PRACTICE GUIDELINE 2011 ACCF/AHA/SCAI Guideline for

90 Pages·2011·1.92 MB·English

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Catheterization andCardiovascularInterventions 00:000–000(2011)
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 COMMITTEE MEMBERS*
Glenn N. Levine, MD,FACC,FAHA,Chair†, Eric R. Bates, MD,FACC,FAHA,ViceChair*†,
James C. Blankenship, MD,FACC,FSCAI,ViceChair*‡, Steven R. Bailey, MD,FACC,FSCAI*‡,
John A. Bittl, MD,FACC†§, Bojan Cercek, MD,FACC,FAHA†, Charles E. Chambers, MD,FACC,FSCAI‡,
Stephen G. Ellis, MD,FACC*†, Robert A. Guyton, MD,FACC*||, Steven M. Hollenberg, MD,FACC*†,
Umesh N. Khot, MD,FACC*†, Richard A. Lange, MD,FACC,FAHA§, Laura Mauri, MD,MSC,FACC,FSCAI*†,
Roxana Mehran, MD,FACC,FAHA,FSCAI*‡, Issam D. Moussa, MD,FACC,FAHA,FSCAI‡,
Debabrata Mukherjee, MD,FACC,FSCAI†, Brahmajee K. Nallamothu, MD,FACC¶,
Henry H. Ting, MD,FACC,FAHA†
ACCF/AHATASK FORCE MEMBERS
Alice K. Jacobs, MD,FACC,FAHA,Chair, Jeffrey L. Anderson, MD,FACC,FAHA,Chair-Elect,
Nancy Albert, PHD,CCNS,CCRN,FAHA, Mark A. Creager, MD,FACC,FAHA,
Steven M. Ettinger, MD,FACC, Robert A. Guyton, MD,FACC,
Jonathan L. Halperin, MD,FACC,FAHA, Judith S. Hochman, MD,FACC,FAHA,
Frederick G. Kushner, MD,FACC,FAHA, E. Magnus Ohman, MD,FACC,
William Stevenson, MD,FACC,FAHA, and Clyde W. Yancy,MD,FACC,FAHA
Key words: ACCF/AHA Practice Guidelines; acute coronarysyndromes; anticoagulants;
antiplatelet agents; arrhythmias, cardiac; coronary angiography; coronary artery
revascularization interventions: stents; drug therapy; drug delivery systems; heart
diseases;myocardialrevasularization;plateletaggregationinhibitor;ultrasound
*Writingcommitteemembersarerequiredtorecusethemselvesfromvotingonsectionstowhichtheirspecificrelationshipswithindustryand
otherentitiesmayapply;seeAppendix1forrecusalinformation.†ACCF/AHARepresentative.‡SCAIRepresentative.§JointRevascularization
SectionAuthor.||ACCF/AHATaskForceonPracticeGuidelinesLiaison.¶ACCF/AHATaskForceonPerformanceMeasuresLiaison.
ThisdocumentwasapprovedbytheAmericanCollegeofCardiologyFoundationBoardofTrusteesandtheAmericanHeartAssociationSci-
enceAdvisoryandCoordinatingCommitteeinJuly2011,andtheSocietyforCardiovascularAngiographyandInterventionsinAugust2011.
TheAmericanCollegeofCardiologyFoundationrequeststhatthisdocumentbecitedasfollows:LevineGN,BatesER,BlankenshipJC,Bai-
ley SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID,
Mukherjee D, Nallamothu BK, TingHH. 2011ACCF/AHA/SCAIguideline for percutaneous coronaryintervention: a report of the American
CollegeofCardiologyFoundation/AmericanHeartAssociationTaskForceonPracticeGuidelinesandtheSocietyforCardiovascularAngiogra-
phyandInterventions.
ThisarticleiscopublishedinCirculationandCatheterizationandCardiovascularInterventions.
Copies:ThisdocumentisavailableontheWorldWideWebsitesoftheAmericanCollegeofCardiology(www.cardiosource.org),theAmeri-
canHeartAssociation(my.americanheart.org),andtheSocietyforCardiovascularAngiographyandInterventions(www.scai.org).Forcopiesof
thisdocument,pleasecontactElsevierInc.ReprintDepartment,fax[phone],[email protected].
Permissions:Multiplecopies,modification,alteration,enhancement,and/ordistributionofthisdocumentarenotpermittedwithouttheexpress
permissionoftheAmer[e-mail].
DOI10.1002/ccd.23390
PublishedonlineMonth00,2011inWileyOnlineLibrary(wileyonlinelibrary.com)
VC 2011bytheAmericanCollegeofCardiologyFoundationandtheAmericanHeartAssociation,Inc.
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2 Levine et al.
