2017ESC心脏支架及搭桥术后双抗指南

2017ESCfocusedupdateondualantiplatelettherapyincoronaryarterydiseasedevelopedincollaborationwithEACTSTheTaskForcefordualantiplatelettherapyincoronaryarterydiseaseoftheEuropeanSocietyofCardiology(ESC)andoftheEuropeanAssociationforCardio-ThoracicSurgery(EACTS)Authors/TaskForceMembers:MarcoValgimigli*(Chairperson)(Switzerland),HéctorBueno(Spain),RobertA.Byrne(Germany),Jean-PhilippeCollet(France),FrancescoCosta(Italy),AndersJeppsson1(Sweden),PeterJüni(Canada),AdnanKastrati(Germany),PhilippeKolh(Belgium),LauraMauri(USA),GillesMontalescot(France),Franz-JosefNeumann(Germany),MatePetricevic1(Croatia),MarcoRoffi(Switzerland),PhilippeGabrielSteg(France),StephanWindecker(Switzerland),andJoseLuisZamorano(Spain)AdditionalContributor:GlennN.Levine(USA)DocumentReviewers:LinaBadimon(CPGReviewCoordinator)(Spain),PascalVranckx(CPGReviewCoordinator)(Belgium),StefanAgewall(Norway),FelicitaAndreotti(Italy),ElliottAntman(USA),EmanueleBarbato(Italy),Jean-PierreBassand(France),RaffaeleBugiardini(Italy),MustafaCikirikcioglu1(Switzerland),ThomasCuisset(France),MicheleDeBonis(Italy),VictoraDelgado(TheNetherlands),*Correspondingauthor:MarcoValgimigli,Cardiology,Inselspital,Freiburgstrasse8,3010Bern,Switzerland.Tel:þ41316323077,Fax:þ41107035258,E-mail:marco.valgimigli@insel.ch.ESCCommitteeforPracticeGuidelines(CPG)andNationalCardiacSocietiesdocumentreviewers:listedintheAppendix.1RepresentingtheEACTSESCentitieshavingparticipatedinthedevelopmentofthisdocument:Associations:AcuteCardiovascularCareAssociation(ACCA),EuropeanAssociationofPreventiveCardiology(EAPC),EuropeanAssociationofPercutaneousCardiovascularInterventions(EAPCI).WorkingGroups:CardiovascularPharmacotherapy,CardiovascularSurgery,CoronaryPathophysiologyandMicrocirculation,PeripheralCirculation,PulmonaryCirculationandRightVentricularFunction,Thrombosis,ValvularHeartDisease.ThecontentoftheseEuropeanSocietyofCardiology(ESC)Guidelineshasbeenpublishedforpersonalandeducationaluseonly.Nocommercialuseisauthorized.NopartoftheESCGuidelinesmaybetranslatedorreproducedinanyformwithoutwrittenpermissionfromtheESC.PermissioncanbeobtaineduponsubmissionofawrittenrequesttoOxfordUniversityPress,thepublisheroftheEuropeanHeartJournalandthepartyauthorizedtohandlesuchpermissionsonbehalfoftheESC(journals.permissions@oxfordjournals.org).Disclaimer.TheESCGuidelinesrepresenttheviewsoftheESCandwereproducedaftercarefulconsiderationofthescientificandmedicalknowledgeandtheevidenceavailableatthetimeoftheirpublication.TheESCisnotresponsibleintheeventofanycontradiction,discrepancyand/orambiguitybetweentheESCGuidelinesandanyotherofficialrecom-mendationsorguidelinesissuedbytherelevantpublichealthauthorities,inparticularinrelationtogooduseofhealthcareortherapeuticstrategies.Healthprofessionalsareencour-agedtotaketheESCGuidelinesfullyintoaccountwhenexercisingtheirclinicaljudgment,aswellasinthedeterminationandtheimplementationofpreventive,diagnosticortherapeuticmedicalstrategies;however,theESCGuidelinesdonotoverride,inanywaywhatsoever,theindividualresponsibilityofhealthprofessionalstomakeappropriateandaccuratedecisionsinconsiderationofeachpatient’shealthconditionandinconsultationwiththatpatientand,whereappropriateand/ornecessary,thepatient’scaregiver.NordotheESCGuidelinesexempthealthprofessionalsfromtakingintofullandcarefulconsiderationtherelevantofficialupdatedrecommendationsorguidelinesissuedbythecompetentpublichealthauthorities,inordertomanageeachpatient’scaseinlightofthescientificallyaccepteddatapursuanttotheirrespectiveethicalandprofessionalobligations.Itisalsothehealthprofessional’sresponsibilitytoverifytheapplicablerulesandregulationsrelatingtodrugsandmedicaldevicesatthetimeofprescription.Thearticlehasbeenco-publishedwithpermissionintheEuropeanHeartJournal[DOI:10.1093/eurheartj/ehx419]onbehalfoftheEuropeanSocietyofCardiologyandEuropeanJournalofCardio-ThoracicSurgery[DOI10.1093/ejcts/ezx334]onbehalfoftheEuropeanAssociationforCardio-ThoracicSurgery.AllrightsreservedinrespectofEuropeanHeartJournal,VCEuropeanSocietyofCardiology2017.Thearticlesareidenticalexceptforminorstylisticandspellingdifferencesinkeepingwitheachjournal’sstyle.Eithercitationcanbeusedwhencitingthisarticle.Forpermissions,pleaseemailjournals.permissions@oup.com.EuropeanHeartJournal(2017)0,1–48ESCGUIDELINESdoi:10.1093/eurheartj/ehx419Downloadedfromhttps://academic.oup.com/eurheartj/advance-article-abstract/doi/10.1093/eurheartj/ehx419/4095043bygueston25November2017...............................................................................................DonnaFitzsimons(UK),OliverGaemperli(Switzerland),NazzarenoGaliè(Italy),MartineGilard(France),ChristianW.Hamm(Germany),BorjaIbanez(Spain),BernardIung(France),StefanJames(Sweden),JuhaniKnuuti(Finland),UlfLandmesser(Germany),ChristopheLeclercq(France),MaddalenaLettino(Italy),GregoryLip(UK),MassimoFrancescoPiepoli(Italy),LucPierard(Belgium),MarkusSchwerzmann(Switzerland),UdoSechtem(Germany),IainA.Simpson(UK),MiguelSousaUva1(Portugal),EugenioStabile(Italy),RobertF.Storey(UK),MichalTendera(Poland),FransVandeWerf(Belgium),FreekVerheugt(TheNetherlands),andVictorAboyans(CPGSupervisor)(France)ThedisclosureformsofallexpertsinvolvedinthedevelopmentofthisfocusedupdateareavailableontheESCwebsitehttp://www.escardio.org/guidelines.TheAddendaandClinicalCasescompaniondocumentofthisfocusedupdateareavailableat:www.escardio.org/Guidelines/Clinical-Practice-Guidelines/2017-focused-update-on-dual-antiplatelet-therapy-dapt...................................................................................................................................................................................................KeywordsGuidelines•Aspirin•Clopidogrel•Ticagrelor•Prasugrel•Dualantiplatelettherapy•Acutecoronarysyndromes•Coronaryarterybypassgrafting•Coronaryarterydisease•Drug-elutingstents•Myocardialinfarction•Stentthrombosis•Bleeding•Percutaneouscoronaryintervention•Recommendation•Revascularization•Riskstratification•Stents•Stableangina•Stablecoronaryarterydisease•Oralanticoagulant•Tripletherapy•DAPTscore•PRECISE-DAPTscore•Non-cardiacsurgeryTableofContentsAbbreviationsandacronyms..........................................31.Preamble..........................................................42.Introduction.......................................................62.1Short-andlong-termoutcomesafterpercutaneouscoronaryintervention.......................................................72.2Riskofstentthrombosisinrelationtostenttype.................72.3Short-andlong-termoutcomesaftercoronaryarterybypasssurgery............................................................