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Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE |
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| Institution: | 1. Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland;2. Montefiore Medical Center, New York, New York, USA;3. Clinique Hopitaliere Erasme, Université Libre de Bruxelles, Brussels, Belgium;4. Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA;5. Cardiovascular Research Foundation, New York, New York, USA;6. Piedmont Heart Institute, Atlanta, Georgia, USA;7. Mount Sinai Medical Center, New York, New York, USA;8. Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA;9. Instituto do Coracao, São Paulo, Brazil;10. University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA;11. GenesisCare Cardiology, Alexandria, Australia;12. Freeman Hospital, Newcastle University, Newcastle upon Tyne, United Kingdom;13. Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia;14. Hospital Serdang, Kajang, Malaysia;15. Acibadem City Clinic, Sofia, Bulgaria;p. Galway University Hospitals, Galway, Ireland;q. Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Spain;r. Hospital de la Paz Institute for Health Research, Hospital Universitario La Paz, Madrid, Spain;s. Centro Cardiologico Monzino IRCCS, Milan, Italy;t. Waikato Hospital, Hamilton, New Zealand;u. Seoul National University Hospital, Seoul, Republic of Korea;v. Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium;w. St Andrew''s Hospital, Adelaide, Australia;x. Miedziowe Centrum Zdrowia, Lubin, Poland;y. Keimyung University Dongsan Medical Center, Daegu, Republic of Korea;z. St. Francis Hospital and Heart Center, Roslyn, New York, USA;11. Medtronic, Santa Rosa, California, USA;22. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA |
| Abstract: | BackgroundResolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year.ObjectivesThis study reports the final 2-year results of the randomized Onyx ONE trial.MethodsThe Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years.ResultsA total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: ?3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: ?2.5% to 4.8%; P = 0.54).ConclusionsAmong patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy DAPT] for High-Bleeding Risk Patients Onyx ONE]; NCT03344653) |
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