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APPROPRIATE USE CRITERIA

ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria forCoronary Revascularization in PatientsWith Stable Ischemic Heart Disease

A Report of the American College of Cardiology Appropriate Use Criteria Task Force,American Association for Thoracic Surgery, American Heart Association,American Society of Echocardiography, American Society of Nuclear Cardiology,Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography,and Society of Thoracic Surgeons

CoronaryRevascularizationWriting Group

Manesh R. Patel, MD, FACC, FAHA, FSCAI, Cha

John H. Calhoon, MD

ir

Gregory J. Dehmer, MD, MACC, MSCAI, FAHA*James Aaron Grantham, MD, FACCThomas M. Maddox, MD, MSC, FACC, FAHA

This document was approved by the American College of Cardiology Cl

January 2017.

The American College of Cardiology requests that this document be cited

Maron DJ, Smith PK. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 appro

ischemic heart disease: a report of the American College of Cardiology Appro

American Heart Association, American Society of Echocardiography, Americ

and Interventions, Society of Cardiovascular Computed Tomography, and S

This document has been reprinted in the Journal of Nuclear Cardiology an

Copies: This document is available on the World Wide Web site of the Am

please contact Elsevier Reprint Department, fax (212) 633-3820 or e-mail rep

Permissions: Multiple copies, modification, alteration, enhancement, and

permission of the American College of Cardiology. Requests may be compl

author-agreement/obtaining-permission).

David J. Maron, MD, FACC, FAHAPeter K. Smith, MD, FACCy

*Society for Cardiovascular Angiography and Interventions

Representative. ySociety of Thoracic Surgeons Representative.

Rating Panel

Michael J. Wolk, MD, MACC, Moderator

Manesh R. Patel, MD, FACC, FAHA, FSCAI,Writing Group LiaisonGregory J. Dehmer, MD, MACC, FSCAI, FAHA,Writing Group Liaison*Peter K. Smith, MD, FACC, Writing Group Liaison

James C. Blankenship, MD, MACC, MSCAIz

Alfred A. Bove, MD, PHD, MACCzSteven M. Bradley, MDxLarry S. Dean, MD, FACC, FSCAI*

Peter L. Duffy, MD, FACC, FSCAI*T. Bruce Ferguson, JR, MD, FACCzFrederick L. Grover, MD, FACCzRobert A. Guyton, MD, FACCkMark A. Hlatky, MD, FACCzHarold L. Lazar, MD, FACC{Vera H. Rigolin, MD, FACCzGeoffrey A. Rose, MD, FACC, FASE#Richard J. Shemin, MD, FACCkJacqueline E. Tamis-Holland, MD, FACCzCarl L. Tommaso, MD, FACC, FSCAI*

inical Policy Approval Committee on behalf of the Board of Trustees in

as follows: Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM,

priate use criteria for coronary revascularization in patients with stable

priate Use Criteria Task Force, American Association for Thoracic Surgery,

an Society of Nuclear Cardiology, Society for Cardiovascular Angiography

ociety of Thoracic Surgeons. J Am Coll Cardiol 2017;69:2212–41.

d the Journal of Thoracic and Cardiovascular Surgery.

erican College of Cardiology (www.acc.org). For copies of this document,

[email protected].

/or distribution of this document are not permitted without the express

eted online via the Elsevier site (http://www.elsevier.com/about/policies/

J A C C V O L . 6 9 , N O . 1 7 , 2 0 1 7 Patel et al.M A Y 2 , 2 0 1 7 : 2 2 1 2 – 4 1 AUC for Coronary Revascularization in Patients With SIHD

2213

L. Samuel Wann, MD, MACC**John B. Wong, MDz

zAmerican College of Cardiology Representative.xAmerican Heart Association Representative.

kSociety of Thoracic Surgeons Representative. {AmericanAssociation for Thoracic Surgery Representative. #American Society

of Echocardiography Representative. **American Society of Nuclear

Cardiology Representative.

Appropriate UseCriteria TaskForce

John U. Doherty, MD, FACC, Co-ChairGregory J. Dehmer, MD, MACC, Co-Chair

Steven R. Bailey, MD, FACC, FSCAI, FAHANicole M. Bhave, MD, FACCAlan S. Brown, MD, FACCyyStacie L. Daugherty, MD, FACCMilind Y. Desai, MBBS, FACCClaire S. Duvernoy, MD, FACCLinda D. Gillam, MD, FACCRobert C. Hendel, MD, FACC, FAHAyyChristopher M. Kramer, MD, FACC, FAHAzzBruce D. Lindsay, MD, FACCyy

Warren J. Manning, MD, FACCManesh R. Patel, MD, FACC, FAHAxxRitu Sachdeva, MBBS, FACCL. Samuel Wann, MD, MACCyyDavid E. Winchester, MD, FACCMichael J. Wolk, MD, MACCyyJoseph M. Allen, MA

yyFormer Task Force member; current member during the writingeffort. zzFormer Task Force Co-Chair; current Co-Chair during thewriting effort. xxFormer Task Force Chair; current Chair during thewriting effort.

TABLE OF CONTENTS

ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2214

PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2214

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2214

2. METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2215

Indication Development . . . . . . . . . . . . . . . . . . . . . . . 2215

Scope of Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . 2217

Figure 1 AUC Development Process . . . . . . . . . . . . . . 2217

3. ASSUMPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2218

General Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . 2218

Assumptions for Rating Multiple TreatmentOptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2219

4. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2219

Table A. Revascularization to Improve SurvivalCompared With Medical Therapy . . . . . . . . . . . . . . . . 2220

Table B. Noninvasive Risk Stratification . . . . . . . . . . . 2222

5. ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2223

6. CORONARY REVASCULARIZATION IN

PATIENTS WITH STABLE ISCHEMIC

HEART DISEASE: APPROPRIATE USE

CRITERIA (BY INDICATION) . . . . . . . . . . . . . . . . . . 2223

Section 1. SIHD Without Prior CABG . . . . . . . . . . . . . . 2223

Table 1.1 One-Vessel Disease . . . . . . . . . . . . . . . . . 2224

Table 1.2 Two-Vessel Disease . . . . . . . . . . . . . . . . . 2225

Table 1.3 Three-Vessel Disease . . . . . . . . . . . . . . . . 2226

Table 1.4 Left Main Coronary Artery Stenosis . . . . 2227

Section 2. Tables 2.1 and 2.2 SIHD With Prior CABG . 2226

Table 2.1 IMA to LAD Patent and WithoutSignificant Stenoses . . . . . . . . . . . . . . . . . . . . . . . . 2228

Table 2.2 IMA to LAD Not Patent . . . . . . . . . . . . . . 2229

Section 3. Table 3.1 SIHD Undergoing Procedures forWhich Coronary Revascularization May BeConsidered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2227

Table 3.1 Stable Ischemic Heart DiseaseUndergoing Procedures for Which CoronaryRevascularization May Be Considered . . . . . . . . . . 2230

7. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2228

APPENDIX A

ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS2017 Appropriate Use Criteria for CoronaryRevascularization in Patients With StableIschemic Heart Disease: Participants . . . . . . . . . . . . . 2233

APPENDIX B

Relationships With Industry and Other Entities . . . . 2235

Patel et al. J A C C V O L . 6 9 , N O . 1 7 , 2 0 1 7

AUC for Coronary Revascularization in Patients With SIHD M A Y 2 , 2 0 1 7 : 2 2 1 2 – 4 12214

ABSTRACT

The American College of Cardiology, Society for Cardio-vascular Angiography and Interventions, Society ofThoracic Surgeons, and American Association for ThoracicSurgery, along with key specialty and subspecialty soci-eties, have completed a 2-part revision of the appropriateuse criteria (AUC) for coronary revascularization. In priorcoronary revascularization AUC documents, indications forrevascularization in acute coronary syndromes and stableischemic heart disease (SIHD) were combined into 1 docu-ment. To address the expanding clinical indications forcoronary revascularization, and to align the subject matterwith the most current American College of Cardiology/American Heart Association guidelines, the new AUC forcoronary artery revascularization were separated into 2documents addressing SIHD and acute coronary syndromesindividually. This document presents the AUC for SIHD.

Clinical scenarios were developed to mimic patient pre-sentations encountered in everyday practice. These sce-narios included information on symptom status; risk levelas assessed by noninvasive testing; coronary diseaseburden; and, in some scenarios, fractional flow reservetesting, presence or absence of diabetes, and SYNTAX score.This update provides a reassessment of clinical scenariosthat the writing group felt were affected by significantchanges in the medical literature or gaps from prior criteria.The methodology used in this update is similar to the initialdocument but employs the recent modifications in themethods for developing AUC, most notably, alterations inthe nomenclature for appropriate use categorization.

