Independent Study Shows New Data on Shortened DAPT in STEMI Patients with Medtronic Resolute Integrity Drug-Eluting Stent
(Thomson Reuters ONE) -
DAPT-STEMI Late-Breaker at TCT Reveals Results of Shortened DAPT Duration in
Higher-Risk Patients
DUBLIN and DENVER - November 1, 2017 - Investigators today unveiled clinical
data from the independently run DAPT-STEMI trial, which found no difference in
patient outcomes between six-and 12-month dual anti-platelet therapy (DAPT)
duration in ST-Elevation Myocardial Infarction (STEMI) patients implanted with
the Resolute(TM) Integrity(TM) Drug-Eluting Stent (DES). The results help inform
physician decision making around the use of newer-generation DES in high-risk
patients who typically receive a longer DAPT regimen after percutaneous coronary
intervention (PCI). The DAPT-STEMI trial was presented today during a Late-
Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics
(TCT) Annual Meeting.
The DAPT-STEMI trial evaluated 1,100 STEMI patients who were treated with the
Resolute Integrity DES. Event-free patients (N=870) at six months were
randomized 1:1 to either stop dual antiplatelet therapy (and receive aspirin
only) or continue DAPT (receive aspirin plus a second anti-platelet medicine) to
12-months. The primary non-inferiority endpoint - composite of all-cause
mortality, myocardial infarction, revascularization, stroke, or TIMI major
bleeding - was met at two years showing no difference between the six-month and
12-month DAPT arms (P=0.004 for non-inferiority).
"These data help expand the growing body of clinical evidence that may support
physicians in tailoring DAPT regimens for patients," said Dr. Elvin Kedhi, M.D.,
Ph.D., interventional cardiologist at Isala Hartcentrum in Zwolle, the
Netherlands, principal investigator of the trial and presenter of the data at
TCT. "We believe the results from DAPT-STEMI, in addition to the future outcomes
from the RESOLUTE ONYX ONE study, will help to inform DAPT guidelines for newer-
generation DES."
STEMI results from the blockage (thrombosis) of a major coronary artery.
Consequently, these patients remain at higher risk following PCI due to this
high thrombotic risk. Contemporary guidelines suggest STEMI patients receive 12-
months of DAPT after PCI. After PCI, approximately 20 percent of patients
interrupted or discontinued DAPT early for a variety of reasons within one year
as shown in the RESOLUTE Pooled Analysis.(1)
"Physicians are the ultimate DAPT decision-makers, therefore it's critical that
we invest in providing relevant and clinically meaningful evidence around DAPT
duration," said Martin Rothman, M.D., vice president, medical affairs for the
Coronary and Structural Heart division, which is part of the Cardiac and
Vascular Group at Medtronic. "We look forward to continuing this important
research with the upcoming enrollment initiation of our ONYX ONE study that will
evaluate one-month DAPT with the Resolute Onyx DES in patients at a high
bleeding risk."
Stents from the Resolute DES family have been implanted in approximately seven
million patients around the world, one million of whom have been implanted with
the latest generation Resolute Onyx DES. The Resolute Onyx DES received CE
(Conformité Européene) Mark in September 2014 and FDA approval in April 2017.
The Resolute Integrity and Resolute Onyx stents are not indicated for the
treatment of STEMI patients in the United States. However, the Resolute family
of stents received CE Mark to treat patients with Acute Coronary Syndrome (ACS),
which includes STEMI.
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 plc (www.medtronic.com), headquartered in Dublin, Ireland, is among
the world's largest medical technology, services and solutions companies -
alleviating pain, restoring health and extending life for millions of people
around the world. Medtronic employs more than 84,000 people worldwide, serving
physicians, hospitals and patients in more than 160 countries. The company is
focused on collaborating with stakeholders around the world to take healthcare
Further, Together.
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.
- end -
(1) Kandzari D. Pharmacodynamic considerations and clinical impact of dual
antiplatelet therapy interruption after Resolute zotarolimus-eluting stent
implantation. ACC 2014.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire
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