug-eluting stent
from Medtronic, Inc. (NYSE: MDT) as participants in one of several clinical
studies and interrupted or discontinued their dual antiplatelet therapy after
one month of the implant procedure showed no increased safety risk through one
year of follow-up.
This finding comes from a new analysis of nearly 5,000 patients from the global
RESOLUTE clinical program, which included two large studies that enrolled "all
Ajay Kirtane, M.D., chief academic officer and director of the interventional
cardiology fellowship program at NewYork-Presbyterian Hospital/Columbia
Center, presented the analysis at the 62(nd) Annual
Scientific Session & Expo of the American College of Cardiology (ACC).
"While most physicians would expect patients who interrupted their dual
antiplatelet therapy after as few as 30 days following drug-eluting stent
implantation to be at a much greater risk for stent thrombosis, this was not
observed with the Resolute stent," Dr. Kirtane said. "These data should be very
reassuring to physicians as well as to patients in whom this newer generation
stent is implanted."
As part of the new analysis, the investigators also examined patients who
interrupted their dual antiplatelet therapy after at least one month following
the implant procedure for a period of more than 14 days, by which time normal
platelet function typically resumes. Interestingly, these patients -- who
constituted the vast majority of those who interrupted their dual antiplatelet
therapy after one month -- experienced no instances of stent thrombosis (0.0%)
through one year of follow-up.
Based on this analysis, Medtronic recently received approval from European
regulators to update the CE (Conformité Européenne) mark labeling for the
Resolute Integrity drug-eluting stent with new language related to one-month
duration of dual antiplatelet therapy. This labeling update applies to product
distributed in countries that accept the CE mark. It does not apply to product
distributed outside this region, including the United States.
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.
The applicable guidelines are referenced in the country-specific labeling for
In other data presented at ACC.13, the RESOLUTE Pooled Safety update, which
includes data on all 5,130 patients who received a Resolute stent as
participants in the program, showed a consistently low rate of stent thrombosis
of 1.1 percent out to three years after implant; and in the RESOLUTE US study,
which enrolled 1,402 U.S. patients, the stent thrombosis rate out to three years
was a low 0.37 percent.
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