ACC/AATS/AHA/ASE/ASNC/SCAI/ - SCCT/STS 2016 Appropriate Use Criteria for Coronary Revascularization in Patients With Acute Coronary Syndromes
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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. -, NO. -, 2016 ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 0735-1097/$36.00 PUBLISHED BY ELSEVIER http://dx.doi.org/10.1016/j.jacc.2016.10.034 APPROPRIATE USE CRITERIA ACC/AATS/AHA/ASE/ASNC/SCAI/ SCCT/STS 2016 Appropriate Use Criteria for Coronary Revascularization in Patients With Acute Coronary Syndromes 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 the Society of Thoracic Surgeons Coronary Manesh R. Patel, MD, FACC, FAHA, FSCAI, Chair David J. Maron, MD, FACC, FAHA Revascularization Peter K. Smith, MD, FACCy Writing Group John H. Calhoon, MD Gregory J. Dehmer, MD, MACC, MSCAI, FACP, FAHA* *Society for Cardiovascular Angiography and Interventions James Aaron Grantham, MD, FACC Representative. ySociety of Thoracic Surgeons Representative. Thomas M. Maddox, MD, MSC, FACC, FAHA Rating Panel Michael J. Wolk, MD, MACC, Moderator Mark A. Hlatky, MD, FACCz Manesh R. Patel, MD, FACC, FAHA, FSCAI, Harold L. Lazar, MD, FACC{ Writing Group Liaison Vera H. Rigolin, MD, FACCz Gregory J. Dehmer, MD, MACC, MSCAI, FACP, FAHA, Geoffrey A. Rose, MD, FACC, FASE# Writing Group Liaison* Richard J. Shemin, MD, FACCk Peter K. Smith, MD, FACC, Writing Group Liaison Jacqueline E. Tamis-Holland, MD, FACCz Carl L. Tommaso, MD, FACC, FSCAI* James C. Blankenship, MD, MACCz L. Samuel Wann, MD, MACC** Alfred A. Bove, MD, PHD, MACCz John B. Wong, MDz Steven M. Bradley, MDx Larry S. Dean, MD, FACC, FSCAI* zAmerican College of Cardiology Representative. xAmerican Heart Peter L. Duffy, MD, FACC, FSCAI* Association Representative. kSociety of Thoracic Surgeons Representative. T. Bruce Ferguson, JR, MD, FACCz {American Association for Thoracic Surgery Representative. #American Frederick L. Grover, MD, FACCz Society of Echocardiography Representative. **American Society of Robert A. Guyton, MD, FACCk Nuclear Cardiology Representative. This document was approved by the American College of Cardiology Board of Trustees in October 2016. The American College of Cardiology requests that this document be cited as follows: Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM, Maron DJ, Smith PK. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2016 appropriate use criteria for coronary revascularization in patients with acute coronary syndromes: 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 the Society of Thoracic Surgeons. J Am Coll Cardiol 2016;XX:xxx–xx. This document has been reprinted in Catheterization and Cardiovascular Interventions and the Journal of Nuclear Cardiology. Copies: This document is available on the World Wide Web site of the American College of Cardiology (www.acc.org). For copies of this document, please contact Elsevier Reprint Department, fax (212) 633-3820 or e-mail reprints@elsevier.com. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. Please contact healthpermissions@elsevier.com.
2 Patel et al. JACC VOL. -, NO. -, 2016 AUC for Coronary Revascularization in Patients With ACS -, 2016:-–- Appropriate Use John U. Doherty, MD, FACC, Co-Chair Warren J. Manning, MD, FACC Criteria Task Gregory J. Dehmer, MD, MACC, Co-Chair Manesh R. Patel, MD, FACC, FAHAxx Force Ritu Sachdeva, MBBS, FACC Steven R. Bailey, MD, FACC, FSCAI, FAHA L. Samuel Wann, MD, MACCyy Nicole M. Bhave, MD, FACC David E. Winchester, MD, FACC Alan S. Brown, MD, FACCyy Michael J. Wolk, MD, MACCyy Stacie L. Daugherty, MD, FACC Joseph M. Allen, MA Milind Y. Desai, MBBS, FACC Claire S. Duvernoy, MD, FACC yyFormer Task Force member, current member during the writing Linda D. Gillam, MD, FACC effort. zzFormer Task Force Co-Chair, current Co-Chair during the Robert C. Hendel, MD, FACC, FAHAyy writing effort. xxFormer Task Force Chair, current Chair during the Christopher M. Kramer, MD, FACC, FAHAzz writing effort. Bruce D. Lindsay, MD, FACCyy TABLE OF CONTENTS ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Table 1.3 STEMI – Revascularization of Nonculprit Artery During the Initial Hospitalization . . . . . . . . . . . . - PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Table 1.4 NSTEMI/Unstable Angina . . . . . . . . . . . . . . . . - 1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - 7. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - 2. METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Indication Development . . . . . . . . . . . . . . . . . . . . . . . . . - APPENDIX A Scope of Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Appropriate Use Criteria for Coronary Revascularization in Patients With Acute Coronary 3. ASSUMPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Syndromes: Participants . . . . . . . . . . . . . . . . . . . . . . . . . - General Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . - APPENDIX B 4. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Relationships With Industry and Other Entities . . . . . . - Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Cardiac Risk Factor Modification and Antianginal ABSTRACT Medical Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - Culprit Stenosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - The American College of Cardiology, Society for Cardiovas- cular Angiography and Interventions, Society of Thoracic Symptoms of Myocardial Ischemia . . . . . . . . . . . . . . . . . - Surgeons, and American Association for Thoracic Surgery, Unstable Angina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - along with key specialty and subspecialty societies, have completed a 2-part revision of the appropriate use criteria Stress Testing and Risk of Findings on Noninvasive Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - (AUC) for coronary revascularization. In prior coronary revascularization AUC documents, indications for revascu- The Role of Patient Preference in the AUC . . . . . . . . . . - larization in acute coronary syndromes (ACS) and stable Specific Acute Coronary Syndromes . . . . . . . . . . . . . . . . - ischemic heart disease were combined into 1 document. To address the expanding clinical indications for coronary 5. ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - revascularization, and in an effort to align the subject matter with the most current American College of Cardiology/ 6. CORONARY REVASCULARIZATION IN PATIENTS American Heart Association guidelines, the new AUC for WITH ACS: AUC (BY INDICATION) . . . . . . . . . . . . . . . - coronary artery revascularization were separated into 2 Table 1.1 STEMI – Immediate Revascularization by documents addressing ACS and stable ischemic heart dis- PCI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - ease individually. This document presents the AUC for ACS. Table 1.2 STEMI – Initial Treatment by Fibrinolytic Clinical scenarios were developed to mimic patient Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - presentations encountered in everyday practice and
