| Background:Reducing or interrupting in coronary artery blood flow will induce acute myocardial infarction(AMI)and leads to the myocardial necrosis of the culprit vessel control area.The annual growth rate of AMI is 10.9% and the mortality rate goes up to 30% in China,and the patents of AMI tend to be younger.Therefore,it is urgent to improve the quality of medical treatment and strengthen the clinical research.Thrombolytic therapy and primary percutaneous coronary intervention(PPCI)are the mainly methods to open up the culprit vessel in patients with AMI.Numerous studies have demonstrated the latter is the preferred,which is timely and effectively realize myocardial reperfusion,save ischemic myocardium,and reduce the infarct size.However,it has been indicated in past studies that 30%-50% patients still cannot achieve effective myocardial reperfusion after PCI,even with TIMI 3 blood flow.The microcirculation reperfusion in myocardial in patients after PCI is closely related to cardiac function and clinical prognosis.Microcirculation embolism is an important factor to affect myocardial reperfusion,but it is almost inevitable during PCI.Myocardial reperfusion is seen as the ultimate goal in patients with ST-elevation myocardial infarction(STEMI)to save more ischemic myocardium,reduce infarct size,improve the quality of medical treatment and improve clinical prognosis.Myocardial contrast echocardiography(MCE)is an invasive detection method that obtain high-noising images via the special ultrasound imaging technology,which not only can observe the ventricle and analyze the ventricular wall motion,but also can observed the perfusion level of the microcirculation.While,it can quantitively concludes video intensity of peakvalue and the rate of signal via QLab software,then estimate the Myocardial Blood Flow(MBF)by the relationship between the myocardial video intensity and the rate of signal.Recombinant human pro-urokinase(rh-pro UK,Shanghai Tasly Pharmaceutical Co.,Ltd.)is the precursor of urokinase and has no activity in the blood,it mainly work on fibrin of thrombi and dissolute the fibrin through combine with fibrinolytic enzyme,Which is recommended for thrombolytic therapy of STEMI by the guidelines because of its better thrombolysis effect.Relevant researchers about application of rh-pro UK in coronary artery abroad are small sample size and have no clear curative effect.Therefore,we designed the study to investigate the impact of intracoronary administration of pro-urokinase via balloon catheter on myocardial reperfusion in STEMI patients undergoing primary PCI.Objective:To evaluate the effect of myocardial perfusion of patients with acute ST-segment elevation myocardial infarction(STEMI)and undergoing emergency coronary intervention by intracoronary prourokinase administration.Methods:1 Objects of study:STEMI Patients undergoing primary PCI were enrolled into study from January 2015 to December 2016.Inclusion criteria:(1)18-75 years old,gender not limited;(2)Symptom onset < 12 hours,indications for primary PCI,and without contraindication with thrombolysis;(3)Informed consent signed.Exclusion criteria:(1)Ischemic cerebral stroke within 3 months;(2)History of intracranial hemorrhage;(3)Active hemorrhage or hemorrhagic factors(including menstruation);(4)Suspicious aortic dissection;(5)Severe or uncontrolled hypertension(>180/110 mm Hg);(6)Patients with malignant tumor;(7)Severe trauma,major operation within 3weeks or vascular puncture that could not be controlled by compression;(8)Patients complicated with severe hepatic or renal dysfunction;(9)Patientsknown to be allergic to and contraindicated with pro-urokinase;(10)Patients after coronary artery bypass grafting.2 Methods:2.1 A total of 230 acute STEMI patients were randomly assigned into test group(n=118)to receive 10 ml(10mg)of pro-urokinase via balloon catheter at remote end of occlusive lesion,or control group(n=112)to receive saline of equal dose by the same way.2.2 Basic therapyAll included patients were given aspirin 300 mg and ticagrelor 180 mg before coronary angiography and a maintaining dose of aspirin 100 mg daily and ticagrelor 90 mg twice a day after operation.Other medications like statins,?