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Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE
DC Field | Value | Language |
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dc.contributor.author | Windecker, Stephan | - |
dc.contributor.author | Latib, Azeem | - |
dc.contributor.author | Kedhi, Elvin | - |
dc.contributor.author | Kirtane, Ajay J. | - |
dc.contributor.author | Kandzari, David E. | - |
dc.contributor.author | Mehran, Roxana | - |
dc.contributor.author | Price, Matthew J. | - |
dc.contributor.author | Abizaid, Alexandre | - |
dc.contributor.author | Simon, Daniel I. | - |
dc.contributor.author | Worthley, Stephen G. | - |
dc.contributor.author | Zaman, Azfar | - |
dc.contributor.author | Hudec, Martin | - |
dc.contributor.author | Poliacikova, Petra | - |
dc.contributor.author | Kahar bin Abdul Ghapar, Abdul | - |
dc.contributor.author | Selvaraj, Kamaraj | - |
dc.contributor.author | Petrov, Ivo | - |
dc.contributor.author | Mylotte, Darren | - |
dc.contributor.author | Pinar, Eduardo | - |
dc.contributor.author | Moreno, Raul | - |
dc.contributor.author | Fabbiocchi, Franco | - |
dc.contributor.author | Pasupati, Sanjeevan | - |
dc.contributor.author | Kim, Hyo-Soo | - |
dc.contributor.author | Aminian, Adel | - |
dc.contributor.author | Tie, Charles | - |
dc.contributor.author | Wlodarczak, Adrian | - |
dc.contributor.author | Hur, Seung-Ho | - |
dc.contributor.author | Marx, Steven O. | - |
dc.contributor.author | Ali, Ziad A. | - |
dc.contributor.author | Parke, Maria | - |
dc.contributor.author | Lung, Te-Hsin | - |
dc.contributor.author | Stone, Gregg W. | - |
dc.date.accessioned | 2022-09-30T06:00:01Z | - |
dc.date.available | 2022-09-30T06:00:01Z | - |
dc.date.created | 2022-06-15 | - |
dc.date.issued | 2022-06 | - |
dc.identifier.citation | JACC: Cardiovascular Interventions, Vol.15 No.11, pp.1153-1163 | - |
dc.identifier.issn | 1936-8798 | - |
dc.identifier.uri | https://hdl.handle.net/10371/185115 | - |
dc.description.abstract | © 2022 American College of Cardiology FoundationBackground: 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 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. 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) | - |
dc.language | 영어 | - |
dc.publisher | Elsevier BV | - |
dc.title | Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.jcin.2022.04.010 | - |
dc.citation.journaltitle | JACC: Cardiovascular Interventions | - |
dc.identifier.scopusid | 2-s2.0-85130882807 | - |
dc.citation.endpage | 1163 | - |
dc.citation.number | 11 | - |
dc.citation.startpage | 1153 | - |
dc.citation.volume | 15 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Hyo-Soo | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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