A separate, independent rating panel scored the clin-ical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicatethat revascularization is considered appropriate for theclinical scenario presented. Scores of 1 to 3 indicate thatrevascularization is considered rarely appropriate for theclinical scenario, whereas scores in the mid-range of 4 to 6indicate that coronary revascularization may be appro-priate for the clinical scenario.

As seen with the prior coronary revascularization AUC,revascularization in clinical scenarios with high symptomburden, high-risk features, and high coronary diseaseburden, as well as in patients receiving antianginal ther-apy, are deemed appropriate. Additionally, scenariosassessing the appropriateness of revascularization beforekidney transplantation or transcatheter valve therapy arenow rated. The primary objective of the AUC is to providea framework for the assessment of practice patterns thatwill hopefully improve physician decision making.

PREFACE

The American College of Cardiology (ACC), in collabora-tion with the Society for Cardiovascular Angiography and

Interventions, Society of Thoracic Surgeons, AmericanAssociation for Thoracic Surgery, and other societies,developed and published the first version of the AUC forcoronary revascularization in 2009, releasing the lastupdate in 2012. The AUC are an effort to assist cliniciansin the rational use of coronary revascularization incommon clinical scenarios found in everyday practice.The new AUC for coronary revascularization weredeveloped as separate documents for stable ischemicheart disease (SIHD) and acute coronary syndromes. Thiswas done to address the expanding clinical indicationsfor coronary revascularization, include new literaturepublished since the last update, and align the subjectmatter with the ACC/American Heart Association guide-lines. An additional goal was to address several of theshortcomings of the initial document that becameevident as experience with the use of the AUC accumu-lated in clinical practice.

The publication of AUC reflects 1 of several ongoingefforts by the ACC and its partners to assist clinicians whoare caring for patients with cardiovascular diseases and tosupport high-quality cardiovascular care. The ACC/American Heart Association clinical practice guidelinesprovide a foundation for summarizing evidence-basedcardiovascular care and, when evidence is lacking, pro-vide expert consensus opinion that is approved in reviewby the ACC and American Heart Association. However, inmany areas, variability remains in the use of cardiovas-cular procedures, raising questions of over- or underuse.The AUC provide a practical standard upon which toassess and better understand variability.

We are grateful to the writing committee for thedevelopment of the overall structure of the document andclinical scenarios and to the rating panel—a professionalgroup with a wide range of skills and insights—for theirthoughtful deliberation on the merits of coronary revas-cularization for various clinical scenarios. We would alsolike to thank the parent AUC Task Force and the ACCstaff—Joseph Allen, Leah White, and specifically, MariaVelasquez—for their skilled support in the generation ofthis document.

Manesh R. Patel, MD, FACC, FAHA, FSCAIChair, Coronary Revascularization Writing Group

Immediate Past Chair, Appropriate Use Criteria Task Force

Michael J. Wolk, MD, MACC, Moderator,Appropriate Use Criteria Task Force

1. INTRODUCTION

In a continuing effort to provide information to patients,physicians, and policy makers, the Appropriate Use TaskForce approved this revision of the 2012 CoronaryRevascularization AUC (1). Since publication of the 2012AUC focused update, the original nomenclature used to


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characterize appropriate use has changed (2). New clinicalpractice guidelines (CPGs) for SIHD have been released,and new clinical trials extending the knowledge and evi-dence around coronary revascularization have been pub-lished (3,4). These trials include studies not only on theuse of percutaneous coronary intervention (PCI), but alsoon coronary artery bypass graft surgery (CABG), medicaltherapy, and diagnostic technologies such as fractionalflow reserve (FFR) to guide revascularization (5–8).Additional studies, some based on data from the NationalCardiovascular Data Registry (NCDR), have been pub-lished providing insights into practice patterns and in-formation around clinical scenarios and patient featuresnot previously addressed (9–13).

Improvements in our understanding of the variablesaffecting patient outcomes before and after coronaryrevascularization, continued emphasis on the role ofmedical therapy for coronary artery disease (CAD), and anincreasing emphasis on shared decision making and pa-tient preferences also make a revision of the coronaryrevascularization AUC timely (14). This document focuseson SIHD and is a companion to the AUC specifically foracute coronary syndromes.

2. METHODS

Indication Development

A multidisciplinary writing group consisting of cardio-vascular health outcomes researchers, interventionalcardiologists, cardiothoracic surgeons, and general car-diologists was convened to review and revise the priorcoronary revascularization AUC. The writing group wastasked with developing clinical indications (scenarios)that reflect typical situations encountered in everydaypractice that were then rated by a technical panel. In thisdocument, the term “indication” is used interchangeablywith the phrase “clinical scenario.” Critical data elementsand mapping of the criteria to the elements will be pro-vided for end-users of the revascularization AUC so thatprocedure notes and chart abstraction can be more easilymapped to the AUC. A key goal of this effort is to leveragethe NCDR (National Cardiovascular Data Registry) Cath-PCI registry to map indications to appropriateness ratings,so that minimal additional data collection is needed tosupport quarterly feedback to sites of their performanceas a foundation for improving patient selection forrevascularization. The AUC Task Force is committed tosupporting linkage of the AUC with daily workflow tocapture the data elements needed for AUC ratings.

The revascularization AUC are based on our currentunderstanding of procedure outcomes plus the potentialpatient benefits and risks of the revascularization strate-gies examined. Although the AUC are developed toaddress many of the common clinical scenarios

encountered in practice, it would be impossible to includeevery conceivable patient presentation and maintain aworkable document for clinicians. The writing group ac-knowledges that the current AUC do not evaluate all pa-tient variables that might affect 1 or more strategies forthe management of patients with CAD. Examples of con-ditions not explicitly considered within the scenariosinclude severe chronic kidney disease, severe peripheralvascular disease, known malignancies, poor lung func-tion, advanced liver disease, advanced dementia, and/orother comorbidities that might have excluded patientsfrom the clinical trials that provide the evidence base forcoronary revascularization. Nevertheless, it is necessaryfor the clinician to include these conditions in the finaldecision-making process for an individual patient, andthis may result in the actual therapy deviating from theAUC rating. It is expected that all clinicians will occa-sionally treat patients with extenuating conditions thatare not captured in the current AUC, and this could resultin a treatment rating of “rarely appropriate” for the cho-sen therapy in a specific patient. However, these situa-tions should not constitute a majority of treatmentdecisions, and it is presumed that they will affect allpractitioners equally, thereby minimizing substantialbiases in assessing the performance of individual clini-cians compared with their peers. Additionally, these AUCwere developed in parallel with efforts to update datacollection within the NCDR registries to include datafields that capture some of these extenuating circum-stances, thereby improving the characterization of sce-narios in the AUC.

AUC documents often contain specific clinical sce-narios rather than the more generalized situationscovered in CPGs; thus, subtle differences between thesedocuments may exist. The treatment of patients withSIHD should always include therapies to modify riskfactors and/or reduce cardiovascular events—so-calledsecondary prevention. In several CPGs, the phrase“guideline-directed medical therapy” is used and,depending on the context, may include the use of anti-anginal therapy in addition to therapies for secondaryprevention. In this AUC, it is assumed that all patients willbe receiving comprehensive secondary prevention thera-pies as needed. Antianginal therapy has a central role inthe treatment of patients with SIHD. In some patients, itmay be the sole therapy, whereas in others it may becontinued, albeit in lower doses, following a revasculari-zation procedure. The earlier coronary revascularizationAUC included information about the intensity of anti-anginal therapy in several scenarios, with language suchas “receiving no or minimal anti-ischemic therapy” or“receiving a course of maximal anti-ischemic therapy.”The new AUC adopts a different format, including optionsfor the initiation or escalation of antianginal therapy

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patterned after recommendations made in the 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diag-nosis and Management of Patients With Stable IschemicHeart Disease (2012 SIHD guideline) (3), using a structurethat mimics clinical practice. However, the primary pur-pose of these AUCs is to rate the appropriateness ofrevascularization with the understanding that decisionsabout revascularization are frequently made in thecontext of ongoing antianginal therapy. Because recom-mendations for revascularization or the medical man-agement of CAD are found throughout several CPGs, theAUC ratings herein are meant to unify related CPGs andother data sources and provide a useful tool for clinicians.

