Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention.
The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent thrombosis following DAPT interruption or discontinuation after one month with a next-gen drug-eluting stent, according to Medtronic.
“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,” Dr. Gregg Stone, professor of medicine at Columbia University and program chair of the Onyx One Month DAPT Program, said in prepared remarks.
“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,” Stone added.
Medtronic’s Onyx One Clear study is slated to assess participants prescribed one month of DAPT – a combination of aspirin and an anti-clotting medicine – after PCI with the Resolute Onyx device.
“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,” Dr. David Kandzari, director of interventional cardiology & chief scientific officer at the Piedmont Heart Institute and co-principal investigator in the study, said.
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