TABLEOFCONTENTS 5.ProceduralConsiderations............................................................25
Preamble..............................................................................................3 5.1.VascularAccess:Recommendation........................................25
1.Introduction....................................................................................5 5.2.PCIinSpecificClinicalSituations.........................................26
1.1.MethodologyandEvidenceReview..........................................5 5.2.1.UA/NSTEMI:Recommendations................................26
1.2.OrganizationoftheWritingCommittee..................................6 5.2.2.ST-ElevationMyocardialInfarction.............................27
1.3.DocumentReviewandApproval..............................................6 5.2.2.1.CORONARYANGIOGRAPHY
1.4.PCIGuidelines:HistoryandEvolution...................................6 STRATEGIESINSTEMI:
2.CADRevascularization...................................................................7 RECOMMENDATIONS................................27
2.1.HeartTeamApproachtoRevascularization 5.2.2.2.PRIMARYPCIOFTHEINFARCT
Decisions:Recommendations...................................................7 ARTERY:RECOMMENDATIONS..............28
2.2.RevascularizationtoImproveSurvival: 5.2.2.3.DELAYEDORELECTIVEPCIIN
Recommendations.....................................................................7 PATIENTSWITHSTEMI:
2.3.RevascularizationtoImproveSymptoms: RECOMMENDATIONS................................29
Recommendations...................................................................11 5.2.3.CardiogenicShock:Recommendations........................30
2.4.CABGVersusContemporaneousMedicalTherapy..............11 5.2.3.1.PROCEDURALCONSIDERATIONS
2.5.PCIVersusMedicalTherapy.................................................12 FORCARDIOGENICSHOCK.....................30
2.6.CABGVersusPCI.................................................................12 5.2.4.RevascularizationBeforeNoncardiacSurgery:
2.6.1.CABGVersusBalloonAngioplastyorBMS...............12 Recommendations.........................................................30
2.6.2.CABGVersusDES......................................................13 5.3.CoronaryStents:Recommendations......................................31
2.7.LeftMainCAD......................................................................13 5.4.AdjunctiveDiagnosticDevices...............................................32
2.7.1.CABGorPCIVersusMedicalTherapyfor 5.4.1.FFR:Recommendation................................................32
LeftMainCAD............................................................13 5.4.2.IVUS:Recommendations.............................................33
2.7.2.StudiesComparingPCIVersusCABGfor 5.4.3.OpticalCoherenceTomography...................................33
LeftMainCAD............................................................14 5.5.AdjunctiveTherapeuticDevices.............................................34
2.7.3.RevascularizationConsiderationsforLeft 5.5.1.CoronaryAtherectomy:Recommendations.................34
MainCAD....................................................................14 5.5.2.Thrombectomy:Recommendation...............................34
2.8.ProximalLADArteryDisease...............................................15 5.5.3.LaserAngioplasty:Recommendations.........................34
2.9.ClinicalFactorsThatMayInfluencetheChoiceof 5.5.4.CuttingBalloonAngioplasty:Recommendations........34
Revascularization...................................................................15 5.5.5.EmbolicProtectionDevices:Recommendation............34
2.9.1.DiabetesMellitus..........................................................15 5.6.PercutaneousHemodynamicSupportDevices:
2.9.2.ChronicKidneyDisease...............................................15 Recommendation....................................................................34
2.9.3.CompletenessofRevascularization..............................16 5.7.InterventionalPharmacotherapy...........................................35
2.9.4.LVSystolicDysfunction...............................................16 5.7.1.ProceduralSedation......................................................35
2.9.5.PreviousCABG............................................................16 5.7.2.OralAntiplateletTherapy:Recommendations.............36
2.9.6.UnstableAngina/Non-ST-ElevationMyocardial 5.7.3.IVAntiplateletTherapy:Recommendations................37
Infarction......................................................................17 5.7.4.AnticoagulantTherapy.................................................39
2.9.7.DAPTComplianceandStentThrombosis: 5.7.4.1.USEOFPARENTERAL
Recommendation..........................................................17 ANTICOAGULANTSDURINGPCI:
2.10.TMRasanAdjuncttoCABG.............................................17 RECOMMENDATION..................................39
2.11.HybridCoronaryRevascularization: 5.7.4.2.UFH:RECOMMENDATION.......................39
Recommendations.................................................................18 5.7.4.3.ENOXAPARIN:
3.PCIOutcomes...............................................................................18 RECOMMENDATIONS................................39
3.1.DefinitionsofPCISuccess......................................................18 5.7.4.4.BIVALIRUDINANDARGATROBAN:
3.1.1.AngiographicSuccess...................................................18 RECOMMENDATIONS................................41
3.1.2.ProceduralSuccess........................................................18 5.7.4.5.FONDAPARINUX:
3.1.3.ClinicalSuccess.............................................................18 RECOMMENDATION..................................41
3.2.PredictorsofClinicalOutcomeAfterPCI...........................18 5.7.5.No-ReflowPharmacologicalTherapies:
3.3.PCIComplications.................................................................19 Recommendation..........................................................41
4.PreproceduralConsiderations......................................................20 5.8.PCIinSpecificAnatomicSituations......................................42
4.1.CardiacCatheterizationLaboratory 5.8.1.CTOs:Recommendation..............................................42
Requirements..........................................................................20 5.8.2.SVGs:Recommendations.............................................42
4.1.1.Equipment.....................................................................20 5.8.3.BifurcationLesions:Recommendations.......................43
4.1.2.Staffing..........................................................................20 5.8.4.Aorto-OstialStenoses:Recommendations....................43
4.1.3. ‘Time-Out’Procedures.................................................20 5.8.5.CalcifiedLesions:Recommendation
4.2.EthicalAspects.......................................................................20 5.9.PCIinSpecificPatientPopulations.......................................44
4.2.1.InformedConsent.........................................................21 5.9.1.Elderly...........................................................................44
4.2.2.PotentialConflictsofInterest.......................................22 5.9.2.Diabetes........................................................................44
4.3.RadiationSafety:Recommendation.......................................22 5.9.3.Women..........................................................................44
4.4.Contrast-InducedAKI:Recommendations............................22 5.9.4.CKD:Recommendation...............................................44
4.5.AnaphylactoidReactions:Recommendations.........................23 5.9.5.CardiacAllografts.........................................................45
4.6.StatinTreatment:Recommendation......................................23 5.10.PeriproceduralMIAssessment:Recommendations.............45
4.7.BleedingRisk:Recommendation...........................................24 5.11.VascularClosureDevices:Recommendations......................45
4.8.PCIinHospitalsWithoutOn-SiteSurgicalBackup: 6.PostproceduralConsiderations.....................................................46
Recommendations...................................................................24 6.1.PostproceduralAntiplateletTherapy:Recommendations.....46
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2011ACCF/AHA/SCAIPCI Guideline 3
available evidence to develop balanced, patient-centric
6.1.1.PPIsandAntiplateletTherapy:Recommendations.....46
6.1.2.ClopidogrelGeneticTesting:Recommendations.........48 recommendations for clinical practice.