JACC VOL. -, NO. -, 2016 Patel et al. 3 -, 2016:-–- AUC for Coronary Revascularization in Patients With ACS included information on symptom status, presence of the last update, and align the subject matter with the clinical instability or ongoing ischemic symptoms, prior ACC/American Heart Association guidelines An addi- reperfusion therapy, risk level as assessed by noninvasive tional goal was to address several of the shortcomings testing, fractional flow reserve testing, and coronary of the initial document that became evident as experi- anatomy. This update provides a reassessment of clinical ence with the use of the AUC accumulated in clinical scenarios that the writing group felt to be affected by practice. significant changes in the medical literature or gaps from The publication of AUC reflects 1 of several ongoing prior criteria. The methodology used in this update is efforts by the ACC and its partners to assist clinicians who similar to the initial document but employs the recent are caring for patients with cardiovascular diseases and in modifications in the methods for developing AUC, most support of high-quality cardiovascular care. The ACC/ notably, alterations in the nomenclature for appropriate American Heart Association clinical practice guidelines use categorization. provide a foundation for summarizing evidence-based A separate, independent rating panel scored the cardiovascular care and, when evidence is lacking, pro- clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 vide expert consensus opinion that is approved in review indicate that revascularization is considered appropriate by the ACC and American Heart Association. However, in for the clinical scenario presented. Scores of 1 to 3 many areas, variability remains in the use of cardiovas- indicate that revascularization is considered rarely cular procedures, raising questions of over- or under-use. appropriate for the clinical scenario, whereas scores in The AUC provide a practical standard upon which to the mid-range (4 to 6) indicate that coronary revascu- assess and better understand variability. larization may be appropriate for the clinical scenario. We are grateful to the writing committee for the Seventeen clinical scenarios were developed by a development of the overall structure of the document and writing committee and scored by the rating panel: 10 clinical scenarios and to the rating panel, a professional were identified as appropriate, 6 as may be appropriate, group with a wide range of skills and insights, for their and 1 as rarely appropriate. thoughtful deliberation of the merits of coronary revas- As seen with the prior coronary revascularization AUC, cularization for various clinical scenarios. We would also revascularization in clinical scenarios with ST-segment like to thank the parent AUC Task Force and the ACC staff, elevation myocardial infarction and non–ST-segment Joseph Allen, Leah White, and specifically Maria Velas- elevation myocardial infarction were considered appro- quez, for their skilled support in the generation of this priate. Likewise, clinical scenarios with unstable angina document. and intermediate- or high-risk features were deemed Manesh R. Patel, MD, FACC appropriate. Additionally, the management of nonculprit Chair, Coronary Revascularization Writing Group artery disease and the timing of revascularization are Chair, Appropriate Use Criteria Task Force now also rated. The primary objective of the AUC is to Michael J. Wolk, MD, MACC provide a framework for the assessment of practice pat- Moderator, Appropriate Use Criteria Task Force terns that will hopefully improve physician decision making. 1. INTRODUCTION PREFACE In a continuing effort to provide information to patients, physicians, and policy makers, the Appropriate Use Task The American College of Cardiology (ACC), in collabo- Force approved this revision of the 2012 coronary revas- ration with the Society for Cardiovascular Angiography cularization AUC (1). Since publication of the 2012 AUC and Interventions, Society for Thoracic Surgeons, document, new guidelines for ST-segment elevation American Association for Thoracic Surgery, and other myocardial infarction (STEMI) (2) and non–ST-segment societies, developed and published the first version of elevation myocardial infarction (NSTEMI)/unstable the appropriate use criteria (AUC) for coronary revas- angina (3) have been published with additional focused cularization in 2009, with the last update in 2012. The updates of the SIHD guideline and a combined focused AUC are an effort to assist clinicians in the rational use update of the percutaneous coronary intervention (PCI) of coronary revascularization in common clinical sce- and STEMI guideline (4,5). New clinical trials have been narios found in everyday practice. The new AUC for published extending the knowledge and evidence around coronary revascularization was developed as separate coronary revascularization, including trials that challenge documents for acute coronary syndromes (ACS) and earlier recommendations about the timing of nonculprit stable ischemic heart disease (SIHD). This was done to vessel PCI in the setting of STEMI (6–8). Additional address the expanding clinical indications for coronary studies related to coronary artery bypass graft surgery, revascularization, include new literature published since medical therapy, and diagnostic technologies such as
