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2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention PDF

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JournaloftheAmericanCollegeofCardiology Vol.58,No.24,2011 ©2011bytheAmericanCollegeofCardiologyFoundationandtheAmericanHeartAssociation,Inc. ISSN0735-1097/$36.00 PublishedbyElsevierInc. doi:10.1016/j.jacc.2011.08.007 PRACTICE GUIDELINE 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions Writing Glenn N. Levine, MD, FACC, FAHA, Chair† Richard A. Lange, MD, FACC, FAHA§ Committee Eric R. Bates, MD, FACC, FAHA, Laura Mauri, MD, MSC, FACC, FSCAI*† Members* Vice Chair*† RoxanaMehran,MD,FACC,FAHA,FSCAI*‡ James C. Blankenship, MD, FACC, FSCAI, IssamD.Moussa,MD,FACC,FAHA,FSCAI‡ Vice Chair*‡ Debabrata Mukherjee, MD, FACC, FSCAI† Brahmajee K. Nallamothu, MD, FACC¶ Steven R. Bailey, MD, FACC, FSCAI*‡ Henry H. Ting, MD, FACC, FAHA† John A. Bittl, MD, FACC†§ Bojan Cercek, MD, FACC, FAHA† *Writingcommitteemembersarerequiredtorecusethemselvesfrom Charles E. Chambers, MD, FACC, FSCAI‡ votingonsectionstowhichtheirspecificrelationshipswithindustryand other entities may apply; see Appendix 1 for recusal information. Stephen G. Ellis, MD, FACC*† †ACCF/AHARepresentative.‡SCAIRepresentative.§JointRevascu- Robert A. Guyton, MD, FACC*(cid:1) larization Section Author. (cid:1)ACCF/AHA Task Force on Practice Steven M. Hollenberg, MD, FACC*† Guidelines Liaison. ¶ACCF/AHA Task Force on Performance MeasuresLiaison. Umesh N. Khot, MD, FACC*† ACCF/AHA Alice K. Jacobs, MD, FACC, FAHA, Chair Robert A. Guyton, MD, FACC TaskForce Jeffrey L. Anderson, MD, FACC, FAHA, Jonathan L. Halperin, MD, FACC, FAHA Members Chair-Elect Judith S. Hochman, MD, FACC, FAHA Frederick G. Kushner, MD, FACC, FAHA Nancy Albert, PHD, CCNS, CCRN, FAHA E. Magnus Ohman, MD, FACC Mark A. Creager, MD, FACC, FAHA William Stevenson, MD, FACC, FAHA Steven M. Ettinger, MD, FACC Clyde W. Yancy, MD, FACC, FAHA ThisdocumentwasapprovedbytheAmericanCollegeofCardiologyFoundation ThisarticleiscopublishedinCirculationandCatheterizationandCardiovascular Board of Trustees and the American Heart Association Science Advisory and Interventions. CoordinatingCommitteeinJuly2011,andtheSocietyforCardiovascularAngiog- Copies:ThisdocumentisavailableontheWorldWideWebsitesoftheAmerican raphyandInterventionsinAugust2011. College of Cardiology (www.cardiosource.org), the American Heart Association TheAmericanCollegeofCardiologyFoundationrequeststhatthisdocumentbecitedas (my.americanheart.org),andtheSocietyforCardiovascularAngiographyandInter- follows: Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, ventions(www.scai.org).Forcopiesofthisdocument,pleasecontactElsevierInc. ChambersCE,EllisSG,GuytonRA,HollenbergSM,KhotUN,LangeRA,MauriL, ReprintDepartment,fax(212)633-3820,[email protected]. MehranR,MoussaID,MukherjeeD,NallamothuBK,TingHH.2011ACCF/AHA/ Permissions:Multiplecopies,modification,alteration,enhancement,and/ordis- SCAIguidelineforpercutaneouscoronaryintervention:areportoftheAmericanCollege tribution of thisdocumentarenotpermittedwithouttheexpresspermissionofthe ofCardiologyFoundation/AmericanHeartAssociationTaskForceonPracticeGuide- American College of Cardiology Foundation. Please contact healthpermissions@ lines and the Society for Cardiovascular Angiography and Interventions. J Am Coll elsevier.com. Cardiol2011;58:e44–122. JACCVol.58,No.24,2011 Levineetal. e45 December6,2011:e44–122 2011ACCF/AHA/SCAIPCIGuideline 4.1.2. Staffing.........................................e61 TABLE OF CONTENTS 4.1.3. ‘Time-Out’Procedures.........................e62 4.2. EthicalAspects......................................e63 Preamble......................................................e46 4.2.1. InformedConsent..............................e63 4.2.2. PotentialConflictsofInterest..................e63 1. Introduction...............................................e48 4.3. RadiationSafety:Recommendation..............e63 4.4. Contrast-InducedAKI:Recommendations........e63 1.1. MethodologyandEvidenceReview...............e48 4.5. AnaphylactoidReactions:Recommendations....e64 1.2. OrganizationoftheWritingCommittee..........e49 4.6. StatinTreatment:Recommendation..............e65 1.3. DocumentReviewandApproval...................e49 4.7. BleedingRisk:Recommendation..................e65 1.4. PCIGuidelines:HistoryandEvolution............e49 4.8. PCIinHospitalsWithoutOn-SiteSurgical 2. CADRevascularization..................................e50 Backup:Recommendations........................e65 5. ProceduralConsiderations.............................e65 2.1. HeartTeamApproachtoRevascularization Decisions:Recommendations.....................e50 5.1. VascularAccess:Recommendation...............e65 2.2. RevascularizationtoImproveSurvival: 5.2. PCIinSpecificClinicalSituations ................e66 Recommendations..................................e52 5.2.1. UA/NSTEMI:Recommendations..............e66 2.3. RevascularizationtoImproveSymptoms: 5.2.2. ST-ElevationMyocardialInfarction............e68 Recommendations..................................e53 5.2.2.1. CORONARYANGIOGRAPHYSTRATEGIESINSTEMI: RECOMMENDATIONS.........................e68 2.4. CABGVersusContemporaneousMedicalTherapy...e53 5.2.2.2. PRIMARYPCIOFTHEINFARCTARTERY: 2.5. PCIVersusMedicalTherapy.......................e54 RECOMMENDATIONS.........................e69 2.6. CABGVersusPCI....................................e54 5.2.2.3. DELAYEDORELECTIVEPCIINPATIENTSWITHSTEMI: 2.6.1. CABGVersusBalloonAngioplastyorBMS...e54 RECOMMENDATIONS.........................e69 2.6.2. CABGVersusDES............................e55 5.2.3. CardiogenicShock:Recommendations.........e70 5.2.3.1. PROCEDURALCONSIDERATIONSFORCARDIOGENIC 2.7. LeftMainCAD.......................................e55 SHOCK....................................e70 2.7.1. CABGorPCIVersusMedicalTherapyfor 5.2.4. RevascularizationBeforeNoncardiacSurgery: LeftMainCAD................................e55 Recommendations..............................e71 2.7.2. StudiesComparingPCIVersusCABGfor 5.3. CoronaryStents:Recommendations..............e71 LeftMainCAD................................e56 2.7.3. RevascularizationConsiderationsfor 5.4. AdjunctiveDiagnosticDevices....................e73 LeftMainCAD................................e56 5.4.1. FFR:Recommendation.........................e73 2.8. ProximalLADArteryDisease......................e57 55..44..23.. IOVpUtiSca:lRCecoohmermenecnedTatoiomnos.g.r.a.p.h.y.................................ee7733 2.9. ClinicalFactorsThatMayInfluencethe ChoiceofRevascularization.......................e57 5.5. 