Appropriateness Criteria ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for

135 Pages·2009·1.77 MB·English

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for
Coronary Revascularization. A Report of the American College of Cardiology
Foundation Appropriateness Criteria Task Force, Society for Cardiovascular
Angiography and Interventions, Society of Thoracic Surgeons, American
Association for Thoracic Surgery, American Heart Association, and the
American Society of Nuclear Cardiology
Manesh R. Patel, Gregory J. Dehmer, John W. Hirshfeld, Peter K. Smith and John A.
Spertus
Circulation published online Jan 8, 2009;
DOI: 10.1161/CIRCULATIONAHA.108.191768
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Appropriateness Criteria
Appropriateness Criteria
ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness
Criteria for Coronary Revascularization
A Report of the American College of Cardiology Foundation Appropriateness
Criteria Task Force, Society for Cardiovascular Angiography and Interventions,
Society of Thoracic Surgeons, American Association for Thoracic Surgery,
American Heart Association, and the American Society of Nuclear Cardiology
Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the
Society of Cardiovascular Computed Tomography
CORONARYREVASCULARIZATIONWRITINGGROUP
Manesh R. Patel, MD, Chair; Gregory J. Dehmer, MD, FACC, FACP, FSCAI, FAHA*;
John W. Hirshfeld, MD†; Peter K. Smith, MD, FACC‡; John A. Spertus, MD, MPH, FACC†
TECHNICAL PANEL
Frederick A. Masoudi, MD, MSPH, FACC, Moderator;
Ralph G. Brindis, MD, MSH, FACC, FSCAI, Methodology Liaison;
Gregory J. Dehmer, MD, FACC, FACP, FSCAI, FAHA, Writing Group Liaison*;
Manesh R. Patel, MD, Writing Group Liaison; Peter K. Smith, MD, FACC, Writing Group Liaison‡;
Karen J. Beckman, MD, FACC§; Charles E. Chambers, MD, FACC, FSCAI, FAHA*;
T. Bruce Ferguson, Jr, MD, FACC, FAHA(cid:1); Mario J. Garcia, MD, FACC¶;
Frederick L. Grover, MD, FACC(cid:1); David R. Holmes, Jr, MD, FACC, FSCAI*;
Lloyd W. Klein, MD, FACC, FSCAI, FAHA†; Marian Limacher, MD, FACC†;
Michael J. Mack, MD(cid:1); David J. Malenka, MD, FACC††; Myung H. Park, MD, FACC#;
Michael Ragosta III, MD, FACC, FSCAI*; James L. Ritchie, MD, FACC, FAHA†;
Geoffrey A. Rose, MD, FACC, FASE**; Alan B. Rosenberg, MD††;
Richard J. Shemin, MD, FACC, FAHA(cid:1); William S. Weintraub, MD, FACC, FAHA††
*SocietyforCardiovascularAngiographyandInterventionsRepresentative.
†AmericanCollegeofCardiologyFoundationRepresentative.
‡SocietyofThoracicSurgeonsRepresentative.
§HeartRhythmSocietyRepresentative.
||AmericanAssociationforThoracicSurgery/SocietyofThoracicSurgeonsRepresentative.
¶SocietyofCardiovascularComputedTomographyRepresentative.
#HeartFailureSocietyofAmericaRepresentative.
**AmericanSocietyofEchocardiographyRepresentative.
††AmericanHeartAssociationRepresentative.
‡‡FormerTaskForceChairduringthiswritingeffort.
ThisdocumentwasapprovedbytheAmericanCollegeofCardiologyFoundationBoardofTrusteesinMay2008.
The American Heart Association requests that this document be cited as follows: Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA.
ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization: a report of the American College of Cardiology
FoundationAppropriatenessCriteriaTaskForce,SocietyforCardiovascularAngiographyandInterventions,SocietyofThoracicSurgeons,American
AssociationforThoracicSurgery,AmericanHeartAssociation,andtheAmericanSocietyofNuclearCardiology.Circulation.2009;119:xxx–xxx.
ThisarticlehasbeencopublishedintheJournaloftheAmericanCollegeofCardiologyandCatheterizationandCardiovascularInterventions.
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©2009bytheAmericanCollegeofCardiologyFoundation.