4 Patel et al. JACC VOL. -, NO. -, 2016 AUC for Coronary Revascularization in Patients With ACS -, 2016:-–- F I G U R E 1 AUC Development Process Indication Development D Develop liist of indiccations, Literaturre Review and assumptionns, and deffinitions Guidelin ne Mappinng Review Paanel >30 members R m proviide feedbaack Writingg Group Revises R Inndications Rating Panel P Ratees the IIndication ns in Two Rounds R Appropriateness Determination 1st round – No Intteraction Approopriate Usse Score (7–9) Apppropriatee (4–6) May Be App propriate (1–3) Raarely Apprropriate Prospective C Clinical D Decision Aids A Validation Increase Approp priate Use Proospective Comparisson w Cliniccal Record with ds % Use that is Appropriate, May Be A A Appropria ate, Rarelyy Approopriate AUC ¼ appropriate use criteria. fractional flow reserve (FFR) have emerged as well as using methodology previously described in detail (12) analyses from The National Cardiovascular Data Registry (Figure 1). In addition, step-by-step flow charts are pro- (NCDR) on the existing AUC that provide insights into vided to help use the criteria. practice patterns, clinical scenarios, and patient features not previously addressed (9–11). 2. METHODS In an effort to make the AUC usable, meaningful, and as up-to-date as possible, the writing group was asked to Indication Development develop AUC specifically for coronary revascularization in A multidisciplinary writing group consisting of cardio- ACS including STEMI to coincide with the recently pub- vascular health outcomes researchers, interventional lished focused update of the STEMI guidelines (5). A new cardiologists, cardiothoracic surgeons, and general car- separate AUC document specific to SIHD is under prepa- diologists was convened to review and revise the coro- ration and will be forthcoming. The goal of the writing nary revascularization AUC. group was to develop clinical indications (scenarios) that The revascularization AUC are on the basis of our cur- reflect typical situations encountered in everyday prac- rent understanding of procedure outcomes plus the po- tice, which are then classified by a separate rating panel tential patient benefits and risks of the revascularization
JACC VOL. -, NO. -, 2016 Patel et al. 5 -, 2016:-–- AUC for Coronary Revascularization in Patients With ACS strategies examined. The AUC are developed to identify used to measure overall patterns of clinical care rather many of the common clinical scenarios encountered in than to adjudicate the appropriateness of individual practice, but cannot possibly include every conceivable cases. The ACC and its collaborators believe that an patient presentation. (In this document, the phrase ongoing review of one’s practice using these criteria will “clinical scenario” is frequently used interchangeably help guide more effective, efficient, and equitable allo- with the term “indication.”) Some patients seen in clinical cation of healthcare resources, and ultimately lead to practice are not represented in these AUC or have addi- better patient outcomes. Under no circumstances should tional extenuating features that would alter the appro- the AUC be used as the sole means to adjudicate or priateness of treatment compared with the exact clinical determine payment for individual patients—rather, the scenarios presented. intent of the AUC is to provide a framework to evaluate AUC documents often contain more detailed clinical overall clinical practice and to improve the quality of care. scenarios than the more generalized situations covered in In developing these AUC for coronary revasculariza- clinical practice guidelines, and thus, subtle differences tion, the rating panel was asked to rate each indication between these documents may exist. Furthermore, using the following definition of appropriate use: because recommendations for revascularization or the A coronary revascularization or antianginal thera- medical management of coronary artery disease (CAD) are peutic strategy is appropriate care when the potential found throughout several clinical practice guidelines, the benefits, in terms of survival or health outcomes AUC ratings herein are meant to unify related clinical (symptoms, functional status, and/or quality of life) practice guidelines and other data sources and provide a exceed the potential negative consequences of the useful tool for clinicians. The AUC were developed with treatment strategy. the intent to assist patients and clinicians, but are not intended to diminish the acknowledged complexity or Although antianginal therapy is mentioned in this uncertainty of clinical decision-making and should not be definition, the writing committee acknowledges that the a substitute for sound clinical judgment. There are focus of this document is revascularization, as it is the acknowledged evidence gaps in many areas where clinical dominant therapy for patients with ACS. Medical therapy judgement and experience must be blended with patient may have a role in the management of ongoing ischemic preferences, and the existing knowledge base must be symptoms, but not to the extent that it does for SIHD. defined in clinical practice guidelines. The rating panel scored each indication on a scale from It is important to emphasize that a rating of appro- 1 to 9 as follows: priate care does not mandate that a procedure or Score 7 to 9: Appropriate care revascularization strategy be performed, may be appro- priate care represents reasonable care and can be Score 4 to 6: May be appropriate care considered by the patient and provider, and finally, a Score 1 to 3: Rarely appropriate care rating of rarely appropriate care should not prevent a therapy from being performed. It is anticipated that Appropriate Use Definition and Ratings there will be some clinical scenarios rated as rarely In rating these criteria, the rating panel was asked to appropriate where an alternative therapy or performing assess whether the use of revascularization for each revascularization may still be in the best interest of a indication is “appropriate care,” “may be appropriate particular patient. Situations where the clinician believes care,” or “rarely appropriate care” using the following a therapy contrary to the AUC rating is best for the pa- definitions and their associated numeric ranges. tient may require careful documentation as to the spe- cific patient features not captured in the clinical scenario Median Score 7 to 9: Appropriate Care or the rationale for the chosen therapy. Depending on the urgency of care, obtaining a second opinion may be An appropriate option for management of patients in this helpful in some of these settings. population due to benefits generally