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AcuteMyocardialInfarction(AMI):
TheUrgentInterventionAMIDiseaseStateAMIoccurswhenanarterysupplyingtheheartmusclebecomesoccludedOcclusionisusuallycausedbyatherosclerosisaccompaniedbyacutethrombusformationAtheroscleroticplaquesinsidethearterialwallcanrupture,triggering
theformationofthethrombusIfathrombusgrowslargeenough,itcanoccludethebloodvesselcompletelycausingischemiaintheheartmuscleProlongedischemiacanleadtoinfarction,reducingthepowerofthe
hearttopumpoxygenatedbloodaroundthebody,andpotentially
leadingtoheartfailureanddeathRiskfactorsforAMIincludehypercholesterolemia,diabetes,
hypertension,smoking,previoushistoryofcoronaryartery
disease(CAD),familyhistoryofCAD,andmetabolicsyndrome./medlineplus/ency/imagepages/17004.htmAMIDiseaseStateAnatheroscleroticplaqueisshownobstructingacoronaryarteryAMIDiseaseStateInAMI,plaquespontaneouslyruptureswithinthevessel.Plateletsbecomeactivated,triggeringtheformationofthrombusAMIDiseaseStateThrombuspresentinthevesselisshowninthisangiogramAMIDiseaseStateClumpsofactivatedplateletscanbreakoffandtraveldownstream,blockingthemicrovesselsandpreventingbloodfromreachingtheheartmuscleAMIDiagnosisSTEMI(ST-segmentelevationMI)Ischemicsymptomslasting>30mins(chestpain,dyspnea,etc.)Onelectrocardiogram(EKG),ST-segmentelevationof1mminatleasttwocontiguousleads
ConfirmatoryEvidenceElevationincreatinekinasetoatleastthreetimestheupperlimitofnormalwithaconcomitantriseinMBisoenzymeElevationintroponinlevelsNewQwaveonECGCoronaryarteryocclusionwithangiographicappearance
ofthrombus/medlineplus/ency/imagepages/17004.htmAbciximabIndicationAbciximabisindicatedasanadjuncttopercutaneouscoronaryintervention(PCI)forthepreventionofcardiacischemiccomplications:InpatientsundergoingPCIInpatientswithunstableangina(UA)notresponding
toconventionalmedicaltherapywhenPCIisplannedwithin24hours.SafetyandefficacyofabciximabuseinpatientsnotundergoingPCIhavenotbeenestablished.Abciximabisintendedforusewithaspirinandheparinandhasbeenstudiedonlyinthatsetting.
ClinicalStudiesofAMIandAbciximabAbciximabhasbeenstudiedinthefollowingtrialsoutlinedinthispresentation:RAPPORT1Neumannetal.2ISAR-23ADMIRAL4CADILLAC5,6ACE71.BrenerSJetal.Circulation1998;98:734–41.2.NeumannF-Jetal.Circulation1998;98:2695–701.3.NeumannF-Jetal.JAmCollCardiology2000;35:915–21.4.MontalescotGetal.NEngJMed2001;344:1895–903.5.TchengJEetal.Circulation2003;108:1316–23.6.StoneGWetal.NEnglJMed2002;346:957–66.7.AntoniucciDetal.JAmCollCardiol2003;42:1879–85.PCIwithAbciximabforAMIDatafromthestudiesoutlinedinthispresentationwillillustratetheeffectthatprimaryPCIwithabciximabforAMIpatientshason:Clinicaloutcomes1Microvascularperfusion2Leftventricular(LV)function1,2Combinedwithstenting,abciximabinitiatedbeforecatheterizationimprovedthecompositeofdeath,reinfarction,ortargetvesselrevascularization(TVR)inpatientswithAMI,ascomparedwithplaceboat30days11.MontalescotG,BarraganP,WittenbergOetal.NEnglJMed2001;344:1895–903.2.NeumannF-J,BlasiniR,SchmittCetal.Circulation1998;98:2695–701.AbciximabAdministrationAbciximab(representedasthetealgreencloudenteringthevessel)isshownflowingthroughaheavilyartherosclerosedvesselPCIInterventionwithaballoonandstentresultsintheflatteningandcrackingofplaque,andthedislodgingofsectionsoftheplaqueAbciximabandPCIAbciximabpreventsthethrombusformation