These AUC were developed with the intent of assistingpatients and clinicians, but they are not intended todiminish the acknowledged complexity or uncertainty ofclinical decision making and should not be used as asubstitute for sound clinical judgment. There areacknowledged evidence gaps in many areas where clinicaljudgment and experience must be blended with patientpreferences and the existing knowledge base defined inCPGs. It is important to emphasize that a rating ofappropriate care does not mandate that a revasculariza-tion procedure be performed; likewise, a rating of rarelyappropriate care should not prevent a revascularizationprocedure from being performed. It is anticipated, asnoted in the previous text, that there will be occasionalclinical scenarios rated rarely appropriate in which per-forming revascularization may still be in the best interestof a particular patient. In situations in which the AUCrating is not followed, clinicians should document thespecific patient features not captured in the clinical sce-nario or the rationale for the chosen therapy. Dependingon the urgency of care, convening a heart team orobtaining a second opinion may be helpful in some ofthese settings.

The AUC can be used in several ways. As a clinical tool,the AUC assist clinicians in evaluating possible therapiesunder consideration and can help better inform patientsabout their therapeutic options. As an administrative andresearch tool, the AUC provide a means of comparingutilization patterns among providers to thereby derive anassessment of an individual clinician’s managementstrategies compared with his/her peers. It is critical tounderstand that the AUC should be used to assess anoverall pattern of clinical care rather than being the finalarbitrator of specific individual cases. The ACC and itscollaborators believe that an ongoing review of one’spractice using these criteria will help guide more effec-tive, efficient, and equitable allocation of healthcare re-sources, and ultimately, better patient outcomes.However, under no circumstances should the AUC be

used to adjudicate or determine payment for individual

patients. Rather, the intent of the AUC is to provide a

framework to evaluate overall clinical practice patterns

and improve the quality of care.

In developing these AUC for coronary revasculariza-tion, the rating panel was asked to rate each indicationusing the following definition of appropriate use:

A coronary revascularization is appropriate carewhen the potential benefits, in terms of survival orhealth outcomes (symptoms, functional status, and/

or quality of life), exceed the potential negativeconsequences of the treatment strategy.

The rating panel scored each indication on a scale from1 to 9 as follows:

re 7 to 9: Appropriate care

re 4 to 6: May be appropriate care

re 1 to 3: Rarely appropriate care

Appropriate Use Definition and Ratings

In rating these criteria, the rating panel was asked to assesswhether the use of revascularization for each indication is“appropriate care,” “may be appropriate care,” or is“rarely appropriate care” using the following definitionsand their associated numeric ranges. Anonymized indi-vidual scores are available in an online appendix.

Median Score 7 to 9: Appropriate Care

An appropriate option for management of patients in thispopulation, as the benefits generally outweigh the risks;an effective option for individual care plans, although notalways necessary depending on physician judgment andpatient-specific preferences (i.e., procedure is generallyacceptable and is generally reasonable for the indication).

Median Score 4 to 6: May Be Appropriate Care

At times an appropriate option for management of pa-tients in this population due to variable evidence oragreement regarding the benefit to risk ratio, potentialbenefit based on practice experience in the absence ofevidence, and/or variability in the population; effective-ness for individual care must be determined by a patient’sphysician in consultation with the patient on the basis ofadditional clinical variables and judgment along withpatient preferences (i.e., procedure may be acceptableand may be reasonable for the indication).

Median Score 1 to 3: Rarely Appropriate Care

Rarely an appropriate option for management of patientsin this population due to the lack of a clear benefit/riskadvantage; rarely an effective option for individual careplans; exceptions should have documentation of theclinical reasons for proceeding with this care option (i.e.,procedure is not generally acceptable and is not generallyreasonable for the indication).


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The process for development of the AUC is shown inFigure 1 and described in detail in previous documents(1,2).

After completion and tabulation of the second round ofratings, it became apparent to the writing group that theoriginal structure of certain rating tables may haveconfused some members of the rating panel, causingratings that were not internally consistent. This resultedin a re-evaluation and redesign of the rating table struc-ture, which then required a third round of ratings. ThisAUC document presents the end result of that process andthe results of the third round of ratings.

Scope of Indications

The indications for coronary revascularization in SIHDweredeveloped considering the following common variables:

1. The clinical presentation (e.g., low or high activitylevel to provoke ischemic symptoms);

2. Use of antianginal medications;3. Results of noninvasive tests to evaluate the presence

and severity of myocardial ischemia;4. Presence of other confounding factors and comorbid-

ities such as diabetes;5. Extent of anatomic disease;6. Prior coronary artery bypass surgery; and

FIGURE 1 AUC Development Process

Develop list of indications, assumptions, and definitions

Review Panprovid

Writing Gind

Rating Pindication

1st round

2nd round–

Approp(7–9) Ap(4–6) MaAppropr(1–3) RaApproprProspective comparison

with clinical records

% use that is Appropriate, May Be

Appropriate, or Rarely Appropriate

Indi

catio

n D

evel

opm

ent

App

ropr

iate

ness

D

eter

min

atio

nV

alid

atio

n

AUC indicates appropriate use criteria.

7. Invasive testing such as intravascular ultrasound(IVUS) and invasive physiology such as FFR.

The anatomic construct for CAD is based on the pres-ence or absence of flow-limiting obstructions in the cor-onary arteries categorized by the number of vesselsinvolved (1-, 2-, and 3-vessel, and/or left main CAD).Additionally, we included in the anatomic construct thepresence or absence of proximal left anterior descending(LAD) disease. This specific stenosis location was identi-fied in both the 2011 ACCF/AHA guideline for coronaryartery bypass graft surgery (2011 CABG guidelines) and2012 ACC/AHA/SCAI guideline for percutaneous coronaryintervention (2012 PCI guidelines) and was included inclinical trial recruitment to guide revascularization de-cisions (6,15,16). Other factors such as diabetes and thecomplexity of disease were included in certain clinicalscenarios given their effect on cardiac risk and associationwith more favorable outcomes from surgical revasculari-zation. As before, noninvasive test findings are includedin many scenarios to distinguish patients with a low riskfor future adverse events from those with intermediate-or high-risk findings, as these terms are routinely used inclinical practice.

Antianginal treatment of CAD is incorporated into thestructure of the tables following the pattern of

Literature review and guideline mapping

el >30 members e feedback

roup revises ications

anel rates the s in 2 rounds

–no interaction

panel interaction

riate Use Scorepropriatey Beiate rely iate

Prospective clinical decision aids

Increase appropriate use



recommendations in the SIHD guideline (see 2012 SIHDguidelines, Section 4.4.3.1.) but without specific drug ordose recommendations (3,4). In general, beta blockers arerecommended as the initial treatment for symptom relief(Class I recommendation), with calcium channel blockers,long-acting nitrates, or ranolazine prescribed in combi-nation with beta blockers when initial treatment with betablockers is inadequate to control symptoms despiteappropriate dosing. Calcium channel blockers, long-acting nitrates, or ranolazine should be prescribed forrelief of symptoms when beta blockers are contra-indicated or cause unacceptable side effects. Long-actingnondihydropyridine calcium channel blockers arereasonable alternatives to beta blockers as first-linetherapy for antianginal symptoms (Class IIa, Level ofEvidence: B). The use of FFR was incorporated to a greaterextent than in the previous AUC as more data on theusefulness of this testing modality have emerged.

3. ASSUMPTIONS

General Assumptions

Specific assumptions provided to the rating panel for theiruse in rating the relevant clinical scenarios are summa-rized in the following text.

1. When available, each clinical scenario includes thepatient’s clinical status/symptom complex, ischemicburden as determined by noninvasive functionaltesting, burden of coronary atherosclerosis as deter-mined by angiography, and additional invasivetesting evaluations by invasive physiology (e.g., FFR,instantaneous wave-free ratio) or intravascularimaging.

2. When utilized, stress testing, with or without anassociated imaging procedure, was performedcorrectly and with sufficient quality to produce ameaningful and accurate result within the limits ofthe test performance. Evidence of myocardial viabilityis also an important finding and in some clinical sit-uations may influence the decision for revasculariza-tion, but it was not used to further expand the numberof indications.

3. As the main focus of this AUC is revascularization,assume that coronary angiography has been per-formed. The rating panel should judge the appropri-ateness of revascularization on the basis of the clinicalscenario presented, including the coronary diseaseidentified, independent of a judgment about theappropriateness of the coronary angiogram in thescenario.