outweighing risks; The AUC can be used in several ways. As a clinical tool, an effective option for individual care plans, although not the AUC assist clinicians in evaluating possible therapies always necessary depending on physician judgment and under consideration and can help better inform patients patient-specific preferences (i.e., procedure is generally about their therapeutic options. As an administrative and acceptable and is generally reasonable for the indication). research tool, the AUC provide a means to compare utili- zation patterns across a large subset of providers to Median Score 4 to 6: May Be Appropriate Care deliver an assessment of an individual clinician’s man- At times, an appropriate option for management of pa- agement strategies with those of similar physicians. It is tients in this population due to variable evidence or important to again emphasize that the AUC should be agreement regarding the risk-benefit ratio, potential
6 Patel et al. JACC VOL. -, NO. -, 2016 AUC for Coronary Revascularization in Patients With ACS -, 2016:-–- benefit on the basis of practice experience in the ACS to evaluate nonculprit vessels (6). Nevertheless, the absence of evidence, and/or variability in the popula- writing group provided some indications with invasive tion; effectiveness for individual care must be deter- physiology testing (represented by FFR) in nonculprit mined by a patient’s physician in consultation with the vessels in patients with ACS. patient on the basis of additional clinical variables and judgment along with patient preferences (i.e., procedure 3. ASSUMPTIONS may be acceptable and may be reasonable for the indication). General Assumptions Median Score 1 to 3: Rarely Appropriate Care Specific instructions and assumptions used by the rating panel to assist in the rating of clinical scenarios are listed Rarely an appropriate option for management of patients in the following text: in this population due to the lack of a clear benefit/risk advantage; rarely, an effective option for individual care 1. Each clinical scenario is intended to provide the key plans; exceptions should have documentation of the information typically available when a patient pre- clinical reasons for proceeding with this care option (i.e., sents with an ACS, recognizing that especially in the procedure is not generally acceptable and is not generally setting of an STEMI, the need for rapid treatment may reasonable for the indication). prevent a complete evaluation. 2. Although the clinical scenarios should be rated on the Scope of Indications basis of the published literature, the writing commit- The indications for coronary revascularization in ACS were tee acknowledges that in daily practice, decisions developed considering the following common variables: about therapy are required in certain patient pop- ulations that are poorly represented in the literature. 1. The clinical presentation (STEMI, NSTEMI, or other ACS); Therefore, rating panel members were instructed to 2. Time from onset of symptoms; use their best clinical judgment and experience in 3. Presence of other complicating factors (severe heart assigning ratings to clinical scenarios that have low failure or cardiogenic shock; hemodynamic or elec- levels of evidence. trical instability, presence of left ventricular dysfunc- 3. In ACS, the percent luminal diameter narrowing of a tion, persistent or recurring ischemic symptoms); stenosis may be difficult to assess. Determining the 4. Prior treatment by fibrinolysis; significance of a stenosis includes not only the 5. Predicted risk as estimated by the Thrombolysis In percent luminal diameter narrowing, but also the Myocardial Infarction score; angiographic appearance of the stenosis and distal 6. Relevant comorbidities; and flow pattern. For these clinical scenarios, a coronary 7. Extent of anatomic disease in the culprit and non- stenosis in an artery is defined as: culprit arteries. n Severe: The writing group characterized ACS and their man- a. A $70% luminal diameter narrowing of an agement into the 2 common clinical presentations: STEMI epicardial stenosis made by visual assessment and NSTEMI/unstable angina. The anatomic construct for in the “worst view” angiographic projection; or CAD is on the basis of the presence or absence of impor- b. A $50% luminal diameter narrowing of the left tant obstructions in the coronary arteries categorized by main artery made by visual assessment, in the the number of vessels involved 1-, 2-, and 3-vessel CAD) “worst view” angiographic projection. and the ability to identify the culprit artery responsible n Intermediate: for the ACS Although the culprit stenosis is frequently c. A $50% and
JACC VOL. -, NO. -, 2016 Patel et al. 7 -, 2016:-–- AUC for Coronary Revascularization in Patients With ACS 6. Revascularization by either percutaneous or surgical including antiplatelet and anticoagulant medications, methods is performed in a manner consistent with beta-blockers, statins, and other medications as indicated established standards of care at centers with quality/ by their clinical condition. volume standards (18–20). 7. No unusual extenuating circumstances exist in the Culprit Stenosis clinical scenarios such as but not limited to do-not- The phrase “culprit stenosis” is often used interchange- resuscitate status, advanced malignancy, unwilling- ably with “infarct-related artery” to identify the coronary ness to consider revascularization, technical reasons artery stenosis and/or artery responsible for the ACS. In rendering revascularization infeasible, or comorbid- this document, the phrase “culprit stenosis or culprit ar- ities likely to markedly increase procedural risk. tery” is preferred, because in the setting of unstable angina 8. Assume that the appropriateness rating applies only there may be a culprit stenosis or culprit artery, but by to the specific treatment strategy outlined in the definition, there is no evidence of a myocardial infarction. scenario and not additional revascularization pro- cedures that may be performed later in the patient’s Symptoms of Myocardial Ischemia course. Specifically, additional elective revasculari- For the purposes of the clinical scenarios in this docu- zation procedures (so called delayed staged proced- ment, the AUC are intended to apply to patients who have ures) performed after the hospitalization for ACS are