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2 Circulation February 10, 2009
ACCF APPROPRIATENESS CRITERIA TASK FORCE
Michael J. Wolk, MD, MACC, Chair; Ralph G. Brindis, MD, MPH, FACC, FSCAI‡‡;
Joseph M. Allen, MA; Pamela S. Douglas, MD, MACC, FAHA, FASE;
RobertC.Hendel,MD,FACC,FAHA;ManeshR.Patel,MD;EricD.Peterson,MD,MPH,FACC,FAHA
TABLE OF CONTENTS AppendixD: ACCF/SCAI/STS/AATS/AHA/ASNC2009
CoronaryRevascularizationAppropriateness
CriteriaWritingGroup,TechnicalPanel,Task
Abstract ..................................................XXXX Force,andIndicationReviewers—
Preface ...................................................XXXX RelationshipsWithIndustry.................XXXX
Introduction ..............................................XXXX
Methods..................................................XXXX References ...............................................XXXX
Indication Development.................................XXXX
Scope of Indications....................................XXXX Abstract
Panel Selection.........................................XXXX
Rating Process and Scoring.............................XXXX TheAmericanCollegeofCardiologyFoundation(ACCF),Society
General Assumptions.....................................XXXX for Cardiovascular Angiography and Interventions, Society of
Table A. CAD Prognostic Index........................XXXX Thoracic Surgeons, and the American Association for Thoracic
Definitions................................................XXXX Surgery,alongwithkeyspecialtyandsubspecialtysocieties,con-
ductedanappropriatenessreviewofcommonclinicalscenariosin
TableB.GradingofAnginaPectorisbytheCanadian
Cardiovascular Society Classification System.........XXXX which coronary revascularization is frequently considered. The
Abbreviations.............................................XXXX clinical scenarios were developed to mimic common situations
encountered in everyday practice and included information on
Results of Ratings........................................XXXX
symptomstatus,extentofmedicaltherapy,risklevelasassessedby
CoronaryRevascularizationAppropriateness
noninvasive testing, and coronary anatomy. Approximately 180
Criteria (By Indication)..................................XXXX clinical scenarios were developed by a writing committee and
Table 1. Patients With Acute Coronary Syndromes .....XXXX scoredbyaseparatetechnicalpanelonascaleof1to9.Scoresof
Table 2. Patients Without Prior Bypass Surgery.........XXXX 7to9indicatethatrevascularizationwasconsideredappropriateand
Table3.PatientsWithPriorBypassSurgery
likely to improve health outcomes or survival. Scores of 1 to 3
(Without Acute Coronary Syndromes)................XXXX
indicate revascularization was considered inappropriate and un-
Rating Revascularization Methods.......................XXXX likelytoimprovehealthoutcomesorsurvival.Themidrange(4to
ModeofRevascularizationforHighSeverityofCAD
6)indicatesaclinicalscenarioforwhichthelikelihoodthatcoronary
(Indications 60 to 73)...................................XXXX
revascularizationwouldimprovehealthoutcomesorsurvivalwas
Mortality Risk..........................................XXXX
considereduncertain.Forthemajorityoftheclinicalscenarios,the
Advanced CAD.........................................XXXX
panel only considered the appropriateness of revascularization
Table4.MethodofRevascularization:Advanced
irrespective of whether this was accomplished by percutaneous
CoronaryDisease,CCSAnginaGreaterThanor
EqualtoClassIII,and/orEvidenceofIntermediate- coronaryintervention(PCI)orcoronaryarterybypassgraftsurgery
to High-Risk Findings on Noninvasive Testing........XXXX (CABG). In a select subgroup of clinical scenarios in which
Discussion................................................XXXX revascularizationisgenerallyconsideredappropriate,theappropri-
Clinical Judgment.......................................XXXX ateness of PCI and CABG individually as the primary mode of
GeneralThemesinAppropriatenessCriteriafor revascularizationwasconsidered.
Revascularization.......................................XXXX Ingeneral,theuseofcoronaryrevascularizationforpatients
Acute Coronary Syndromes.............................XXXX withacutecoronarysyndromesandcombinationsofsignificant
StableIschemicHeartDiseaseWithoutPriorCABG.......XXXX symptoms and/or ischemia was viewed favorably. In contrast,
Stable Ischemic Heart Disease With Prior CABG.......XXXX revascularization of asymptomatic patients or patients with
PCI and CABG in Patients With Advanced CAD.......XXXX low-risk findings on noninvasive testing and minimal medical
Application of Criteria..................................XXXX therapy were viewed less favorably. It is anticipated that these
AppendixA:AdditionalCoronaryRevascularization results will have an impact on physician decision making and
Definitions.............................................XXXX patient education regarding expected benefits from revascular-
Table A1. Clinical Classification of Chest Pain.........XXXX izationandwillhelpguidefutureresearch.
Table A2. Noninvasive Risk Stratification...............XXXX
Appendix B: Additional Methods........................XXXX Preface
Relationships With Industry.............................XXXX
Literature Review.......................................XXXX Thepublicationofappropriatenesscriteriareflectsoneofseveral
AppendixC:ACCF/SCAI/STS/AATS/AHA/ASNC2009 ongoingeffortsbytheACCFanditspartnerstoassistclinicians
AppropriatenessCriteriaforCoronaryRevascularization caringforpatientswithcardiovasculardiseasestodeliverhigh-
Participants ..........................................XXXX quality cardiovascular care. The American College of Cardiol-
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Patel et al Appropriateness Criteria for Coronary Revascularization 3
ogy(ACC)/AmericanHeartAssociation(AHA)practiceguide- criteriaistoallowassessmentofutilizationpatternsforatest
lines provide a foundation for summarizing evidence-based or procedure. Comparing utilization patterns across a large
cardiovascular care and, when evidence is lacking, provide subsetofprovider’spatientscanallowforanassessmentofa
expert consensus opinion that is approved in review by the provider’smanagementstrategieswiththoseofhis/herpeers.
