Medtronic Announces One-Month DAPT Clinical Study in the U.S. and Japan With Resolute Onyx DES in High Bleeding Risk Patients
The Onyx ONE Clear Study Builds Upon Body of Clinical Evidence to Inform Individualized DAPT Duration Following Stent Procedures
DUBLIN – September 10, 2018 – Medtronic plc announced the start of the Onyx ONE Clear Study in the U.S. and Japan that will evaluate one-month dual antiplatelet therapy (DAPT) in high bleeding risk patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES) during percutaneous coronary intervention (PCI).[i] The Onyx ONE Clear Study is one of the first studies in the U.S. and Japan designed to investigate safety – such as risk of cardiac death, heart attack and stent thrombosis – following DAPT interruption or discontinuation at one month with a next generation DES.
“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,” said Gregg W. Stone, M.D., professor of medicine at Columbia University in New York, and program chair of the Onyx ONE Month DAPT Program. “This study will provide insight as to whether one-month DAPT after Resolute Onyx in high bleeding risk patients is effective in minimizing stent thrombosis and other complications, thereby reducing bleeding-related harm with prolonged anti-platelet therapy.”
Designed similarly to the randomized Onyx ONE Global Study, which began enrollment in late 2017, the Onyx ONE Clear Study will assess patients prescribed one month of DAPT, the combination of aspirin and an anti-clotting medication, 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 enroll approximately 2,700 patients at up to 140 sites worldwide.
“As newer-generation DES 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 dual antiplatelet therapy after DES implantation,” said Ajay Kirtane, M.D., director, New York-Presbyterian Hospital/Columbia University Cardiac Catheterization Laboratories, associate professor of medicine at Columbia University. “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.”
To date, more than 20,000 patients have been studied in Medtronic clinical trials that have addressed DAPT duration.The Resolute Onyx DES received CE (Conformité Européene) Mark in September 2014 and FDA approval in April 2017.
“This large-scale clinical study will help address an unmet need as high bleeding risk patients have been largely underrepresented in previous studies looking at shorter DAPT duration,” added David Kandzari, M.D., director of interventional cardiology and chief scientific officer, Piedmont Heart Institute in Atlanta, Ga., and co-principal investigator in the study.
[i] The Onyx ONE Clear Study will also include patients medically unsuitable for more than one-month DAPT treatment.