6.1.3.PlateletFunctionTesting:Recommendations..............48 Experts in the subject under consideration are
6.2.StentThrombosis....................................................................49 selected by the ACCF and AHA to examine subject-
6.3.Restenosis:Recommendations................................................49
specific data and write guidelines in partnership with
6.3.1.BackgroundandIncidence...........................................49
representatives from other medical organizations and
6.3.2.RestenosisAfterBalloonAngioplasty..........................50
6.3.3.RestenosisAfterBMS..................................................50 specialty groups. Writing committees are asked to per-
6.3.4.RestenosisAfterDES...................................................50 form a formal literature review; weigh the strength of
6.4.ClinicalFollow-Up..................................................................50 evidence for or against particular tests, treatments, or
6.4.1.ExerciseTesting:Recommendations.............................50
procedures; and include estimates of expected out-
6.4.2.ActivityandReturntoWork.......................................51
comes where such data exist. Patient-specific modifiers,
6.4.3.CardiacRehabilitation:Recommendation...................51
6.5.SecondaryPrevention.............................................................51 comorbidities, and issues of patient preference that
7.QualityandPerformanceConsiderations.....................................52 may influence the choice of tests or therapies are con-
7.1.QualityandPerformance:Recommendations.......................52 sidered. When available, information from studies on
7.2.Training..................................................................................52
cost is considered, but data on efficacy and outcomes
7.3.CertificationandMaintenanceofCertification:
constitute the primary basis for the recommendations
Recommendation....................................................................52
7.4.OperatorandInstitutionalCompetencyandVolume: contained herein.
Recommendations...................................................................52 In analyzing the data and developing recommenda-
7.5.ParticipationinACCNCDRorNationalQuality tions and supporting text, the writing committee uses
Database.................................................................................53
evidence-based methodologies developed by the Task
8.FutureChallenges.........................................................................53
Force (1). The Class of Recommendation (COR) is an
References.........................................................................................54
Appendix1.AuthorRelationshipsWithIndustryand estimate of the size of the treatment effect considering
OtherEntities(Relevant).............................................83 risks versus benefits in addition to evidence and/or
Appendix2.ReviewerRelationshipsWithIndustryand agreement that a given treatment or procedure is or is
OtherEntities(Relevant).............................................86
not useful/effective or in some situations may cause
Appendix3.AbbreviationList..........................................................88
harm. The Level of Evidence (LOE) is an estimate of
Appendix4.AdditionalTables/Figures............................................88
the certainty or precision of the treatment effect. The
writing committee reviews and ranks evidence support-
PREAMBLE ing each recommendation with the weight of evidence
The medical profession should play a central role in ranked as LOE A, B, or C according to specific defini-
evaluating the evidence related to drugs, devices, and tions that are included in Table 1. Studies are identified T1
procedures for the detection, management, and preven- as observational, retrospective, prospective, or random-
tion of disease. When properly applied, expert analysis ized where appropriate. For certain conditions for
of available data on the benefits and risks of these thera- which inadequate data are available, recommendations
pies and procedures can improve the quality of care, are based on expert consensus and clinical experience
optimize patient outcomes, and favorably affect costs by and are ranked as LOE C. When recommendations at
focusing resources on the most effective strategies. An LOE C are supported by historical clinical data, appro-
organized and directed approach to a thorough review priate references (including clinical reviews) are cited
of evidence has resulted in the production of clinical if available. For issues for which sparse data are avail-
practice guidelines that assist physicians in selecting the able, a survey of current practice among the clinicians
best management strategy for an individual patient. on the writing committee is the basis for LOE C rec-
Moreover, clinical practice guidelines can provide a ommendations and no references are cited. The schema
foundation for other applications, such as performance for COR and LOE is summarized in Table 1, which
measures, appropriate use criteria, and both quality also provides suggested phrases for writing recommen-
improvement and clinical decision support tools. dations within each COR. A new addition to this meth-
The American College of Cardiology Foundation odology is separation of the Class III recommendations
(ACCF) and the American Heart Association (AHA) to delineate if the recommendation is determined to be
have jointly produced guidelines in the area of cardio- of ‘‘no benefit’’ or is associated with ‘‘harm’’ to the
vascular disease since 1980. The ACCF/AHA Task patient. In addition, in view of the increasing number
Force on Practice Guidelines (Task Force), charged of comparative effectiveness studies, comparator verbs
with developing, updating, and revising practice guide- and suggested phrases for writing recommendations for
lines for cardiovascular diseases and procedures, the comparative effectiveness of one treatment or strat-
directs and oversees this effort. Writing committees are egy versus another have been added for COR I and IIa,
charged with regularly reviewing and evaluating all LOE A or B only.