the typical underlying pathology of an ACS, not simply an evaluated and rated in the forthcoming AUC docu- elevated troponin value in the absence of an appropriate ment on SIHD. For data collection purposes, this will clinical syndrome. The symptoms of an ACS may be require documenting that the procedure is staged described as both typical and atypical angina or symp- (either PCI or hybrid revascularization with surgery). toms felt to represent myocardial ischemia, such as ex- 9. As with all previously published clinical policies, de- ertional dyspnea, and are captured under the broad term viations by the rating panel from prior published “ischemic symptoms.” Although previous AUC had used documents were driven by new evidence and/or the Canadian Cardiovascular Society system for anginal implementation of knowledge that justifies such classification, the writing group recognized that the broad evolution. However, the reader is advised to pay spectrum of ischemic symptoms may limit patients’ careful attention to the wording of an indication in the functional status in a variety of ways, and capturing the present document and should avoid making compar- Canadian Cardiovascular Society status in clinical practice isons to prior documents. may also vary widely. Therefore, the presence or absence 10. Indication ratings contained herein supersede the of ischemic symptoms are presented without specific ratings of similar indications contained in previous scale. Additionally, post–ACS symptoms may persist and/ AUC coronary revascularization documents. or be easily provoked with minimal activity. 4. DEFINITIONS Unstable Angina The definition of unstable angina is largely on the basis of Definitions of terms used throughout the indication set the clinical presentation. Unstable angina is defined as are listed here. These definitions were provided to and typical chest pain or other ischemic symptoms occurring discussed with the rating panel before the rating of in- at rest or with minimal exertion, and presumed to be dications. The writing group assumed that noninvasive related to an acutely active coronary plaque. In contrast assessments of coronary anatomy (i.e., cardiac computed to stable angina, unstable angina is often described as tomography, cardiac magnetic resonance angiography) severe and as a frank pain. Moreover, unstable angina provide anatomic information that is potentially similar may be new in onset or occur in a crescendo pattern in a to X-ray angiography. However, these modalities do not patient with a previous stable pattern of angina. Unstable currently provide information on ischemic burden and are angina may be associated with new electrocardiographic not assumed to be present in the clinical scenarios. changes such as transient ST-segment elevation, ST- Indication segment depression, or T-wave inversion, but may be present in the absence of electrocardiographic changes. A set of patient-specific conditions defines an “indica- Several scoring systems exist for determining high-risk tion,” which is used interchangeably with the phrase patients with ACS (Tables A and B). “clinical scenario.” Cardiac Risk Factor Modification and Stress Testing and Risk of Findings on Noninvasive Testing Antianginal Medical Therapy Stress testing and coronary CTA are commonly used for The indications assume that patients are receiving both diagnosis and risk stratification of patients with cor- guideline-directed medical therapies for their ACS onary artery disease or those with suspected ACS.
8 Patel et al. JACC VOL. -, NO. -, 2016 AUC for Coronary Revascularization in Patients With ACS -, 2016:-–- High-Risk Features for Short-Term Risk of decision paradigm, often referred to as medical pater- TABLE A Death or Nonfatal MI in Patients With nalism, places decision authority with physicians and NSTEMI/UA gives the patient a more passive role (26). At least 1 of the following: Shared decision-making respects both the provider’s n History—accelerating tempo of anginal symptoms in preceding 48 hours knowledge and the patient’s right to be fully informed of n Character of pain—prolonged ongoing (>20 minutes) rest pain n Clinical findings all care options with their associated risks and benefits. It n Pulmonary edema, most likely due to ischemia also suggests that the healthcare team has educated the n New or worsening MR murmur n S 3 or new/worsening rales patient to the extent the patient desires with regard to the n Hypotension, bradycardia, tachycardia risk and benefits of different treatment options. The pa- n Age >75 years n ECG tient is given the opportunity to participate in the deci- n Transient ST-segment deviation >0.5 mm sion regarding the preferred treatment. Especially n Bundle-branch block, new or presumed new n Sustained ventricular tachycardia regarding primary PCI for STEMI, the need for rapid n Cardiac marker treatment will often preclude a detailed discussion of the n Elevated cardiac TnT, TnI, or CK-MB (e.g., TnT or TnI >0.1 ng per ml) risks and benefits of invasive therapy or other possible High-risk features were defined as in the ACS guidelines (21). treatment decisions. However, patient preferences should CK-MB ¼ creatine kinase, MB isoenzyme; ECG ¼ electrocardiogram; MI ¼ myocardial infarction; MR ¼ mitral regurgitation; NSTEMI ¼ non–ST segment elevation myocardial be considered when the treatment of a nonculprit stenosis infarction; TnI ¼ troponin I; TnT ¼ troponin T; UA ¼ unstable angina. is contemplated later during the hospitalization. Although often contraindicated in ACS, stress testing may Specific Acute Coronary Syndromes be performed for further risk stratification later during the The writing group developed these clinical scenarios index hospitalization. Risk stratification by noninvasive around the common clinical situations in which coronary testing is defined as (4): revascularization is typically considered on the basis of Low-risk stress test findings: associated with a 3% initial hospitalization is also explored (5–8). Previously, per year cardiac mortality rate. treatment of nonculprit stenoses during the initial pro- cedure or during the same hospitalization in the absence The Role of Patient Preference in the AUC of clinical instability or further testing documenting Patients often make decisions about medical treatments ischemia was assigned a Class III recommendation in without a