ACCF and AHA. However, in many areas, marked variability TheACCFanditscollaboratorsbelievethatanongoingreview
remains in the use of cardiovascular procedures, raising ques- of one’s practice using these criteria will help guide a more
tionsofover-orunder-use.Onereasonforthisvariabilityisa effective, efficient, and equitable allocation of health care re-
paucity of large randomized clinical trials conducted assessing sources,andultimately,betterpatientoutcomes.
the value of technology for specific patients, including cardiac In developing these appropriateness criteria for coronary
imaging, catheterization, and coronary revascularization. As revascularization, the technical panel was asked to assess
such,therearemanyinstancesinpracticewheretheguidelines whether coronary revascularization for each indication was
providenorecommendation,oralternatively,aLevelCrecom- appropriate, uncertain, or inappropriate using the following
mendation(expertopinion).Forotherareas,evidenceisavailable definition of appropriateness:
butvariabilityinclinicalpracticeremains.Ineithercase,appropri- Coronary revascularization is appropriate when the ex-
atenesscriteriaprovidepracticaltoolstomeasurethisvariabilityto pected benefits, in terms of survival or health outcomes
examineutilizationpatterns. (symptoms, functional status, and/or quality of life) exceed
Appropriatenesscriteriaaredevelopedtoserveasasupplement the expected negative consequences of the procedure.
to ACC/AHA guideline documents. Appropriateness criteria are Thetechnicalpanelscoredeachindicationonascalefrom
designedtoexaminetheuseofdiagnosticandtherapeuticproce- 1 to 9 as follows:
durestosupportefficientuseofmedicalresourcesduringthepursuit
Appropriate: Score 7 to 9
of quality medical care. The process of appropriateness criteria
Appropriatefortheindicationprovided,meaningcoronary
developmenthasbeendefinedpreviously.1Briefly,theappropriate-
revascularization is generally acceptable and is a reasonable
nesscriteriawritinggroupcombinesspecificclinicalcharacteristics
approach for the indication and is likely to improve the
to create prototypical patient scenarios. These scenarios are then
patients’ health outcomes or survival.
provided to a separate technical panel for appropriateness rating.
Thetechnicalpaneliscreatedfromnominationsgivenbymultiple Uncertain: Score 4 to 6
relevant professional societies and provider-led organizations as Uncertain for the indication provided, meaning coronary
well as from health policy and payer communities. To preserve revascularizationmaybeacceptableandmaybeareasonable
objectivity,thetechnicalpanelsarecreatedsoastonotincludea approachfortheindicationbutwithuncertaintyimplyingthat
majorityofindividualswhoselivelihoodistiedtothetechnology
moreresearchand/orpatientinformationisneededtofurther
understudy.
classify the indication.
In making its appropriateness determinations, the technical
panelisprovidedwithsummariesoftherelevantevidencefrom Inappropriate: Score 1 to 3
the medical literature and practice guidelines. They are then Inappropriate for the indication provided, meaning coro-
asked first individually and then collectively to assess the nary revascularization is not generally acceptable and is not
benefits and risks of a test or procedure in the context of the a reasonable approach for the indication and is unlikely to
potential benefits to patients’ outcomes and an implicit under- improve the patients’ health outcomes or survival.
standing of the associated resource use and costs. After the Itisacknowledgedthatgroupingthesescoresinto3catego-
ranking process, the final appropriateness ratings are summa- ries is somewhat arbitrary and that the numeric designations
rizedusinganestablishedrigorousmethodology.2 should be viewed as a continuum. Since some diversity in
Appropriatenesscriteriaarebasedoncurrentunderstandingof clinical opinions for particular clinical scenarios will exist or
the technical capabilities and potential patient benefits of the available research is limited or conflicting, scores in the inter-
proceduresexamined.Futureevidencedevelopmentmayrequire mediate level of appropriateness are labeled “uncertain.” This
theseratingstobeupdated.Theappropriatenesscriteriaarealso identifiestheneedfortargetedinvestigationstoclarifythebest
developed to identify common clinical scenarios—but they therapy in these circumstances. It is anticipated that these
cannot possibly include every conceivable clinical situation. appropriateness criteria will require updates as further data are
Thus,somepatientsseeninclinicalpracticearenotrepresented generated and information from the implementation of these
in these appropriateness criteria or have additional extenuating criteriaaccumulates.
features compared with the clinical scenarios presented. Addi- Topreventbiasinthescoringprocess,thetechnicalpanelwas
tionally,althoughappropriatenesscriteriaindicationsandratings deliberatelycomprisedofphysicianswithvaryingperspectives
areshapedbythepracticeguidelines,theappropriatenesscriteria on coronary revascularization and not comprised solely of
oftencontainmoredetailedscenariosthanthemoregeneralized experts (eg, interventional cardiologists or cardiovascular sur-
situationscoveredinclinicalpracticeguidelines,andthus,subtle geons) in the particular procedure under evaluation. Such ex-
differencesbetweenthese2guidancetoolsispossible. perts, while offering important clinical and technical insights,
Finally, appropriateness criteria are intended to assist mighthaveanaturaltendencytoratetheindicationswithintheir
patients and clinicians, but are not intended to diminish the specialty as more appropriate than nonspecialists. In addition,
acknowledged difficulty or uncertainty of clinical decision care was taken in providing objective, nonbiased information,
making and cannot act as substitutes for sound clinical includingnationalpracticeguidelinesandabroadrangeofkey
judgment and practice experience. Rather, the aim of these references,tothetechnicalpanel.
