Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
Department of Health Technology and Services Research, Faculty BMS, Technical Medical Center, University of Twente, Enschede, The Netherlands.
Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E188-E196. doi: 10.1002/ccd.29594. Epub 2021 Mar 10.
To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents.
In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx.
This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods.
Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; p = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; p = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053).
Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes.
比较急性心肌梗死（MI）与非 MI 临床综合征患者接受药物洗脱支架（DES）治疗的 2 年结局。在急性 MI 患者中，进行了支架水平的比较，比较了 Resolute Onyx 与 Orsiro 支架。
在发生急性 MI 的患者中，报告了更高的不良事件发生率。迄今为止，尚未发表接受 Resolute Onyx 治疗的急性 MI 患者超过 1 年的临床结果。
这项对随机 BIONYX 试验（NCT02508714）的事后分析评估了主要结局靶血管失败（TVF：心脏死亡、靶血管 MI 或靶血管血运重建），使用 Kaplan-Meier 方法。
在所有 2488 名试验参与者中，急性 MI 患者（n=1275[51.2%]）明显比非 MI 患者（n=1213[48.8%]）年轻且合并症较少。急性 MI 患者的 TVF 发生率较低（77/1275[6.1%]比 103/1213[8.6%]，HR：0.70，95%-CI 0.52-0.94；p=0.02），主要归因于靶血管血运重建（4.1%比 6.1%，p=0.03）。多变量分析显示，临床综合征与 TVF 无独立关联（调整后 HR：0.81，95%-CI 0.60-1.10；p=0.17）。在接受 Resolute Onyx（n=626）与 Orsiro（n=649）治疗的 MI 患者中，TVF（6.2%比 6.1%；p=0.97）及其组成部分没有差异。在 RO-ZES 中只有 1 例（0.2%）为确定或可能的支架血栓形成，而在 O-SES 中则有 8 例（1.2%）（p=0.053）。
在这项随机试验中，接受薄壁 DES 治疗 2 年后，接受治疗的急性 MI 患者的不良事件发生率低于非 MI 患者。然而，这些发现主要归因于患者和病变特征的组间差异。在接受经皮冠状动脉介入治疗（PCI）的急性 MI 患者中，Resolute Onyx 和 Orsiro 均显示出良好且相似的 2 年结局。