complete understanding of their options. Pa- guideline documents and is thus considered inappro- tient participation or shared decision-making describes a priate using the original terminology for the AUC. The 3 collaborative approach where patients are provided new randomized studies have challenged this concept, evidence-based information on treatment choices and are leading to a focused update of the PCI/STEMI guideline encouraged to use the information in an informed dia- and the new Class IIb assignment for treatment of non- logue with their provider to make decisions that not only culprit stenoses in the setting of primary PCI. use the scientific evidence, but also align with their However, the timing of treatment and criteria for values, preferences, and lifestyle (23–25). The alternative nonculprit stenosis treatment varied among these 3 studies as shown in Table C. Thrombolysis In Myocardial Infarction Risk In PRAMI (Preventive Angioplasty in Acute Myocardial TABLE B Infarction Trial), the nonculprit stenosis needed to have a Score—For Patients With Suspected ACS (22) Variables (1 point each) diameter stenosis >50% and be deemed treatable by the n Age $65 years operator. There were exclusions to immediate nonculprit n $3 risk factors (HTN, DM, FH, lipids, smoking) n Known CAD (stenosis $50%) PCI, such as left main stenosis, ostial left anterior n Aspirin use in past 7 days descending coronary artery and circumflex stenoses, and n Severe angina ($2 episodes within 24 hours) n ST-segment deviation $0.5 mm prior coronary artery bypass graft surgery. Treatment at n Elevated cardiac markers any time other than during the primary PCI was discour- Risk of death or ischemic event through 14 days aged. In CvLPRIT (Complete Versus Lesion-Only Primary n Low: 0–2 (50% in 2 planes and in an artery >2 mm suitable for stent ACS ¼ acute coronary syndrome; CAD ¼ coronary artery disease; DM ¼ diabetes mel- litus; FH ¼ family history; HTN ¼ hypertension. implantation. Treatment of the nonculprit stenosis
JACC VOL. -, NO. -, 2016 Patel et al. 9 -, 2016:-–- AUC for Coronary Revascularization in Patients With ACS TABLE C Treatment of Nonculprit Stenoses in the Patient With STEMI PRAMI CvLPRIT DANAMI3-PRIMULTI (n ¼ 465) (n ¼ 296) (n ¼ 627) Randomization After primary PCI “During” primary PCI After primary PCI Lesion criteria >50% DS >70% DS or >50% DS in 2 views >50% DS and FFR 90% DS Strategy for non–IRA lesions Immediate—at time of primary PCI Immediate or staged within index admission Staged within index admission (average day 2) CvLPRIT ¼ Complete Versus Lesion-Only Primary PCI Trial; DANAMI3-PRIMULTI ¼ The Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Mul- tivessel Disease; DS ¼ diameter stenosis; FFR ¼ fractional flow reserve; IRA ¼ infarct-related artery; PCI ¼ percutaneous coronary intervention; PRAMI ¼ Preventive Angioplasty in Acute Myocardial Infarction Trial. immediately following the primary PCI was encouraged, of nonculprit stenosis treatment. However, if the char- but could be deferred to later during the same hospitali- acteristics of the patient are such that treatment of non- zation. In DANAMI3-PRIMULTI (The Third Danish Study of culprit stenoses are deferred beyond the initial Optimal Acute Treatment of Patients with STEMI: Primary hospitalization, it is assumed the patient is clinically PCI in Multivessel Disease), nonculprit stenoses were stable. These clinical scenarios will be evaluated in the treated if the diameter stenosis was >50% and the forthcoming SIHD document. FFR 90%. 5. ABBREVIATIONS Treatment of the nonculprit stenoses was planned for 2 days after the primary PCI during the index hospitaliza- ACS ¼ acute coronary syndrome tion. These variations in the criteria for nonculprit stenosis AUC ¼ appropriate use criteria treatment and timing of treatment from these 3 relatively small studies make it challenging to develop clinical sce- CAD ¼ coronary artery disease narios. This is an evolving shift in the treatment paradigm FFR ¼ fractional flow reserve for patients presenting with STEMI that, at present, is NSTEMI ¼ non–ST-segment elevation myocardial infarction incompletely understood. Scenarios were developed to PCI ¼ percutaneous coronary intervention allow the rating panel to evaluate clinical situations that mirror the evidence provided in these new trials. SIHD ¼ stable ischemic heart disease This AUC only covers clinical scenarios where the STEMI ¼ ST-segment elevation myocardial infarction culprit artery and additional nonculprit arteries are treated at the time of primary PCI or later during the 6. CORONARY REVASCULARIZATION IN initial hospitalization. The writing group recognizes there PATIENTS WITH ACS: AUC (BY INDICATION) may be circumstances where treatment of a nonculprit artery is deferred beyond the initial hospitalization. That Scenarios 1 to 3 in Table 1.1 specifically address treatment specific circumstance was not studied in the 3 recent trials of the culprit stenosis at the time intervals and with the TABLE 1.1 STEMI—Immediate Revascularization by PCI Indication Appropriate Use Score (1–9) Revascularization of the Presumed Culprit Artery by PCI (Primary PCI) 1. n Less than or equal to 12 hours from onset of symptoms A (9) 2. n Onset of symptoms within the prior 12–24 hours AND A (8) n Severe HF, persistent ischemic symptoms, or hemodynamic or electrical instability present 3. n Onset of symptoms within the prior 12–24 hours AND M (6) n Stable without severe HF, persistent ischemic symptoms, or hemodynamic or electrical instability Successful Treatment of the Culprit Artery by Primary PCI Followed by Immediate Revascularization of 1 or More Nonculprit Arteries During the Same Procedure 4. n Cardiogenic shock persisting after PCI of the presumed culprit artery A (8) n PCI or CABG of 1 or more additional vessels 5. n Stable patient immediately following PCI of the presumed culprit artery M (6) n One or more additional severe stenoses 6. n Stable patient immediately following PCI of the presumed culprit artery M (4) n One or more additional intermediate (50%–70%) stenoses The number in parenthesis next to the rating reflects the median score for that indication. A ¼ appropriate; CABG ¼ coronary artery bypass graft; HF ¼ heart failure; M ¼ may be appropriate; PCI ¼ percutaneous coronary intervention; R ¼ rarely appropriate; STEMI ¼ ST-segment elevation myocardial infarction.