4. Assume no other significant coronary artery stenosesare present except those specifically described in theclinical scenario.

5. A significant coronary stenosis for the purpose of theclinical scenarios is defined as:

n $70% luminal diameter narrowing, by visualassessment, of an epicardial stenosis measured inthe “worst view” angiographic projection;

n $50% luminal diameter narrowing, by visualassessment, of a left main stenosis measured inthe “worst view” angiographic projection; or

n 40% to 70% luminal narrowing, by visual assess-ment, of an epicardial stenosis measured in the“worst view” angiographic projection with anabnormal FFR as defined in the following text.

6. An FFR #0.80 is abnormal and is consistent withdownstream inducible ischemia.

7. All patients included in these scenarios are receivingneeded therapies to modify existing risk factors asoutlined in CPGs and other documents (17–19). Despitethe best efforts of the clinician, all patients may notachieve target goals for cardiac risk factor modifica-tion. However, a continuing effort and plan of care toaddress risk factors are assumed to exist.

8. For patients with SIHD, the writing group recognizesthere are many choices for antianginal therapy andconsiderable variation in the use and tolerance ofantianginal medications among patients. The use ofantianginal therapy adopted in this AUC follows therecommendations of the SIHD guideline. Assume thatantianginal therapy is prescribed at a dose thatadequately controls the patient’s symptoms or is themaximally tolerated dose for a particular drug.

9. Operators performing percutaneous or surgicalrevascularization have appropriate clinical trainingand experience and have satisfactory outcomes asassessed by quality assurance monitoring (15,20,21).

10. Revascularization by either percutaneous or surgicalmethods is performed in a manner consistent withestablished standards of care at centers with quality/volume standards (15,20,21).

11. In the clinical scenarios, no unusual extenuating cir-cumstances exist (e.g., an inability to comply withantiplatelet agents, do-not-resuscitate status, a pa-tient unwilling to consider revascularization, tech-nical reasons rendering revascularization infeasible,or comorbidities likely to markedly increase proce-dural risk). If any of these circumstances exist, it iscritical that the clinician provide adequate documen-tation in the medical record to support exclusionsfrom the AUC and the alternative management de-cisions made in the patient.

12. Patient history and physical examination are assumedto be comprehensive and thorough. Descriptions ofthe patient’s symptoms are assumed to accuratelyrepresent the current status of the patient (e.g.,asymptomatic patients are truly asymptomatic rather


2219

than asymptomatic due to self-imposed lifestylelimitations).

13. When PCI is being considered in patients with multi-vessel disease, it may be clinically prudent to performthe procedures in a sequential fashion (so-called“staged procedures”). If this is the initial managementplan, the intent for a staged procedure should beclearly outlined and the appropriateness rating shouldapply to the entire revascularization procedure. Spe-cifically, planned staged procedures should not beassessed by individual arteries but rather in terms ofthe plan for the entire revascularization strategy. Fordata collection purposes, this will require document-ing how the procedure is staged (either PCI or hybridrevascularization with surgery), and it is assumed thatall stenoses covered under the umbrella of the plan-ned staged procedure are functionally significant.

14. Although the clinical scenarios should be rated on thebasis of the published literature, the writing committeeacknowledges that decisions about coronary arteryrevascularization in patient populations that are poorlyrepresented in the literature are still required in dailypractice. Therefore, rating panel members should as-sume that some of the clinical scenarios presented willhave low levels of evidence to guide rating decisions.Key to the application of the AUC in settings wherethere are extenuating circumstances or low levels ofsupporting evidence is enhanced documentation bythe clinician to support the clinical decisions made.

15. As with all previously published clinical policies, de-viations by the rating panel from prior publisheddocuments were directed by new evidence that jus-tifies such evolution. However, the reader is advisedto pay careful attention to the wording of an indica-tion in the present document when making compari-sons to prior publications.

16. Indication ratings contained herein supersede theratings of similar indications contained in previousAUC coronary revascularization documents.

Assumptions for Rating Multiple Treatment Options

1. The goal of this document is to identify revasculariza-tion treatments that are considered reasonable for agiven clinical indication. Therefore, each treatmentoption (PCI or CABG) should be rated independently forits level of appropriateness in the specific clinical sce-nario, rather than being placed into a forced or artificialrank-order comparison against each other. Identifyingoptions that may or may not be reasonable for specificindications is the goal of this document, rather thandetermining a single best treatment for each clinical

indication or a rank-order. Therefore, more than 1treatment or even all treatments may be considered

“Appropriate,” “May Be Appropriate,” or “RarelyAppropriate” for any given clinical indication.

2. If more than 1 treatment falls into the same appropriateuse category, it is assumed that patient preferencecombined with physician judgment and available localexpertise will be used to determine the final treatmentused.

4. DEFINITIONS

Definitions of some key terms used throughout the sce-narios are shown in the following text. A complete set ofdefinitions is found in Appendix A. These definitions wereprovided to and discussed with the rating panel beforethe rating process started.

Indication

A set of patient-specific conditions defines an “indica-tion.” The term “clinical indication” (used interchange-ably with “clinical scenario”) provides the context for therating of therapeutic options. However, an “appropriate”rating assigned by the rating panel does not necessarilymean the therapy is mandatory, nor does a “rarelyappropriate” rating mean it is prohibited.

Risk Factor Modification (Secondary Prevention) andAntianginal Medical Therapy

As previously stated, the indications assume that patientsare receiving all indicated treatments for the secondaryprevention of cardiovascular events. This includes life-style and pharmacological interventions according toguideline-based recommendations. Antianginal medicaltherapy is incorporated into the structure of the ratingtables and should follow the recommendations of theSIHD guideline, with a beta blocker as initial therapy andthe option to administer calcium channel blockers, long-acting nitrates, and/or ranolazine if the beta blocker isineffective or not tolerated (3,4).

Specific target doses of drugs are not provided as thismust be individualized, but for beta blockers, it isassumed the dose is sufficient to blunt the exercise heartrate without causing intolerable fatigue, bradycardia, orhypotension. It is assumed that the maximally tolerateddose of beta blockers is being used before the addition ofother drugs, and when other drugs are added, the dose istitrated to alleviate symptoms or is also the maximallytolerated dose. Using multiple drugs at less than optimaldoses is an inefficient and expensive strategy. The SIHDguideline recommends calcium channel blockers or long-acting nitrates if beta blockers are contraindicated orcause unacceptable side effects. The SIHD guideline alsorecommends adding calcium channel blockers or long-acting nitrates to beta blockers for relief of symptomswhen initial treatment with beta blockers is unsuccessful.

TABLE

AnatomicSetting

UPLM or c

CABG a

CABG a

UPLM*

CABG

PCI



Initiating, continuing, or intensifying antianginal therapyis integrated into the ratings tables along with revascu-larization options, as this is typical of real-world practice.

Stress Testing and Risk of Findings on Noninvasive Testing

Stress testing is commonly used for both diagnosis andrisk stratification of patients with CAD. Therapies toimprove survival in patients with SIHD are outlined indetail in the 2012 SIHD guideline (Table A) (3). The variousnoninvasive findings associated with high (>3% annualdeath or myocardial infarction), intermediate (1% to 3%annual death or myocardial infarction) and low (

TABLE A Continued

AnatomicSetting COR LOE References

3-vessel disease with or without proximal LAD artery disease*

CABG I B (353,412,959,985–987)

IIa—It is reasonable to choose CABG over PCI in patients with complex 3-vessel CAD(e.g., SYNTAX score >22) who are good candidates for CABG.