-receptor blockers,ACEI or ARB,glycoprotein IIb/IIIa inhibitor,unfractionated heparin and angiotensin converting enzyme inhibitors were left to cardiologist according to the recommendation of guidelines.The patients were monitored by ECG,finger pulse oxygen and blood pressure after operation.2.3 Coronary angiographyRadial or femoral artery was punctured to perform coronary angiography and interventional therapy.After successful puncture,6F artery sheath was inserted,and 3000 U of heparin was injected through sheath.A 5F TIG multipurpose angiography catheter was used to perform coronary angiography.ECG and invasive blood pressure were continuously monitored during the operation.Heparin would be added at the dose of 70U/Kg if the PCI would be performed after coronary angiography.Guiding catheter was sent to the ostium of coronary artery,and guide wire was delivered to the distal segment of occlusive coronary artery.Balloon was sent along with the guide wire to the lesion and dilatated.Then the balloon was retreated and punctured a micropore on the membrane.The punctured balloon was sent to the remote end of occlusive artery,and pro-urokinase(10mg dissolved in 10 ml of normal saline,and injected within 3 min)or normal saline(10ml,injected within 3 min)was gradually injected through the balloon.When drug was injecting into coronaryartery,changes of blood pressure and heart rate/rhythm were closely observed.After drug injected,coronary angiography was performed,and stent was implanted if residual stenosis was more than 75%.3 Observation index(1)The resolution of ST segment after PCI.(2)Peak values of markers of myocardial injury.(3)Myocardial blood flow(MBF=AŚ?),time to peak and peak intensity.(4)Left ventricular ejection fraction,left ventricular end-diastolic diameter 1day and left ventricular Wall Motion Score Index 7 days and 1 month after operation.(5)TIMI flow grade after PCI.(6)Major Adverse Cardiac Events(MACE),including acute myocardial reinfarction,sudden cardiac death,cardiac insufficiency and postinfarction angina pectoris during 6 months of follow up.4 Statistical analysisSPSS17.0 software was used for analysis.The continuous variables were reported as means ± standard deviation(SD),and the categorical variables were presented as absolute values and percentages.Comparision of continuous variables were performed by student's t-test for normally distributed value or the Mann-Whitney U test for non-normally distributed values.The categorical variables were compared using chi-square test or Fisher's exact test.P<0.05 was considered statistically significant.Results:1 Basic clinical characteristics of study population: In this study,230 patients were enrolled,118 patients in test group and 112 patients in control group.No significant differences were observed in patients between two groups in gender,age,past history,risk factors,time from admission to balloon dilatation,time from onset of symptom to balloon dilatation,infarction related artery,number of stent implanted,application of IABP and temporary pacemaker(all P>0.05).2 Markers of myocardial injury and ECGThe level of myocardial enzymes in test group were obviously lower than those in control group(P<0.05).The resolution rates of ST segment was obviously more in test group compared with control group(P<0.05).3 Myocardial contrast echocardiography(MCE)resultsBetter results of PI and TP were found in test group compared with control group(P<0.05),the product of A and ? represents MBF was also better in test group than that in control group(P<0.05).4 Cardiac echocardiographyThe values of LVEF and LVEDd were not significantly different between two groups 1 day and 7 days after operation(P>0.05).LVEF in test group was higher than that in control group 1 month after operation(P<0.05).5 Bleeding complication and clinical follow upNone of patient was found intracranial hemorrhage in both two groups.There were 2 patients in test group and 1 patient in control group occurred local hematoma.All of local hematomas were occurred in femral artery puncture site.No significant differences of TIMI major or minor bleeding complication were observed in both two groups(P>0.05).Lower MACE events were found in test group,but there were still no statistical differences between two groups in MACE events during 1 and 6 months of follow up.Conclusion:1 The intracoronary administration of pro-urokinase can improved the myocardial perfusion for STEMI undergoing primary PCI.2 The intracoronary administration of pro-urokinase did not increase bleeding complications,suggesting that intracoronary pro-urokinase is safe... |
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