72.4Short-andlong-termoutcomesaftermedicallymanagedacutecoronarysyndrome................................................73.Efficacyandsafetyofdualantiplatelettherapyandriskstratificationtools....................................................73.1Dualantiplatelettherapyforthepreventionofstentthrombosis........................................................73.2Dualantiplatelettherapyforthepreventionofspontaneousmyocardialinfarction...............................................73.3Dualantiplatelettherapyandmortalityrate......................73.4Safetyofdualantiplatelettherapy...............................73.5Riskstratificationtoolsforischaemiaandbleedingrisks..........73.6TypeofP2Y12inhibitorandtimingofinitiation...................93.7Measurestominimizebleedingwhileondualantiplatelettherapy...............................................113.8SwitchingbetweenoralP2Y12inhibitors........................134.Dualantiplatelettherapyandpercutaneouscoronaryintervention.........................................................144.1Dualantiplatelettherapyafterpercutaneouscoronaryinterventionforstablecoronaryarterydisease.....................144.2Dualantiplatelettherapyafterpercutaneouscoronaryinterventionforacutecoronarysyndrome.........................194.3Gapsintheevidence..........................................215.Dualantiplatelettherapyandcardiacsurgery.......................225.1Dualantiplatelettherapyinpatientstreatedwithcoronaryarterybypasssurgeryforstablecoronaryarterydisease............225.2Dualantiplatelettherapyinpatientstreatedwithcoronaryarterybypasssurgeryforacutecoronarysyndrome................225.3Dualantiplatelettherapyforpreventionofgraftocclusion.......245.4Gapsintheevidence..........................................256.Dualantiplatelettherapyforpatientswithmedicallymanagedacutecoronarysyndrome...........................................257.Dualantiplatelettherapyforpatientswithindicationfororalanticoagulation......................................................267.1Riskstratificationandstrategiestoimproveoutcomeafterpercutaneouscoronaryintervention...............................267.2Durationoftripletherapy.....................................277.3Cessationofallantiplateletagents..............................307.4Typeofanticoagulants.........................................307.5Typeofstent..................................................308.Electivenon-cardiacsurgeryinpatientsondualantiplatelettherapy.............................................................309.Genderconsiderationandspecialpopulations......................339.1Genderspecificities...........................................339.2Diabetesmellitus..............................................339.3Lower-extremitiesarterydisease..............................339.4Complexpercutaneouscoronaryintervention.................369.5Dualantiplatelettherapydecisionmakinginpatientswithstentthrombosis.................................................369.6Patientswhodevelopbleedingwhileontreatment..............3610.Keymessages....................................................3711.Evidenced-based‘todoandnottodo’messages..................3712.WebaddendaandClinicalCasescompaniondocument...........392ESCGuidelinesDownloadedfromhttps://academic.oup.com/eurheartj/advance-article