Due to a miscommunication during the process of transferring this manuscript from our editorial team to Production, the Members of the American College of Emergency Physicians Clinical Policies Committee (Oversight Committee) were not properly indexed in PubMed. This has now been corrected online. The publisher would like to apologize for any inconvenience caused.
Due to a miscommunication during the process of transferring this manuscript from our editorial team to Production, the Members of the American College of Emergency Physicians Clinical Policies Committee (Oversight Committee) were not properly indexed in PubMed. This has now been corrected online. This has now been corrected online. The publisher would like to apologize for any inconvenience caused.
OBJECTIVE:To describe QI initiative in reducing DTN time. BACKGROUND: Earlier intra-venous tissue-type plasminogen activator (tPA) treatment for acute ischemic stroke increases efficacy and safety. We describe interventions to reduce door-to-needle times (DTN) for tPA at Erlanger Medical Center. MATERIAL AND METHODS: All consecutive ischemic stroke patients who received tPA were retrospectively and prospectively registered in stroke registry. A series of interventions to reduce treatment delays were implemented as follows: • Pre hospital: - Extensive EMS education and feedback - MENDS replaced by FAST - Focus on pertinent info- time of onset/last seen normal /OAC status • Emergency Department (ED): - ED RN education-Stroke recognition by FAST protocol - Bypass ED: when appropriate - 'Code Stroke': pre existing -reinforced - Focused /Pertinent information gathering for tPA : - Trauma Model: evaluation/labs/EKG/CT in parallel - 'Stroke bag' • CT/Lab: - Priority CT for 'code stroke' pre-existing - 'Stroke alert ' label for all labs (PT/INR) • Stroke Team: - 24hrs; 7days In-house attending stroke neurologist starting April 2013 - CT interpretation and tPA order by stroke neurologist at the CT table before advanced imaging In-hospital delays were analyzed as annual mean/median DTN time with inter quartile range (IQR) RESULTS: A total of 356 patients received IV-tPA between 2011 to 2014.The DTN was reduced annually, from mean 97minutes (median57;IQR 115-73) in 2011, to 41 minutes (median35;IQR 58-20) in 2014. Similarly, the onset-to-treatment time (OTT) was reduced annually, from mean 174 minutes in 2011 to 142 minutes in 2014. In 2013, 16.5[percnt] of ischemic stroke patients admitted to our hospital were treated (from 4.2[percnt] in 2011). The in-hospital mortality, LOS (length of stay) and sICH (symptomatic ICH) were not adversely affected. CONCLUSION: With multiple institution specific interventions it is possible to improve the DTN time even at a high volume non-academic center. One of the key component appears to be the in-house presence of a stroke neurologist 24hours /7days a week.
OBJECTIVES:The effect of emergency medicine (EM) residents on the clinical efficiency of attending physicians is controversial. The authors hypothesized that implementing a new EM residency program would result in an increase in relative value units (RVUs) generated per hour by attending physicians and decrease staffing requirements.METHODS:This was a retrospective observational analysis of an emergency department before, during, and after the establishment of a new EM residency program. We analyzed the change in RVUs billed, patients seen, and hours worked by attending physicians, midlevel providers (MLPs), and residents, and addressed potential confounding factors.RESULTS:The clinical efficiency of attending physicians increased by 70%, or 4.98 RVUs/hour (from 7.12 [SD ± 1.4] RVUs/hour to 12.1 [SD ± 2.2] RVUs/hour, p < 0.001) with the implementation of an EM residency program. Overall, net department RVU generation rose by 32%, even as attending physician coverage decreased by 6.3% (p < 0.05), and MLP coverage dropped by 60% (p < 0.05). We estimated that the implementation of the residency saved 4,860 hours of attending physician coverage and 5,828 hours of MLP coverage per year. This represents an estimated $1,741,265 in annual staffing savings, comparable to the residency program's annual operating cost of $1,821,108.CONCLUSIONS:The implementation of an EM residency program had a positive effect on the clinical efficiency of attending physicians and decreased staffing requirements.
[West J Emerg Med. 2014;15(1):109–110.]
This clinical policy from the American College of Emergency Physicians is the revision of a 2004 policy on critical issues in the evaluation and management of adult patients with seizures in the emergency department.(1) A writing subcommittee reviewed the literature to derive evidence-based recommendations to help clinicians answer the following critical questions: (1) In patients with a first generalized convulsive seizure who have returned to their baseline clinical status, should antiepileptic therapy be initiated in the emergency department to prevent additional seizures? (2) In patients with a first unprovoked seizure who have returned to their baseline clinical status in the emergency department, should the patient be admitted to the hospital to prevent adverse events? (3) In patients with a known seizure disorder in which resuming their antiepileptic medication in the emergency department is deemed appropriate, does the route of administration impact recurrence of seizures? (4) In emergency department patients with generalized convulsive status epilepticus who continue to have seizures despite receiving optimal dosing of a benzodiazepine, which agent or agents should be administered next to terminate seizures? A literature search was performed, the evidence was graded, and recommendations were given based on the strength of the available data in the medical literature.
Background: Since 1991, the incidence of injuries associated with pneumatic and explosive powered nail guns has steadily been rising due to increasing use of these devices by the untrained consumer. The vast majority of injuries involve the extremities, but injuries have been reported to occur in virtually every area of the body. Objective: Discuss the epidemiology, pathophysiology, and management of penetrating cardiac nail gun injuries. Case Report: A 33-year-old man sustained a penetrating cardiac injury from accidental discharge of a nail gun. The patient had successful repair of a laceration to his right ventricle. Conclusions: Penetrating cardiac injuries from pneumatic nail guns are rare and have mortality similar to stab wounds. Improved safety mechanisms and training are the keys to prevention. Consideration also should be given to implementing legislation restricting the sale of nail guns. (c) 2013 Elsevier Inc.