thattheinterventiontriggers.BloodflowsfreelyandthePCImayproceedsmoothlyRAPPORTStudyFirstdedicatedrandomizedtrialofplateletGPIIb/IIIainhibitioninAMIpatientsduringpercutaneoustransluminalcoronaryangioplasty(PTCA)PatientswithacuteMI(within12hours)undergoingPTCAwererandomizedtoplaceboorabciximabTheprimaryefficacyendpointwasdeath,MI,oranyTVRat
6monthsbyintent-to-treat(ITT)analysisBrenerSJetal.Circulation1998;98:734–41.RAPPORT:TrialDesign * 0.25mg/kgbolusfollowedbya0.125g/kg/min(max.10g/min)for12h ** 100U/kgbolusfollowedbyadditionalweight-adjusteddoses(maintainanactivatedclottingtime[ACT]>300secondsduringprocedure).Heparininfusioncouldbecontinuedforamaximumof48htomaintainpartialthromboplastintime(PTT)60–85secondsHeparin**
Abciximab*(n=241)Placebo*(n=242)AspirinActualtreatment(AT)analysis(n=409)ITTanalysis(n=483)ST,AMI<12hRandomize1oendpoint:death,recurrentMIoranyTVRat6monthsbyITTanalysis2oendpoint:death,recurrentMI,orurgentTVRat7and30daysBrenerSJetal.Circulation1998;98:734–41.RAPPORT:6-MonthITTOutcome6.6051015202530Death,MI,oranyTVRDeath,MI,orurgentTVRDeathRepeatMIDeathorRepeatMIUrgentTVRIncidence(%)p=0.048RR35%p=0.82p=0.70p=0.36p=0.01p=0.908.73.3Placebo(n=242)Abciximab(n=241)BrenerSJetal.Circulation1998;98:734–41.Placebo(n=242)Abciximab(n=241)RAPPORT:ITTAnalysis9.95.811.6051015207-day30-day6-month*Incidenceofdeath,MI,orurgentTVR(%)p=0.003RR67%p=0.048RR35%p=0.03RR48%*6-monthcompositeofdeath,MI,orurgentTVRwasnotaprespecifiedsecondaryendpointBrenerSJetal.Circulation1998;98:734–41.051015207-day30-day6-monthIncidenceofdeath,MI,orurgentTVR(%)RAPPORT:ActualTreatment(AT)Analysis10.512.010.6p=0.001RR73%p=0.004RR47%p=0.005RR62%Placebo(n=191)Abciximab(n=218)25BrenerSJetal.Circulation1998;98:734–41.Abciximab(n=241)Placebo(n=242)9.507.916.6013.7024681012141618TIMImajorbleedingIntracranialhemorrhageAlltransfusionsIncidence(%)p=0.02p=0.04RAPPORT:30-DaySafetyp=nsBrenerSJetal.Circulation1998;98:734–41.RAPPORT:ConclusionsAbciximabreducedthemajoradverseoutcomes–death,reinfarction,orurgentTVR–at7days,30daysandextendedto6monthsAbciximabduringPTCAdidnotshowareductioninTVRand,therefore,didnotmeetitsprimaryendpoint.Asthistrialwasperformedinthemid-1990s,stentswerehighlydiscouragedandrarelyusedinthistrialBrenerSJetal.Circulation1998;98:734–41.NeumannStudyNeumannetal.investigatedtheeffectofabciximabon
papaverine-inducedcoronarypeakflowvelocityandonwallmotionintheinfarctareawithin14daysaftersuccessfulstentplacementintheinfarct-relatedarteryPatientsundergoingstentinginAMI(within48hours)wererandomizedtostandard-doseheparinorabciximabplusheparinProspectiverandomizedtrialtoinvestigatemicrovascularandcontractilerecoveryafterrevascularizationwithstentplacement
