Medtronic has announced the start of the Onyx ONE Clear Study in the USA and Japan that will evaluate one-month dual antiplatelet therapy (DAPT) in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention (PCI). A press release reports that the Onyx ONE Clear Study is one of the first studies in the USA and Japan designed to investigate safety following DAPT interruption or discontinuation at one month with a next-generation drug-eluting stent.
Designed similarly to the randomised Onyx ONE Global Study, which began enrolment in late 2017, the Onyx ONE Clear study aims to assess patients prescribed one month of DAPT following PCI with the Resolute Onyx DES. Onyx ONE Clear Study and the Onyx ONE Global Study make up the Medtronic Onyx ONE Month DAPT Program that will enrol approximately 2,700 patients at up to 140 sites worldwide.
Gregg W Stone (Columbia University, New York, USA) programme chair of the Onyx ONE Month DAPT programme, comments: “One-month DAPT duration after coronary stenting in high bleeding risk patients offers the potential to substantially enhance the safety of interventional procedures in these high-risk patients. This study will provide insight as to whether one-month DAPT after Resolute Onyx in high bleeding risk patients is effective in minimising stent thrombosis and other complications, thereby reducing bleeding-related harm with prolonged anti-platelet therapy.”
Ajay Kirtane (New York-Presbyterian Hospital/Columbia University Cardiac Catheterization Laboratories, New York, USA), says: “As newer-generation drug-eluting stents have not only grown more and more efficacious, but also have demonstrated excellent safety, a major clinical question that remains is whether we can further reduce the mandatory duration of DAPT after drug-eluting stent implantation. The Onyx One Clear study will provide important insights applicable to many patients—both patients identified at high risk of bleeding, as well as those in whom unexpected bleeding events may occur.”