10 Patel et al. JACC VOL. -, NO. -, 2016 AUC for Coronary Revascularization in Patients With ACS -, 2016:-–- TABLE 1.2 STEMI—Initial Treatment by Fibrinolytic Therapy Indication Appropriate Use Score (1–9) PCI of the Presumed Culprit Artery After Fibrinolysis 7. n Evidence of failed reperfusion after fibrinolysis (e.g., failure of ST-segment resolution, presence of acute A (9) severe HF, ongoing myocardial ischemia, or unstable ventricular arrhythmias) 8. n Stable after fibrinolysis AND A (7) n Asymptomatic (no HF, myocardial ischemia, or unstable ventricular arrhythmias) AND n PCI performed 3–24 hours after fibrinolytic therapy 9. n Stable after fibrinolysis AND M (5) n Asymptomatic (no HF, myocardial ischemia, or unstable ventricular arrhythmias) AND n PCI >24 hours after onset of STEMI The number in parenthesis next to the rating reflects the median score for that indication. A ¼ appropriate; CABG ¼ coronary artery bypass graft; HF ¼ heart failure; M ¼ may be appropriate; PCI ¼ percutaneous coronary intervention; R ¼ rarely appropriate; STEMI ¼ ST-segment elevation myocardial infarction. TABLE 1.3 STEMI—Revascularization of Nonculprit Artery During the Initial Hospitalization Indication Appropriate Use Score (1–9) Successful Treatment of the Culprit Artery by Primary PCI or Fibrinolysis Revascularization of 1 or More Nonculprit Arteries During the Same Hospitalization Revascularization by PCI or CABG 10. n Spontaneous or easily provoked symptoms of myocardial ischemia A (8) n One or more additional severe stenoses 11. n Asymptomatic A (7) n Findings of ischemia on noninvasive testing n One or more additional severe stenoses 12. n Asymptomatic (no additional testing performed) M (6) n One or more additional severe stenoses 13 n Asymptomatic (no additional testing performed) R (3) n One or more additional intermediate stenoses 14. n Asymptomatic A (7) n One or more additional intermediate (50%–70%) stenoses n FFR performed and #0.80 The number in parenthesis next to the rating reflects the median score for that indication. A ¼ appropriate; CABG ¼ coronary artery bypass graft; FFR ¼ fractional flow reserve; M ¼ may be appropriate; PCI ¼ percutaneous coronary intervention; R ¼ rarely appropriate; STEMI ¼ ST-segment elevation myocardial infarction. presence or absence of symptoms as noted. Scenarios 4 to primary PCI, the criteria for treatment used in DANAMI3- 6 in Table 1.1 specifically address treatment of 1 or more PRIMULTI cannot be applied in this table. nonculprit stenoses during the same procedure as treat- As noted in Table 1.1, treatment of the nonculprit artery ment of the culprit stenosis. Because these scenarios are can occur at several different times after treatment of the specific for nonculprit treatment immediately following culprit stenosis. Because Table 1.1 covers those scenarios TABLE 1.4 NSTEMI/Unstable Angina Indication Appropriate Use Score (1–9) Revascularization by PCI or CABG 15. n Evidence of cardiogenic shock A (9) n Immediate revascularization of 1 or more coronary arteries 16. n Patient stabilized A (7) n Intermediate- OR high-risk features for clinical events (e.g., TIMI score 3–4) n Revascularization of 1 or more coronary arteries 17. n Patient stabilized after presentation M (5) n Low-risk features for clinical events (e.g., TIMI score #2) n Revascularization of 1 or more coronary arteries The number in parenthesis next to the rating reflects the median score for that indication. A ¼ appropriate; CABG ¼ coronary artery bypass graft; M ¼ may be appropriate; NSTEMI ¼ non–ST-segment elevation myocardial infarction; PCI ¼ percutaneous coronary intervention; R ¼ rarely appropriate; TIMI ¼ Thrombolysis In Myocardial Infarction.
