Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy

Abstract Background and Rationale. Polymer-free drug-eluting stent (DES) implantation in combination with 1-month DAPT has shown superior safety and efficacy outcomes compared with bare metal stents among patients with high-bleeding risk (HBR) treated with 1-month dual antiplatelet therapy (DAPT). The safety and efficacy of the newer generation durable-polymer DES Resolute Onyx™ compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. Trial Design. The Onyx ONE Global Randomized Trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention (PCI). The trial will randomize up to 2000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom™ ⁎ DES. Post-index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy (SAPT) thereafter. The primary endpoint is the composite endpoint of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary endpoint is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization) at 1 year. Patient follow-up is planned for 1, 2 and 6 months and 1 and 2 years post-procedure. Conclusions The Onyx ONE Global Randomized Trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1 month of DAPT.