-abstract/doi/10.1093/eurheartj/ehx419/4095043bygueston25November2017............................................................................................................................................................................13.Appendix.......................................................3914.References......................................................40AbbreviationsandacronymsABCAge,Biomarkers(GDF-15,cTnT-hs,andhaemoglobin),andClinicalhistory(previousbleeding)ACCAAcuteCardiovascularCareAssociationACCOASTAComparisonofPrasugrelattheTimeofPercutaneousCoronaryInterventionOrasPretreatmentAttheTimeofDiagnosisinPatientswithNon-ST-ElevationMyocardialInfarctionACSAcutecoronarysyndromeADPAdenosine5’-diphosphateAFAtrialfibrillationANTARCTICPlateletFunctionMonitoringtoAdjustAntiplateletTherapyinElderlyPatientsStentedforanAcuteCoronarySyndromeARCTIC-InterruptionAssessmentbyaDoubleRandomisationofaConventionalAntiplateletStrategyVersusaMonitoring-GuidedStrategyforDrug-ElutingStentImplantationand,ofTreatmentInterruptionVersusContinuation1YearAfterStenting-InterruptionARTArterialRevascularisationTrialASAAcetylsalicylicacidATACASAspirinandTranexamicAcidforCoronaryArterySurgeryATLANTICAdministrationofTicagrelorintheCathLaborintheAmbulanceforNewSTElevationMyocardialInfarctiontoOpentheCoronaryArteryBARCBleedingAcademicResearchConsortiumb.i.dBisindie(twiceaday)BMSBare-metalstentCABGCoronaryarterybypassgraftsurgeryCADCoronaryarterydiseaseCHADS2Cardiacfailure,Hypertension,Age,Diabetes,Stroke(Doubled)CHA2DS2-VAScCardiacfailure,Hypertension,Age>_75(2points),Diabetes,Stroke(2points)–Vasculardisease,Age65–74,SexcategoryCHARISMAClopidogrelforHighAtherothromboticRiskandIschemicStabilization,Management,andAvoidanceCIConfidenceintervalCOGENTClopidogrelandtheOptimizationofGastrointestinalEventsTrialCORONARYCABGOfforOnPumpRevascularizationStudyCPGCommitteeforPracticeGuidelinesCrClCreatinineclearanceCREDOClopidogrelfortheReductionofEventsDuringObservationCRUSADECanRapidriskstratificationofUnstableanginapatientsSuppressADverseoutcomeswithEarlyimplementationoftheACC/AHAGuidelinesCUREClopidogrelinUnstableAnginatoPreventRecurrentEventsCYPCytochromeP450DAPTDualantiplatelettherapyDESDrug-elutingstentEACTSEuropeanAssociationforCardio-ThoracicSurgeryEAPCEuropeanAssociationofPreventiveCardiologyEAPCIEuropeanAssociationofPercutaneousCardiovascularInterventionsESCEuropeanSocietyofCardiologyEXAMINATIONClinicalEvaluationoftheXience-VstentinAcuteMyocardialINfArcTIONEXCELLENTEfficacyofXience/PromusVersusCyphertoReduceLateLossAfterStentingFDAFoodandDrugAdministrationGUSTOGlobalUseofStrategiestoOpenOccludedCoronaryArteriesHAS-BLEDHypertension,Abnormalrenalandliverfunction,Stroke,Bleedinghistoryorpredisposition,LabileINR,Elderly(>65years),DrugsandalcoholHRHazardratioI-LOVE-IT2EvaluateSafetyandEffectivenessoftheTivoliDESandtheFirebirdDESforTreatmentofCoronaryRevascularizationINRInternationalnormalizedratioISARIntracoronaryStentingandAntithromboticRegimenISAR-SAFEIntracoronaryStentingandAntithromboticRegimen:SafetyandEfficacyof6MonthsDualAntiplateletTherapyAfterDrug-ElutingStentingISAR-TRIPLEIntracoronaryStentingandAntithromboticRegimen–Testingofa6-WeekVersusa6-MonthClopidogrelTreatmentRegimeninPatientsWithConcomitantAspirinandOralAnticoagulantTherapyFollowingDrug