HomeCirculationVol. 127, No. 42013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: Executive Summary Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUB2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: Executive SummaryA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Patrick T. O’Gara, MD, FACC, FAHA, Frederick G. Kushner, MD, FACC, FAHA, FSCAI, Deborah D. Ascheim, MD, FACC, Donald E. CaseyJr, MD, MPH, MBA, FACP, FAHA, Mina K. Chung, MD, FACC, FAHA, James A. de Lemos, MD, FACC, Steven M. Ettinger, MD, FACC, James C. Fang, MD, FACC, FAHA, Francis M. Fesmire, MD, FACEP, Barry A. Franklin, PhD, FAHA, Christopher B. Granger, MD, FACC, FAHA, Harlan M. Krumholz, MD, SM, FACC, FAHA, Jane A. Linderbaum, MS, CNP-BC, David A. Morrow, MD, MPH, FACC, FAHA, L. Kristin Newby, MD, MHS, FACC, FAHA, Joseph P. Ornato, MD, FACC, FAHA, FACP, FACEP, Narith Ou, PharmD, Martha J. Radford, MD, FACC, FAHA, Jacqueline E. Tamis-Holland, MD, FACC, Jacqueline E. Tommaso, MD, FACC, FAHA, FSCAI, Cynthia M. Tracy, MD, FACC, FAHA, Y. Joseph Woo, MD, FACC, FAHA and David X. Zhao, MD, FACC Patrick T. O’GaraPatrick T. O’Gara *, †, ‡, §, ║, , #, ** Search for more papers by this author , Frederick G. KushnerFrederick G. Kushner *, †, ‡, §, ║, , #, ** Search for more papers by this author , Deborah D. AscheimDeborah D. Ascheim *, †, ‡, §, ║, , #, ** Search for more papers by this author , Donald E. CaseyJrDonald E. CaseyJr *, †, ‡, §, ║, , #, ** Search for more papers by this author , Mina K. ChungMina K. Chung *, †, ‡, §, ║, , #, ** Search for more papers by this author , James A. de LemosJames A. de Lemos *, †, ‡, §, ║, , #, ** Search for more papers by this author , Steven M. EttingerSteven M. Ettinger *, †, ‡, §, ║, , #, ** Search for more papers by this author , James C. FangJames C. Fang *, †, ‡, §, ║, , #, ** Search for more papers by this author , Francis M. FesmireFrancis M. Fesmire *, †, ‡, §, ║, , #, ** Search for more papers by this author , Barry A. FranklinBarry A. Franklin *, †, ‡, §, ║, , #, ** Search for more papers by this author , Christopher B. GrangerChristopher B. Granger *, †, ‡, §, ║, , #, ** Search for more papers by this author , Harlan M. KrumholzHarlan M. Krumholz *, †, ‡, §, ║, , #, ** Search for more papers by this author , Jane A. LinderbaumJane A. Linderbaum *, †, ‡, §, ║, , #, ** Search for more papers by this author , David A. MorrowDavid A. Morrow *, †, ‡, §, ║, , #, ** Search for more papers by this author , L. Kristin NewbyL. Kristin Newby *, †, ‡, §, ║, , #, ** Search for more papers by this author , Joseph P. OrnatoJoseph P. Ornato *, †, ‡, §, ║, , #, ** Search for more papers by this author , Narith OuNarith Ou *, †, ‡, §, ║, , #, ** Search for more papers by this author , Martha J. RadfordMartha J. Radford *, †, ‡, §, ║, , #, ** Search for more papers by this author , Jacqueline E. Tamis-HollandJacqueline E. Tamis-Holland *, †, ‡, §, ║, , #, ** Search for more papers by this author , Jacqueline E. TommasoJacqueline E. Tommaso *, †, ‡, §, ║, , #, ** Search for more papers by this author , Cynthia M. TracyCynthia M. Tracy *, †, ‡, §, ║, , #, ** Search for more papers by this author , Y. Joseph WooY. Joseph Woo *, †, ‡, §, ║, , #, ** Search for more papers by this author and David X. ZhaoDavid X. Zhao *, †, ‡, §, ║, , #, ** Search for more papers by this author Originally published17 Dec 2012https://doi.org/10.1161/CIR.0b013e3182742c84Circulation. 2013;127:529–555Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2012: Previous Version 1 Table of ContentsPreamble5301. Introduction5331.1. Methodology and Evidence Review5331.2. Organization of the Writing Committee5331.3. Document Review and Approval5332. Onset of Myocardial Infarction: Recommendations5332.1. Regional Systems of STEMI Care, Reperfusion Therapy, and Time-to-Treatment Goals5332.2. Evaluation and Management of Patients With STEMI and Out-of-Hospital Cardiac Arrest5343. Reperfusion at a PCI-Capable Hospital: Recommendations5343.1. Primary PCI in STEMI5343.2. Aspiration Thrombectomy5353.3. Use of Stents in Patients With STEMI5353.4. Antiplatelet Therapy to Support Primary PCI for STEMI5353.5. Anticoagulant Therapy to Support Primary PCI5354. Reperfusion at a Non–PCI-Capable Hospital: Recommendations5374.1. Fibrinolytic Therapy When There Is an Anticipated Delay to Performing Primary PCI Within 120 Minutes of FMC5374.2. Adjunctive Antithrombotic Therapy With Fibrinolysis5374.2.1. