Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction

(整期优先)网络出版时间:2011-04-14
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BackgroundThecombinationofglycoproteinⅡb/Ⅲainhibitorsandheparinhasnotbeencomparedwithbivalirudininstudiesspecificallyinvolvingpatientswithnon-ST-segmentelevationmyocardialinfarctionundergoingpercutaneouscoronaryintervention(PCI).Wecomparedthetwotreatmentsinthispatientpopulation.MethodsImmediatelybeforePCI,werandomlyassigned,inadouble-blindmanner,1721patientswithacutenon-ST-segmentelevationmyocardialinfarctiontoreceiveabciximabplusunfractionatedheparin(861patients)orbivalirudin(860patients).Thestudytestedthehypothesisthatabciximabandheparinwouldbesuperiortobivalirudinwithrespecttotheprimarycompositeendpointofdeath,largerecurrentmyocardialinfarction,urgenttarget-vesselrevascularization,ormajorbleedingwithin30days.Secondaryendpointsincludedthecompositeofdeath,anyrecurrentmyocardialinfarction,orurgenttarget-vesselrevascularization(efficacyendpoint)andmajorbleeding(safetyendpoint)within30days.ResultsTheprimaryendpointoccurredin10.9%ofthepatientsintheabciximabgroup(94patients)andin11.0%inthebivalirudingroup(95patients)(relativeriskwithabciximab,0.99;95%confidenceinterval[CI],0.74to1.32;P=0.94).Death,anyrecurrentmyocardialinfarction,orurgenttarget-vesselrevascularizationoccurredin12.8%ofthepatientsintheabciximabgroup(110patients)andin13.4%inthebivalirudingroup(115patients)(relativerisk,0.96;95%CI,0.74to1.25;P=0.76).Majorbleedingoccurredin4.6%ofthepatientsintheabciximabgroup(40patients)ascomparedwith2.6%inthebivalirudingroup(22patients)(relativerisk,1.84;95%CI,1.10to3.07;P=0.02).ConclusionsAbciximabandunfractionatedheparin,ascomparedwithbivalirudin,failedtoreducetherateoftheprimaryendpointandincreasedtheriskofbleedingamongpatientswithnon-ST-segmentelevationmyocardialinfarctionwhowereundergoingPCI.(FundedbyNycomedPharmaandothers;