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冠状动脉内注射尿激酶原或替罗非班对急性心肌梗死直接经皮冠状动脉介入治疗时冠状动脉血流的影响:一项多中心、安慰剂对照、单盲、随机临床试验

Effects of Intracoronary Pro-urokinase or Tirofiban on Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction: A Multi-Center, Placebo-Controlled, Single-Blind, Randomized Clinical Trial.

作者信息

Huang Dong, Qian Juying, Liu Zongjun, Xu Yawei, Zhao Xianxian, Qiao Zengyong, Fang Weiyi, Jiang Li, Hu Wei, Shen Chengxing, Liang Chun, Zhang Qi, Ge Junbo

机构信息

Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Cardiology, Putuo District Central Hospital, Shanghai, China.

出版信息

Front Cardiovasc Med. 2021 Aug 2;8:710994. doi: 10.3389/fcvm.2021.710994. eCollection 2021.

Abstract

To determine whether intracoronary pro-urokinase or tirofiban improves myocardial reperfusion during primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI). The study included patients with acute STEMI presenting within 12 h of symptoms at 11 hospitals in China between November 2015 and July 2017. Patients were randomized to receive selective intracoronary infusion of recombinant pro-urokinase (20 mg), tirofiban (10 μg/kg), or saline (20 mL) proximal to the infarct-related lesion over a 3-min period before stent implantation during primary PCI. The primary outcome was final corrected thrombolysis in myocardial infarction (TIMI) frame count (CTFC) after PCI. This study included 345 patients. Initial angiography identified a high-grade thrombus (TIMI 4-5) in 80% of patients. Final CTFC after PCI was significantly lower in the pro-urokinase ( < 0.001) and tirofiban ( < 0.001) groups than in the saline group and similar between the pro-urokinase and tirofiban groups ( > 0.05). The pro-urokinase ( = 0.008) and tirofiban groups ( = 0.022) had more complete ST-segment resolution at 2 h and lower peak creatine kinase-MB levels after PCI than the saline group ( = 0.006 and = 0.023). The 30-day incidence of major adverse cardiac events was 4.5% in the pro-urokinase group, 3.4% in the tirofiban group, and 2.6% in the saline group. The incidence of in-hospital TIMI major bleeding events was low and comparable between groups. Adjunctive intracoronary pro-urokinase or tirofiban given before stent implantation during primary PCI improves myocardial reperfusion without increasing the incidence of major bleeding events.

摘要

旨在确定在急性ST段抬高型心肌梗死(STEMI)的直接经皮冠状动脉介入治疗(PCI)期间,冠状动脉内注射重组人尿激酶原或替罗非班是否能改善心肌再灌注。该研究纳入了2015年11月至2017年7月期间在中国11家医院症状发作12小时内就诊的急性STEMI患者。在直接PCI期间支架植入前3分钟内,患者被随机分配接受梗死相关病变近端选择性冠状动脉内输注重组人尿激酶原(20 mg)、替罗非班(10 μg/kg)或生理盐水(20 mL)。主要结局是PCI术后最终校正的心肌梗死溶栓(TIMI)帧数(CTFC)。本研究共纳入345例患者。初始血管造影显示80%的患者存在高度血栓(TIMI 4 - 5级)。PCI术后最终CTFC在重组人尿激酶原组(<0.001)和替罗非班组(<0.001)显著低于生理盐水组,且重组人尿激酶原组和替罗非班组之间相似(>0.05)。重组人尿激酶原组(=0.008)和替罗非班组(=0.022)在PCI术后2小时ST段更完全回落,且肌酸激酶同工酶峰值水平低于生理盐水组(=0.006和=0.023)。重组人尿激酶原组主要不良心脏事件30天发生率为4.5%,替罗非班组为3.4%,生理盐水组为2.6%。住院期间TIMI大出血事件发生率低,且各组之间相当。在直接PCI期间支架植入前给予冠状动脉内注射重组人尿激酶原或替罗非班可改善心肌再灌注,且不增加大出血事件发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0492/8364959/3b101a10b601/fcvm-08-710994-g0001.jpg

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