Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Cardiac Research Centre and Centre for Heart Failure Research, University of Oslo, Oslo, Norway.
Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
J Am Coll Cardiol. 2021 Apr 20;77(15):1845-1855. doi: 10.1016/j.jacc.2021.02.049.
Prompt myocardial revascularization with percutaneous coronary intervention (PCI) reduces infarct size and improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). However, as much as 50% of the loss of viable myocardium may be attributed to the reperfusion injury and the associated inflammatory response.
This study sought to evaluate the effect of the interleukin-6 receptor inhibitor tocilizumab on myocardial salvage in acute STEMI.
The ASSAIL-MI trial was a randomized, double-blind, placebo-controlled trial conducted at 3 high-volume PCI centers in Norway. Patients admitted with STEMI within 6 h of symptom onset were eligible. Consenting patients were randomized in a 1:1 fashion to promptly receive a single infusion of 280 mg tocilizumab or placebo. The primary endpoint was the myocardial salvage index as measured by magnetic resonance imaging after 3 to 7 days.
We randomized 101 patients to tocilizumab and 98 patients to placebo. The myocardial salvage index was larger in the tocilizumab group than in the placebo group (adjusted between-group difference 5.6 [95% confidence interval: 0.2 to 11.3] percentage points, p = 0.04). Microvascular obstruction was less extensive in the tocilizumab arm, but there was no significant difference in the final infarct size between the tocilizumab arm and the placebo arm (7.2% vs. 9.1% of myocardial volume, p = 0.08). Adverse events were evenly distributed across the treatment groups.
Tocilizumab increased myocardial salvage in patients with acute STEMI. (ASSessing the effect of Anti-IL-6 treatment in Myocardial Infarction [ASSAIL-MI]; NCT03004703).
经皮冠状动脉介入治疗（PCI）即刻血运重建可缩小 ST 段抬高型心肌梗死（STEMI）患者的梗死面积，改善其预后。然而，多达 50%的存活心肌损失可能归因于再灌注损伤和相关的炎症反应。
本研究旨在评估白细胞介素-6 受体抑制剂托珠单抗对急性 STEMI 患者心肌挽救的影响。
ASSAIL-MI 试验是在挪威 3 家高容量 PCI 中心进行的一项随机、双盲、安慰剂对照试验。符合条件的患者为症状发作后 6 小时内入院的 STEMI 患者。同意参加的患者以 1:1 的比例随机迅速接受单次输注 280mg 托珠单抗或安慰剂。主要终点是磁共振成像（MRI）在 3 至 7 天后测量的心肌挽救指数。
我们将 101 例患者随机分为托珠单抗组，98 例患者分为安慰剂组。托珠单抗组的心肌挽救指数大于安慰剂组（校正组间差异为 5.6[95%置信区间：0.2 至 11.3]个百分点，p=0.04）。托珠单抗组的微血管阻塞程度较轻，但托珠单抗组与安慰剂组之间的最终梗死面积无显著差异（心肌体积的 7.2%对 9.1%，p=0.08）。不良事件在治疗组之间均匀分布。
托珠单抗可增加急性 STEMI 患者的心肌挽救。（评估抗白细胞介素-6 治疗对心肌梗死的影响[ASSAIL-MI]；NCT03004703）。