5A.d5j.u1.ncCtiovreonTahryerAatpheeuretcitcomDey:vRiceecsom..m..e.n..d.a.t.i.o.n.s...........ee7744 2.9.1. DiabetesMellitus...............................e57 5.5.2. Thrombectomy:Recommendation..............e74 2.9.2. ChronicKidneyDisease........................e57 5.5.3. LaserAngioplasty:Recommendations..........e74 2.9.3. CompletenessofRevascularization .............e58 5.5.4. CuttingBalloonAngioplasty: 2.9.4. LVSystolicDysfunction........................e58 Recommendations..............................e74 2.9.5. PreviousCABG................................e58 5.5.5. EmbolicProtectionDevices:Recommendation...e74 2.9.6. UnstableAngina/Non–ST-Elevation 5.6. PercutaneousHemodynamicSupportDevices: MyocardialInfarction ..........................e58 2.9.7. DAPTComplianceandStentThrombosis: Recommendation....................................e74 Recommendation...............................e58 5.7. InterventionalPharmacotherapy..................e75 2.10. TMRasanAdjuncttoCABG........................e59 5.7.1. ProceduralSedation............................e75 2.11. HybridCoronaryRevascularization: 5.7.2. OralAntiplateletTherapy:Recommendations....e75 Recommendations..................................e59 55..77..34.. IAVntAicnotaigpulalatenltetTThherearpapyy.:..R.e.c.o..m..m..e.n.d.a.t.i.o.n.s.........ee7778 3. PCIOutcomes............................................e59 5.7.4.1. USEOFPARENTERALANTICOAGULANTSDURINGPCI: RECOMMENDATION..........................e78 5.7.4.2. UFH:RECOMMENDATION......................e78 3.1. DefinitionsofPCISuccess.........................e59 5.7.4.3. ENOXAPARIN:RECOMMENDATIONS..............e79 3.1.1. AngiographicSuccess...........................e60 5.7.4.4. BIVALIRUDINANDARGATROBAN: 3.1.2. ProceduralSuccess..............................e60 RECOMMENDATIONS.........................e80 3.1.3. ClinicalSuccess ................................e60 5.7.4.5. FONDAPARINUX:RECOMMENDATION.............e80 3.2. PredictorsofClinicalOutcomeAfterPCI........e60 5.7.5. No-ReflowPharmacologicalTherapies: 3.3. PCIComplications ..................................e60 Recommendation...............................e80 5.8. PCIinSpecificAnatomicSituations..............e81 4. PreproceduralConsiderations.........................e61 5.8.1. CTOs:Recommendation.......................e81 5.8.2. SVGs:Recommendations ......................e81 4.1. CardiacCatheterizationLaboratory 5.8.3. BifurcationLesions:Recommendations.........e81 Requirements........................................e61 5.8.4. Aorto-OstialStenoses:Recommendations......e82 4.1.1. Equipment.....................................e61 5.8.5. CalcifiedLesions:Recommendation............e82 e46 Levineetal. JACCVol.58,No.24,2011 2011ACCF/AHA/SCAIPCIGuideline December6,2011:e44–122 5.9. PCIinSpecificPatientPopulations...............e82 detection, management, and prevention of disease. When 5.9.1. Elderly .........................................e83 properly applied, expert analysis of available data on the 5.9.2. Diabetes........................................e83 benefits and risks of these therapies and procedures can 5.9.3. Women ........................................e83 improve the quality of care, optimize patient outcomes, and 5.9.4. CKD:Recommendation........................e83 5.9.5. CardiacAllografts..............................e83 favorablyaffectcostsbyfocusingresourcesonthemosteffective 5.10. PeriproceduralMIAssessment: strategies.Anorganizedanddirectedapproachtoathorough Recommendations..................................e83 review of evidence has resulted in the production of clinical 5.11. VascularClosureDevices:Recommendations...e84 practice guidelines that assist physicians in selecting the best managementstrategyforanindividualpatient.Moreover,clinical 6. PostproceduralConsiderations.......................e84 practiceguidelinescanprovideafoundationforotherapplications, 6.1. PostproceduralAntiplateletTherapy: suchasperformancemeasures,appropriateusecriteria,andboth Recommendations..................................e84 qualityimprovementandclinicaldecisionsupporttools. 6.1.1. PPIsandAntiplateletTherapy: The American College of Cardiology Foundation Recommendations..............................e86 (ACCF)andtheAmericanHeartAssociation(AHA)have 6.1.2. ClopidogrelGeneticTesting: jointly produced guidelines in the area of cardiovascular Recommendations..............................e86 disease since 1980. The ACCF/AHA Task Force on 6.1.3. PlateletFunctionTesting:Recommendations.....e86 PracticeGuidelines(TaskForce),chargedwithdeveloping, 6.2. StentThrombosis...................................e87 updating,andrevisingpracticeguidelinesforcardiovascular 6.3. Restenosis:Recommendations....................e87 diseases and procedures, directs and oversees this effort. 6.3.1. BackgroundandIncidence .....................e87 6.3.2. RestenosisAfterBalloonAngioplasty ..........e88 Writing committees are charged with regularly reviewing 6.3.3. RestenosisAfterBMS..........................e88 and evaluating all available evidence to develop balanced, 6.3.4. RestenosisAfterDES..........................e88 patient-centric recommendations for clinical practice. 