B (964,980,987–989)

PCI IIb—Of uncertain benefit B (366,959,980,985,987)

2-vessel disease with proximal LAD artery disease*

CABG I B (353,412,959,985–987)

PCI IIb—Of uncertain benefit B (366,959,985,987)

2-vessel disease without proximal LAD artery disease*

CABG IIa—With extensive ischemia B (327,990–992)

IIb—Of uncertain benefit without extensive ischemia C (987)


1-vessel proximal LAD artery disease

CABG IIa—With LIMA for long-term benefit B (412 987,993,994)


1-vessel disease without proximal LAD artery involvement

CABG III: Harm B (306,327,412,985,990,995–998)

PCI III: Harm B (306,327,412,985,990,995–998)

LV dysfunction

CABG IIa—EF 35% to 50% B (365,412,999–1002)

CABG IIb—EF

TABLE B Noninvasive Risk Stratification

High risk (>3% annual death or MI)1. Severe resting LV dysfunction (LVEF

BB

CA

CA

FF

IM

LA

LV

PC

SIH


2223

The Role of Patient Preference in the AUC

Patients often make decisions about medical treatmentswithout a complete understanding of their options. Pa-tient participation or shared decision making (SDM) de-scribes a collaborative approach whereby patients areprovided with evidence-based information on treatmentchoices and encouraged to use the information in aninformed dialogue with their provider to make decisionsthat not only use the scientific evidence, but also alignwith their values, preferences, and lifestyle (26–28). Thealternative decision paradigm, often referred to as medi-cal paternalism, places decision authority with physiciansand assigns the patient a more passive role (29). SDM re-spects both the provider’s knowledge and the patient’sright to be fully informed of all care options with theirassociated risks and benefits. SDM often uses decisionaids such as written materials, online modules, or videosto present information about treatment options that helpthe patient evaluate the risks and benefits of a particulartreatment. The most effective decision aids to help pa-tients make truly informed decisions provide relevantfacts and videos of real patient perspectives regarding theparticular treatment (30). Many professional organiza-tions now endorse SDM in practice (31,32).

More than 1 treatment option often exists with no clearevidence identifying the best option. This is compoundedwhen there is variation in experts’ recommendationsabout the best treatment under different circumstances(33). A challenging situation exists when scientific datasuggest 1 treatment is likely to have better outcomes, yetthe patient prefers an alternative treatment. Within thecontext of the AUC, this would be manifest as the patientrequesting a therapy with a lower AUC rating (e.g.,wanting a therapy rated as rarely appropriate when atherapy rated appropriate exists). Informed consent isfundamental to SDM (34). Without understanding the prosand cons of all treatment options, patients cannot properlyengage in SDM and blend their personal desires with thescientific data. Without question, it is important thatblending AUC ratings into clinical decision making providea pathway for including patient preference and SDM.However, the mechanism for that process is beyond thescope of this AUC document. The purpose of this docu-ment is to develop clinical scenarios and provide ratings ofthose scenarios by an expert panel. A complete discussionabout treatment options with SDM can only be finalizedonce the category of appropriate use is determined.

5. ABBREVIATIONS

AA

AC

AU

¼ antianginalS ¼ acute coronary syndromeC ¼ appropriate use criteria

¼ beta-blockersBG ¼ coronary artery bypass graftD ¼ coronary artery diseaseR ¼ fractional flow reserveA ¼ internal mammary arteryD ¼ left anterior descending coronary arteryEF ¼ left ventricular ejection fractionI ¼ percutaneous coronary interventionD ¼ stable ischemic heart disease

6. CORONARY REVASCULARIZATION IN

PATIENTS WITH STABLE ISCHEMIC HEART

DISEASE: APPROPRIATE USE CRITERIA

(BY INDICATION)

Section 1. SIHD Without Prior CABG

The format for tables in Section 1 is similar, with separatetables for 1-, 2-, and 3-vessel disease and left main dis-ease. The columns in each table are stratified into 2 cat-egories. There is a single column combining patients whoare asymptomatic and not receiving antianginal therapywith patients who are asymptomatic and receiving anti-anginal therapy. The remaining columns are devoted topatients with ischemic symptoms, with 3 separate cate-gories: ischemic symptoms and receiving no antianginaltherapy, ischemic symptoms and receiving 1 antianginaldrug (beta blocker preferred), and ischemic symptomsreceiving 2 or more antianginal drugs. As outlined in theSIHD guideline, in the absence of contraindications,initial therapy should be a beta blocker prescribed at adose that reduces heart rate without excessive restingbradycardia, hypotension, or fatigue. Other antianginaldrugs are then added to beta blockers depending on theindividual needs of the patient until symptoms are sup-pressed to the satisfaction of the patient or higher dosescannot be used because of side effects. In each of thesubordinate columns, the panel was asked to rate theoptions for revascularization, specifically PCI or CABG. Asnoted earlier, the rating panel was asked to rate eachrevascularization option independent of the other, withthe intent to rate each therapy on its own merits ratherthan in comparison to the other option. In this construct,both revascularization options could be assigned identicalratings.

In this and subsequent tables, clinical scenarios oftencontain the phrase “noninvasive testing.” In this docu-ment, that phrase includes all forms of stress testing usingeither dynamic or pharmacological stress that may becoupled with various imaging tests. It also could includeother imaging, such as coronary computed tomographyangiography or magnetic resonance imaging, to assess

TABLE

Appropri

One-Vess

Indication

No Proxim

1.

2.

3.

Proximal

4.

5.

6.

The numbe

A indicatartery; LCX



myocardial viability. Some would favor the term “func-tional testing,” but the writing committee did not viewthis as inclusive of computed tomography or magneticresonance imaging and thus favored the term “noninva-sive testing.” FFR is considered as part of an invasiveevaluation and is cited separately in some scenarios. Anemerging technology, computed tomography-derivedFFR is a combination technique that is noninvasive likecomputed tomography but provides FFR, which hastraditionally only been an invasive test.

Table 1.1. One-Vessel Disease

Similar to the 2011 CABG and 2012 SIHD guidelines, thisdocument uses proximal LAD disease as an additionalanatomic discriminator for 1-vessel CAD. Although dataare minimal, the writing committee felt that proximaldisease of a dominant circumflex should be considered ashigh-risk anatomy with similar implications as proximalLAD disease, and thus, it was considered in a separatesection along with proximal LAD disease.

Table 1.2. Two-Vessel Disease

The format of this table is similar to that for 1-vesseldisease. Similar to the 2011 CABG and 2012 SIHD guide-lines, this document makes a distinction regarding thepresence or absence of proximal LAD disease. The writinggroup did not add proximal left dominant circumflexdisease as an additional discriminator, because mostwould consider an isolated stenosis in this location to be

1 .1 One-Vessel Disease

ate Use Score (1-9)

el Disease

Asymptomatic

Not on AATherapy or With

AA Therapy

PCI CABG

al LAD or Proximal Left Dominant LCX Involvement

n Low-risk findings on noninvasive testing R (2) R (1)

n Intermediate- or high-risk findings onnoninvasive testing

M (4) R (3)

n No stress test performed or, if performed,results are indeterminate

n FFR #0.80*

M (4) R (2)

LAD or Proximal Left Dominant LCX Involvement Present

n Low-risk findings on noninvasive testing M (4) R (3)

n Intermediate- or high-risk findings onnoninvasive testing

M (5) M (5)

n No stress test performed or, if performed,results are indeterminate

n FFR #0.80

M (5) M (5)

r in parentheses next to the rating reflects the median score for that indication. *iFR measur

es appropriate; AA, antianginal; BB, beta blockers; CABG, coronary artery bypass graft; FFR, fra, left circumflex artery; M, may be appropriate; PCI, percutaneous coronary intervention; and

the equivalent of 2-vessel disease (i.e., right coronaryartery and circumflex disease). Following this construct,the combination of proximal LAD disease and proximalleft dominant circumflex disease would be considered as3-vessel disease and rated using the 3-vessel disease table(Table 1.3.). In the absence of exercise data, invasivephysiological testing of both involved vessels is includedin several of the indications. To remain in this table of2-vessel disease, such testing must be abnormal in bothvessels. If this testing shows only 1 vessel to be abnormal,the patient would no longer be rated using this table, butrather would be rated in the table for 1-vessel CAD.Finally, because of the increasing body of literature thathas identified diabetes as an important factor to considerwhen recommending revascularization, scenarios indi-cating the presence of diabetes are provided.

Table 1.3. Three-Vessel Disease

Similar to Table 1.2., because of the increasing body ofliterature that has identified diabetes as an importantfactor to consider when recommending revascularization,categories indicating the presence or absence of diabetesare provided among the individual indications. Stenosiscomplexity is also an important factor to consider in anyrevascularization procedure, probably more so for PCIthan for CABG. The SYNTAX (Synergy between Percuta-neous Coronary Intervention with TAXUS and CardiacSurgery) trial provided a comprehensive comparison ofPCI and CABG and a structure that may be helpful in

Ischemic Symptoms

Not on AATherapy

On 1 AA Drug(BB Preferred) On $2 AA Drugs

PCI CABG PCI CABG PCI CABG

R (3) R (2) M (4) R (3) A (7) M (5)

M (5) M (4) M (6) M (4) A (8) M (6)

M (5) R (3) M (6) M (4) A (8) M (6)

M (4) M (4) M (5) M (5) A (7) A (7)

M (6) M (6) A (7) A (7) A (8) A (8)

M (6) M (6) M (6) M (6) A (8) A (7)

ements with appropriate normal ranges may be substituted for FFR.

ctional flow reserve; iFR, instant wave-free ratio; LAD, left anterior descending coronaryR, rarely appropriate.