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4 Levine et al.
TABLE1. ApplyingClassificationofRecommendationsandLevelofEvidence
ArecommendationwithLevelofEvidenceBorCdoesnotimplythattherecommendationisweak.Manyimportantclinicalquestionsaddressedin
theguidelinesdonotlendthemselvestoclinicaltrials.Althoughrandomizedtrialsareunavailable,theremaybeaveryclearclinicalconsensusthat
aparticulartestortherapyisusefuloreffective.
*Dataavailablefromclinicaltrialsorregistriesabouttheusefulness/efficacyindifferentsubpopulations,suchassex,age,historyofdiabetes,history
ofpriormyocardialinfarction,historyofheartfailure,andprioraspirinuse.†Forcomparativeeffectivenessrecommendations(ClassIandIIa;Level
ofEvidenceAandBonly),studiesthatsupporttheuseofcomparatorverbsshouldinvolvedirectcomparisonsofthetreatmentsorstrategiesbeing
evaluated.
In view of the advances in medical therapy across able in North America are discussed in the text without
the spectrum of cardiovascular diseases, the Task Force a specific COR. For studies performed in large num-
has designated the term guideline-directed medical bers of subjects outside North America, each writing
therapy (GDMT) to represent optimal medical therapy committee reviews the potential influence of different
as defined by ACCF/AHA guideline recommended practice patterns and patient populations on the treat-
therapies (primarily Class I). This new term, ment effect and relevance to the ACCF/AHA target
GDMT, will be used herein and throughout all future population to determine whether the findings should
guidelines. inform a specific recommendation.
Because the ACCF/AHA practice guidelines address The ACCF/AHA practice guidelines are intended to
patient populations (and healthcare providers) residing assist healthcare providers in clinical decision making
in North America, drugs that are not currently avail- by describing a range of generally acceptable
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2011ACCF/AHA/SCAIPCI Guideline 5
approaches to the diagnosis, management, and preven- Appendix 1. Authors’ and peer reviewers’ RWI perti-
tion of specific diseases or conditions. The guidelines nent to this guideline are disclosed in Appendixes 1
attempt to define practices that meet the needs of most and 2, respectively. Additionally, to ensure complete
patients in most circumstances. The ultimate judgment transparency, writing committee members’ comprehen-
regarding care of a particular patient must be made by sive disclosure information—including RWI not perti-
the healthcare provider and patient in light of all the nent to this document—is available as an online sup-
circumstances presented by that patient. As a result, plement. Comprehensive disclosure information for the
situations may arise for which deviations from these Task Force is also available online at www.cardiosour-
guidelines may be appropriate. Clinical decision mak- ce.org/ACC/ About-ACC/Leadership/Guidelines-and-
ing should involve consideration of the quality and Documents-Task-Forces.aspx. The work of the writing
availability of expertise in the area where care is pro- committee was supported exclusively by the ACCF,
vided. When these guidelines are used as the basis for AHA, and the Society for Cardiovascular Angiography
regulatory or payer decisions, the goal should be and Interventions (SCAI) without commercial support.
improvement in quality of care. The Task Force recog- Writing committee members volunteered their time for
nizes that situations arise in which additional data are this activity.
needed to inform patient care more effectively; these In an effort to maintain relevance at the point of
areas will be identified within each respective guideline care for practicing physicians, the Task Force contin-
when appropriate. ues to oversee an ongoing process improvement initia-
Prescribed courses of treatment in accordance with tive. As a result, in response to pilot projects, several
these recommendations are effective only if followed. changes to these guidelines will be apparent, including
Because lack of patient understanding and adherence limited narrative text, a focus on summary and evi-
may adversely affect outcomes, physicians and other dence tables (with references linked to abstracts in
healthcare providers should make every effort to PubMed) and more liberal use of summary recommen-
engage the patient’s active participation in prescribed dation tables (with references that support LOE) to
medical regimens and lifestyles. In addition, patients serve as a quick reference.
should be informed of the risks, benefits, and alterna- In April 2011, the Institute of Medicine released 2
tives to a particular treatment and be involved in reports: Finding What Works in Health Care: Standards
shared decision making whenever feasible, particularly for Systematic Reviews and Clinical Practice Guidelines
for COR IIa and IIb, where the benefit-to-risk ratio We Can Trust (2, 3). It is noteworthy that the ACCF/
may be lower. AHA guidelines were cited as being compliant with
The Task Force makes every effort to avoid actual, many of the standards that were proposed. A thorough
potential, or perceived conflicts of interest that may review of these reports and of our current methodology
arise as a result of industry relationships or personal is under way, with further enhancements anticipated.