JACC VOL. -, NO. -, 2016 Patel et al. 11 -, 2016:-–- AUC for Coronary Revascularization in Patients With ACS where nonculprit treatment occurs immediately after the CABG is the most commonly used therapy, and this is primary PCI, this table is specific for treatment of non- reflected in the ratings of “appropriate care” or “may be culprit stenoses after the initial procedure, but during the appropriate care” for all but 1 of the 17 scenarios pre- initial hospitalization. sented. Although these AUC ratings do not compare the Unstable angina/NSTEMI category—in patients with merits of PCI versus CABG for revascularization in ACS, in Thrombolysis In Myocardial Infarction 3 flow and multi- clinical practice, patients presenting with STEMI typically ple coronary artery stenoses, consideration should be are treated by PCI of the culprit stenosis. However, the given for heart team evaluation in patients with a high option of surgical revascularization should be considered burden of CAD, such as 2-vessel disease with proximal left for patients with ACS but less acute presentation, espe- anterior descending coronary artery stenosis or more se- cially in those with complex multivessel CAD. vere disease. The current AUC rate revascularization as “appropriate care” for patients presenting within 12 hours of the onset 7. DISCUSSION of STEMI or up to 24 hours if there is clinical instability. For STEMI patients presenting more than 12 and up to 24 The new AUC ratings for ACS are consistent with existing hours from symptom onset but with no signs of clinical guidelines for STEMI and NSTEMI-ACS (Figure 2). For instability, revascularization was rated as “may be patients with ACS, revascularization by either PCI or appropriate,” indicating that many on the technical panel F I G U R E 2 Flow Diagram for the Determination of Appropriate Use in Patients With Acute Coronary Syndromes Asx ¼ asymptomatic; CABG ¼ coronary artery bypass graft; FFR ¼ fractional flow reserve; HF ¼ heart failure; NSTEMI ¼ non–ST-segment elevation myocardial infarction; PCI ¼ percutaneous coronary intervention; STEMI ¼ ST-segment elevation myocardial infarction; UA ¼ unstable angina.
12 Patel et al. JACC VOL. -, NO. -, 2016 AUC for Coronary Revascularization in Patients With ACS -, 2016:-–- consider it reasonable to revascularize such patients. evidence, revascularization was rated as “appropriate Furthermore, nonculprit artery revascularization at the care” in the setting of cardiogenic shock or in a patient time of primary PCI was rated as “may be appropriate,” with intermediate- or high-risk features. For stable pa- but because this is an emerging concept on the basis of tients with low-risk features, revascularization was relatively small studies, clinical judgment by the operator rated as “may be appropriate.” Decisions around the is encouraged. timing of revascularization, management of multivessel For STEMI patients initially treated with fibrinolysis, disease, and concomitant pharmacotherapy should all revascularization was rated as “appropriate therapy” in be on the basis of evidence from the relevant practice the setting of suspected failed fibrinolytic therapy or in guidelines. stable and asymptomatic patients from 3 to 24 hours after In conclusion, the AUC for ACS are consistent with fibrinolysis. In the setting of suspected failed fibrinolysis, the large body of evidence and guideline recommenda- the need for revascularization is usually immediate, tions that support invasive strategies to define anatomy whereas in stable patients with apparent successful and revascularize patients with STEMI and NSTEMI- fibrinolysis, revascularization can be delayed for up to 24 ACS. The evolving evidence around nonculprit stenosis hours. For stable patients >24 hours after fibrinolysis, revascularization has led to ratings that revasculariza- revascularization was rated as “may be appropriate.” tion may be appropriate after primary PCI in selected Revascularization soon after apparent successful fibrino- asymptomatic patients with severe stenoses, defined lysis is supported by data and guideline recommenda- herein as $70% diameter narrowing, or in patients with tions about the management of patients transferred from intermediate-severity stenosis if FFR testing is centers where PCI is not available. abnormal. As in prior versions of the AUC, these Nonculprit artery revascularization during the index revascularization ratings should be used to reinforce hospitalization after primary PCI or fibrinolysis was also existing management strategies and identify patient rated as appropriate and reasonable for patients with 1 or populations that need more information to identify the more severe stenoses and spontaneous or easily provoked most effective treatments. ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. In the presence of an ACC PRESIDENT AND STAFF intermediate-severity nonculprit artery stenosis, revas- cularization was rated as “appropriate therapy” provided Richard A. Chazal, MD, FACC, President that the FFR was #0.80. For patients who are stable and Shalom Jacobovitz, Chief Executive Officer asymptomatic after primary PCI, revascularization was William J. Oetgen, MD, FACC, Executive Vice President, rated as “may be appropriate” for 1 or more severe ste- Science, Education, and Quality noses even in the absence of further testing. The only Joseph M. Allen, MA, Team Leader, Clinical Policy and “rarely appropriate” rating in patients with ACS occurred Pathways for asymptomatic patients with intermediate-severity Leah White, MPH, CCRP, Team Leader, Appropriate Use nonculprit artery stenoses in the absence of any addi- Criteria tional testing to demonstrate the functional significance Marίa Velásquez, Senior Research Specialist, Appropriate of the stenosis. Use Criteria For patients with NSTEMI/unstable angina, and Amelia Scholtz, PhD, Publications Manager, Clinical consistent with existing guidelines and the available Policy and Pathways REFERENCES 1. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, American College of Cardiology Foundation/American Patients With Stable Ischemic Heart Disease: a report Spertus JA. 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