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4 Circulation February 10, 2009
Wearegratefultothetechnicalpanel,aprofessionalgroup majorityofclinicalindicationsonlyfortheappropriatenessof
with a wide range of skills and insights, for their thoughtful revascularization and not to distinguish between the specific
andthoroughdeliberationofthemeritsofcoronaryrevascu- modes of revascularization (i.e., PCI versus CABG). In
larizationforvariousindications.Inadditiontoourthanksto addition, the writing group identified indications for patients
the technical panel for their dedicated work and review, we withadvancedcoronarydiseaseandsymptoms,whererevas-
wouldliketoofferspecialthankstothemanyindividualswho cularizationisgenerallyconsideredtobeappropriate.Inthis
provided a careful review of the draft indications: to Peggy section, PCI and CABG were independently evaluated for
Christiansen, the ACCF librarian, for her comprehensive appropriateness.
literature searches; to Karen Caruth, who continually drove Once the indications were drafted, reviewers from all
the process forward; to Lindsey Law and Kennedy Elliott, participating collaborators and stakeholders, including car-
who helped map these criteria with existing ACC/AHA diovascularandsurgicalsocieties,providedfeedbackregard-
practiceguidelines;andtoManeshPatel,MD,thechairofthe ing the clinical indications for coronary revascularization.
writingcommittee,forhisdedication,insightandleadership. These comments led to substantial improvements and
Frederick A. Masoudi, MD, MSPH, FACC changes in the clinical scenarios.
Moderator, Coronary Revascularization Technical Panel
Scope of Indications
Ralph G. Brindis, MD, MPH, FACC, FSCAI
Chair, Appropriateness Criteria Task Force The indications contained in this report are purposefully
broad and intended to represent the most common patient
Introduction scenariosforwhichcoronaryrevascularizationisconsidered.
Thedevelopmentoftheseclinicalscenariosre-emphasizedto
This report addresses the appropriateness of coronary revas- the writing group the complexity of the decision-making
cularization. The increasing prevalence of coronary artery processforrevascularizationandthenumberofvariablesthat
disease (CAD), advances in surgical and percutaneous tech- inform this decision. The writing group estimated that over
niques for revascularization as well as concomitant medical 4,000separateclinicalscenarioswouldberequiredtoincor-
therapy for CAD, and the costs of revascularization have porate all permutations of these variables. However, provid-
resulted in heightened interest regarding the appropriateness ing that level of granularity to this framework would be
ofcoronaryrevascularization.Clinicians,payers,andpatients cumbersomeandlikelydegradethepurposeofthesecriteria.
are interested in the specific benefits of revascularization. As this was not a viable option, the indications were devel-
Importantly, inappropriate use of revascularization may be oped considering the following common variables:
potentially harmful to patients and generate unwarranted
costs to the health care system, whereas appropriate proce- a. The clinical presentation (eg, acute coronary syndrome,
dures should likely improve patients’ clinical outcomes. stable angina, and so on);
All prior appropriateness criteria publications from the b. Severityofangina(asymptomatic,CanadianCardiovascu-
ACCF and collaborating organizations have reflected an lar Society [CCS] Class I, II, III, or IV);
ongoingefforttocriticallyandsystematicallycreate,review, c. Extentofischemiaonnoninvasivetestingandthepresence
and categorize the appropriateness of certain cardiovascular orabsenceofotherprognosticfactors,suchascongestive
diagnostic tests. This document presents the first attempt to heartfailure(CHF),depressedleftventricularfunction,or
develop appropriateness criteria for therapeutic procedures: diabetes;
in this case, 2 distinct approaches to coronary artery revas- d. Extent of medical therapy; and
cularization.Thisisanimportantshifttotheexplicitconsid- e. Extent of anatomic disease (1-, 2-, 3-vessel disease, with
eration of the potential benefits and risks of a therapeutic orwithoutproximalleftanteriordescendingartery[LAD]
procedure. This document presents the results of this effort, or left main coronary disease).
but it is critical to understand the background and scope of
The clinical indications developed include coronary anat-
this document before interpreting the rating tables.
omy,asthisisthefocusofmuchofthepreviousliteratureon
coronary revascularization. However, the writing group rec-
Methods
ognizes that for everyday patient care, symptom status,
Briefly,thisprocesscombinesevidence-basedmedicine,guide- ischemic burden, and level of medical therapy often play a
lines,andpracticeexperiencebyengagingatechnicalpanelina critical role in decision making even before the coronary
modifiedDelphiexerciseaspreviouslydescribedbyRAND.2 anatomy has been defined by angiography.
Please note that the indications focus on revascularization,
Indication Development
percutaneousorsurgical,andthereforedonotaddressdiagnostic
The writing group for the coronary revascularization indica- catheterizationorcoronaryangiography.Additionally,theclin-
tions was comprised of members from the relevant profes- ical scenarios presented are not inclusive of every possible
sional societies including both practicing interventional car- clinicalsituation.Forexample,theuseofcoronaryrevascular-
diologists and a cardiothoracic surgeon. Recognizing izationforpatientswithmultivesseldiseaseincluding1ormore
variabilityinmanypatientfactors,localpracticepatterns,and occluded vessels and clinical symptoms or ischemia was not
a lack of data comparing PCI with CABG in all possible included as a separate indication since other variations of
clinical scenarios, the technical panel was asked to rate the multivesseldiseasearepresent.