interests among the members of the writing committee. The recommendations in this guideline are consid-
All writing committee members and peer reviewers of ered current until they are superseded by a focused
the guideline are asked to disclose all such current update or the full-text guideline is revised. Guidelines
relationships, as well as those existing 12 months pre- are official policy of both the ACCF and AHA.
viously. In December 2009, the ACCF and AHA
implemented a new policy for relationships with indus- Alice K. Jacobs, MD, FACC, FAHA, Chair
try and other entities (RWI) that requires the writing ACCF/AHA Task Force on Practice Guidelines
committee chair plus a minimum of 50% of the writing
committee to have no relevant RWI (Appendix 1 for
1. INTRODUCTION
the ACCF/AHA definition of relevance). These state-
ments are reviewed by the Task Force and all members 1.1. Methodology and Evidence Review
during each conference call and/or meeting of the writ- The recommendations listed in this document are,
ing committee and are updated as changes occur. All whenever possible, evidence based. An extensive evi-
guideline recommendations require a confidential vote dence review was conducted through November 2010,
by the writing committee and must be approved by a as well as selected other references through August
consensus of the voting members. Members are not 2011. Searches were limited to studies, reviews, and
permitted to write, and must recuse themselves from other evidence conducted in human subjects and that
voting on, any recommendation or section to which were published in English. Key search words included
their RWI apply. Members who recused themselves but were not limited to the following: ad hoc angio-
from voting are indicated in the list of writing commit- plasty, angioplasty, balloon angioplasty, clinical trial,
tee members, and section recusals are noted in coronary stenting, delayed angioplasty, meta-analysis,
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6 Levine et al.
percutaneous transluminal coronary angioplasty, 21 individual content reviewers (including members of
randomized controlled trial (RCT), percutaneous coro- the ACCF Interventional Scientific Council and ACCF
nary intervention (PCI) and angina, angina reduction, Surgeons’ Scientific Council). All information on
antiplatelet therapy, bare-metal stents (BMS), cardiac reviewers’ RWI was distributed to the writing commit-
rehabilitation, chronic stable angina, complication, tee and is published in this document (Appendix 2).
coronary bifurcation lesion, coronary calcified lesion, This document was approved for publication by the
coronary chronic total occlusion (CTO), coronary governing bodies of the ACCF, AHA, and SCAI.
ostial lesions, coronary stent (BMS and drug-eluting
stents [DES]; and BMS versus DES), diabetes, distal
embolization, distal protection, elderly, ethics, late 1.4. PCI Guidelines: History and Evolution
stent thrombosis, medical therapy, microembolization, In 1982, a 2-page manuscript titled ‘‘Guidelines for
mortality, multiple lesions, multi-vessel, myocardial in- the Performance of Percutaneous Transluminal Coro-
farction (MI), non—ST-elevation myocardial infarction nary Angioplasty’’ was published in Circulation (4).
(NSTEMI), no-reflow, optical coherence tomography, The document, which addressed the specific expertise
proton pump inhibitor (PPI), return to work, same-day and experience physicians should have to perform bal-
angioplasty and/or stenting, slow flow, stable ischemic loon angioplasty, as well as laboratory requirements
heart disease (SIHD), staged angioplasty, STEMI, sur- and the need for surgical support, was written by an ad
vival, and unstable angina (UA). Additional searches hoc group whose members included Andreas Gru¨ntzig.
cross-referenced these topics with the following sub- In 1980, the ACC and the AHA established the Task
topics: anticoagulant therapy, contrast nephropathy, Force on Assessment of Diagnostic and Therapeutic
PCI-related vascular complications, unprotected left Cardiovascular Procedures, which was charged with
main PCI, multivessel coronary artery disease (CAD), the development of guidelines related to the role of
adjunctive percutaneous interventional devices, percu- new therapeutic approaches and of specific noninvasive
taneous hemodynamic support devices, and secondary and invasive procedures in the diagnosis and manage-
prevention. Additionally, the committee reviewed ment of cardiovascular disease. The first ACC/ AHA
documents related to the subject matter previously pub- Task Force report on guidelines for coronary balloon
lished by the ACCF and AHA. References selected and angioplasty was published in 1988 (5). The 18-page
published in this document are representative and not document discussed and made recommendations about
all-inclusive. lesion classification and success rates, indications for
To provide clinicians with a comprehensive set of and contraindications to balloon angioplasty, institu-
data, whenever deemed appropriate or when published, tional review of angioplasty procedures, ad hoc angio-
the absolute risk difference and number needed to treat plasty after angiography, and on-site surgical backup.
or harm will be provided in the guideline, along with Further iterations of the guidelines were published in
confidence intervals (CIs) and data related to the rela- 1993 (6), 2001 (7), and 2005 (8). In 2007 and 2009,
tive treatment effects such as odds ratio (OR), relative focused updates to the guideline were published to
risk, hazard ratio (HR), or incidence rate ratio. expeditiously address new study results and recent
The focus of this guideline is the safe, appropriate, changes in the field of interventional cardiology (9,
and efficacious performance of PCI. The risks of PCI 10). The 2009 focused update is notable in that there
must be balanced against the likelihood of improved was direct collaboration between the writing commit-
survival, symptoms, or functional status. This is espe- tees for the STEMI guidelines and the PCI guidelines,
cially important in patients with SIHD. resulting in a single publication of focused updates on
STEMI and PCI (10).
