在接受直接经皮冠状动脉介入治疗的ST段抬高型心肌梗死（COAT-STEMI）患者中，冠状动脉内给予他克莫司可改善心肌灌注和左心室功能。
Intra-Coronary Administration of Tacrolimus Improves Myocardial Perfusion and Left Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction (COAT-STEMI) Undergoing Primary Percutaneous Coronary Intervention.
作者信息
Sung Pei-Hsun, Huang Wei-Chun, Chao Ting-Hsing, Lee Cheng-Han, Yang Teng-Yao, Lin Yu-Sheng, Chang Rei-Yeuh, Chong Jun-Ted, Yang Cheng-Hsu, Chen Chieh-Jen, Chung Sheng-Ying, Hsueh Shu-Kai, Wu Chiung-Jen, Yip Hon-Kan
机构信息
Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine.
Institute for Translational Research in Biomedicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine.
出版信息
Acta Cardiol Sin. 2021 May;37(3):239-253. doi: 10.6515/ACS.202105_37(3).20201025C.
BACKGROUND
Ischemia-reperfusion injury following acute ST-segment elevation myocardial infarction (STEMI) is strongly related to inflammation. However, whether intracoronary (IC) tacrolimus, an immunosuppressant, can improve myocardial perfusion is uncertain.
METHODS
A multicenter double-blind randomized controlled trial was conducted in Taiwan from 2014 to 2017. Among 316 STEMI patients with Killip class ≤ 3 undergoing primary percutaneous coronary intervention (PCI), 151 were assigned to the study group treated with IC tacrolimus 2.5 mg to the culprit vessel before first balloon inflation, and the remaining 165 were assigned to the placebo group receiving IC saline only. The primary endpoint was percentage of post-PCI TIMI-3 flow. The primary composite endpoints included achievement of TIMI-3 flow, TIMI- myocardial perfusion (TMP) grade, or 90-min ST-segment resolution (STR). The secondary endpoints were left ventricular ejection fraction (LVEF) and 1-month/1-year major adverse cardio-cerebral vascular events (MACCEs) (defined as death, myocardial infarction, stroke, target-vessel revascularization or re-hospitalization for heart failure).
RESULTS
Although post-PCI TIMI-3 epicardial flow and MACCE rate at 1 month and 1 year did not differ between the two groups, TMP grade (2.54 vs. 2.23, p < 0.001) and 90-min STR (67% vs. 61%, p < 0.001) were significantly higher in the tacrolimus-treated group than in the placebo group. The STEMI patients treated with tacrolimus also had significantly higher 3D LVEF and less grade 2 or 3 LV diastolic dysfunction at 9 months compared to those without.
CONCLUSIONS
IC tacrolimus for STEMI improved coronary microcirculation and 9-month LV systolic and diastolic functions. However, the benefit of tacrolimus on clinical outcomes remains inconclusive due to insufficient patient enrollment.
背景
急性ST段抬高型心肌梗死（STEMI）后的缺血再灌注损伤与炎症密切相关。然而，免疫抑制剂冠状动脉内（IC）注射他克莫司是否能改善心肌灌注尚不确定。
方法
2014年至2017年在台湾进行了一项多中心双盲随机对照试验。在316例接受直接经皮冠状动脉介入治疗（PCI）且Killip分级≤3级的STEMI患者中，151例被分配到研究组，在首次球囊扩张前向罪犯血管内注射2.5mg他克莫司，其余165例被分配到安慰剂组，仅接受冠状动脉内注射生理盐水。主要终点是PCI术后TIMI-3级血流的百分比。主要复合终点包括达到TIMI-3级血流、TIMI心肌灌注（TMP）分级或90分钟ST段回落（STR）。次要终点是左心室射血分数（LVEF）和1个月/1年主要不良心脑血管事件（MACCE）（定义为死亡、心肌梗死、中风、靶血管血运重建或因心力衰竭再次住院）。
结果
尽管两组之间PCI术后TIMI-3级心外膜血流以及1个月和1年时的MACCE发生率没有差异，但他克莫司治疗组的TMP分级（2.54对2.23，p<0.001）和90分钟STR（67%对61%，p<0.001）显著高于安慰剂组。与未接受他克莫司治疗的STEMI患者相比，接受他克莫司治疗的患者在9个月时3D LVEF也显著更高，2级或3级左心室舒张功能障碍更少。
结论
STEMI患者冠状动脉内注射他克莫司可改善冠状动脉微循环以及9个月时的左心室收缩和舒张功能。然而，由于入组患者不足，他克莫司对临床结局的益处仍不确定。
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