6.4. ClinicalFollow-Up...................................e88 Expertsinthesubjectunderconsiderationareselectedby 6.4.1. ExerciseTesting:Recommendations............e88 the ACCF and AHA to examine subject-specific data and 6.4.2. ActivityandReturntoWork...................e89 write guidelines in partnership with representatives from 6.4.3. CardiacRehabilitation:Recommendation......e89 other medical organizations and specialty groups. Writing 6.5. SecondaryPrevention..............................e89 committeesareaskedtoperformaformalliteraturereview; 7. QualityandPerformanceConsiderations...........e90 weighthestrengthofevidencefororagainstparticulartests, treatments,orprocedures;andincludeestimatesofexpected 7.1. QualityandPerformance:Recommendations....e90 outcomes where such data exist. Patient-specific modifiers, 7.2. Training...............................................e90 comorbidities, and issues of patient preference that may 7.3. CertificationandMaintenanceofCertification: influence the choice of tests or therapies are considered. Recommendation....................................e90 When available, information from studies on cost is con- 7.4. OperatorandInstitutionalCompetencyand sidered, but data on efficacy and outcomes constitute the Volume:Recommendations........................e90 primary basis for the recommendations contained herein. 7.5. ParticipationinACCNCDRor In analyzing the data and developing recommendations NationalQualityDatabase.........................e91 and supporting text, the writing committee uses evidence- 8. FutureChallenges.......................................e91 basedmethodologiesdevelopedbytheTaskForce(1).The ClassofRecommendation(COR)isanestimateofthesize References...................................................e91 of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treat- Appendix1.AuthorRelationshipsWithIndustryand ment or procedure is or is not useful/effective or in some OtherEntities(Relevant).................................e115 situationsmaycauseharm.TheLevelofEvidence(LOE)is an estimate of the certainty or precision of the treatment Appendix2.ReviewerRelationshipsWithIndustry effect. The writing committee reviews and ranks evidence andOtherEntities(Relevant)............................e117 supporting each recommendation with the weight of evi- dence ranked as LOE A, B, or C according to specific Appendix3.AbbreviationList............................e119 definitions that are included in Table 1. Studies are identi- fiedasobservational,retrospective,prospective,orrandom- Appendix4.AdditionalTables/Figures.................e120 ized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked Preamble as LOE C. When recommendations at LOE C are sup- ported by historical clinical data, appropriate references Themedicalprofessionshouldplayacentralroleinevaluating (including clinical reviews) are cited if available. For issues the evidence related to drugs, devices, and procedures for the for which sparse data are available, a survey of current JACCVol.58,No.24,2011 Levineetal. e47 December6,2011:e44–122 2011ACCF/AHA/SCAIPCIGuideline Table1. ApplyingClassificationofRecommendationsandLevelofEvidence ArecommendationwithLevelofEvidenceBorCdoesnotimplythattherecommendationisweak.Manyimportantclinicalquestionsaddressedintheguidelinesdonotlendthemselvestoclinicaltrials. Althoughrandomizedtrialsareunavailable,theremaybeaveryclearclinicalconsensusthataparticulartestortherapyisusefuloreffective. *Dataavailablefromclinicaltrialsorregistriesabouttheusefulness/efficacyindifferentsubpopulations,suchassex,age,historyofdiabetes,historyofpriormyocardialinfarction,historyofheart failure,andprioraspirinuse.†Forcomparativeeffectivenessrecommendations(ClassIandIIa;LevelofEvidenceAandBonly),studiesthatsupporttheuseofcomparatorverbsshouldinvolvedirect comparisonsofthetreatmentsorstrategiesbeingevaluated. practiceamongthecliniciansonthewritingcommitteeis In view of the advances in medical therapy across the thebasisforLOECrecommendationsandnoreferences spectrum of cardiovascular diseases, the Task Force has are cited. The schema for COR and LOE is summarized designated the term guideline-directed medical therapy in Table 1, which also provides suggested phrases for (GDMT)torepresentoptimalmedicaltherapyasdefinedby writing recommendations within each COR. A new ACCF/AHA guideline recommended therapies (primarily addition to this methodology is separation of the Class Class I). This new term, GDMT, will be used herein and III recommendations to delineate if the recommendation throughout all future guidelines. is determined to be of “no benefit” or is associated with Because the ACCF/AHA practice guidelines address “harm” to the patient. In addition, in view of the patient populations (and healthcare providers) residing in increasing number of comparative effectiveness studies, North America, drugs that are not currently available in comparator verbs and suggested phrases for writing North America are discussed in the text without a specific recommendations for the comparative effectiveness of COR. For studies performed in large numbers of subjects onetreatmentorstrategyversusanotherhavebeenadded outsideNorthAmerica,eachwritingcommitteereviewsthe for COR I and IIa, LOE A or B only. potentialinfluenceofdifferentpracticepatternsandpatient e48 Levineetal. JACCVol.58,No.24,2011 2011ACCF/AHA/SCAIPCIGuideline December6,2011:e44–122 populations on the treatment effect and relevance to the aredisclosedinAppendixes1and2,respectively.Additionally, ACCF/AHA target population to determine whether the toensurecompletetransparency,writingcommitteemembers’ findings should inform a specific recommendation. comprehensive disclosure information—including RWI not The ACCF/AHA practice guidelines are intended to pertinent to this document—is available as an online supple- assist healthcare providers in clinical decision making by ment. Comprehensive disclosure information for the Task describingarangeofgenerallyacceptableapproachestothe Force is also available online at www.cardiosource.org/ACC/ diagnosis, management, and prevention of specific diseases About-ACC/Leadership/Guidelines-and-Documents-Task- or conditions. The guidelines attempt to define practices Forces.aspx.Theworkofthewritingcommitteewassupported thatmeettheneedsofmostpatientsinmostcircumstances. exclusivelybytheACCF,AHA,andtheSocietyforCardio- Theultimatejudgmentregardingcareofaparticularpatient vascularAngiographyandInterventions(SCAI)withoutcom- mustbemadebythehealthcareproviderandpatientinlight mercial support. Writing committee