-ElutingStentingITALICIsThereaLifeforDESAfterDiscontinuationofClopidogrelIVUSXPLImpactofIntravascularUltrasoundGuidanceonOutcomesofXIENCEPRIMEStentsinLongLesionsLATELatecoronaryArterialThromboticEventsLEADLower-extremitiesarterydiseaseLEADERS-FREEProspectiverandomizedcomparisonoftheBioFreedombiolimusA9drug-coatedstentversusthegazellebare-metalstentinpatientsathighbleedingriskESCGuidelines3Downloadedfromhttps://academic.oup.com/eurheartj/advance-article-abstract/doi/10.1093/eurheartj/ehx419/4095043bygueston25November2017............................................................................................................................................................................LVEFLeftventricularejectionfractionMACCEMajoradversecardiacandcerebrovasculareventsMACEMajoradversecardiovasculareventsMATRIXMinimizingAdverseHaemorrhagicEventsbyTRansradialAccessSiteandSystemicImplementationofangioXMIMyocardialinfarctionNACENetadverseclinicaleventsNCDRNationalCardiovascularDataRegistryNNTNumberneededtotreatNOACNon-vitaminKoralanticoagulantNORSTENTNORwegiancoronarySTENTtrialNSTE-ACSNon-STelevationacutecoronarysyndromeNSTEMINon-ST-segmentelevationmyocardialinfarctionOACOralanticoagulanto.d.Omnidie(onceaday)OPTIMIZEOptimizedDurationofClopidogrelTherapyFollowingTreatmentWiththeZotarolimus-ElutingStentinReal-WorldClinicalPracticeOROddsratioPARISPatternsofNonadherencetoAntiplateletRegimensinStentedPatientsPCIPercutaneouscoronaryinterventionPEGASUS-TIMI54PreventionofCardiovascularEventsinPatientswithPriorHeartAttackUsingTicagrelorComparedtoPlaceboonaBackgroundofAspirin–ThrombolysisinMyocardialInfarction54PIONEERAF-PCIRivaroxabanandadose-adjustedoralvitaminKantagonisttreatmentstrategyinsubjectswithatrialfibrillationwhoundergopercutaneouscoronaryinterventionPLATOPLATeletinhibitionandpatientOutcomesPPIProtonpumpinhibitorPRECISE-DAPTPREdictingbleedingComplicationsInpatientsundergoingStentimplantationandsubsEquentDualAntiPlateletTherapyPRODIGYPROlongingDualantiplatelettreatmentafterGradingstent-inducedintimalhYperplasiastudyPROTECTPatient-RelatedOutcomesWithEndeavorvsCypherStentingq.d.Quaquedie(oneaday)RCTRandomizedcontrolledtrialREDUAL-PCIEvaluationofDualTherapyWithDabigatranvs.TripleTherapyWithWarfarininPatientsWithAFibThatUndergoaPCIWithStentingRESETRealSafetyandEfficacyof3-MonthDualAntiplateletTherapyFollowingEndeavorZotarolimus-ElutingStentImplantationROOBYVeteransAffairsRandomizedOn/OffBypasstrialRRRelativeriskRRRRelativeriskreductionSECURITYSecondGenerationDrug-ElutingStentImplantationFollowedbySix-VersusTwelve-MonthDualAntiplateletTherapySTEMIST-segmentelevationmyocardialinfarctionSTREAMSTrategicReperfusionEarlyAfterMyocardialInfarctionSYNTAXSynergyBetweenPercutaneousCoronaryInterventionWithTaxusandCardiacSurgeryTIATransientischaemicattackTIMIThrombolysisInMyocardialInfarctionTL-PASTaxusLibertéPostApprovalStudyTRA2P-TIMI50ThrombinReceptorAntagonistinSecondaryPreventionofAtherothromboticIschemicEventsTRACERThrombinReceptorAntagonistforClinicalEventReductioninAcuteCoronarySyndromeTRILOGYACSTargetedPlateletInhibitiontoClarifytheOptimalStrategytoMedicallyManageAcuteCoronarySyndromesTRITON-TIMI38TrialtoAssessImprovementinTherapeuticOutcomesbyOptimizingPlateletInhibitionwithPrasugrel–ThrombolysisinMyocardialInfarctionTROPICAL-ACSTestingResponsivenesstoPlateletInhibitiononChronicAntiplateletTreatmentForAcuteCoronarySyndromesTrialVAVeterans’AdministrationVKAVitaminKantagonistWOESTWhatistheOptimalantiplatEletandanticoagulanttherapyinpatientswithOACandcoronaryStenTingZESZotarolimus-elutingstentZEUSZotarolimus-elutingEndeavorsprintstentinUncertainDESCandidates24/724haday,sevendaysaweek1.PreambleGuidelinesandFocusedUpdateswrittenundertheauspicesoftheEuropeanSocietyofCardiology’s(ESC)CommitteeforPracticeGuidelines(CPG)summarizeandevaluateavailableevidencewiththeaimofassistinghealthprofessionalsinselectingthebestmanage-mentstrategiesforanindividualpatientwithagivencondition.TheCPGGuidelines’andFocusedUpdates’recommendationsshouldfacilitatedecisionmakingofhealthprofessionalsintheirdailypractice.However,thefinaldecisionsconcerninganindividualpatientmustbemadebytheresponsiblehealthprofessional(s)inconsultationwiththepatientandcaregiverasappropriate.4ESCGuidelinesDownloadedfromhttps://academic.oup.com/eurheartj/advance-article-abstract/doi/10.1093/eurheartj/ehx419/4095043bygueston25November2017......................................................AgreatnumberofguidelinesandfocusedupdateshavebeenissuedinrecentyearsbytheESCandbytheEuropeanAssociationforCardio-ThoracicSurgery(EACTS)aswellasbyothersocietiesandorganizations.Becauseoftheimpactonclinicalpractice,qualitycriteriaforthedevelopmentofguidelineshavebeenestablishedinordertomakealldecisionstransparenttotheuser.Therecommen-dationsforformulatingandissuingESCGuidelinescanbefoundontheESCwebsite(http://www.escardio.org/Guidelines-&-Education/Clinical-Practice-Guidelines/Guidelines-development/Writing-ESC-Guidelines).ESCGuidelinesrepresenttheofficialpositionoftheESConagiventopicandareregularlyupdated.MembersofthisTaskForcewereselectedbytheESCandEACTStorepresentprofessionalsinvolvedwiththemedicalcareofpatientswiththispathology.Selectedexpertsinthefieldundertookacom-prehensivereviewofthepublishedevidenceformanagementofagivenconditionaccordingtoESCCommitteeforPracticeGuidelines(CPG)policyandapprovedbytheEACTS.Acriticalevaluationofdiagnosticandtherapeuticprocedureswasperformed,includingassessmentoftherisk–benefitratio.Thelevelofevidenceandthestrengthoftherecommendationofparticularmanagementoptionswereweighedandgradedaccordingtopredefinedscales,asoutlinedinTables1and2.Theexpertsofthewritingandreviewingpanelsprovideddeclara-tionofinterestformsforallrelationshipsthatmightbeperceivedasrealorpotentialsourcesofconflictsofinterest.TheseformswerecompiledintoonefileandcanbefoundontheESCwebsite(http://www.escardio.org/guidelines).AnychangesindeclarationsofinterestthatariseduringthewritingperiodwerenotifiedtotheESCandupdated.TheTaskForcereceiveditsentirefinancialsupportfromtheESCwithoutanyinvolvementfromthehealthcareindustry.TheESCCPGsupervisesandcoordinatesthepreparationofnewGuidelinesandofitsFocusedUpdates.TheCommitteeisalsoresponsiblefortheendorsementprocessofthesedocuments.TheseCPGdocumentsundergoextensivereviewbytheCPGandexternalexperts,andinthiscasebyEACTS-appointedexperts.Afterappro-priaterevisionstheCPGdocumentsareapprovedbyalltheexpertsinvolvedintheTaskForce.ThefinalizeddocumentisapprovedbytheCPGforpublicationintheEuropeanHeartJournalandintheEuropeanJournalofCardio-ThoracicSurgery.TheseCPGdocu-mentsweredevelopedaftercarefulconsiderationofthesc