| Objective: This trial was randomly and contrastly to explore thedifference of treatment effect and safety evaluation between full-dose andhalf-dose tirofiban joint elective PCI on patients with non-STsegment acutecoronary syndrome, through recording and comparing the revascularizationcircumstances, TIMI coronary flow level,myocardial blush perfusion(TIMImyocardial perfusion grading,TMPG),Corrected TIMI Frame Count(CTFC)during primary percutaneous coronary intervention, systolic and diastolicfunctions of left ventricle,the Platelet aggregation rate,the situation of anginato control after admission, bleeding complications and thrombocytopenia,major adverse cardiac events(MACE),in-hospital stay and charges.Methods: Total of163pateints with non-STsegment acute coronarysyndrome, include131male and32female,average age57.63±10.14(35-75)years old, were enrolled into this study from october2009to February2012.All of the patients were randomly divided into full-dose group andhalf-dose group. Tirofiban was intravenously administered in strict accordancewith the package insert and patient kilogram of body weight after allowed theinformed consent of relationships of patients. The full-dose group,83patients,10μg/kg loading dose in3min bolus,and then continuous intravenousinfusion of0.15μg/(kg. min) for24h after PCI and half-dose group,80patients,5μg/kg loading dose in3min bolus,and then continuous intravenousinfusion of0.075μg/(kg. min) for24h after PCI. The way to withdrawaltirofiban in the two groups was that gradually to reduce and overlapclopidogrel75mg by oral2hours before completely stopping it. Theconventional basis drug of the two groups: Aspirin300mg one time per day,Clopidogrel75mg one time per day,low molecular weight heparin5000u wasinjected subcutaneously two times per day. Such as adjuvant drug included: Nitroglycerin,ACEI,β-blocker,Statin and so on were administrated in all thepatients by conventional.3days after admission, all of the patients wereperformed coronary angiography and PCI treatment. We detailed collected andrecorded the two groups patients' based clinical data including sex, age,weight,risk factor and bleed biochemical index inculding glucose levels,bloodlipids,the platelet aggregation rate,creatine kinase isoenzyme (CK-MB) andtroponin I (cTnI). Cardiac function including NYHA classification, leftventricular end-diastolic volume (LVEDV), left ventricular end-systolicvolume(LVESV), left ventricular ejection fraction(LVEF)after PCI, Symptomcontrol in patients with angina pectoris after tirofiban administration,GRACErisk score,the observation situation of interventional treatment lncluding:theoccurrence of coronary TIMI3level flow,the CTFC after dilation withballoon,the TIMI3grade flow and TMPG myocardial blush perfusion gradeafter stenting. Inhospital and30days follow-up major adverse cardiacevents(MACE): malignant ventricular arrhythmia,severe heart failure,recurrent myocardial infarction,target vessel vascularization and cardiac death.Cardiogenic rehospitalization rate, the chage of hospitalization and the state ofcardiac function recovery. And the hospital bleeding events (according to theTIMI bleeding classification standards to assess the degree of bleeding) andthe incidence of thrombocytopenia were also observatived and compared.Finally, Statistical analysis was performed with the Statistical Package forthe Social Sciences SPSS (version13.0) software, we presented categoricalvariables as a percentage and compared groups with Chi-square tests orFishers exact probability, we presented continuous variables as means±standard deviation,and compared them with Student's T-test, the differencewas considered significant with P <0.05.Result:1Comparion of the clinical data at baseline between the two groups:Compared the basal constitution of sex, age,wight,the risk of coronaryheart disease, the smoker, diabetic patients, hyperlipidemia, the plateletaggregation rate, angina pectoris attacks and GRACE score, there was no significant difference between the two groups at baseline.2In full dose group(83patients),23patients were diagnosised withnon-ST segment elevation myocardial infarction (NSTEMI), in half groupthere were13patients diagnosised with NSTEMI, and there was nosignificant difference in ratio of the NSTEMI between the two groups.3The outcome of coronary angiography and PCI:Coronary angiography showed no significant difference on lesions relatedcoronary artery(IRA) and TIMI coronary flow grade(the incidence of TIMI1and TIMI2) between the two groups. Compared with the full group, theincidence of TIMI3(86.7%vs85.0%P=0.749) and the CTFC after balloondilatation(24.37±6.57vs.26.00±6.70, P=0.120)had no significant differencein half dose group. After PCI, the difference of TIMI coronary blood flowgrade of IRA between the two groups was no statistically significant (allP>0.05).4Comparion of cardiac function between the two groups:There was no statistically significant difference of cardiac function inLVEDV(129.82±31.95ml vs.132.89±29.42ml),LVESV(75.95±17.50ml vs.69.40±21.57ml) and LVEF (51.89±8.08%vs.54.56±7.48%) between the twogroups before PCI, all P>0.05．30days after PCI, we found that the volume ofLVEDV (119.82±29.85ml vs.121.79±28.42ml,P<0.05) and LVESV(60.05±16.50ml vs.61.10±20.56ml,P<0.05)in the two groups were bothsignificantly lower than that before PCI,and LVEF were significantly raisethan that before PCI(62.75±7.94%vs60.04±8.02%,P<0.05),and comparedwith that in half dose group, the full dose group was higher, but the differencehad no statistically significant(P>0.05).5Comparison of incidence about thrombocytopenia and bleeding compli-cations:There was a significant difference in the rate of bleeding between the twogroups. The incidence of TIMI minor bleeding were21.7%vs.7.5%,P=0.000. When undergoing PCI, the incidence of transradial puncture sitebleeding and forearm hematoma were3.6%vs.2.5%, P=0.000. One patient was found TIMI major bleeding in the full dose group(1.2%), while no casewas found in the half dose group,which was no statistically significantdifference. Thrombocytopenia was not found in both groups duringhospitalization and30days after PCI.6Comparison of the incidence of cardiac rehospitalization and MACEevents:Angina symptoms was under control after tirofiban on admission,and thedifference was not statistically significant between the two groups of patientson admission(32.5%vs.37.3%, P=0.516).The incidence of the cardiac rehospitalization was not statisticallysignificant difference between the two groups (3.6%vs.8.8%, P=0.299)；Theincidence of MACE events which including: severe malignant arrhythmias,myocardial re-infarction, heart failure, target lesion revascularization andcardiac death were no statistically significant difference between the twogroups.7The charge and days in hospital:The days of hospital in the full dose group and half dose group were15.11±4.98days vs.16.04±5.05days, P=0.239；The charge of pateions in halfdose group was lower than that in the full dose group and the difference wasstatistically significant (41954.85±10272.31Yuan vs.40102.23±11749.05Yuan, P<0.05).Conclusion:1Tirofiban joint PCI can significantly improve cardiac function in thetreatment of non-ST elevation acute coronary syndrome, and there was nostatistically significant difference between the full dose group and half dosegroup.2Compared with that in full dose tirofiban joint PCI group, the bleedingrisk was significantly lower in the half dose tirofiban joint PCI group, and thesecurity significantly increased.3There was no significantly difference of MACE incidence between thefull dose tirofiban group and half dose group joint PCI in intreatment of no-ST elevation acute coronary syndrome during30days after PCI, but the inhospitalcharge significantly lower in half dose group than that in full dose group. |
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