members volunteered of all the circumstances presented by that patient. As a theirtimeforthisactivity. result, situations may arise for which deviations from these Inanefforttomaintainrelevanceatthepointofcarefor guidelines may be appropriate. Clinical decision making practicing physicians, the Task Force continues to oversee should involve consideration of the quality and availability an ongoing process improvement initiative. As a result, in ofexpertiseintheareawherecareisprovided.Whenthese response to pilot projects, several changes to these guide- guidelines are used as the basis for regulatory or payer lines will be apparent, including limited narrative text, a decisions,thegoalshouldbeimprovementinqualityofcare. focus on summary and evidence tables (with references The Task Force recognizes that situations arise in which linked to abstracts in PubMed) and more liberal use of additional data are needed to inform patient care more summaryrecommendationtables(withreferencesthatsup- effectively;theseareaswillbeidentifiedwithineachrespec- port LOE) to serve as a quick reference. tive guideline when appropriate. In April 2011, the Institute of Medicine released 2 Prescribed courses of treatment in accordance with these reports: Finding What Works in Health Care: Standards for recommendationsareeffectiveonlyiffollowed.Becauselack Systematic Reviews and Clinical Practice Guidelines We Can ofpatientunderstandingandadherencemayadverselyaffect Trust (2,3). It is noteworthy that the ACCF/AHA guide- outcomes,physiciansandotherhealthcareprovidersshould lines were cited as being compliant with many of the makeeveryefforttoengagethepatient’sactiveparticipation standards that were proposed. A thorough review of these in prescribed medical regimens and lifestyles. In addition, reports and of our current methodology is under way, with patients should be informed of the risks, benefits, and further enhancements anticipated. alternatives to a particular treatment and be involved in The recommendations in this guideline are considered shared decision making whenever feasible, particularly for currentuntiltheyaresupersededbyafocusedupdateorthe COR IIa and IIb, where the benefit-to-risk ratio may be full-textguidelineisrevised.Guidelinesareofficialpolicyof lower. both the ACCF and AHA. The Task Force makes every effort to avoid actual, Alice K. Jacobs, MD, FACC, FAHA, Chair potential,orperceivedconflictsofinterestthatmayariseas ACCF/AHA Task Force on Practice Guidelines aresultofindustryrelationshipsorpersonalinterestsamong the members of the writing committee. All writing com- 1. Introduction mittee members and peer reviewers of the guideline are asked to disclose all such current relationships, as well as 1.1. Methodology and Evidence Review thoseexisting12monthspreviously.InDecember2009,the ACCF and AHA implemented a new policy for relation- The recommendations listed in this document are, when- ships with industry and other entities (RWI) that requires everpossible,evidencebased.Anextensiveevidencereview thewritingcommitteechairplusaminimumof50%ofthe wasconductedthroughNovember2010,aswellasselected writingcommitteetohavenorelevantRWI(Appendix1for other references through August 2011. Searches were lim- theACCF/AHAdefinitionofrelevance).Thesestatements ited to studies, reviews, and other evidence conducted in arereviewedbytheTaskForceandallmembersduringeach human subjects and that were published in English. Key conference call and/or meeting of the writing committee searchwordsincludedbutwerenotlimitedtothefollowing: andareupdatedaschangesoccur.Allguidelinerecommen- ad hoc angioplasty, angioplasty, balloon angioplasty, clinical dationsrequireaconfidentialvotebythewritingcommittee trial, coronary stenting, delayed angioplasty, meta-analysis, and must be approved by a consensus of the voting mem- percutaneous transluminal coronary angioplasty, randomized bers. Members are not permitted to write, and must recuse controlled trial (RCT), percutaneous coronary intervention themselvesfromvotingon,anyrecommendationorsectionto (PCI) and angina, angina reduction, antiplatelet therapy, which their RWI apply. Members who recused themselves bare-metal stents (BMS), cardiac rehabilitation, chronic stable from voting are indicated in the list of writing committee angina, complication, coronary bifurcation lesion, coronary members, and section recusals are noted in Appendix 1. calcifiedlesion,coronarychronictotalocclusion(CTO),coronary Authors’ and peer reviewers’ RWI pertinent to this guideline ostial lesions, coronary stent (BMS and drug-eluting stents JACCVol.58,No.24,2011 Levineetal. e49 December6,2011:e44–122 2011ACCF/AHA/SCAIPCIGuideline [DES]; and BMS versus DES), diabetes, distal embolization, port, was written by an ad hoc group whose members distal protection, elderly, ethics, late stent thrombosis, medical included Andreas Grüntzig. In 1980, the ACC and the therapy, microembolization, mortality, multiple lesions, multi- AHA established the Task Force on Assessment of Diag- vessel, myocardial infarction (MI), non–ST-elevation myocar- nostic and Therapeutic Cardiovascular Procedures, which dialinfarction(NSTEMI),no-reflow,opticalcoherencetomog- was charged with the development of guidelines related to raphy,protonpumpinhibitor(PPI),returntowork,same-day the role of new therapeutic approaches and of specific angioplasty and/or stenting, slow flow, stable ischemic heart noninvasive and invasive procedures in the diagnosis and disease (SIHD), staged angioplasty, STEMI, survival, and management of cardiovascular disease. The first ACC/ unstable angina (UA). Additional searches cross-referenced AHATaskForcereportonguidelinesforcoronaryballoon these topics with the following subtopics: anticoagulant angioplasty was published in 1988 (5). The 18-page docu- therapy, contrast nephropathy, PCI-related vascular complica- ment discussed and made recommendations about lesion tions, unprotected left main PCI, multivessel coronary artery classification and success rates, indications for and contra- disease(CAD),adjunctivepercutaneousinterventionaldevices, indications