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Patel et al Appropriateness Criteria for Coronary Revascularization 5
Panel Selection TableA. CADPrognosticIndex
Stakeholdersweregiventheopportunitytoparticipateinthe Prognostic 5-Year
appropriatenesscriteriaprocessbysubmittingnomineesfrom Weight SurvivalRate
theirorganizationsthroughacallfornominationsannounced ExtentofCAD (0–100) (%)*
in the summer of 2006. From this list of nominees, the task 1-vesseldisease,75% 23 93
forceandwritinggroupselectedtechnicalpanelmembersto (cid:2)1-vesseldisease,50%to74% 23 93
ensure an appropriate balance with respect to expertise. The 1-vesseldisease,(cid:1)95% 32 91
17-membertechnicalpanelwascomposedof4interventional 2-vesseldisease 37 88
cardiologists, 4 cardiovascular surgeons, 8 members repre- 2-vesseldisease,both(cid:1)95% 42 86
sentingcardiologists,otherphysicianswhotreatpatientswith 1-vesseldisease,(cid:1)95%proximalLAD 48 83
cardiovascular disease, health outcome researchers, and 1
2-vesseldisease,(cid:1)95%LAD 48 83
medical officer from a health plan.
2-vesseldisease,(cid:1)95%proximalLAD 56 79
Rating Process and Scoring 3-vesseldisease 56 79
The panel members first rated indications independently. 3-vesseldisease,(cid:1)95%inatleast1 63 73
Thenthepanelmetforadiscussionofeachindication.After 3-vesseldisease,75%proximalLAD 67 67
the face-to-face discussion, panel members then indepen- 3-vesseldisease,(cid:1)95%proximalLAD 74 59
dently provided their final scores for each indication. Each
panelmemberhadequalweightinproducingthefinalresult *Assumingmedicaltreatmentonly.CADindicatescoronaryarterydisease;
for the indications and was not forced into consensus. For LAD,leftanteriordescendingcoronaryartery.FromCaliffRM,ArmstrongPW,
eachindication,themediannumericalscorewasdetermined. CarverJR,etal.TaskForce5.Stratificationofpatientsintohigh-,medium-,
At the face-to-face meeting, each panelist received a and low-risk subgroups for purposes of risk factor management. J Am Coll
Cardiol.1996;27:964–1047.4
personalizedratingformthatindicatedhis/herratingforeach
indicationandthedistributionofdeidentifiedratingsofother
members of the panel. In addition, the moderator received a The panel should rate the appropriateness of revascular-
summary rating form with similar information (including ization based upon the clinical features and coronary
panelist identification), along with other statistics reflecting findings,andnottheappropriatenessofdiagnosticcoro-
the level of agreement among panel members. The level of nary angiography.
agreement among panelists, as defined by RAND, was 3. Assumeleftmaincoronaryarterystenosis(greaterthanor
analyzed for each indication based on the BIOMED rule for equal to 50% luminal diameter narrowing) or proximal
a panel of 14 to 16 (a simplified RAND method for deter- LADstenosis(greaterthanorequalto70%luminaldiam-
mining disagreement).2 Per the BIOMED definition, agree- eter narrowing) is not present unless specifically noted.
mentwasdefinedasanindicationwhere4orfewerpanelists’ Assume no other significant coronary artery stenoses are
ratings fell outside the 3-point region containing the median presentexceptthosenotedintheclinicalscenario.
score.Disagreementwasdefinedasasituationwhereatleast 4. The clinical scenarios should be rated based on the
5 panelists’ ratings fell in both the appropriate and the published literature regarding the risks and benefits of
inappropriatecategories.Becausethepanelhad17represen- percutaneous and surgical coronary revascularization.
tatives, which exceeded the 16 addressed in this rule, an Note that specific patient groups not well represented in
additionallevelofagreementanalysisasdescribedbyRAND the literature are not presented in the current clinical
was performed that examines the interpercentile range com- scenarios. However, the writing group recognizes that
pared to interpercentile range adjusted for symmetry.2 This decisionsaboutcoronaryarteryrevascularizationinsuch
information was used by the moderator to guide the panel’s patients are frequently required. Examples of such pa-
discussion by highlighting areas of differences among the tients include those with end-stage renal disease or
panelists. advanced age.
5. Clinical outcome is related to the extent of coronary
arterydisease3(TableA).Basedonthisobservationand
General Assumptions
clinical guideline recommendations regarding “border-
line” angiographic stenoses (50% to 60%) in epicardial
Specific assumptions are provided that were considered by
(non-leftmain)locations,asignificantcoronarystenosis
the technical panel in rating the relevant clinical indications
for the purpose of the clinical scenarios is defined as:
for the appropriateness of revascularization:
• greaterthanorequalto70%luminaldiameternarrow-
1. Each clinical indication includes the patient’s clinical
ing, by visual assessment, of an epicardial stenosis
status/symptom complex, ischemic burden by noninva-
measuredinthe“worstview”angiographicprojection.
sive functional testing when presented, burden of coro-
• greaterthanorequalto50%luminaldiameternarrow-
nary atherosclerosis as determined by angiography, and
ing, by visual assessment, of a left main stenosis
intensity of medical therapy in the determination of the
measuredinthe“worstview”angiographicprojection.
appropriateness of coronary revascularization.