andtocomparetheeffectofglycoprotein(GP)IIb/IIIablockadebyabciximabwithstandard-doseheparinNeumannF-Jetal.Circulation1998;98:2695–701.NeumannTrialDesignAMI<48hHeparin(5000U)+aspirin(500mg)Abciximab**(n=102)1oendpoints:differencesinpapaverine-inducedcoronaryflowvelocityandinwallmotionindexbetweentheinitialstudyand14-dayfollow-up
2oendpoint:clinicaloutcomeduring30-dayfollow-up*Heparin(10,000U)followedbyheparin(1000U/hfor12haftersheathremoval)**0.25mg/kgbolusfollowedby10g/minfor12hplusheparin(25000U)RandomizeTiclopidine(250mgtwicedailyforfourweeks)Aspirin(100mgtwicedailythroughoutstudy)Nitroglycerin(0.2mgafterre-establishingantegradeflow)Usualcare*(n=98)NeumannF-Jetal.Circulation1998;98:2695–701.CardiacFunctionParametersat14days0.440.1500.85662020406080p=0.007p=0.003n=79n=72n=72n=79p=0.024n=72n=8010.418.10510152025peakflowvelocity(cm/s)wallmotionindex(SD/Chords)GlobalLVEF(%)UsualcareAbciximabCirc1998;98:2695-701Neumannetal.PrimaryPCIforAMIUsualcare(n=72)Abciximab(n=79)8.33.80123456789BloodtransfusionsIncidence(%)p=0.32Neumann:30-DaySafetyNeumannF-Jetal.Circulation1998;98:2695–701.Neumann:ConclusionsAbciximabimprovedmicrovascularperfusionandrecoveryofcontractilefunctionLVfunctionwasimprovedinpatientswhoreceivedabciximabNeumannF-Jetal.Circulation1998;98:2695–701.ISAR-2StudyISAR-2investigatedtheeffectsofabciximabwithstentingforAMIPatientsundergoingstenting(<48hoursafterAMI)wererandomizedtostandard-doseheparinorabciximabplus
reduced-doseheparin(open-label)Theprimaryendpointwasangiographicrestenosisasdefinedbylatelossat6monthsAlsoanalyzedclinicaloutcomebythecompositeendpointofdeath,recurrentnonfatalMI,andtargetlesionrevascularization(TLR)NeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.ISAR-2:TrialDesignAMI<48hHeparin(5000U)+aspirin(500mg)Abciximab**(n=201)Usualcare*(n=200)1oendpoint:lateloss2oendpoint:compositeofdeath,recurrentMI,andTLRat30days,6months,and1year*Heparin(10,000U)followedbyheparin(1000U/hfor12haftersheathremoval)**0.25mg/kgbolusfollowedby10g/minfor12hplusheparin(2500U)Eligiblefor6-monthangiographicfollow-up(n=292/366)RandomizeTiclopidine(250mgtwicedailyforfourweeks)Aspirin(100mgtwicedailythroughoutstudy)NeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.ISAR-2:6-MonthLateLossp=0.611.260.851.210.74Usualcare(n=144)Abciximab(n=148)00.511.522.5Lateloss(mm)NeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.UsualCare(n=200)Abciximab(n=201)ISAR-2:30-DayOutcome(SecondaryEndpoint)10.56.05.02.52.00.53.0024681012AnycardiaceventDeathorRepeatMIDeathNon-fatalMITLRIncidence(%)p=0.038RR52%p=0.08p=0.16p=0.62p=0.30NeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.ISAR-2:1-YearEvent-FreeSurvivalHeparinMonthAfterStentPlacementNeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.05060708090100GlobalEF(%)*AbsoluteRRinadversecardiacevents5.7%*Abciximab5.5%*P=0.17Event-FreeSurvival(%)0121110123456789ISAR-2:30-DaySafetyData03.504.500.511.522.533.544.55StrokeBloodtransfusionsIncidence(%)p=0.79UsualCare(n=200)Abciximab(n=201)p=nsNeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.ISAR-2:ConclusionsNoeffectofabciximabonangiographicrestenosisat6monthswasmeasuredbylatelossAbciximabsignificantlyreducedthecompositeofdeath,reinfarction,orTLRat30daysTheresultssupporttheadjunctiveuseofabciximabwithstentinginAMIpatientsNeumannF-Jetal.JAm
