Comparison Of Half-Dose Rh-ProUK Thrombolysis Combined With PCI And Primary PCI In STEMI

Objective:To compare the effect of early percutaneous coronary intervention(PCI)after thrombolysis with half-dose recombinant human prourokinase(rh Pro-UK)with primary PCI in patients with ST-segment elevation myocardial infarction(STEMI).Methods:1 Research objectsThis study was a prospective,single-center,open-label,randomized,controlled trials.The research object were the patients who were diagnosed with STEMI and planed to get the early reperfusion therapy in Chengde Central Hospital from October 2019 to October 2020.Quasi random number method was used to selected patients divided into PCI after half-dose thrombolysis group(experiment group)and primary PCI group(control group).Inclusion criteria:(1)meeting STEMI diagnostic criteria: typical symptoms of ischemic chest pain and ECG changes:(1)at least 2 adjacent leads have new ST-segment elevation at J point,≥0.2m V for male or ≥0.15 m V for female in V2-V3 or other adjacent thoracic or limb leads ≥0.1m V;(2)necrotic Q wave;(3)new or suspected new left bundle branch block;(4)ST segment depression in multi-lead combined with elevation in a VR;(5)evolution of ischemic T wave;(2)STEMI was within 12 hours of onset;(3)vital signs,hemodynamics and ECG stability;(4)willing for early reperfusion therapy.Exclusion criteria:(1)more than 80-year-old;(2)with high risk of bleeding and other contraindications for thrombolysis;(3)recurrent myocardial infarction at the same area;(4)with severe hepatic and renal insufficiency;(5)malignant tumor;(6)revious allergy to iodine contrast agent or thrombolytic agent.2 Research methods2.1 Basic treatmentAll patients were given basic treatment as aspirin 300 mg,ticagrelor 180 mg or clopidogrel 300 mg after diagnosis immediately.Nitrates,beta blockers,and angiotensin-converting enzyme inhibitors would be used depending on the condition.2.2 Experiment groupThe patients were firstly injected with heparin by intravenous with the dose of 60U/kg and 4000 U maximum.Then 10 mg rh Pro-UK was administered through a separate venous access within 3 min,and the remaining 15 mg rh Pro-UK was completed by intravenous infusion within 30 min.Activated partial thromboplastin time(APTT)was monitored every 4hours during 24 hours in thrombolysis,and was maintained at 1.5～2.0 times of the normal level(about 50～70 s).The thrombolysis outcome was assessed90 min after the initiation of thrombolysis.Diagnostic criteria for successful thrombolysis include:(1)ST-segment regression of ECG elevation≥50%;(2)disappearance of the symptoms with chest pain;(3)reperfusion arrhythmia;(4)the peak of serum creatine kinase was advanced.Patients with successful thrombolysis would receive diagnostic coronary angiography within 3-24 hours after thrombolysis,and PCI treatment was decided according to the angiography results.Patients with failed thrombolysis were immediately given rescue PCI.2.3 Control groupAdditional 300 mg clopidogrel was added to clopidogrel users and no more additional dose to the ticagrelor users.A dose of 5000 U heparin mainline was given to the patients after enrolled.After the contrast agent skin test,the patients were transferred to the catheterization room.Patients who were confirmed by coronary angiography to need further PCI were given heparin supplement to 100U/kg.The infarction related vascular blood flow condition would be assessed during the coronary angiography procedure.PCI would be practiced if vascular occlusion(TIMI =0 or 1),patency but with slow reflow(TIMI=2)or normal flow(TIMI=3)but with more than 75% stenosis in coronary.2.4 Coronary angiographyCoronary arteriography was performed in the catheterization room of our hospital.Seldinger method was used to the angiography with multiple position via radial artery or femoral artery for patients.The results of the angiography would be assessed by at least two doctors with years of experience and with the title above associate chief physicians.For patients with obvious coronary stenosis or occlusion would receive PCI treatment after consent in he or herself and the relatives.After the angiography or PCI treatment,all patients were admitted to the department of cardiology of our hospital for further treatment.3 Observation indexes3.1 Clinical data indicatorsAll clinical data including gender,age,ischemic time,symptom characteristics,history of hypertension,diabetes,cerebral infarction,history of smoking and drinking,family history of coronary heart disease,height and weight were collected within 2 hours after admission.3.2 Cardiac ultrasound resultsThe results included left atrial diameter,left ventricle,left ventricular ejection fraction,ventricular aneurism,etc.Re-examined by the same physician and the same machine before discharge.3.3 Laboratory indicatorsWithin 24 hours after admission,routine examination of blood,urine and stool,blood group,electrolyte level,blood lipid indexes,liver and kidney function,thyroid function,brain natriuretic peptide(BNP)level,myocardial enzymology and other laboratory tests were completed.3.4 Medication status,vital signs,major cardiovascular adverse events(MACE),bleeding events,hospital duration and cost during hospitalization were recorded.4 Statistical methodAll data were statistically analyzed using SPSS 23.0 software.Measurement data were first tested to see if they were normally distributed.Continuous variables that were normally distributed were represented as mean±standard deviation(`x±s).When homogeneity of variance was met,t-test was used for inter-group comparison or corrected t-test was used.Data that do not follow normal distribution would be represented by median(quaternary)[M,(Q1,Q3)],and be compared by non-parametric test.Enumerative data would be presented as binary counting.Chi-square test was used for comparison between groups,and Fisher’s exact probability test was used when the theoretical frequency within the group was less than 5.A P value of < 0.05 was considered significant.Results:1 A total of 101 patients were included in this study,including 48 in the experiment group and 53 in the control group,with an overall age of 58.81±10.69 years old and 81 males.2 Clinical baseline data: The age of the experiment group was 58.05±9.13 years old,with 40 males.The control group was 59.29±11.61 years old,with41 males.There showed no statistical significance in previous medical history,tobacco and alcohol history,obesity,infarction area,Killip grade and other clinical baseline data(all P value > 0.05).3 Vital signs: There were no significant differences in the mean systolic blood pressure,diastolic blood pressure and ventricular rate between the two groups(all P value >0.05).4 Echocardiography: There were no significant differences in left atrial diameter,left ventricular diameter,left ventricular ejection fraction and ventricular aneurysm between the two groups in initial examination after admission and re-examination before discharge(all P value > 0.05).5 Laboratory indicators: The analysis showed that Hb(P value =0.024)and BNP(P value <0.001)were statistical different,and no statistical significance in the white blood cells,blood lipid,creatinine and other data(all P value > 0.05).6 Medication: There was no statistical difference in drug use between the two groups(all P value > 0.05).But there was a growing trendency among the vasoactive agent.7 MACE and bleeding events: MACE included recurrence angina and recurrent myocardial infarction,severe arrhythmia,congestive heart failure,cardiogenic death.A total of 20 patients in the groups had MACE,9 cases in experiment group(3,0,4,2,0)and 11 cases in the control group(5,0,3,2,0),there was no statistically significant difference(P value = 0.801),and bleeding events in two groups were similar(2:3,P value = 0.73).8 Duration and cost: There were no significant differences in length of hospital duration and total cost between the two groups(P value =0.59,P value =0.327).Conclusion:Compared with primary PCI therapy,half-dose rh Pro-UK thrombolysis combined with PCI did not increase the incidence of MACE and bleeding events in STEMI patients during their hospitalization,and did not prolong the length of hospital duration or increase the economic burden of patients.The research were non-inferiority.The therapy of half-dose rh Pro-UK thrombolysis combined with PCI is worthy of further clinical study.