Medtronic Begins 1-Month DAPT Clinical Study in the United States and Japan
September 13, 2018—Medtronic announced the start of the Onyx ONE Clear study in the United States and Japan. Onyx ONE Clear will evaluate 1-month dual antiplatelet therapy (DAPT; a combination of aspirin and an anticlotting medication) in high bleeding-risk patients implanted with the next-generation Resolute Onyx drug-eluting stent (DES) during percutaneous coronary intervention. The study will also include patients medically unsuitable for more than 1-month DAPT.
The study will investigate safety (including risk of cardiac death, heart attack, and stent thrombosis) after DAPT interruption or discontinuation at 1 month after DES treatment.
The design of the study is similar to the randomized Onyx ONE Global study, which began enrollment in late 2017. The 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. The Resolute Onyx DES received European CE Mark approval in September 2014 and FDA approval in April 2017.
Gregg W. Stone, MD, who serves as Program Chair of the Onyx ONE Month DAPT Program, commented in Medtronic's announcement, "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 1-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 antiplatelet therapy."
Ajay Kirtane, MD, added, "As newer-generation DESs 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 DES 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."
Finally, the study's coprincipal investigator David Kandzari, MD, noted, "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."