Windecker Stephan, Latib Azeem, Kedhi Elvin, Kirtane Ajay J, Kandzari David E, Mehran Roxana, Price Matthew J, Abizaid Alexandre, Simon Daniel I, Worthley Stephen G, Zaman Azfar, Hudec Martin, Poliacikova Petra, Kahar Bin Abdul Ghapar Abdul, Selvaraj Kamaraj, Petrov Ivo, Mylotte Darren, Pinar Eduardo, Moreno Raul, Fabbiocchi Franco, Pasupati Sanjeevan, Kim Hyo-Soo, Aminian Adel, Tie Charles, Wlodarczak Adrian, Hur Seung-Ho, Marx Steven O, Ali Ziad A, Parke Maria, Lung Te-Hsin, Stone Gregg W
Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Montefiore Medical Center, New York, New York, USA.
JACC Cardiovasc Interv. 2022 Jun 13;15(11):1153-1163. doi: 10.1016/j.jcin.2022.04.010.
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.
This study reports the final 2-year results of the randomized Onyx ONE trial.
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 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.
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).
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).
在接受1个月双联抗血小板治疗（DAPT）随后1年单联抗血小板治疗（SAPT）的高出血风险（HBR）患者中，基于Resolute Onyx聚合物的佐他莫司洗脱支架（ZES）在安全性和有效性方面不劣于无聚合物的生物雷帕霉素A9涂层支架（DCS）。
本研究报告随机化的Onyx ONE试验的最终2年结果。
Onyx ONE（一项针对高出血风险患者使用Resolute Onyx进行1个月双联抗血小板治疗的随机对照试验）将HBR患者随机分配接受ZES或DCS治疗。在1个月DAPT后，无事件患者接受SAPT（由医生决定使用阿司匹林或P2Y抑制剂）。主要安全终点为1年时的心源性死亡、心肌梗死或支架血栓形成的复合终点，在1年时确定。在2年最终随访后计算主要和次要终点的发生率。
共有1003例患者被随机分配至ZES组，993例患者被分配至DCS组。2年时，980例（97.7%）ZES组患者和962例（96.9%）DCS组患者完成随访。2年时，ZES组208例（21.2%）患者和DCS组199例（20.7%）患者发生主要安全终点（风险差异：0.5%；95%CI：-3.1%至4.2%；P = 0.78），复合终点各单项成分无显著差异。次要有效性终点在ZES组217例（22.1%）患者和DCS组202例（21.0%）患者中出现（风险差异：1.1%；95%CI：-2.5%至4.8%；P = 0.54）。
在接受1个月DAPT随后SAPT治疗的HBR患者中，基于Resolute Onyx聚合物的ZES与无聚合物的BioFreedom DCS相比，在主要安全终点和次要有效性终点方面2年结局相似。（一项针对高出血风险患者使用Resolute Onyx进行1个月双联抗血小板治疗的随机对照试验[Onyx ONE]；NCT03344653）