TABLE 1.2 Two-Vessel Disease

Appropriate Use Score (1–9)

Two-Vessel Disease

Indication

Asymptomatic Ischemic Symptoms


AA TherapyNot on AATherapy


PCI CABG PCI CABG PCI CABG PCI CABG

No Proximal LAD Involvement

7. n Low-risk findings on noninvasive testing R (3) R (2) M (4) R (3) M (5) M (4) A (7) M (6)

8. n Intermediate- or high-risk findings onnoninvasive testing

M (5) M (4) M (6) M (5) A (7) M (6) A (8) A (7)

9. n No stress test performed or, if performed,results are indeterminate

n FFR #0.80* in both vessels

M (5) M (4) M (6) M (4) A (7) M (5) A (8) A (7)

Proximal LAD Involvement and No Diabetes Present

10. n Low-risk findings on noninvasive testing M (4) M (4) M (5) M (5) M (6) M (6) A (7) A (7)


M (6) M (6) A (7) A (7) A (7) A (7) A (8) A (8)


n FFR #0.80 in both vessels

M (6) M (6) M (6) M (6) A (7) A (7) A (8) A (8)

Proximal LAD Involvement With Diabetes Present

13. n Low-risk findings on noninvasive testing M (4) M (5) M (4) M (6) M (6) A (7) A (7) A (8)


M (5) A (7) M (6) A (7) A (7) A (8) A (8) A (9)


n FFR #0.80 in both vessels*

M (5) M (6) M (6) A (7) A (7) A (8) A (7) A (8)

The number in parentheses next to the rating reflects the median score for that indication. *iFR measurements with appropriate normal ranges may be substituted for FFR.

A indicates appropriate; AA, antianginal; BB, beta blockers; CABG, coronary artery bypass graft; FFR, fractional flow reserve; iFR, instant wave-free ratio; LAD, left anterior descending coronaryartery; M, may be appropriate; PCI, percutaneous coronary intervention; and R, rarely appropriate.


2225

formulating revascularization recommendations (35).Factors such as vessel occlusion, bifurcation or trifurca-tion at branch points, ostial stenosis location, length>20 mm, tortuosity, calcification, and thrombus all add tothe complexity of PCI. The presence of multiple complexfeatures (SYNTAX score >22) is associated with morefavorable outcomes with CABG. Although limitations ofthe SYNTAX score for certain revascularization recom-mendations are recognized and it may be impractical toapply this scoring system to all patients with multivesseldisease, it is a reasonable surrogate for the extent andcomplexity of CAD and provides important informationthat can be helpful when making revascularizationdecisions.

Accordingly, in this table specifically for patients with3-vessel disease, the rating panel was asked to considerthe indications in patients with low complexity comparedwith those with intermediate and high complexity.

Table 1.4. Left Main Coronary Artery Stenosis

Literature on the treatment of significant left main dis-ease is dominated by surgical revascularization

procedures and, more recently, comparisons with PCI insome anatomic situations. There are data suggesting thatstenting of the left main ostium or trunk is morestraightforward than treating distal bifurcation or trifur-cation stenoses and is associated with a lower rate ofrestenosis. In comparison, left main lesion location has anegligible influence on the success and long-term resultsof CABG. Accordingly, there are separate rating optionsfor ostial and mid-shaft left main disease and distal orbifurcation left main disease. The definition of a signifi-cant left main stenosis used herein is $50% narrowing byangiography. However, the angiographic assessment ofthe severity of left main disease has several shortcomings,and other assessments such as IVUS or FFR may beneeded. For left main coronary artery stenoses, a mini-mum lumen diameter of

TABLE 1.3 Three-Vessel Disease


Three-Vessel Disease

Indication






Low Disease Complexity (e.g., Focal Stenoses, SYNTAX #22)

16. n Low-risk findings on noninvasive testingn No diabetes

M (4) M (5) M (5) M (5) M (6) M (6) A (7) A (7)


n No diabetes

M (6) A (7) A (7) A (7) A (7) A (8) A (8) A (8)

18. n Low-risk findings on noninvasive testingn Diabetes present

M (4) M (6) M (5) M (6) M (6) A (7) A (7) A (8)


n Diabetes present

M (6) A (7) M (6) A (8) A (7) A (8) A (7) A (9)

Intermediate or High Disease Complexity (e.g. Multiple Features of Complexity as Noted Previously, SYNTAX >22)

20. n Low-risk findings on noninvasive testingn No diabetes

M (4) M (6) M (4) A (7) M (5) A (7) M (6) A (8)


n No diabetes

M (5) A (7) M (6) A (7) M (6) A (8) M (6) A (9)

22. n Low-risk findings on noninvasive testingn Diabetes present

M (4) A (7) M (4) A (7) M (5) A (8) M (6) A (9)


n Diabetes present

M (4) A (8) M (5) A (8) M (5) A (8) M (6) A (9)

The number in parentheses next to the rating reflects the median score for that indication.

A indicates appropriate; AA, antianginal; BB, beta blockers; CABG, coronary artery bypass graft; M, may be appropriate; PCI, percutaneous coronary intervention; and SYNTAX, Synergy betweenPCI with Taxus and Cardiac Surgery trial.



first modality to assess ambiguous left main severity, andthe criteria for a significant stenosis are the same as fornon–left main stenosis (21,36,37).

Section 2. Tables 2.1 and 2.2 SIHD With Prior CABG

Patients with prior CABG surgery can present with a widespectrum of disease progression. This includes thedevelopment of new obstructive disease in coronary ar-teries not bypassed in the first operation, new stenoses inexisting bypass grafts, and territory previously bypassedbut jeopardized again because of graft occlusion. Devel-oping indications inclusive of all of these anatomic pos-sibilities would be impractical. Accordingly, the writingcommittee adopted a more compact construct based onthe presence of a significant stenosis in a bypass graft ornative coronary artery supplying 1, 2, or 3 distinctvascular territories roughly corresponding to the terri-tories of the 3 main coronary arteries. As in patientswithout prior CABG, the indications included an assess-ment of risk based on noninvasive testing (low versusintermediate or high risk).

Evaluation of the severity and physiological signifi-cance of a stenosis in saphenous vein grafts (SVG) can

be particularly challenging because of the usual markedsize difference between the SVG and native artery.Although FFR measurements are well-validated innative vessels, data on the use of FFR in vein grafts arelimited (38). After CABG surgery, the bypass conduitshould act in a similar fashion to the native, low-resistance epicardial vessel. However, the assessmentof ischemia due to a stenosis in a vein graft is compli-cated by several features, which include: 1) the poten-tial for competing flow (and pressure) from both thenative and conduit vessels; 2) the presence of collateralsfrom longstanding native coronary occlusion; and 3) thepotential for microvascular abnormalities due toischemic fibrosis and scarring, pre-existing or bypasssurgery–related myocardial infarction, or chronic low-flow ischemia. Despite these complicating features, thetheory of FFR should apply equally to both a lesion inan SVG to the right coronary artery feeding a normalmyocardial bed and a lesion in the native right coro-nary. However, if the native and collateral supplyare sufficiently large, the FFR across an SVG stenosiscould be normal. FFR measurements may be mostuseful in the setting of an occluded bypass graft to a

TABLE 1.4 Left Main Coronary Artery Stenosis


Left Main Disease

Indication






24. n Isolated LMCA diseasen Ostial or midshaft stenosis

M (6) A (8) A (7) A (8) A (7) A (9) A (7) A (9)

25. n Isolated LMCA diseasen Bifurcation involvement

M (5) A (8) M (5) A (8) M (5) A (9) M (6) A (9)

26. n LMCA diseasen Ostial or midshaft stenosisn Concurrent multivessel diseasen Low disease burden (e.g., 1–2 additional focal

stenoses, SYNTAX score #22)

M (6) A (8) M (6) A (9) A (7) A (9) A (7) A (9)

27. n Ostial or midshaft stenosisn Concurrent multivessel diseasen Intermediate or high disease burden (e.g., 1–2

additional bifurcation stenosis, long stenoses,SYNTAX score >22)

M (4) A (9) M (4) A (9) M (4) A (9) M (4) A (9)

28. n LMCA diseasen Bifurcation involvementn Low disease burden in other vessels (e.g., 1–2

additional focal stenosis, SYNTAX score #22)

M (4) A (8) M (5) A (8) M (5) A (9) M (6) A (9)

29. n LMCA diseasen Bifurcation involvementn Intermediate or high disease burden in other

vessels (e.g., 1–2 additional bifurcation ste-nosis, long stenoses, SYNTAX score >22)

R (3) A (8) R (3) A (9) R (3) A (9) R (3) A (9)


A indicates appropriate; AA, antianginal; BB, beta blockers; CABG, coronary artery bypass graft; LMCA, left main coronary artery; M, may be appropriate; PCI, percutaneous coronaryintervention; R, rarely appropriate; and SYNTAX, Synergy between PCI with Taxus and Cardiac Surgery trial.


