Elvin Kedhi1, Azeem Latib2, Alexandre Abizaid3, David Kandzari4, Ajay J Kirtane5, Roxana Mehran6, Matthew J Price7, Daniel Simon8, Stephen Worthley9, Azfar Zaman10, Sandeep Brar11, Minglei Liu11, Gregg W Stone5, Stephan Windecker12. 1. Isala Hartcentrum, Zwolle, the Netherlands. Electronic address: e.kedhi@isala.nl. 2. Department of Cardiology, Montefiore Medical Center, New York, NY. 3. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. 4. Piedmont Atlanta Hospital, Atlanta, GA. 5. Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY. 6. Department of Cardiology, Mount Sinai Medical Center, New York, NY. 7. Department of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA. 8. University Hospitals Cleveland Medical Center, Cleveland, OH. 9. Royal Adelaide Hospital, Adelaide, Australia. 10. Freeman Hospital and Newcastle University, Newcastle upon Tyne, UK. 11. Medtronic, Santa Rosa, CA. 12. Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
Abstract
BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month 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-monthDAPT 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. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either thedurable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point 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 after the 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.
RCT Entities:
BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month 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. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point 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 after the 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.
Authors: David E Kandzari; Ajay J Kirtane; Stephan Windecker; Azeem Latib; Elvin Kedhi; Roxana Mehran; Matthew J Price; Alexandre Abizaid; Daniel I Simon; Stephen G Worthley; Azfar Zaman; James W Choi; Ronald Caputo; Mihir Kanitkar; Brent McLaurin; Srinivasa Potluri; Timothy Smith; Douglas Spriggs; Thaddeus Tolleson; Tamim Nazif; Maria Parke; Lilian C Lee; Te-Hsin Lung; Gregg W Stone Journal: Circ Cardiovasc Interv Date: 2020-11-10 Impact factor: 6.546