The evolution of the PCI guideline reflects the
1.2. Organization of the Writing Committee
growth of knowledge in the field and parallels the
The committee was composed of physicians with ex-
many advances and innovations in the field of interven-
pertise in interventional cardiology, general cardiology,
tional cardiology, including primary PCI, BMS and
critical care cardiology, cardiothoracic surgery, clinical
DES, intravascular ultrasound (IVUS) and physiologic
trials, and health services research. The committee
assessments of stenosis, and newer antiplatelet and
included representatives from the ACCF, AHA, and
anticoagulant therapies. The 2011 iteration of the
SCAI.
guideline continues this process, addressing ethical
aspects of PCI, vascular access considerations, CAD
1.3. Document Review and Approval revascularization including hybrid revascularization, re-
This document was reviewed by 2 official reviewers vascularization before noncardiac surgery, optical co-
nominated by the ACCF, AHA, and SCAI, as well as herence tomography, advanced hemodynamic support
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2011ACCF/AHA/SCAIPCI Guideline 7
devices, no-reflow therapies, and vascular closure devi- onary stenoses with FFR (cid:3) 0.80 can also be considered
ces. Most of this document is organized according to to be ‘‘significant’’ (11, 12).
‘‘patient flow,’’ consisting of preprocedural considera- As noted, the revascularization recommendations
tions, procedural considerations, and postprocedural have been formulated to address issues related to 1)
considerations. In a major undertaking, the STEMI, improved survival and/or 2) improved symptoms.
PCI, and coronary artery bypass graft (CABG) surgery When one method of revascularization is preferred
guidelines were written concurrently, with additional over the other for improved survival, this considera-
collaboration with the SIHD guideline writing commit- tion, in general, takes precedence over improved symp-
tee, allowing greater collaboration between the differ- toms. When discussing options for revascularization
ent writing committees on topics such as PCI in with the patient, he or she should understand when the
STEMI and revascularization strategies in patients with procedure is being performed in an attempt to improve
CAD (including unprotected left main PCI, multivessel symptoms, survival, or both.
disease revascularization, and hybrid procedures). Although some results from the SYNTAX (Synergy
In accordance with direction from the Task Force between Percutaneous Coronary Intervention with
and feedback from readers, in this iteration of the TAXUS and Cardiac Surgery) study are best character-
guideline, the text has been shortened, with an empha- ized as subgroup analyses and ‘‘hypothesis generat-
sis on summary statements rather than detailed discus- ing,’’ SYNTAX nonetheless represents the latest and
sion of numerous individual trials. Online supplemental most comprehensive comparison of PCI and CABG
evidence and summary tables have been created to (13, 14). Therefore, the results of SYNTAX have been
document the studies and data considered for new or considered appropriately when formulating our revas-
changed guideline recommendations. cularization recommendations. Although the limitations
of using the SYNTAX score for certain revasculariza-
tion recommendations are recognized, the SYNTAX
2. CAD REVASCULARIZATION
score is a reasonable surrogate for the extent of CAD
Recommendations and text in this section are the and its complexity and serves as important information
result of extensive collaborative discussions between the that should be considered when making revasculariza-
PCI and CABG writing committees, as well as key tion decisions. Recommendations that refer to SYN-
members of the SIHD and UA/NSTEMI writing com- TAX scores use them as surrogates for the extent and
mittees. Certain issues, such as older versus more con- complexity of CAD.
temporary studies, primary analyses versus subgroup Revascularization recommendations to improve sur-
analyses, and prospective versus post hoc analyses, have vival and symptoms are provided in the following text
been carefully weighed in designating COR and LOE; and are summarized in Tables 2 and 3. References to T2T3
they are addressed in the appropriate corresponding text. studies comparing revascularization with medical ther-
The goals of revascularization for patients with CAD apy are presented when available for each anatomic
are to 1) improve survival and/or 2) relieve symptoms. subgroup.
Revascularization recommendations in this section are See Online Data Supplements 1 and 2 for additional
predominantly based on studies of patients with sympto- data regarding the survival and symptomatic benefits
matic SIHD and should be interpreted in this context. with CABG or PCI for different anatomic subsets.
As discussed later in this section, recommendations on
the type of revascularization are, in general, applicable
to patients with UA/NSTEMI. In some cases (e.g.,
2.1. Heart Team Approach to Revascularization
unprotected left main CAD), specific recommendations
Decisions: Recommendations
are made for patients with UA/NSTEMI or STEMI.
CLASS I
Historically, most studies of revascularization have
been based on and reported according to angiographic 1. A Heart Team approach to revascularization is
criteria. Most studies have defined a ‘‘significant’’ ste- recommended in patients with unprotected left
nosis as (cid:2) 70% diameter narrowing; therefore, for re- main or complex CAD (14–16). (Level of Evi-
vascularization decisions and recommendations in this dence: C)
section, a ‘‘significant’’ stenosis has been defined as (cid:2)
CLASS IIa
70% diameter narrowing ((cid:2)50% for left main CAD).