Coll
Cardiol2000;35:915–21.ADMIRALStudyAmulticenter,double-blind,randomizedtrialtoreflectthecommonpracticeofprimarystentinginpatientswithAMIPatientswithAMIwererandomizedtoeitherabciximab
plusstentingorplaceboplusstentingbeforeundergoingcoronaryangiographyTheprimaryendpointwasacompositeofdeath,MI,or
urgentTVRat30daysMontalescotGetal.NEngJMed2001;344:1895–903.ADMIRAL:TrialDesignFourcoronaryangiogramsAdmissionPost-PCI24hpost-PCI6mpost-PCI*0.25mg/kgbolusfollowedbya0.125g/kg/min(max.10g/min)for12h**70U/kg(max.7000U)followedby7U/kg/h(maintainaPTTbetween1.5–2.0xcontrolvalue)
untilthe24hfollow-upangiogramcompletedST,<12hUnfractionatedheparin(UFH)Abciximab*+stentPlacebo+stentTiclopidine(noloadingdose)250mgtwicedailyfor30dayspost-PCI1oendpoint:death,recurrentMI,orurgentTVRthrough30days2oendpoint:death,recurrentMI,oranyTVRat30daysand6monthsRandomizeMontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:InclusionCriteriaPatientswhowerescheduledtoundergoprimaryPCIwereeligible
forenrollmentaccordingtothefollowingcriteria:Enrollmentage>18yearsoldFirstsymptomsofAMIwithin12hoursbeforeenrollmentST-segmentelevation>1mminatleast2contiguous
EKGleadsPatientswithsmallarteriesorwithcardiogenicshockwere
notexcludedfromthistrialMontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:30-DayClinicalEvents6.67.920.54.712.10510152025Death,MI,orurgentTVRDeathRepeatMIUrgentTVRDeathorrepeatMIDeath,MI,oranyTVRIncidence(%)p=0.01RR59%p=0.19p=0.42p=0.02p=0.25p=0.047Placebo(n=151)Abciximab(n=149)MontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:30-DayDeath,MI,orUrgentTVRPlacebo(n=151)14.66.0StentplusplaceboCumulativeincidence(%)8121416024610Stentplusabciximab05101520253035Daysp=0.01Abciximab(n=149)MontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:6-MonthClinicalEvents7.34.06.69.92.02.05.415.922.80510152025303540Death,MI,orurgentTVRDeathRepeatMIUrgentTVRDeathorrepeatMIDeath,MI,oranyTVRIncidence(%)p=0.02RR53%p=0.32p=0.049p=0.14p=0.03p=0.13Placebo(n=151)Abciximab(n=149)MontalescotGetal.NEnglJMed2001;344:1895–903.050100150200ADMIRAL:CumulativeIncidenceofDeath,MI,
orUrgentTVRat6MonthsMontalescotGetal.NEnglJMed2001;344:1895–903.0-4-8-12-16-CumulativeIncidence(%)Timesincerandomization(days)Placebo(n=151)Abciximab(n=149)15.9%7.4%p=0.02ADMIRAL:EarlyAbciximabAdministrationMICU=MobileintensivecareunitER=Emergencyroom21.112.423.72.59.20510152025MICUorER30dayICCUorCL30dayMICUorER6monthICCUorCL6monthPatients(%)RR88%RR33%RR89%RR31%Placebo(n=151)Abciximab(n=149)ICCU=IntensivecardiaccareunitCL=CatheterizationlaboratoryMontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:LVEF53.957.057.061.15052545658606224h6monthsLVEF(%)p<0.05p=0.05Placebo(n=92)Abciximab(n=101)MontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:30-DaySafetyData00.702468101214TIMImajorbleedingTIMIminorbleedingPlatelets<100,000/LPlatelets<50,000/LIncidence(%)p=0.08p=0.004p=0.31p=nsPlacebo(n=151)Abciximab(n=149)MontalescotGetal.NEnglJMed2001;344:1895–903.ADMIRAL:ConclusionsIntheADMIRALtrial,earlyadministrationofabciximab(priortosheathinsertion)inpatientswithAMIwasassociatedwith:HigherTIMIgrade3flowthanplaceboHigherrateofproceduralsuccessthanwithplaceboAnimprovementinleftventricularfunctionascomparedwithplaceboReducedincidenceoftheprimaryendpointat30daysand6months,ascomparedwithplaceboADMIRALshowsthatabciximabimprovesoutcomesforpatientsundergoingprimaryrevascularizationforAMI,eveninspecificsubgroupswhoareusuallyexcludedfromclinicaltrials–thosewithcardiogenicshockorsmallvesselsMontalescotGetal.NEnglJMed2001;344:1895–903.CADILLACStudyTheCADILLACtrialinvestigatedtheuseofGPIIb/IIIainhibitorswithcoronaryPCIinAMIpatients1,2Patientswererandomizedtostentornostentandabciximabor
noabciximabina2x2factorialdesign1Theprimaryendpointwasdeath,MI,ischemia-drivenTVR,
ordisablingstroke(majoradversecardiacevents[MACE])
at6months2TchengJEetal.Circulation2003;108:1316–23.StoneGWetal.NEnglJMed2002;346:957–66.CADILLAC:OverallStudyDesignAMI<12h,cardiogenicshockexcluded(n=2681)PrimaryPTCA(n=518)MultiLinkstent+abciximab(n=524)MultiLinkstent(n=512)PrimaryPTCA+abciximab(n=528)NoRegistryn=599(22%)Patientswithhigh-riskcoronaryanatomyYesn=2082(78%)AngiographyDopatientsmeetangiographiccriteria?RandomizeStoneGWetal.NEnglJMed2002;346:957–66.CADILLAC:
AddressingtheAbciximabQuestionAMI<12h,cardiogenicshockexcluded(n=2082)Randomize*0.25mg/kgbolusfollowedbya0.125g/kg/minfor12h**Adjustedtoachieveanactivatedclottingtimeof>350sinnon-abciximab-treatedpatientsand200-300sabciximab-treatedpatientsuntilthe24hfollow-upangiogramwascompleted2oprotocol-specifiedhypothesis:death,MI,ischemia-drivenTVR,ordisablingstrokeat30daysProspectivelydefined3oefficacyendpoints:compositeMACEanditscomponentsat1year;myocardialsalvage,restenosis,
andinfarct-arteryreocclusionat7monthsAspirin,ticlopidine,andheparin**Noabciximab(n=1030)Abciximab*(n=1052)TchengJEetal.Circulation2003;108:1316–23.CADILLAC:30-DayOutcomesNoabciximab(n=1030)Abciximab(n=1052)7.0012345678MACEDeathRepeatMIIschemicTVRDisablingstrokeIncidence(%)p=0.01p=0.49p=0.76p=0.02p=0.54TchengJEetal.Circulation2003;108:1316–23.CADILLAC:30-DaySubacuteThrombosisNoabciximab(1030)Abciximab(n=1052)0.41.501.6SubacutethrombosisIncidence(%)TchengJEetal.Circulation2003;108:1316–23.p=0.01CADILLAC:1-YearOutcomes14.40.412.20.705101520MACEDeathRepeatMIIschemicTVRDisablingstrokeIncidence(%)p=0.29p=0.79p=0.64p=0.15p=0.4Noabciximab(n=1030)Abciximab(n=1052)TchengJEetal.Circulation2003;108:1316–23.CADILLAC:30-DaySafetyData3.405.00.40123456SeverebleedingModeratebleedingIntracranialhemorrhageThrombocytopenia(<100,000cells/mm3)Blood-producttransfusionIncidence(%)p=0.55p=0.16p=0.99p=0.008p=0.21Noabciximab(n=1030)Abciximab(n=1052)TchengJEetal.Circulation2003;108:1316–23.CADILLAC:ConclusionsPatientstreatedwithadjunctiveabciximabduringPCIsignificantlyincreased30-dayevent-freesurvival.
