Bivalirudin versus heparin with or without glycoprotein Ⅱ b/Ⅲ a inhibitors in？ patients with STEMI undergoing primary percutaneous coronary intervention： Pooled patient-level analysis from the

BackgroundIntheHORIZONS-AMI(HarmonizingOutcomeswithRevasculariZatiONandStentsinAcuteMyocardialInfarction)trial,3,602patientsundergoingprimarypercutaneouscoronaryintervention(PCI)forST-segmentelevationmyocardialinfarction(STEMI)treatedwithbivalirudinhadlowerbleedingandmortalityrates,buthigheracutestentthrombosisratescomparedwithheparin+aglycoproteinⅡb/Ⅲainhibitor(GPI).SubsequentchangesinprimaryPCI,includingtheuseofpotentP2Y12inhibitors,frequentradialintervention,andpre-hospitalmedicationadministration,wereincorporatedintotheEUROMAX(EuropeanAmbulanceAcuteCoronarySyndromeAngiography)trial,whichassigned2,218patientstobivalirudinversusheparin±GPIbeforeprimaryPCI.ObjectivesThegoalofthisstudywastoexaminetheoutcomesofproceduralanticoagulationwithbivalirudinversusheparin±GPIforprimaryPCI,giventheevolutioninprimaryPCI.MethodsDatabasesfromHORIZONS-AMIandEUROMAXwerepooledforpatient-levelanalysis.TheBreslow-Daytestevaluatedheterogeneitybetweentrials.ResultsAtotalof5,800patientswererandomizedtobivalirudin(n=2,889)orheparin±GPI(n=2,911).Theradialapproachwasusedin21.3%ofpatients,prasugrel/ticagrelorwasusedin18.1%ofpatients,andGPIwasusedin84.8%ofthecontrolgroup.Bivalirudincomparedwithheparin±GPIresultedinreduced30-dayratesofmajorbleeding(4.2%vs.7.8%;relativerisk[RR]:0.53;95%confidenceinterval[CI]:0.43to0.66;P<0.0001),thrombocytopenia(1.4%vs.2.9%,RR:0.48;95%CI:0.33to0.71;P=0.0002),andcardiacmortality(2.0%vs.2.9%;RR:0.70;95%CI:0.50to0.97;P=0.03),withnonsignificantlydifferentratesofreinfarction,ischemia-drivenrevascularization,stroke,andall-causemortality.Bivalirudinresultedinincreasedacute(<24h)stentthrombosisrates(1.2%vs.0.2%;RR:6.04;95%CI:2.55to14.31;P<0.0001),withnonsignificantlydifferentratesofsubacutestentthrombosis.Compositenetadversec