Onyx ONE Global Study, a randomsed, one-month DAPT trial that compared Resolute Onyx to a competitive DES (BioFreedom DCS) has supported the regulatory approval
Medtronic operational headquarters. (Credit: Medtronic.)
Medtronic has received Conformité Européenne (CE) Mark approval for its one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx Drug-Eluting Stent (DES).
The new indication would enable physicians to recommend a shorter, one-month regimen of DAPT for HBR patients, whose bleeding risk may be increased due to longer DAPT regimens, after a percutaneous coronary intervention (PCI) with Resolute Onyx.
Medtronic coronary and renal denervation business vice president and general manager Dave Moeller said: “The growing body of clinical evidence supports the use of Resolute Onyx to meet the needs of complex patient populations.
“Resolute Onyx has shown exceptional outcomes in complex patient populations and anatomies, including those at a high risk of bleeding, which has helped pave the way for this first-of-its-kind approval.”
CE Mark approval for Resolute Onyx DES is based on results from the Onyx ONE Global Study
Resolute Onyx DES is available for use in the US, Europe and other countries that recognise the CE Mark.
In the pre-clinical and clinical studies, Resolute Onyx DES has demonstrated that it is well-suited for patients who may benefit from a shorter DAPT duration due to its biocompatible polymer and its capability to promote fast vessel healing,
The new indication is based on results from the Onyx ONE Global Study, a randomsed, one-month DAPT trial that compared Resolute Onyx to a competitive DES (BioFreedom DCS) in approximately 2,000 HBR patients.
The study has met its primary composite endpoint of cardiac death, myocardial infarction (MI) or stent thrombosis (ST) at one-year showing non-inferiority of Resolute Onyx DES versus BioFreedom DCS.
The Onyx ONE Global Study, along with the Onyx ONE Clear Study that evaluated Resolute Onyx DES in the US and Japan, together forms the Medtronic Onyx ONE Month DAPT Program, which enrolled approximately 2,700 patients at up to 130 sites across the world.
Montefiore Medical Center interventional cardiology section head and structural heart interventions medical director Azeem Latib said: “The use of DAPT for DES is a challenge for HBR patients who may not be able to safely tolerate the same therapy duration as recommended for the broader patient population.
“Through the Onyx ONE Global Clinical Program, we have observed that Resolute Onyx DES with one-month of DAPT in these complex patients is safe and effective. This indication will further substantiate the option for shorter DAPT regimens, if individual patient needs demand it.”