Medtronic plc announced it has received U.S. Food and Drug Administration (FDA) approval for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx DES.
The Resolute Onyx DES is the first-and-only DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT – the combination of aspirin and an anti-clotting medication – following a percutaneous coronary intervention (PCI) in patients at high bleeding risk.
Patients that are at risk for high bleeding include older patients, those with history of bleeding, or those on oral blood-thinning drugs, and account for up to 40 percent of PCI patients. Clinical studies have demonstrated that Resolute Onyx DES and its biocompatible polymer and stent design promote fast vessel healing and is well-suited for patients who may benefit from a DAPT duration as short as one month.
Using a broad criteria for HBR, the approval is based on results from the Onyx ONE Clear Study that evaluated approximately 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx. At one year, the study met its primary endpoint of cardiac death or myocardial infarction and showed Resolute Onyx to be safe and effective in HBR patients on one-month DAPT. Results from the study were shared virtually in March at the American College of Cardiology together with the World Congress of Cardiology Scientific Sessions (ACC.20/WCC). The Onyx ONE Clear study, coupled with the Onyx ONE Global study, make up the Onyx ONE Month DAPT Program that supports the advancement of DAPT evidence, initiated by physicians and Medtronic.
