Why the study?
The safety and efficacy of the newer-generation durable-polymer Resolute Onyx DES compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown.
Does the durable-polymer Resolute Onyx DES improve outcomes compared to the polymer-free BioFreedom DES in high-bleeding risk patients undergoing PCI with 1 month of DAPT?
Does the durable-polymer Resolute Onyx DES improve outcomes compared to the polymer-free BioFreedom DES in high-bleeding risk patients undergoing PCI with 1 month of DAPT?
The Onyx ONE trial will provide the first direct comparison of a durable-polymer DES versus a polymer-free DES in high-bleeding risk patients treated with 1 month of DAPT.
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Resolute Onyx meets noninferiority to polymer-free DES for safety and efficacy with 1-month DAPT in HBR patients; extends stent options in this population.
Kedhi et al. (2019) studied this question.
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