Physiological criteria, such as an assessment of frac- 1. Calculation of the Society of Thoracic Surgeons
tional flow reserve (FFR), has been used in deciding (STS) and SYNTAX scores is reasonable in
when revascularization is indicated. Thus, for recom- patients with unprotected left main and complex
mendations about revascularization in this section, cor- CAD (13, 14, 17–22). (Level of Evidence: B)
CatheterizationandCardiovascularInterventionsDOI10.1002/ccd.
PublishedonbehalfofTheSocietyforCardiovascularAngiographyandInterventions(SCAI).
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8 Levine et al.
One protocol used in RCTs (14–16, 23) often witha lowriskofPCI procedural complicationsand a
involves a multidisciplinary approach referred to as the high likelihood of good long-term outcome (e.g., a
Heart Team. Composed of an interventional cardiolo- low SYNTAX score [(cid:3)22], ostial or trunk left main
gist and a cardiac surgeon, the Heart Team 1) reviews CAD);and2)clinicalcharacteristicsthatpredictasig-
the patient’s medical condition and coronary anatomy, nificantly increased risk of adverse surgical outcomes
2) determines that PCI and/or CABG are technically (e.g., STS-predicted risk of operative mortality (cid:2)5%)
feasible and reasonable, and 3) discusses revasculariza- (13,17,19,23,31–48).(LevelofEvidence:B)
tion options with the patient before a treatment strategy 2. PCI to improve survival is reasonable in patients
is selected. Support for using a Heart Team approach with UA/NSTEMI when an unprotected left main
comes from reports that patients with complex CAD coronary artery is the culprit lesion and the patient
referred specifically for PCI or CABG in concurrent is not a candidate for CABG (13, 36–39, 44, 45,
trial registries have lower mortality rates than those 47–49). (Level of Evidence: B)
randomly assigned to PCI or CABG in controlled trials 3. PCI to improve survival is reasonable in patients
(15, 16). with acute STEMI when an unprotected left main
The SIHD, PCI, and CABG guideline writing com- coronary artery is the culprit lesion, distal coronary
mittees endorse a Heart Team approach in patients flow is less than TIMI (Thrombolysis In Myocardial
with unprotected left main CAD and/or complex CAD Infarction) grade 3, and PCI can be performed more
in whom the optimal revascularization strategy is not rapidly and safely than CABG (33, 50, 51). (Level
straightforward. A collaborative assessment of revascu- of Evidence: C)
larization options, or the decision to treat with GDMT
without revascularization, involving an interventional
CLASS IIb
cardiologist, a cardiac surgeon, and (often) the patient’s
general cardiologist, followed by discussion with the 1. PCI to improve survival may be reasonable as an al-
patient about treatment options, is optimal. Particularly ternativetoCABGinselectedstablepatientswithsig-
in patients with SIHD and unprotected left main and/or nificant ((cid:2)50% diameter stenosis) unprotected left
complex CAD for whom a revascularization strategy is main CAD with: 1) anatomic conditions associated
not straightforward, an approach has been endorsed with a low to intermediate risk of PCI procedural
that involves terminating the procedure after diagnostic complications and an intermediate to high likelihood
coronary angiography is completed: this allows a thor- of good long-term outcome (e.g., low-intermediate
ough discussion and affords both the interventional car- SYNTAX score of <33, bifurcation left main CAD);
diologist and cardiac surgeon the opportunity to discuss and 2) clinical characteristicsthatpredictanincreased
revascularization options with the patient. Because the risk of adverse surgical outcomes (e.g., moderate-
STS score and the SYNTAX score have been shown to severe chronic obstructive pulmonary disease, disabil-
predict adverse outcomes in patients undergoing ity from previous stroke, or previous cardiac surgery;
CABG and PCI, respectively, calculation of these STS-predicted risk of operative mortality >2%) (13,
scores is often useful in making revascularization deci- 17,19,23,31–48,52).(LevelofEvidence:B)
sions (13, 14, 17–22).
CLASS III: HARM
2.2. Revascularization to Improve Survival:
1. PCI to improve survival should not be performed in
Recommendations
stablepatientswithsignificant((cid:2)50%diametersteno-
Left Main CAD Revascularization
sis)unprotectedleft mainCADwhohaveunfavorable
anatomy for PCI and who are good candidates for
CLASS I
CABG(13,17,19,24–32).(LevelofEvidence:B)
1. CABG to improve survival is recommended for
patients with significant ((cid:2)50% diameter stenosis) Non-Left Main CAD Revascularization
left main coronary artery stenosis (24–30). (Level of
Evidence: B) CLASS I
1. CABG to improve survival is beneficial in patients
CLASS IIa
with significant ((cid:2)70% diameter) stenoses in 3 major
1. PCI to improve survival is reasonable as an alterna- coronary arteries (with or without involvement of the
tive to CABG in selected stable patients with signif- proximal left anterior descending [LAD] artery) or in
icant ((cid:2)50% diameter stenosis) unprotected left the proximal LAD plus 1 other major coronary artery
main CAD with: 1) anatomic conditions associated (26, 30, 53–56). (Level of Evidence: B)
CatheterizationandCardiovascularInterventionsDOI10.1002/ccd.