Thiswasduemainlytoasignificantdecreaseinthe
rateofischemia-drivenTVRAbciximabreducedearlyischemicsubacutethrombosisandabruptvesselclosureovertheshorttermAbciximabtreatmentdidnotaffectthecompositeendpoint
at1year,reflectingalackofeffectontherateofrestenosisTchengJEetal.Circulation2003;108:1316–23.ACEStudyTheACE(AbciximabandCarbostentEvaluation)trialwasamulticenter,multinational,randomizedtrialinAMIpatients
treatedbyprimaryPCIPatientswererandomlyassignedtoreceiveabciximabplusstent
orstentaloneFourhundredpatientswereenrolled:200intheabciximabplusstentgroupand200inthestentalonegroupTheprimaryendpointwasthecompositeofdeathfromany
cause,reinfarction,TVR,andstrokeat30daysAntoniucciDetal.JAmCollCardiol2003;42:1879–85.ACE:TrialDesignUFH**Abciximab*+stent(n=200)Placebo+stent(n=200)Ticlopidine(500mg/day)orclopidogrel(300mgloadingdosethen75mg/day)1oendpoint:compositeofdeathfromanycause,reinfarction,
TVR,andstrokeat30days2oendpoints:ST-segmentreduction;correctedTIMIframecount;
infarctsizeat30days;all-causemortality,reinfarction,
orTVRat6months;andangiographicrestenosisofthe
infarct-relatedarteryat6months*0.25mg/kgbolusfollowedbya0.125g/kg/min(max.10g/min)for12h**70U/kgfollowedbyadditionalbolusesduringtheproceduretomaintainanACTbetween200-300sforabciximabpatientsandatleast300sinstentingalonepatientsRandomize(n=400)AntoniucciDetal.JAmCollCardiol2003;42:1879–85.Stent(n=200)Stent+Abciximab(n=200)ACE:30-DayOutcomes10.54.00.50024681012Death,reinfarction,TVR,andstrokeDeathReinfarctionTVRStrokePatients(%)p=0.023RR57%p=0.792p=0.010p=0.315p=0.317AntoniucciDetal.JAmCollCardiol2003;42:1879–85.Stent(n=188)Stent+Abciximab(n=194)ACE:30-MinuteST-SegmentReduction68.085.00102030405060708090PatientswithST-segmentReduction≥50%(%)p<0.001AntoniucciDetal.JAmCollCardiol2003;42:1879–85.ACE:30-DaySestamibiResultsp=0.067p=0.032AntoniucciDetal.JAmCollCardiol2003;42:1879–85.ACE:30-DaySubacuteThrombosis5.00.50123456Patients(%)D.Antoniucci,M.D.DatapresentedattheAmericanHeartAssociationScientificSessions,November2003,Orlando,FL,USA,usedwithpermissionStent(n=200)Stent+Abciximab(n=200)p=0.006Stent(n=200)Stent+Abciximab(n=200)ACE:6-MonthOutcomes8.05.513.517.04.51.05.516.0024681012141618DeathReinfarctionDeathorreinfarctionTVRPatients(%)p=0.148RR44%p=0.011p=0.006p=0.789AntoniucciDetal.JAmCollCardiol2003;42:1879–85.ACE:ConclusionsTheACEtrialshowedthatabciximabplusstentingprovided
betterSTresolutionwhichsuggestsmoreeffectivemicrovascularreperfusion.Abciximabplusstentingresultedinasmallerinfarctsizecomparedwithstentingalone.Comparedwithstentingalone,stentingplusabciximab
significantlyreduced:thecompositeofdeath,reinfarction,TVR,andstrokeat
30days(p=0.023)ratesofsubacutethrombosisat30daysreinfarction(p=0.011)andthecompositeofdeathor
reinfarction(p=0.006)at6months2004ACC/AHASTEMIGuidelinesAntmanetal.,Circ.2004;110:e82-292ClassII:Conditionsforwhichthereisconflictingevidenceand/oradivergenceofopinionabouttheusefulness/efficacyofaprocedureortreatment.ClassIIa:Weightofevidence/opinionisinfavorofusefulness/efficacy.Benefit>>Risk?LevelofEvidenceB:Dataderivedfromasinglerandomizedtrial,ornonrandomizedstudies.Abciximab–
ClassIIa-ItisreasonabletostarttreatmentwithabciximabasearlyaspossiblebeforeprimaryPCI(withorwithoutstenting)inpatientswithSTEMI.