2. Assumecoronaryangiographyhasbeenperformedwhen 6. All patients are receiving standard care, including
these findings are presented in the clinical indications. guideline-based risk-factor modification for primary or
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6 Circulation February 10, 2009
secondary prevention in cardiovascular patients unless TableB. GradingofAnginaPectorisbytheCanadian
specifically noted.5–9 CardiovascularSocietyClassificationSystem
7. Despite the best efforts of the clinician, all patients may not
ClassI
achieve target goals for risk-factor modification. However, a
Ordinaryphysicalactivitydoesnotcauseangina,suchaswalking,climbing
planofcaretoaddressriskfactorsisassumedtobeoccurring
stairs.Angina(occurs)withstrenuous,rapid,orprolongedexertionat
in patients represented in the indications. For patients with workorrecreation.
chronicstableangina,thewritinggrouprecognizesthatthereis
ClassII
awidevarianceinthemedicaltherapyforangina.Thespecific
Slightlimitationofordinaryactivity.Anginaoccursonwalkingorclimbing
definition of maximal anti-ischemic medical therapy is pre- stairsrapidly,walkinguphill,walkingorstairclimbingaftermealsorin
sentedinthedefinitionsection. cold,orinwind,orunderemotionalstress,oronlyduringthefewhours
8. Operators performing percutaneous or surgical revascu- afterawakening.Anginaoccursonwalkingmorethan2blocksonthe
larization have appropriate clinical training and experi- levelandclimbingmorethanoneflightofordinarystairsatanormal
paceandinnormalcondition.
ence and have satisfactory outcomes as assessed by
quality assurance monitoring.10–12 ClassIII
9. Revascularization by either percutaneous or surgical Markedlimitationsofordinaryphysicalactivity.Anginaoccursonwalking1
to2blocksonthelevelandclimbing1flightofstairsinnormal
methodsisperformedinamannerconsistentwithestab-
conditionsandatanormalpace.
lished standards of care.10–12
ClassIV
10. Intheclinicalscenarios,nounusualextenuatingcircum-
Inabilitytocarryonanyphysicalactivitywithoutdiscomfort—anginal
stancesexist(suchasinabilitytocomplywithantiplatelet
symptomsmaybepresentatrest.
agents, do not resuscitate status, patient unwilling to
consider revascularization, technically not feasible to
perform revascularization, or comorbidities likely to FromCampeauL.Gradingofanginapectoris[letter].Circulation.1976;54:
522–3.14 Copyright 1976 American Heart Association, Inc. Reprinted with
markedly increase procedural risk substantially), unless
permission.
specifically noted.
measureoftheamountofmyocardiumatrisk,orischemic
Definitions myocardium.Forthepurposeoftheclinicalindicationsfor
coronary revascularization, stress test findings are pre-
A complete set of definitions of terms used throughout the sentedbytheseriskcriteria.Forpatientswithoutstresstest
indication set are listed in Appendix A. These definitions findings, please refer to the note below on invasive
wereprovidedanddiscussedwiththetechnicalpanelpriorto methods of determining hemodynamic significance. As-
ratings of indications. sume that when prior testing (including an imaging proce-
dure) is referenced in an indication, the testing was
Maximal Anti-Ischemic Medical Therapy performed correctly and with sufficient quality so as to
As previously stated, the indications assume that patients produce a meaningful and accurate result within the limits
arereceivingrisk-factormodificationaccordingtoguideline- of the test performance.
based recommendations. For the purposes of the clinical
scenarios presented, maximal antianginal medical therapy For the purposes of the clinical indications in this docu-
is defined as the use of at least 2 classes of therapies to ment, patients with both typical and atypical angina are
reduce anginal symptoms. classifiedbythefeatureoftheCCSgradingsystempresented
in Table B. Patients with noncardiac chest pain should be
Stress Testing and Risk of Findings on
considered to be asymptomatic.