PublishedonbehalfofTheSocietyforCardiovascularAngiographyandInterventions(SCAI).
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2011ACCF/AHA/SCAIPCI Guideline 9
TABLE2. RevascularizationtoImproveSurvivalComparedWithMedicalTherapy
*Inpatientswithmultivesseldiseasewhoalsohavediabetes,itisreasonabletochooseCABG(withLIMA)overPCI(6274–81)(C/assIIa;LOE:B)
r
CABGindicatescoronaryarterybypassgraft;CAD,coronaryarterydisease;COPD,chronicobstructivepulmonarydisease;COR,classofrecommenda-
tion;EF,ejectionfraction;LAD,leftanteriordescending;LIMA,leftinternalmammaryartery;LOE,levelofevidence;LV,leftventricular;N/A,notappli-
cable;PCI,percutaneouscoronaryintervention;SIHD,stableischemicheartdisease;STEMI,ST-elevationmyocardialinfarction;STS,SocietyofThoracic
Surgeons;SYNTAX,SynergybetweenPercutaneousCoronaryInterventionwithTAXUSandCardiacSurgery;TIMI,ThrombolysisInMyocardialInfarc-
tion;UA/NSTEMI,unstableangina/non-ST-elevationmyocardialinfarction;UPLM,unprotectedleftmaindisease;andVT,Ventriculartachycardia.
CatheterizationandCardiovascularInterventionsDOI10.1002/ccd.
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10 Levine et al.
TABLE3. RevascularizationtoImproveSymptomsWithSignificantAnatomic((cid:2)50%LeftMainor(cid:2)70%Non-LeftMainCAD)or
Physiological(FFR(cid:3)0.80)CoronaryArteryStenoses
CABG indicates coronary artery bypass graft; CAD, coronary artery disease; COR, class of recommendation; FFR, fractional flow reserve; GDMT,
guideline-directed medical therapy; LOE, level of evidence; N/A, not applicable; PCI, percutaneous coronary intervention; SYNTAX, Synergy
betweenPercutaneousCoronaryInterventionwithTAXUSandCardiacSurgery;andTMR,transmyocardiallaserrevascularization.
2. CABG or PCI to improve survival is beneficial in good candidates for CABG (32, 46, 56, 71, 72).
survivors of sudden cardiac death with presumed (Level of Evidence: B)
ischemia-mediated ventricular tachycardia caused by 5. CABG is probably recommended in preference to
significant ((cid:2)70% diameter) stenosis in a major cor- PCI to improve survival in patients with multivessel
onary artery. (CABG Level of Evidence: B [57–59]; CAD and diabetes mellitus, particularly if a LIMA
PCI Level of Evidence: C [57]) graft can be anastomosed to the LAD artery (62,
74–81). (Level of Evidence: B)
CLASS IIa
CLASS IIb
1. CABG to improve survival is reasonable in patients
with significant ((cid:2)70% diameter) stenoses in 2 1. The usefulness of CABG to improve survival is
major coronary arteries with severe or extensive uncertain in patients with significant ((cid:2)70%) diame-
myocardial ischemia (e.g., high-risk criteria on ter stenoses in 2 major coronary arteries not involv-
stress testing, abnormal intracoronary hemodynamic ing the proximal LAD artery and without extensive
evaluation, or >20% perfusion defect by myocardial ischemia (56). (Level of Evidence: C)
perfusion stress imaging) or target vessels supplying 2. The usefulness of PCI to improve survival is uncer-
a large area of viable myocardium (60–63). (Level tain in patients with 2- or 3-vessel CAD (with or
of Evidence: B) without involvement of the proximal LAD artery) or
2. CABG to improve survival is reasonable in patients 1-vessel proximal LAD disease (26, 53, 56, 82).
with mild-moderate left ventricular (LV) systolic (Level of Evidence: B)
dysfunction (ejection fraction [EF] 35% to 50%) 3. CABG might be considered with the primary or sole
and significant ((cid:2)70% diameter stenosis) multi-ves- intent of improving survival in patients with SIHD
sel CAD or proximal LAD coronary artery stenosis, with severe LV systolic dysfunction (EF <35%)
when viable myocardium is present in the region of whether or not viable myocardium is present (30,
intended revascularization (30, 64–68). (Level of 64–68, 83, 84). (Level of Evidence: B)
Evidence: B) 4. The usefulness of CABG or PCI to improve survival
3. CABG with a left internal mammary artery (LIMA) is uncertain in patients with previous CABG and
graft to improve survival is reasonable in patients extensive anterior wall ischemia on noninvasive
with significant ((cid:2)70% diameter) stenosis in the testing (85–93). (Level of Evidence: B)
proximal LAD artery and evidence of extensive is-
chemia (30, 56, 69, 70). (Level of Evidence: B) CLASS III: HARM
4. It is reasonable to choose CABG over PCI to
improve survival in patients with complex 3-vessel 1. CABG or PCI should not be performed with the pri-
CAD (e.g., SYNTAX score >22), with or without mary or sole intent to improve survival in patients
involvement of the proximal LAD artery who are with SIHD with 1 or more coronary stenoses that
CatheterizationandCardiovascularInterventionsDOI10.1002/ccd.
PublishedonbehalfofTheSocietyforCardiovascularAngiographyandInterventions(SCAI).
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