Medtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet Therapy in High Bleeding Risk Stent Patients Beats Performance ...
30 März 2020 - 4:00PM
Medtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet
Therapy in High Bleeding Risk Stent Patients Beats Performance
Goal
Medtronic plc (NYSE:MDT) today announced positive results of
the Onyx ONE Clear Study that evaluated Resolute Onyx DES in high
bleeding risk (HBR) patients with one-month dual antiplatelet
therapy (DAPT) in the United States and Japan. The study met its
primary endpoint of cardiac death or myocardial infarction by
beating a performance goal derived from contemporary one-month DAPT
trials at one-year post-procedure. Results from the study were
shared virtually at the American College of Cardiology together
with the World Congress of Cardiology Scientific Sessions
(ACC.20/WCC) on March 28, 2020.
“Despite the high-risk population, we observed a
low rate of ischemic outcomes after DAPT discontinuation at one
month,” said Ajay Kirtane, M.D., professor of medicine at Columbia
University Irving Medical Center, lead investigator and presenter
of the data at ACC.20. “These data, in conjunction with the
randomized data from the Onyx ONE Global randomized controlled
trial, offer additional clinical evidence of one-month of DAPT for
appropriately selected patients treated with the Resolute Onyx
DES.”
The prospective, multicenter, single-arm study
included highly complex HBR patients in the U.S. and Japan who were
treated with one-month DAPT (the combination of aspirin and an
anti-clotting medication) following PCI with Resolute Onyx and
were clear of any adverse events and were DAPT compliant at one
month. Patients in the Onyx ONE Clear Study were pooled with
similar patients treated with Resolute Onyx from the Onyx ONE
Global Study, totaling approximately 1500 patients that were
included in the primary endpoint analysis. The Onyx ONE Clear
study’s primary composite endpoint of cardiac death or myocardial
infarction was 7.0%, beating the pre-specified performance goal of
9.7% at one-year post-procedure. The rate of stent thrombosis was
low at 0.7% at one year1. The performance goal was based on
short-DAPT studies.
The Onyx ONE Clear Study was designed to
complement the Onyx ONE Global Study, results of which wererecently
published in the New England Journal of Medicine2. Together,
the Onyx ONE Clear Study and the Onyx ONE Global Study make up
the robust Medtronic Onyx ONE Month DAPT Program that has
enrolled approximately 2,700 patients at up to 130
sites worldwide.
"Onyx ONE Clear demonstrates our commitment to
providing the clinical evidence of greatest interest and benefit to
the interventional cardiology community,” said Dave Moeller, vice
president and general manager of the Coronary and Renal Denervation
business, which is part of the Cardiac and Vascular Group at
Medtronic. “We hope these data will support our submission to the
FDA for a one-month DAPT indication for high-bleeding risk patients
treated with Resolute Onyx.”
To date, more than 22,000 patients have been
studied in Medtronic sponsored and funded clinical trials that have
addressed DAPT duration. Resolute Onyx DES was approved
in the U.S. in 2017 and is not currently indicated for high
bleeding risk patients on one-month DAPT.
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 MedtronicMedtronic 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 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 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 Stent thrombosis was not a powered endpoint
in the Onyx ONE Clear study.
2 Windecker S, et al. N Engl J Med.
2020. doi: 10.1056/NEJMoa1910021. [Epub ahead of print]
Allison KyriagisPublic Relations+1-612-750-6061
Ryan WeispfenningInvestor Relations+1-763-505-4626
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