Noninvasive Testing
Stresstestingiscommonlyusedforbothdiagnosisandrisk High-Risk Features for Short-Term Risk of Death or
stratification of patients with coronary artery disease. Using Nonfatal MI for UA/NSTEMI15
criteria defined for traditional exercise stress tests13: At least 1 of the following:
• History: accelerating tempo of ischemic symptoms in
Low-risk stress test findings: associated with a cardiac
preceding 48 hours
mortality of less than 1% per year;
• Character of pain: prolonged ongoing (greater than 20
Intermediate-riskstresstestfindings:associatedwitha
minutes) rest pain
1% to 3% per year cardiac mortality; • Clinical findings
High-risk stress test findings: associated with a greater X Pulmonary edema, most likely due to ischemia
than 3% per year cardiac mortality. X New or worsening mitral regurgitation murmur
X S or new/worsening rales
Examples of findings from noninvasive studies and their 3
X Hypotension, bradycardia, tachycardia
associatedlevelofriskforcardiacmortalityarepresentedin
X Age greater than 75 years
TableA2.12Asnotedinthefootnotetothistable,forcertain
low-risk findings, there may be additional findings that • Electrocardiogram
alter the assessment of risk, but these relationships have X Angina at rest with transient ST-segment changes
notbeenwellstudied.Implicitintheseriskdefinitionsisa greater than 0.5 mm
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Patel et al Appropriateness Criteria for Coronary Revascularization 7
X Bundle-branch block, new or presumed new PDA (cid:1) patent ductus arteriosus
X Sustained ventricular tachycardia STEMI (cid:1) ST-segment elevation myocardial infarction
• Cardiac marker UA/NSTEMI (cid:1) unstable angina/non–ST-segment elevation
X Elevated cardiac troponin T, troponin I, or creatine myocardial infarction
kinase-MB(eg,troponinTorIgreaterthan0.1ngpermL)
Results of Ratings
Abbreviations
Thefinalratingsforcoronaryrevascularization(Tables1to4)
CABG (cid:1) coronary artery bypass grafting are listed by indication sequentially as obtained from second-
CAD (cid:1) coronary artery disease roundratingsheetssubmittedbyeachpanelist.Figuresdemon-
CCS (cid:1) Canadian Cardiovascular Society strating trends in appropriateness rating by symptom status,
CCT (cid:1) cardiac computed tomography ischemicrisk,andmethodofrevascularizationarealsopresented.
CHF (cid:1) congestive heart failure There was generally less variation in ratings for the indica-
ECG (cid:1) electrocardiogram tions labeled as either appropriate or inappropriate, with 76%
FFR (cid:1) fractional flow reserve and70%,respectively,showingagreementasdefinedpreviously
HF (cid:1) heart failure intheMethodssection.Therewas,however,greatervariability
IVUS (cid:1) intravascular ultrasound intheratingscoresforindicationsdefinedasuncertain,suggest-
LAD (cid:1) left anterior descending artery ingwidevariationinopinion.Severalindicationsfailedtomeet
LIMA (cid:1) left internal mammary artery thedefinitionofagreementnotedabove.Therewerenoratings
LV (cid:1) left ventricular wherethepanelheldsuchopposingviewpointsthatthepanel’s
LVEF (cid:1) left ventricular ejection fraction
votesweredeterminedtobein“disagreement”asdefinedbythe
MI (cid:1) myocardial infarction
strict RAND definitions described previously in the Methods
NTG (cid:1) nitroglycerin
section.
PCI (cid:1) percutaneous coronary intervention
Coronary Revascularization Appropriateness Criteria (By Indication)
Table1. PatientsWithAcuteCoronarySyndromes
Appropriateness
Indication Score(1–9)
1. ●STEMI A(9)*
●(cid:2)12hoursfromonsetofsymptoms
●Revascularizationoftheculpritartery
2. ●STEMI A(9)
●Onsetofsymptomswithintheprior12to24hours
●SevereHF,persistentischemicsymptoms,orhemodynamicorelectricalinstabilitypresent
3. ●STEMI I(3)
●(cid:2)12hoursfromsymptomonset
●Asymptomatic;nohemodynamicinstabilityandnoelectricalinstability
4. ●STEMIwithpresumedsuccessfultreatmentwithfibrinolysis A(9)
●EvidenceofHF,recurrentischemia,orunstableventriculararrhythmiaspresent
●1-vesselCAD,presumedtobetheculpritartery
5. ●STEMIwithpresumedsuccessfultreatmentwithfibrinolysis U(5)
●Asymptomatic;noHFornorecurrentischemicsymptoms,ornounstableventriculararrhythmias
●NormalLVEF
●1-vesselCADpresumedtobetheculpritartery
6. ●STEMIwithpresumedsuccessfultreatmentwithfibrinolysis A(8)
●Asymptomatic;noHF,norecurrentischemicsymptoms,ornounstableventriculararrhythmiasattimeof
presentation
●DepressedLVEF
●3-vesselCAD
●Elective/semi-electiverevascularization
(Continued)
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8 Circulation February 10, 2009
Table1. Continued
Appropriateness
Indication Score(1–9)
7. ●STEMIwithsuccessfultreatmentoftheculpritarterybyprimaryPCIorfibrinolysis I(2)
●Asymptomatic;noHF,noevidenceofrecurrentorprovokableischemiaornounstableventriculararrhythmiasduring
indexhospitalization
●NormalLVEF
●Revascularizationofanon-infarct-relatedarteryduringindexhospitalization
8. ●STEMIorNSTEMIandsuccessfulPCIofculpritarteryduringindexhospitalization A(8)
●Symptomsofrecurrentmyocardialischemiaand/orhigh-riskfindingsonnoninvasivestresstestingperformedafter
indexhospitalization
●Revascularizationof1ormoreadditionalcoronaryarteries
9. ●UA/NSTEMIandhigh-riskfeaturesforshort-termriskofdeathornonfatalMI A(9)
●Revascularizationofthepresumedculpritartery
10. ●UA/NSTEMIandhigh-riskfeaturesforshort-termriskofdeathornonfatalMI A(9)
●Revascularizationofmultiplecoronaryarterieswhentheculpritarterycannotbeclearlydetermined
11. ●Patientswithacutemyocardialinfarction(STEMIorNSTEMI) A(8)
●Evidenceofcardiogenicshock
●Revascularizationof1ormorecoronaryarteries
*Subscripted numbers are a reflection of the continuum as per the appropriateness criteria methodology and should not be interpreted as “degrees of
appropriatenessorinappropriateness.”