to balloon angioplasty, institutional review of percutaneous hemodynamic support devices, and secondary pre- angioplasty procedures, ad hoc angioplasty after angiogra- vention. Additionally, the committee reviewed documents phy, and on-site surgical backup. Further iterations of the related to the subject matter previously published by the guidelines were published in 1993 (6), 2001 (7), and 2005 ACCFandAHA.Referencesselectedandpublishedinthis (8). In 2007 and 2009, focused updates to the guideline document are representative and not all-inclusive. were published to expeditiously address new study results To provide clinicians with a comprehensive set of data, and recent changes in the field of interventional cardiology whenever deemed appropriate or when published, the ab- (9,10). The 2009 focused update is notable in that there solute risk difference and number needed to treat or harm will be provided in the guideline, along with confidence was direct collaboration between the writing committees intervals (CIs) and data related to the relative treatment for the STEMI guidelines and the PCI guidelines, effects such as odds ratio (OR), relative risk, hazard ratio resulting in a single publication of focused updates on (HR), or incidence rate ratio. STEMI and PCI (10). The focus of this guideline is the safe, appropriate, and TheevolutionofthePCIguidelinereflectsthegrowthof efficacious performance of PCI. The risks of PCI must be knowledgeinthefieldandparallelsthemanyadvancesand balancedagainstthelikelihoodofimprovedsurvival,symp- innovationsinthefieldofinterventionalcardiology,includ- toms, or functional status. This is especially important in ing primary PCI, BMS and DES, intravascular ultrasound patients with SIHD. (IVUS) and physiologic assessments of stenosis, and newer antiplateletandanticoagulanttherapies.The2011iteration 1.2. Organization of the Writing Committee of the guideline continues this process, addressing ethical The committee was composed of physicians with expertise aspects of PCI, vascular access considerations, CAD ininterventionalcardiology,generalcardiology,criticalcare revascularization including hybrid revascularization, re- cardiology,cardiothoracicsurgery,clinicaltrials,andhealth vascularization before noncardiac surgery, optical coher- services research. The committee included representatives ence tomography, advanced hemodynamic support de- from the ACCF, AHA, and SCAI. vices, no-reflow therapies, and vascular closure devices. 1.3. Document Review and Approval Mostofthisdocumentisorganizedaccordingto“patient flow,” consisting of preprocedural considerations, proce- This document was reviewed by 2 official reviewers nomi- dural considerations, and postprocedural considerations. nated by the ACCF, AHA, and SCAI, as well as 21 In a major undertaking, the STEMI, PCI, and coronary individual content reviewers (including members of the artery bypass graft (CABG) surgery guidelines were ACCF Interventional Scientific Council and ACCF Sur- written concurrently, with additional collaboration with geons’ Scientific Council). All information on reviewers’ the SIHD guideline writing committee, allowing greater RWI was distributed to the writing committee and is collaboration between the different writing committees published in this document (Appendix 2). This document on topics such as PCI in STEMI and revascularization wasapprovedforpublicationbythegoverningbodiesofthe strategies in patients with CAD (including unprotected ACCF, AHA, and SCAI. left main PCI, multivessel disease revascularization, and 1.4. PCI Guidelines: History and Evolution hybrid procedures). In 1982, a 2-page manuscript titled “Guidelines for the In accordance with direction from the Task Force and Performance of Percutaneous Transluminal Coronary An- feedback from readers, in this iteration of the guideline, gioplasty” was published in Circulation (4). The document, the text has been shortened, with an emphasis on which addressed the specific expertise and experience phy- summary statements rather than detailed discussion of sicians should have to perform balloon angioplasty, as well numerousindividualtrials.Onlinesupplementalevidence as laboratory requirements and the need for surgical sup- and summary tables have been created to document the e50 Levineetal. JACCVol.58,No.24,2011 2011ACCF/AHA/SCAIPCIGuideline December6,2011:e44–122 studiesanddataconsideredforneworchangedguideline theSYNTAXscore isa reasonable surrogatefortheextent recommendations. of CAD and its complexity and serves as important infor- mation that should be considered when making revascular- izationdecisions.RecommendationsthatrefertoSYNTAX 2. CAD Revascularization scoresusethemassurrogatesfortheextentandcomplexity of CAD. Recommendations and text in this section are the result of Revascularizationrecommendationstoimprovesurvivaland extensive collaborative discussions between the PCI and symptomsareprovidedinthefollowingtextandaresumma- CABG writing committees, as well as key members of the rized in Tables 2 and 3. References to studies comparing SIHD and UA/NSTEMI writing committees. Certain revascularization with medical therapy are presented when issues, such as older versus more contemporary studies, availableforeachanatomicsubgroup. primary analyses versus subgroup analyses, and prospective versus post hoc analyses, have been carefully weighed in See Online Data Supplements 1 and 2 for additional data designating COR and LOE; they are addressed in the regarding the survival and symptomatic benefits with CABG or appropriate corresponding text. The goals of revasculariza- PCIfordifferentanatomicsubsets. tion for patients with CAD are to 1) improve survival and/or 2) relieve symptoms. 2.1. Heart Team Approach to Revascularization recommendations in this section are Revascularization Decisions: Recommendations predominantly based on studies of patients with symptom- atic SIHD and should be interpreted in this context. As CLASSI 1. A Heart Team approach to revascularization is recommended in discussedlaterinthissection,recommendationsonthetype patientswithunprotectedleftmainorcomplexCAD(14–16).