2227

native artery with an intermediate-severity stenosis.FFR measurements in bypass grafts are less well-validated and should thus be interpreted with caution.

Two tables are presented for the rating of patients withprior CABG depending on the patency of an existing in-ternal mammary artery (IMA) graft. IMAs have a greaterlong-term patency rate than SVGs—typically >90% after10 years (39,40). Accordingly, use of the IMA as a conduitin CABG surgery has steadily increased. Current use is98%, as reported in the Society of Thoracic Surgeons na-tional database, and use of the IMA as a conduit is 1 of thequality metrics in their composite score. Because of thecurrent high use of the IMA, the writing committee feltthere were too few patients to consider a separate cate-gory consisting of patients who only had SVGs used intheir first operation, although a few such patients mayexist. Moreover, the writing committee did not developany scenarios where the initial operation consisted ofonly bypass grafts to the circumflex and right coronaryartery in the absence of LAD disease. The patency andlongevity of the IMA as a bypass graft was felt by thewriting committee to be an important decision point inthe indication development, as many cardiovascular sur-geons are hesitant to perform a second bypass operation

in the presence of a patent and fully functional IMA graft,especially to the LAD. The path of the IMA, particularly ifit courses medially or is adherent to the back of the ster-num, may be at greater risk during sternal re-entry, withadverse consequences even if the IMA-grafted vessel isregrafted. For Table 2.1., it is assumed that the LAD wassignificantly diseased at the time of the original opera-tion. Therefore, if the IMA to the LAD is no longer patentor is severely diseased, it is assumed that the native LADis also severely diseased or occluded.

Section 3. Table 3.1 SIHD Undergoing Procedures for WhichCoronary Revascularization May Be Considered

In an effort to capture common clinical scenarios that arenot well-represented in guidelines, the writing groupdeveloped indications for preoperative revascularizationin patients being evaluated for renal transplantation orstructural heart procedures. The writing committeerecognized that pre-operative revascularization is some-times requested before transplantation of other organs,but there is insufficient experience or data fromcontrolled studies upon which to develop meaningfulscenarios. These scenarios do not capture all possibleclinical situations, but were felt to capture the majority of

TABLE 2.1 IMA to LAD Patent and Without Significant Stenoses


Indication






Stenosis Supplying 1 Territory Disease (Bypass Graft or Native Artery) to Territory Other Than Anterior

30. n Low-risk findings on noninvasive testing R (3) R (1) R (3) R (2) M (6) R (3) A (7) M (4)


M (5) R (3) M (5) R (3) A (7) M (4) A (8) M (5)

32. n No stress test performed or, if performed, theresults are indeterminate

n FFR of stenosis #0.80*

M (4) R (3) M (4) R (3) M (6) M (4) A (8) M (5)

Stenoses Supplying 2 Territories (Bypass Graft or Native Artery, Either 2 Separate Vessels or Sequential Graft Supplying 2 Territories) Not Including AnteriorTerritory

33. n Low-risk findings on noninvasive testing R (3) R (2) M (4) R (3) M (6) R (3) A (7) M (5)


M (5) R (3) M (5) M (4) A (7) M (5) A (8) M (6)


A indicates appropriate; AA, Antianginal; BB, beta blockers; CABG, coronary artery bypass graft; FFR, fractional flow reserve; iFR, instant wave-free ratio; IMA, internal mammary artery; LAD, leftanterior descending coronary artery; M, may be appropriate; PCI, percutaneous coronary intervention; and R, rarely appropriate.



common clinical situations. If patients have an acutecoronary syndrome, the writing group felt they should

be rated according to the AUC for acute coronary syn-

drome. For many of these patients, symptoms may bedifficult to attribute to myocardial ischemia; thus, theindications used in this table provide only anatomic andnoninvasive test findings for review. Note that for pa-tients being evaluated before a percutaneous valve pro-cedure, the option for CABG surgery is blocked out, as it isassumed such patients have clinical factors making theirrisk of surgery prohibitively high.

7. DISCUSSION

The AUC are intended to inform clinicians, patients, andhealth policy makers about the reasonable use of tech-nologies to help improve patient symptoms and healthoutcomes. Since 2005, the American College of Cardiol-ogy, along with its professional partners, has worked toprovide criteria for both invasive and noninvasive testingand selected treatments, with the intention of furtherexpanding the AUC portfolio.

The 2017 Appropriate Use Criteria for Revascularizationin Patients With Stable Ischemic Heart Disease is theculmination of approximately 2 years of review and revi-sion to the existing AUC. In response to comments frommultiple stakeholders, the current AUC has severalimportant changes (41). First, this document will use thenew terms “appropriate care,” “may be appropriate care,”and “rarely appropriate care,”which were described in theupdated AUC methodology paper (2). Second, the compo-sition of the rating panel was changed slightly to include

5 cardiac surgeons, 5 interventional cardiologists, 6 cardi-ologists not directly involved with performing revascu-larization, and 1 outcomes researcher. Third, the newcriteria stratify symptoms into 2 general group-s—asymptomatic and ischemic symptoms—to be inclusiveof the spectrum of complaints that may occur frommyocardial ischemia. Furthermore, because of the varietyof symptoms that may indicate myocardial ischemia, in-dividual patient variation in how they are described, andobserver variability in the assessment of symptomseverity, the writing group chose to abandon the CanadianCardiac Society classification. However, the currentcriteria continue to emphasize the use of more objectivemeasures of ischemia within indications to stratify pa-tients into low-risk or intermediate-/high-risk findings, asdescribed in the SIHD guideline. Fourth, the scenariosexpand the use of intracoronary physiological testing,mainly with FFR. Fifth, the structure of the AUC tablesconcerning the use of antianginal therapy has changed toreflect typical practice patterns rating patients on the basisof no antianginal therapy, use of 1 antianginal drug, or useof 2 ormore antianginal drugs. As in earlier documents, it isassumed that all patients are being treated with guideline-directed medical therapies to reduce risk. Finally, in aneffort to capture patients who have not previously beencategorized, the current AUC also rate coronary revascu-larization in patients being considered for renal trans-plantation and percutaneous valve procedures.

Review of the ratings demonstrate some themesaround revascularization of patients with SIHD that areconsistent with existing clinical practice guidelines. Ingeneral, in patients with a low burden of coronary disease

TABLE 2.2 IMA to LAD Not Patent


Indication






Stenosis Supplying 1-Territory Disease (Bypass Graft or Native Artery)–Anterior (LAD) Territory

35. n Low-risk findings on noninvasive testing M (4) R (3) M (5) R (3) M (6) M (4) A (7) M (5)


M (6) M (4) M (6) M (4) A (7) M (5) A (8) M (6)

37. n No stress test performed or, if performed, theresults are indeterminate

n FFR of stenosis #0.80*

M (5) M (4) M (6) M (4) A (7) M (5) A (8) M (6)

Stenoses Supplying 2 Territories (Bypass Graft or Native Artery, Either 2 Separate Vessels or Sequential Graft Supplying 2 Territories) LAD Plus Other Territory

38. n Low-risk findings on noninvasive testing M (5) M (4) M (6) M (4) A (7) M (5) A (7) M (6)


M (6) M (5) A (7) M (6) A (7) A (7) A (8) A (8)

Stenoses Supplying 3 Territories (Bypass Graft or Native Arteries, Separate Vessels, Sequential Grafts, or Combination Thereof) LAD Plus 2 Other Territories

40. n Low-risk findings on noninvasive testing M (5) M (5) M (6) M (5) M (6) M (6) A (7) A (7)


A (7) A (7) A (7) A (7) A (7) A (7) A (8) A (8)


A indicates appropriate; AA, Antianginal; BB, beta blockers; CABG, coronary artery bypass graft; FFR, fractional flow reserve; iFR, instant wave-free ratio; IMA, internal mammary artery; LAD, leftanterior descending coronary artery; M, may be appropriate; PCI, percutaneous coronary intervention; and R, rarely appropriate.


