急性心肌梗死患者PCI延时与无延时应用比伐芦定的对照研究

Randomised controlled trial of delayed versus undelayed bivalirudin in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

目的评价急性心肌梗死(AMI)患者接受经皮冠状动脉介入治疗(PCI)时无延时比伐芦定联合仅冠脉内替罗非班方案的疗效和安全性。方法选取2020年4月—2021年3月蚌埠市第二人民医院心内科收治的150例AMI患者,采用随机数字表法随机分为2组:试验组(无延时组,75例)和对照组(延时组,75例)。观察2组患者术后TIMI血流分级(TFG)及校正的TIMI血流帧数计数(cTFC),术后90 min心电图ST段回落(STR)情况,术后第7天心功能指标,术后30 d内所有出血事件及术后30 d主要不良心血管事件(MACE)。结果2组TFG、cTFC、术后90 min心电图STR(Z=0.524,P=0.770)、MACE(1.3%vs.0,P=0.999)、左心室射血分数[(49.5±6.6)vs.(50.6±5.7),t=-1.092,P=0.276]、左心室舒张末期内径[(50.0±8.9)mm vs.(51.2±7.6)mm,t=-0.888,P=0.376]及室壁运动异常(86.7%vs.90.1%,χ^(2)=0.597,P=0.440)比较,差异均无统计学意义。试验组30 d内出血事件显著少于对照组,差异有统计学意义(5.3%vs.18.7%,χ^(2)=6.221,P=0.035)。结论对于急性心肌梗死接受直接PCI的患者,无延时比伐芦定联合仅冠脉内替罗非班方案,疗效确定且具有更佳的安全性,是临床实践中可供选择的治疗方案。

Objective To evaluate the efficacy and safety of undelayed bivalirudin combined with intracoronary tirofiban only during primary percutaneous coronary intervention(PCI)in patients with acute elevation myocardial infarction(AMI).Methods A total of 150 patients with AMI admitted to the Department of Cardiology,Bengbu Second People's Hospital from April 2020 to March 2021 were selected and randomly divided into two groups:the experimental group(n=75)and the control group(n=75).Postoperative TIMI flow grade(TFG),corrected TIMI frame count(cTFC),90 min postoperative ST segment resolution(STR),postoperative cardiac function parameters,any bleeding events and major adverse cardiovascular events(MACEs)after 30 days were recorded and analysed after completion of primary PCI.Results No significant differences between the two groups were found in terms of the TFG,cTFC,STR(Z=0.524,P=0.770),MACE(1.3%vs.0,P=0.999),left ventricular ejection fraction[(49.5±6.6)%vs.(50.6±5.7)%,t=-1.092,P=0.276],left ventricular end-diastolic dimension[(50.0±8.9)mm vs.(51.2±7.6)mm,t=-0.888,P=0.376]and regional wall motion abnormality(86.7%vs.90.1%,χ^(2)=0.597,P=0.440).The bleeding events in the experimental group were significantly less than those in the control group,and the difference was statistically significant(5.3%vs.18.7%,χ^(2)=6.221,P=0.035).Conclusion The undelayed bivalirudin combined with intracoronary tirofiban only strategy,which is associated with good safety demonstrated by reduced bleeding events,is an alternative regimen for patients with AMI undergoing primary PCI.