(Level of revascularization are, in general, applicable to patients ofEvidence:C) with UA/NSTEMI. In some cases (e.g., unprotected left main CAD), specific recommendations are made for pa- CLASSIIa tients with UA/NSTEMI or STEMI. 1. CalculationoftheSocietyofThoracicSurgeons(STS)andSYNTAX Historically, most studies of revascularization have been scores is reasonable in patients with unprotected left main and based on and reported according to angiographic criteria. complexCAD(13,14,17–22).(LevelofEvidence:B) Most studies have defined a “significant” stenosis as (cid:1)70% One protocol used in RCTs (14–16,23) often involves a diameter narrowing; therefore, for revascularization deci- multidisciplinary approach referred to as the Heart Team. sions and recommendations in this section, a “significant” Composed of an interventional cardiologist and a cardiac stenosis has been defined as (cid:1)70% diameter narrowing surgeon, the Heart Team 1) reviews the patient’s medical ((cid:1)50% for left main CAD). Physiological criteria, such as condition and coronary anatomy, 2) determines that PCI an assessment of fractional flow reserve (FFR), has been and/or CABG are technically feasible and reasonable, and used in deciding when revascularization is indicated. Thus, 3)discussesrevascularizationoptionswiththepatientbefore forrecommendationsaboutrevascularizationinthissection, a treatment strategy is selected. Support for using a Heart coronarystenoseswithFFR(cid:2)0.80canalsobeconsideredto Team approach comes from reports that patients with be “significant” (11,12). complex CAD referred specifically for PCI or CABG in As noted, the revascularization recommendations have concurrent trial registries have lower mortality rates than been formulated to address issues related to 1) improved those randomly assigned to PCI or CABG in controlled survival and/or 2) improved symptoms. When one method trials (15,16). ofrevascularizationispreferredovertheotherforimproved TheSIHD,PCI,andCABGguidelinewritingcommit- survival, this consideration, in general, takes precedence tees endorse a Heart Team approach in patients with over improved symptoms. When discussing options for unprotectedleftmainCADand/orcomplexCADinwhom revascularization with the patient, he or she should under- theoptimalrevascularizationstrategyisnotstraightforward. standwhentheprocedureisbeingperformedinanattempt A collaborative assessment of revascularization options, or to improve symptoms, survival, or both. thedecisiontotreatwithGDMTwithoutrevascularization, Although some results from the SYNTAX (Synergy betweenPercutaneousCoronaryInterventionwithTAXUS involving an interventional cardiologist, a cardiac surgeon, and Cardiac Surgery) study are best characterized as sub- and (often) the patient’s general cardiologist, followed by group analyses and “hypothesis generating,” SYNTAX discussion with the patient about treatment options, is nonetheless represents the latest and most comprehensive optimal. Particularly in patients with SIHD and unpro- comparison of PCI and CABG (13,14). Therefore, the tected left main and/or complex CAD for whom a revas- results of SYNTAX have been considered appropriately cularizationstrategyisnotstraightforward,anapproachhas when formulating our revascularization recommendations. beenendorsedthatinvolvesterminatingtheprocedureafter Although the limitations of using the SYNTAX score for diagnosticcoronaryangiographyiscompleted:thisallowsa certain revascularization recommendations are recognized, thorough discussion and affords both the interventional JACCVol.58,No.24,2011 Levineetal. e51 December6,2011:e44–122 2011ACCF/AHA/SCAIPCIGuideline Table2. RevascularizationtoImproveSurvivalComparedWithMedicalTherapy Anatomic Setting COR LOE References UPLMorcomplexCAD CABGandPCI I—HeartTeamapproachrecommended C (14–16) CABGandPCI IIa—CalculationofSTSandSYNTAXscores B (13,14,17–22) UPLM* CABG I B (24–30) PCI IIa—ForSIHDwhenbothofthefollowingarepresent: B (13,17,19,23,31–48) ●AnatomicconditionsassociatedwithalowriskofPCIproceduralcomplicationsandahighlikelihood ofgoodlong-termoutcome(e.g.,alowSYNTAXscoreof(cid:2)22,ostialortrunkleftmainCAD) ●Clinicalcharacteristicsthatpredictasignificantlyincreasedriskofadversesurgicaloutcomes(e.g., STS-predictedriskofoperativemortality(cid:1)5%) IIa—ForUA/NSTEMIifnotaCABGcandidate B (13,36–39,44,45,47–49) IIa—ForSTEMIwhendistalcoronaryflowisTIMIflowgrade(cid:1)3andPCIcanbeperformedmorerapidly C (33,50,51) andsafelythanCABG IIb—ForSIHDwhenbothofthefollowingarepresent: B (13,17,19,23,31–48,52) ●AnatomicconditionsassociatedwithalowtointermediateriskofPCIproceduralcomplicationsand anintermediatetohighlikelihoodofgoodlong-termoutcome(e.g.,low-intermediateSYNTAXscore of(cid:1)33,bifurcationleftmainCAD) ●Clinicalcharacteristicsthatpredictanincreasedriskofadversesurgicaloutcomes(e.g.,moderate- severeCOPD,disabilityfrompriorstroke,orpriorcardiacsurgery;STS-predictedriskofoperative mortality(cid:2)2%) III:Harm—ForSIHDinpatients(versusperformingCABG)withunfavorableanatomyforPCIandwhoare B (13,17,19,24–32) goodcandidatesforCABG 3-vesseldiseasewithorwithoutproximalLADarterydisease* CABG I B (26,3053–56) IIa—ItisreasonabletochooseCABGoverPCIinpatientswithcomplex3-vesselCAD(e.g.,SYNTAXscore B (32,46,56,71,72) (cid:2)22)whoaregoodcandidatesforCABG. PCI IIb—Ofuncertainbenefit B (26,46,53,56,82) 2-vesseldiseasewithproximalLADarterydisease* CABG I B (26,30,53–56) PCI IIb—Ofuncertainbenefit B (26,53,56,82) 2-vesseldiseasewithoutproximalLADarterydisease* CABG IIa—Withextensiveischemia B (60–63) IIb—Ofuncertainbenefitwithoutextensiveischemia C (56) PCI IIb—Ofuncertainbenefit B (26,53,56,82) 1-vesselproximalLADarterydisease CABG IIa—WithLIMAforlong-termbenefit B (30,56,69,70) PCI IIb—Ofuncertainbenefit B (26,53,56,82) 1-vesseldiseasewithoutproximalLADarteryinvolvement CABG III:Harm B (30,53,60,61,94–98) PCI III:Harm B (30,53,60,61,94–98) LVdysfunction CABG IIa—EF35%to50% B (30,64–68) CABG IIb—EF(cid:1)35%withoutsignificantleftmainCAD B (30,64–68,83,84) PCI Insufficientdata N/A Survivorsofsuddencardiacdeathwithpresumedischemia-mediatedVT