| ObjectiveSince the series clinical trials of ARMYDA had come out, periproceduralstatin therapy has always been concerned in cardiovascular field. However,few researches have been reported about the use of statin during emerge-ncy PCI. Moreover, it is still not very clear about the effect of loading-dosetreatment of atorvastatin on the ventricular remodeling and restenosis in STelevation myocardial infarction(STEMI) patients. So, we launched the singlecenter, randomized clinical trial to evaluate the efficacy of loading-dosetreatment of atorvastatin on left ventricular function, late loss, MACE as wellas the safety of it during six months follow-up period in STEMI patients.MethodsFrom May1.2010to December31.2011, STEMI patients who preparedto perform emergency PCI within12hours of pain onset were included in ourstudy. Patients were randomly divided into three groups and written consentwas obtained from them. Group A: received atorvastatin80mg loading dosebefore PCI then followed by40mg daily for one month and a maintenancedose of20mg daily thereafter; Group B: received atorvastatin40mg daily afterPCI for one month and a maintenance dose of20mg daily thereafter; Group C:received atorvastatin20mg daily after PCI. Determination of indicators:1） hs-CRP was detected pre-operation, post-operation24h,7day and1month.2）ST-segment resolution at90min after PCI were evaluated.3）LVEF and LVDdwere detected at2day and6month after PCI.4）MLD(minimal lumendiameter),RVD(reference vascular diameter), DA(diameter stenosis) andLL(late loss) were measured by QCA.5）The1to6month incidence of MACE(Major Adverse Cardiac Events) were also observed.6）safety assessmentcontained muscle pain and rhabdomyolysis during taking medications, liverenzymes increased which was caused by statins (more than3times the upperlimit of normal or above to stop medication, if it is necessary, liver protectiondrugs will be given). Moreover, gastrointestinal reactions were recorded, suchas nausea, abdominal pain,bloating and so on.ResultsA total of118STEMI patients were admitted during the study. Of the118patients,16patients were excluded (transaminase more than3times in6patients before PCI;10patients refused to participate in the trial). Eligiblepatients (n=102) were randomly assigned to A group(n=32), B group(n=32), Cgroup(n=32).(1) The difference in baseline data of patients was not statistically significantand was comparable.(2) hs-CRP was compared among three groups: there were no significantdifferences in hs-CRP among three groups before PCI (P>0.05) and24hoursafter PCI (P>0.05).7days after PCI, the hs-CRP was5.69±1.42mg/L,6.98±1.93mg/L and7.07±1.86mg/L in the three groups respectively. Thehs-CRP was significantly lower in A group than B group and C group（P＜0.05）.There was no difference between B group and C group (P>0.05).1month after PCI,The hs-CRP was2.44±0.69mg/L,2.94±1.04mg/Land3.40±1.01mg/L in the three groups respectively. The hs-CRP was significantlylower in A group than B group and C group（P＜0.05）.The hs-CRP was alsosignificantly lower in B group than C group（P＜0.05）. (3) ST-segment resolution（STR）was compared among three groups:90minutes after PCI, STR was69.61±35.25%,50.20±44.31%and48.61±31.10%in the three groups respectively. The group A was improvedsignificantly (P＜0.05).There was no significant difference between group Band group C (P＞0.05).The frequency of STR was71.88%（23cases）.46.88%（15cases）and42.11%（16cases）in the three groups respectively. The group A was improvedsignificantly (P＜0.05). There was no significant difference between group Band group C (P＞0.05).(4) LV funtion were compared among three groups: there were no significantdifference in LVEF among three groups at2day after PCI (P>0.05). After6month The LVEF was54.73±2.10%，54.86±1.93%and52.14±2.03%in thethree groups respectively. The LVEF was significantly increased in A group andB group than C group.There was no significant difference in LVEF betweengroup A and group B (P＞0.05).There was no significant differences in LVDdamong three groups at2day and6month after PCI(P＞0.05).Compared with initial after6months: LVEF was significantly increased ingroup A（47.89±5.67%vs54.73±2.10%）and group B（48.50±6.21%vs54.86±1.93%）.but there was no significant difference in group C（50.19±5.42%vs52.14±2.03%）.There was also no significant difference in LVDd among thesubgroups of group A,group B and group C (P＞0.05).(5)QCA were compared among three groups after6months: The LL(InStent)was0.20±0.39mm,0.21±0.40mm and0.22±0.37mm in the three groupsrespectively. The LL(Proximal edge) was0.18±0.26mm,0.19±0.21mm and0.19±0.29mm in the three groups respectively.The LL(Distal edge) was0.11±0.25mm,0.09±0.31mm and0.13±0.27mm in the three groupsrespectively. there were no significant differences among threegroups(P>0.05).(6)MACE were compared among three groups：During1month of follow-up, MACE occurred in6.25%,6.25%and7.89%of patients in the three gro-ups respectively and there were no significant differences among three groups (P>0.05). During6months of follow-up, MACE occurred in9.38%,9.38%and10.53%of patients in the three groups respectively and there were no signifi-cant differences among three groups(P>0.05).(7)Monitoring drug safety: At1month,the ALT was61.21±44.00IU/L,61.60±35.22IU/L and56.28±37.44IU/L in the three groups respectively. therewere no significant differences among three groups(P>0.05). At3month, theALT was51.69±30.25IU/L,53.71±25.59IU/L and44.94±16.33IU/L in the threegroups respectively. there were no significant differences among threegroups(P>0.05). At6month,the ALT was41.20±13.65IU/L,44.56±23.86IU/Land37.27±18.73IU/L in the three groups respectively. there were no significantdifferences among three groups(P>0.05).At1month,the AST was49.07±22.13IU/L,55.43±23.86IU/Land47.14±26.91IU/L in the three groups respectively. there were no significantdifferences among three groups(P>0.05).At3month,the AST was42.50±15.26IU/L,50.39±17.18IU/L and42.09±14.31IU/L in the three groupsrespectively. there were no significant differences among three groups(P>0.05).At6month,the AST was36.80±8.65IU/L,39.59±9.64IU/Land33.50±13.71IU/Lin the three groups respectively. there were no significant differences amongthree groups(P>0.05).At1month,the CK was98.04±37.11IU/L,97.40±45.10IU/Land85.92±31.59IU/L in the three groups respectively, there were no significantdifferences among three groups(P>0.05). At3month,the CK was96.69±39.71IU/L,93.96±40.90IU/L and86.30±35.47IU/L in the three groupsrespectively. there were no significant differences among threegroups(P>0.05).At6month,the CK was94.00±38.03IU/L,91.44±39.40IU/Land83.00±30.15IU/L in the three groups respectively. there were no significantdifferences among three groups(P>0.05).Conclusions(1)80mg atorvastatin loading-dose before emergency PCI could inhibit the inflammatory response,increase the stability of the atherosclerotic plaque andimprove the myocardial perfusion.(2)80mg atorvastatin loading-dose before emergency PCI and only40mg/day atorvastatin after PCI could improve left ventricular systolicfunction(3)80mg atorvastatin loading-dose before emergency PCI was safe anddidn’t increase adverse reaction as compared with only40mg/day or20mg/day atorvastatin after PCI... |
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