Table2. PatientsWithoutPriorBypassSurgery
AppropriatenessScore(1–9)
CCSAnginaClass
Indication Asymptomatic IorII IIIorIV
12. ●1-or2-vesselCADwithoutinvolvementofproximalLAD I(1)* I(2) U(5)
●Low-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
13. ●1-or2-vesselCADwithoutinvolvementofproximalLAD I(2) U(5) A(7)
●Low-riskfindingsonnoninvasivetesting
●Receivingacourseofmaximalanti-ischemicmedicaltherapy
14. ●1-or2-vesselCADwithoutinvolvementofproximalLAD I(3) U(5) U(6)
●Intermediate-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
15. ●1-or2-vesselCADwithoutinvolvementofproximalLAD U(4) A(7) A(8)
●Intermediate-riskfindingsonnoninvasivetesting
●Receivingacourseofmaximalanti-ischemicmedicaltherapy
16. ●1-or2-vesselCADwithoutinvolvementofproximalLAD U(6) A(7) A(8)
●High-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
17. ●1-or2-vesselCADwithoutinvolvementofproximalLAD A(7) A(8) A(9)
●High-riskfindingsonnoninvasivetesting
●Receivingacourseofmaximalanti-ischemicmedicaltherapy
18. ●1-or2-vesselCADwithoutinvolvementofproximalLAD † U(5) A(7)
●Nononinvasivetestingperformed
19. ●1-or2-vesselCADwithborderlinestenosis“50%to60%” † I(2) I(3)
●Nononinvasivetestingperformed
●Nofurtherinvasiveevaluationperformed(ie,FFR,IVUS)
20. ●1-or2-vesselCADwithborderlinestenosis“50%to60%” I(3) U(6) A(7)
●Nononinvasivetestingperformedorequivocaltestresultspresent
●FFR(cid:3)0.75and/orIVUSwithsignificantreductionincross-sectionalarea
(Continued)
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Patel et al Appropriateness Criteria for Coronary Revascularization 9
Table2. Continued
AppropriatenessScore(1–9)
CCSAnginaClass
Indication Asymptomatic IorII IIIorIV
21. ●1-or2-vesselCADwithborderlinestenosis“50%to60%” I(1) I(2) I(2)
●Nononinvasivetestingperformedorequivocaltestresultspresent
●FFRorIVUSfindingsdonotmeetcriteriaforsignificantstenosis
22. ●Chronictotalocclusionof1majorepicardialcoronaryartery,withoutothercoronary I(1) I(2) I(3)
stenoses
●Low-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
23. ●Chronictotalocclusionof1majorepicardialcoronaryartery,withoutothercoronary I(1) U(4) U(6)
stenoses
●Low-riskfindingsonnoninvasivetesting
●Receivingacourseofmaximalanti-ischemicmedicaltherapy
24. ●Chronictotalocclusionof1majorepicardialcoronaryartery,withoutothercoronary I(3) U(4) U(6)
stenoses
●Intermediate-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
25. ●Chronictotalocclusionof1majorepicardialcoronaryartery,withoutothercoronary U(4) U(5) A(7)
stenoses
●Intermediate-riskcriteriaonnoninvasivetesting
●Receivingacourseofmaximalanti-ischemicmedicaltherapy
26. ●Chronictotalocclusionof1majorepicardialcoronaryartery,withoutothercoronary U(4) U(5) A(7)
stenoses
●High-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
27. ●Chronictotalocclusionof1majorepicardialcoronaryartery,withoutothercoronary U(5) A(7) A(8)
stenoses
●High-riskcriteriaonnoninvasivetesting
●Receivingacourseofmaximalanti-ischemicmedicaltherapy
28. ●1-vesselCADinvolvingtheproximalLAD U(4) U(5) A(7)
●Low-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
29. ●1-vesselCADinvolvingtheproximalLAD U(4) A(7) A(8)
●Low-riskfindingsonnoninvasivetesting
●Receivingmaximalanti-ischemicmedicaltherapy
30. ●1-vesselCADinvolvingtheproximalLAD U(4) U(6) A(7)
●Intermediate-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
31. ●1-vesselCADinvolvingtheproximalLAD U(5) A(8) A(9)
●Intermediate-riskfindingsonnoninvasivetesting
●Receivingmaximalanti-ischemicmedicaltherapy
32. ●1-vesselCADinvolvingtheproximalLAD A(7) A(8) A(9)
●High-riskfindingsonnoninvasivetesting
●Receivingnoorminimalanti-ischemicmedicaltherapy
33. ●1-vesselCADinvolvingtheproximalLAD A(7) A(9) A(9)
●High-riskfindingsonnoninvasivetesting
●Receivingmaximalanti-ischemicmedicaltherapy
(Continued)
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