(LevelofEvidence:B)ConclusionsAbciximabisthemostwidelystudiedGPIIb/IIIainhibitorinprimaryPCIforAMITheuseofAbciximabinprimaryPCIforAMIhasshowntodecreasetheincidenceofthecompositeofD,MI,orTVRInprimaryPCI,Abciximabhasbeenshowntoimprovemicrovascularperfusion,LVfunctionandtoreduceSTsegmentelevationSafetyInformationPleaseseeimportantsafetyinformationinthispresentation
andfullprescribinginformationavailableatthispresentationBleedingRiskAbciximabhasthepotentialtoincreasetheriskofbleeding,particularlyinthepresenceofanti-coagulationagents,e.g.fromheparinorotheranticoagulants.Theriskofamajorbleedduetoabciximabtherapyisincreasedinpatientsreceivingthrombolyticsandshouldbeweighedagainsttheanticipatedbenefits.IntheEPILOGandEPISTENTtrials,theincidenceofmajorbleedinginpatientsreceivingabciximabandlow-doseheparinwassimilartoplacebolevels.Non-CABGBleedinginTrialsofPercutaneousCoronaryIntervention(EPILOGandEPISTENT)Placebob
(n=1748)Abciximab+
low-doseheparinc
(n=2525)Abciximab+
standard-doseheparind
(n=918)Majora1.0%(18)0.8%(21)1.9%(17)Minor2.6%(46)3.2%(82)7.6%(70)Patientswhohadbleedingin>1classificationarecountedonlyonceaccordingtothemostsevereclassification.Patientswithmultiplebleedingeventsofthesameclassificationarealsocountedoncewithinthatclassification.
Standard-doseheparinwithorwithoutstent(EPILOGandEPISTENT)
Low-doseheparinwithorwithoutstent(EPILOGandEPISTENT)
Standard-doseheparin(EPILOG)GuidelinesforReductioninBleedingUseofalow-dose,weight-adjustedheparinregimenDiscontinuationofheparinoncompletionoftheprocedurewith
removalofthearterialsheathwithin6hoursCarefulvascularaccesssitemanagementandcarefulpatientmanagement,includingattentiontootherpotentialbleedingsitesUseofaweight-adjustedbolusandcontinuous-infusiondoseofabciximabThrombocytopeniaInclinicaltrials,patientstreatedwithabciximabweremorelikelythanpatientswhoreceivedplacebotoexperiencedecreasesinplateletcounts(seeReadministration)EPILOGandEPISTENTpatientstreatedwithabciximabplus
low-doseheparinPatients(%)Anythrombocytopenia(platelets<100,000cells/μL)2.5–3.0Severethrombocytopenia(platelets<50,000cells/μL)0.4–1.0Platelettransfusions0.9–1.1Moderatelylowerrateswereobservedamongpatientstreatedwithplaceboplusstandard-doseheparinDosageandAdministrationThesafetyandefficacyofabciximabhaveonlybeeninvestigatedwithconcomitantadministrationofheparinandaspirinasdescribedinCLINICALSTUDIES.Pleaseseefullpresc
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