Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.
| Autor: | Windecker S; Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch., Latib A; Montefiore Medical Center, New York, New York, USA., Kedhi E; Clinique Hopitaliere Erasme, Université Libre de Bruxelles, Brussels, Belgium., Kirtane AJ; Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA., Kandzari DE; Piedmont Heart Institute, Atlanta, Georgia, USA., Mehran R; Mount Sinai Medical Center, New York, New York, USA., Price MJ; Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA., Abizaid A; Instituto do Coracao, São Paulo, Brazil., Simon DI; University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA., Worthley SG; GenesisCare Cardiology, Alexandria, Australia., Zaman A; Freeman Hospital, Newcastle University, Newcastle upon Tyne, United Kingdom., Hudec M; Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia., Poliacikova P; Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia., Kahar Bin Abdul Ghapar A; Hospital Serdang, Kajang, Malaysia., Selvaraj K; Hospital Serdang, Kajang, Malaysia., Petrov I; Acibadem City Clinic, Sofia, Bulgaria., Mylotte D; Galway University Hospitals, Galway, Ireland., Pinar E; Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Spain., Moreno R; Hospital de la Paz Institute for Health Research, Hospital Universitario La Paz, Madrid, Spain., Fabbiocchi F; Centro Cardiologico Monzino IRCCS, Milan, Italy., Pasupati S; Waikato Hospital, Hamilton, New Zealand., Kim HS; Seoul National University Hospital, Seoul, Republic of Korea., Aminian A; Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium., Tie C; St Andrew's Hospital, Adelaide, Australia., Wlodarczak A; Miedziowe Centrum Zdrowia, Lubin, Poland., Hur SH; Keimyung University Dongsan Medical Center, Daegu, Republic of Korea., Marx SO; Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA., Ali ZA; St. Francis Hospital and Heart Center, Roslyn, New York, USA; Cardiovascular Research Foundation, New York, New York, USA., Parke M; Medtronic, Santa Rosa, California, USA., Lung TH; Medtronic, Santa Rosa, California, USA., Stone GW; Cardiovascular Research Foundation, New York, New York, USA; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. |
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| Jazyk: | angličtina |
| Zdroj: | JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2022 Jun 13; Vol. 15 (11), pp. 1153-1163. |
| DOI: | 10.1016/j.jcin.2022.04.010 |
| Abstrakt: | Background: Resolute 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. Objectives: This study reports the final 2-year results of the randomized Onyx ONE trial. Methods: The 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 P2Y Results: A 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). Conclusions: Among 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). Competing Interests: Funding Support and Author Disclosures The Onyx ONE trial was sponsored by Medtronic. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; served as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, CardioValve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; and has served as a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Latib has received consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. Dr Kedhi has received speaker honoraria and institutional grants from Medtronic and Abbott Vascular. Dr Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, and Neurotronic (in addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content); has served as a consultant for IMDS; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Kandzari has received institutional research or grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Orbus Neich, Medtronic, and Ablative Solutions; and has received personal consulting honoraria from Cardiovascular Systems, Magenta Medical, and Medtronic. Dr Mehran has received institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; has received consulting fees from Abbott Laboratories, Boston Scientific, CardiaWave, Chiesi, Cine-Med Research, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; has received consultant fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; has served on the advisory board, with funding paid to the institution, for Spectranetics/Philips/Volcano Corp; has a spouse who has served as a consultant for Abiomed, The Medicines Company, Merck; Equity <1% from Claret Medical, Elixir Medical, Applied Therapeutics, and STEL; has received Data Safety and Monitoring Board Membership fees paid to the institution from Watermark Research Partners; has served as a consultant (no fee) for Idorsia Pharmaceuticals and Regeneron Pharmaceuticals; and has served as an Associate Editor for the American College of Cardiology and the American Medical Association. Dr Price has received consulting fees and speaker honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Medtronic; and has received consulting fees from Acutus, Baylis Medical, and W.L. Gore. Dr Simon has received honoraria for serving as a course director (<$10,000) from Medtronic. Dr Worthley has received institutional grant or research support from Abbott and Biotronik. Dr Zaman has received consulting fees from Abbott, Boston Scientific, Medtronic, Meril, SMT, and Terumo. Dr Petrov has received consulting, proctor, or speaker fees from Medtronic, Edwards, Philips, Cardiatis, Boehringer Ingelheim, Servier, and Pfizer. Dr Mylotte has received consulting fees from Medtronic, Boston Scientific, and MicroPort. Dr Moreno has received lecture or consulting fees from Medtronic, Biosensors, Abbott Vascular, Boston Scientific, Terumo, and Braun. Dr Pasupati has received consulting, proctor, or speaker fees from Medtronic, Edwards, Boston Scientific, JenaValve, BioExcel, Boehringer Ingelheim, and Pfizer. Dr Kim has received research grants through Seoul National University Hospital from Abbott, Medtronic, Biotronik, B. Braun, and Daiichi-Sankyo; and has received lecture and consulting fees from Edwards Lifesciences, Medtronic, Novartis, Pfizer, Daiichi-Sankyo, AmGen, AstraZeneca, and Boehringer Ingelheim. Dr Tie has received speaker fees from Boehringer Ingelheim, outside the submitted work. Dr Hur has received research grants from Boston Scientific and Terumo. Dr Marx has received an honorarium for Clinical Events Committee membership from the Cardiovascular Research Foundation. Dr Ali has received institutional grant support from Abiomed, Acist Medical, Abbott, Boston Scientific, Cardiovascular Systems, Philips, and Opsens Medical; has received consulting or advisory fees from Amgen and Boston Scientific; has received speaker honoraria from AstraZeneca; and owns equity in Shockwave Medical. Ms. Parke and Dr Lung are employees of Medtronic. Dr Stone has received speaker honoraria from Cook, Infraredx, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and owns equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and the MedFocus family of funds. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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