CABG I B (57–59) PCI I C (57) Noanatomicorphysiologiccriteriaforrevascularization CABG III:Harm B (30,53,60,61,94–98) PCI III:Harm B (30,53,60,61,94–98) *Inpatientswithmultivesseldiseasewhoalsohavediabetes,itisreasonabletochooseCABG(withLIMA)overPCI(62,74–81)(ClassIIa;LOE:B). CABGindicatescoronaryarterybypassgraft;CAD,coronaryarterydisease;COPD,chronicobstructivepulmonarydisease;COR,classofrecommendation;EF,ejectionfraction;LAD,leftanterior descending;LIMA,leftinternalmammaryartery;LOE,levelofevidence;LV,leftventricular;N/A,notapplicable;PCI,percutaneouscoronaryintervention;SIHD,stableischemicheartdisease;STEMI, ST-elevationmyocardialinfarction;STS,SocietyofThoracicSurgeons;SYNTAX,SynergybetweenPercutaneousCoronaryInterventionwithTAXUSandCardiacSurgery;TIMI,ThrombolysisInMyocardial Infarction;UA/NSTEMI,unstableangina/non–ST-elevationmyocardialinfarction;UPLM,unprotectedleftmaindisease;andVT,ventriculartachycardia. e52 Levineetal. JACCVol.58,No.24,2011 2011ACCF/AHA/SCAIPCIGuideline December6,2011:e44–122 Table3. RevascularizationtoImproveSymptomsWithSignificantAnatomic(>50%LeftMainor>70%Non–LeftMainCAD) orPhysiological(FFR<0.80)CoronaryArteryStenoses ClinicalSetting COR LOE References (cid:1)1significantstenosesamenabletorevascularizationandunacceptable I(cid:3)CABG A (82,99–108) anginadespiteGDMT I(cid:3)PCI (cid:1)1significantstenosesandunacceptableanginainwhomGDMTcannotbe IIa(cid:3)CABG C N/A implementedbecauseofmedicationcontraindications,adverseeffects,or IIa(cid:3)PCI patientpreferences PreviousCABGwith(cid:1)1significantstenosesassociatedwithischemiaand IIa(cid:3)PCI C (86,89,92) unacceptableanginadespiteGDMT IIb(cid:3)CABG C (93) Complex3-vesselCAD(e.g.,SYNTAXscore(cid:2)22)withorwithoutinvolvementof IIa(cid:3)CABGpreferred B (32,46,56,71,72) theproximalLADarteryandagoodcandidateforCABG overPCI Viableischemicmyocardiumthatisperfusedbycoronaryarteriesthatarenot IIb(cid:3)TMRasan B (109–113) amenabletografting adjuncttoCABG Noanatomicorphysiologiccriteriaforrevascularization III:Harm(cid:3)CABG C N/A III:Harm(cid:3)PCI CABGindicatescoronaryarterybypassgraft;CAD,coronaryarterydisease;COR,classofrecommendation;FFR,fractionalflowreserve;GDMT,guideline-directedmedicaltherapy;LOE,levelofevidence; N/A,notapplicable;PCI,percutaneouscoronaryintervention;SYNTAX,SynergybetweenPercutaneousCoronaryInterventionwithTAXUSandCardiacSurgery;andTMR,transmyocardiallaser revascularization. cardiologist and cardiac surgeon the opportunity to discuss plicationsandanintermediatetohighlikelihoodofgoodlong-term revascularizationoptionswiththepatient.BecausetheSTS outcome(e.g.,low-intermediateSYNTAXscoreof(cid:1)33,bifurcation score and the SYNTAX score have been shown to predict left main CAD); and 2) clinical characteristics that predict an increasedriskofadversesurgicaloutcomes(e.g.,moderate-severe adverse outcomes in patients undergoing CABG and PCI, chronic obstructive pulmonary disease, disability from previous respectively, calculation of these scores is often useful in stroke,orpreviouscardiacsurgery;STS-predictedriskofoperative making revascularization decisions (13,14,17–22). mortality(cid:2)2%)(13,17,19,23,31–48,52).(LevelofEvidence:B) 2.2. Revascularization to Improve CLASSIII:HARM Survival: Recommendations 1. PCItoimprovesurvivalshouldnotbeperformedinstablepatients Left Main CAD Revascularization with significant ((cid:1)50% diameter stenosis) unprotected left main CAD who have unfavorable anatomy for PCI and who are good CLASSI candidatesforCABG(13,17,19,24–32).(LevelofEvidence:B) 1. CABGtoimprovesurvivalisrecommendedforpatientswithsignif- icant((cid:1)50%diameterstenosis)leftmaincoronaryarterystenosis Non–Left Main CAD Revascularization (24–30).(LevelofEvidence:B) CLASSI CLASSIIa 1. CABGtoimprovesurvivalisbeneficialinpatientswithsignificant 1. PCItoimprovesurvivalisreasonableasanalternativetoCABGin ((cid:1)70% diameter) stenoses in 3 major coronary arteries (with or selectedstablepatientswithsignificant((cid:1)50%diameterstenosis) withoutinvolvementoftheproximalleftanteriordescending[LAD] unprotectedleftmainCADwith:1)anatomicconditionsassociated artery)orintheproximalLADplus1othermajorcoronaryartery withalowriskofPCIproceduralcomplicationsandahighlikelihood (26,30,53–56).(LevelofEvidence:B) ofgoodlong-termoutcome(e.g.,alowSYNTAXscore[(cid:2)22],ostial 2. CABGorPCItoimprovesurvivalisbeneficialinsurvivorsofsudden ortrunkleftmainCAD);and2)clinicalcharacteristicsthatpredicta cardiacdeathwithpresumedischemia-mediatedventriculartachy- significantly increased risk of adverse surgical outcomes (e.g., cardiacausedbysignificant((cid:1)70%diameter)stenosisinamajor STS-predictedriskofoperativemortality(cid:1)5%)(13,17,19,23,31–48). coronaryartery.(CABGLevelofEvidence:B[57–59];PCILevelof (LevelofEvidence:B) Evidence:C[57]) 2. PCItoimprovesurvivalisreasonableinpatientswithUA/NSTEMI CLASSIIa whenanunprotectedleftmaincoronaryarteryistheculpritlesion 1. CABGtoimprovesurvivalisreasonableinpatientswithsignificant andthepatientisnotacandidateforCABG(13,36–39,44,45,47– ((cid:1)70%diameter)stenosesin2majorcoronaryarterieswithsevere 49).(LevelofEvidence:B) orextensivemyocardialischemia(e.g.,high-riskcriteriaonstress 3. PCItoimprovesurvivalisreasonableinpatientswithacuteSTEMI testing,abnormalintracoronaryhemodynamicevaluation,or(cid:2)20% whenanunprotectedleftmaincoronaryarteryistheculpritlesion, perfusiondefectbymyocardialperfusionstressimaging)ortarget distalcoronaryflowislessthanTIMI(ThrombolysisInMyocardial vesselssupplyingalargeareaofviablemyocardium(60–63).(Level Infarction) grade 3, and PCI can be performed more rapidly and ofEvidence:B) safelythanCABG(33,50,51).(LevelofEvidence:C) 2. CABG to improve survival is reasonable in patients with mild- CLASSIIb moderateleftventricular(LV)systolicdysfunction(ejectionfraction 1. PCI to improve survival may be reasonable as an alternative to [EF]35%to50%)andsignificant((cid:1)70%diameterstenosis)multi- CABGinselectedstablepatientswithsignificant((cid:1)50%diameter vesselCADorproximalLADcoronaryarterystenosis,whenviable stenosis)unprotectedleftmainCADwith:1)anatomicconditions myocardiumispresentintheregionofintendedrevascularization associatedwithalowtointermediateriskofPCIproceduralcom- (30,64–68).