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(e.g., single-vessel disease), low-risk findings on nonin-vasive testing, and/or no antianginal therapy, revascu-larization by PCI or CABG surgery for care is felt to berarely appropriate as the initial step. As disease burdenprogresses through 2-vessel to 3-vessel and left maindisease, revascularization by PCI or CABG frequently be-comes rated as “may be appropriate care” or “appropriatecare,” with CABG surgery consistently rated as “appro-priate care” for intermediate or high disease complexity(SYNTAX $22) even in patients with ischemic symptomswho are not on antianginal therapy. Of note, CABG sur-gery was consistently rated as “appropriate care” and PCIas “rarely appropriate care” for left main bifurcation dis-ease with intermediate or high disease burden in othervessels.

Repeat CABG surgery was felt to be rarely appropriatein patients with a functional patent IMA to the LAD in allbut 1 indication, with both PCI and CABG being rated aseither “may be appropriate care” or “appropriate care” inthe other indications, reflecting the complex and indi-vidualized decision making required in these patients.With the exception of a few specific scenarios in asymp-tomatic patients with a low disease burden, revasculari-zation options were considered as “may be appropriatecare” or “appropriate care” options. Although not directlyrated, the use of fractional flow reserve for evaluation ofrenal transplant patients may be considered and will beaddressed in future revascularization documents. Revas-cularization by PCI was considered appropriate care for

the majority of patients being evaluated before a percu-taneous valve procedure.

Application of Criteria

There are many potential applications for AUC, includingtheir adoption by Centers for Medicare & Medicaid Ser-vices regulators as a means of evaluating care. Clinicianscan use the ratings for decision support or as an educa-tional tool when considering the need for revasculariza-tion. Moreover, these criteria can be used to facilitatediscussions with patients and/or referring physiciansabout the need for revascularization. The original intentof the AUC was to provide a tool to identify patterns ofcare, including both the overuse and underuse of variousservices. In fact, some of the initial publications related toAUC identified underuse and the consequences ofunderuse rather than overuse of services (42,43). Facil-ities have used these criteria to design protocols to facil-itate the appropriate care of patients. Some payers haveadopted the AUC for use in the preauthorization of pro-cedures or retrospectively for quality reports. Althoughthe AUC were never intended to determine payment inindividual patients, some payers have adopted the AUCfor this purpose. The desire of payers to control costs isunderstood, but it should be in the context of developingrational payment management strategies to ensure theirmembers receive necessary, beneficial, and cost-effectivecardiovascular care, rather than for other purposes. It isexpected that services performed for “appropriate” or

TABLE 3.1 Stable Ischemic Heart Disease Undergoing Procedures for Which Coronary Revascularization May Be Considered


Indication


Not on AA Therapyor With AATherapy Not on AA Therapy



Patients Undergoing Renal Transplantation, No Diabetes

42. n One- or two-vessel CAD, no proximal LAD involvement, with low-risk noninvasivefindings

R (3) R (2) M (4) R (3) M (6) M (4) A (7) M (5)

43. n One- or two-vessel CAD, no proximal LAD involvement, with intermediate- or high-risknoninvasive findings

M (5) M (4) M (6) M (4) A (7) M (5) A (8) M (6)

44. n One- or two-vessel CAD, including proximal LAD, with low-risk noninvasive findings M (5) M (4) M (6) M (5) M (6) M (6) A (8) A (7)

45. n One- or two-vessel CAD, including proximal LAD, with intermediate- or high-risknoninvasive findings

M (6) M (6) A (7) A (7) A (7) A (7) A (8) A (8)

46. n Left main and/or three-vessel disease, with intermediate- or high-risk noninvasivefindings (e.g., SYNTAX #22)

M (6) A (7) A (7) A (7) A (7) A (7) A (8) A (8)

47. n Left main and/or three-vessel disease, with intermediate- or high-risk noninvasivefindings (e.g., SYNTAX >22)

M (5) A (7) M (6) A (8) M (6) A (8) M (6) A (9)

Patients Undergoing Renal Transplantation, Diabetes Present


R (3) R (3) M (4) R (3) M (5) M (4) A (7) M (6)


M (5) M (4) M (5) M (4) M (6) M (5) A (7) A (7)

50. n One- or two-vessel CAD, including proximal LAD, with low-risk noninvasive findings M (5) M (5) M (5) M (6) M (5) A (7) A (7) A (7)


M (6) M (6) M (6) A (7) M (6) A (7) A (7) A (8)


M (6) A (8) M (6) A (8) M (6) A (8) A (7) A (9)


M (5) A (8) M (5) A (8) M (5) A (9) M (5) A (9)

Patient Who Will Undergo a Percutaneous Valve Procedure (TAVR, MitraClip, Others)


M (4) M (4) M (6) A (8)


A (7) A (7) A (7) A (8)

56. n One- or two-vessel CAD, including proximal LAD, with low-risk noninvasive findings M (6) M (6) A (7) A (8)


A (7) A (7) A (8) A (9)


A (8) A (8) A (8) A (9)


A (7) A (7) A (8) A (8)


A indicates appropriate; AA, Antianginal; BB, beta blockers; CABG, coronary artery bypass graft; CAD, coronary artery disease; LAD, left anterior descending coronary artery; M, may be appropriate; PCI, percutaneous coronary intervention;R, rarely appropriate; SYNTAX, Synergy between PCI with Taxus and Cardiac Surgery trial; and TAVR, transcatheter aortic valve replacement.

Patelet

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VOL.69,NO.17,2017

AUCfor

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SIHD

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“may be appropriate” indications will receive reim-

bursement. In contrast, services performed for “rarelyappropriate” indications should be justified by additionaldocumentation to justify payment because of the uniquecircumstances or the clinical profile that must exist insuch a patient. It is critical to emphasize that the writinggroup, technical panel, Appropriate Use Criteria TaskForce, and clinical community do not believe a rating of“may be appropriate” is justification to deny reimburse-ment for revascularization. Rather, “may be appropriate”ratings are those in which the available data vary andmany other factors exist that may affect the decision toperform or not perform revascularization. The opinions ofthe technical panel often varied for these indications,reflecting that additional research is needed.

The writing group recognizes the need to align thecollection of clinical data required for the determinationof appropriate use with appropriate methods to reducethe burden of data collection. To this end, the NCDRCathPCI Registry group has been engaged in a parallelprocess to ensure that needed data elements are incor-porated into the Registry. The criteria will also be eval-uated for collection by the Society for Thoracic Surgeonsregistry. Incorporating fields to identify patients who arenot felt to be candidates for PCI or CABG surgery hasbeen suggested to ensure proper mapping of the AUC inthe course of medical decision making. The writingcommittee believes the key step to ensuring that theAUC are iterated and continually improved is the use ofa feedback cycle of data between current clinical practiceand the Registry. The writing group also believes thatthe mapping of the data elements on the NCDR CathPCIRegistry data collection from the AUC should be

transparent for all providers to review and implementlocal systems of care.

In conclusion, this document represents the currentunderstanding of the clinical benefit of coronary revascu-larization with respect to health outcomes and survival.These criteria have been developed through the AUC pro-cess and alignment with the evidence and recommenda-tions from clinical practice guidelines. This is intended toprovide a practical guide to clinicians and patients whenconsidering revascularization. As with all AUC, some ofthese ratings will require research and further evaluationto provide the greatest information and benefit to clinicaldecision making. We anticipate that the utility and abilityof these criteria to improve the quality of care will bemeasured by the overall use and adoption of the criteria.With each update, the AUC for coronary revascularizationin SIHD have becomemore refined and specific, while areasfor continued focus and research have been identified.

ACC PRESIDENT AND STAFF

Richard A. Chazal, MD, FACC, PresidentShalom Jacobovitz, Chief Executive OfficerWilliam J. Oetgen, MD, FACC, Executive Vice President,

Science, Education and QualityJoseph M. Allen, MA, Director, Team Leader, Clinical

Policy and PathwaysLeah White, MPH, CCRP, Team Leader, Appropriate Use

CriteriaMarίa Velásquez, Senior Research Specialist, Appropriate

Use CriteriaAmelia Scholtz, PhD, Publications Manager, Clinical Policy

and Pathways

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