(LevelofEvidence:B) JACCVol.58,No.24,2011 Levineetal. e53 December6,2011:e44–122 2011ACCF/AHA/SCAIPCIGuideline 3. CABGwithaleftinternalmammaryartery(LIMA)grafttoimprove or without involvement of the proximal LAD artery who are good survivalisreasonableinpatientswithsignificant((cid:1)70%diameter) candidatesforCABG(32,46,56,72,73).(LevelofEvidence:B) stenosis in the proximal LAD artery and evidence of extensive ischemia(30,56,69,70).(LevelofEvidence:B) CLASSIIb 1. CABGtoimprovesymptomsmightbereasonableforpatientswith 4. It is reasonable to choose CABG over PCI to improve survival in previous CABG, 1 or more significant ((cid:1)70% diameter) coronary patientswithcomplex3-vesselCAD(e.g.,SYNTAXscore(cid:2)22),with artery stenoses not amenable to PCI, and unacceptable angina or without involvement of the proximal LAD artery who are good despiteGDMT(93).(LevelofEvidence:C) candidatesforCABG(32,46,56,71,72).(LevelofEvidence:B) 2. Transmyocardial laser revascularization (TMR) performed as an 5. CABG is probably recommended in preference to PCI to improve adjunct to CABG to improve symptoms may be reasonable in survival in patients with multivessel CAD and diabetes mellitus, patients with viable ischemic myocardium that is perfused by particularlyifaLIMAgraftcanbeanastomosedtotheLADartery arteries that are not amenable to grafting (109–113). (Level of (62,74–81).(LevelofEvidence:B) Evidence:B) CLASSIIb CLASSIII:HARM 1. TheusefulnessofCABGtoimprovesurvivalisuncertaininpatients 1. CABG or PCI to improve symptoms should not be performed in with significant ((cid:1)70%) diameter stenoses in 2 major coronary patientswhodonotmeetanatomic((cid:1)50%diameterleftmainor arteriesnotinvolvingtheproximalLADarteryandwithoutextensive (cid:1)70% non–left main stenosis diameter) or physiological (e.g., ischemia(56).(LevelofEvidence:C) abnormalFFR)criteriaforrevascularization.(LevelofEvidence:C) 2. TheusefulnessofPCItoimprovesurvivalisuncertaininpatients with2-or3-vesselCAD(withorwithoutinvolvementoftheproximal 2.4. CABG Versus Contemporaneous LADartery)or1-vesselproximalLADdisease(26,53,56,82).(Level Medical Therapy ofEvidence:B) In the 1970s and 1980s, 3 RCTs established the survival 3. CABG might be considered with the primary or sole intent of benefit of CABG compared with contemporaneous (al- improving survival in patients with SIHD with severe LV systolic though minimal by current standards) medical therapy dysfunction(EF(cid:1)35%)whetherornotviablemyocardiumispresent without revascularization in certain subjects with stable (30,64–68,83,84).(LevelofEvidence:B) angina: the Veterans Affairs Cooperative Study (114), Eu- 4. TheusefulnessofCABGorPCItoimprovesurvivalisuncertainin ropeanCoronarySurgeryStudy(55),andCASS(Coronary patientswithpreviousCABGandextensiveanteriorwallischemia Artery Surgery Study) (115). Subsequently, a 1994 meta- onnoninvasivetesting(85–93).(LevelofEvidence:B) analysis of 7 studies that randomized a total of 2,649 CLASSIII:HARM patients to medical therapy or CABG (30) showed that 1. CABGorPCIshouldnotbeperformedwiththeprimaryorsoleintent CABGofferedasurvivaladvantageovermedicaltherapyfor toimprovesurvivalinpatientswithSIHDwith1ormorecoronary patientswithleftmainor3-vesselCAD.Thestudiesalso stenosesthatarenotanatomicallyorfunctionallysignificant(e.g., established that CABG is more effective than medical (cid:1)70%diameternon–leftmaincoronaryarterystenosis,FFR(cid:2)0.80, therapy for relieving anginal symptoms. These studies nooronlymildischemiaonnoninvasivetesting),involveonlythe havebeenreplicatedonlyonceduringthepastdecade.In leftcircumflexorrightcoronaryartery,orsubtendonlyasmallarea MASS II (Medicine, Angioplasty, or Surgery Study II), ofviablemyocardium(30,53,60,61,94–98).(LevelofEvidence:B) patients with multivessel CAD who were treated with CABG were less likely than those treated with medical 2.3. Revascularization to Improve Symptoms: therapy to have a subsequent MI, need additional revas- Recommendations cularization, or experience cardiac death in the 10 years after randomization (104). CLASSI 1. CABGorPCItoimprovesymptomsisbeneficialinpatientswith1or Surgical techniques and medical therapy have improved moresignificant((cid:1)70%diameter)coronaryarterystenosesame- substantially during the intervening years. As a result, if nabletorevascularizationandunacceptableanginadespiteGDMT CABGweretobecomparedwithGDMTinRCTstoday, (82,99–108).(LevelofEvidence:A) the relative benefits for survival and angina relief observed several decades ago might no longer be observed. Con- CLASSIIa versely, the concurrent administration of GDMT may 1. CABGorPCItoimprovesymptomsisreasonableinpatientswith1 substantially improve long-term outcomes in patients ormoresignificant((cid:1)70%diameter)coronaryarterystenosesand treated with CABG in comparison with those receiving unacceptable angina for whom GDMT cannot be implemented medical therapy alone. In the BARI 2D (Bypass Angio- becauseofmedicationcontraindications,adverseeffects,orpatient preferences.(LevelofEvidence:C) plasty Revascularization Investigation 2 Diabetes) trial of 2. PCItoimprovesymptomsisreasonableinpatientswithprevious patients with diabetes mellitus, no significant difference in CABG, 1 or more significant ((cid:1)70% diameter) coronary artery risk of mortality in the cohort of patients randomized to stenoses associated with ischemia, and unacceptable angina de- GDMT plus CABG or GDMT alone was observed, spiteGDMT(86,89,92).(LevelofEvidence:C) although the study was not powered for this endpoint, 3. ItisreasonabletochooseCABGoverPCItoimprovesymptomsin excluded patients with significant left main CAD, and patientswithcomplex3-vesselCAD(e.g.,SYNTAXscore(cid:2)22),with included only a small percentage of patients with proximal

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the ACCF and AHA to examine subject-specific data and write guidelines in CAD in the Veterans Administration Cooperative Study (28).
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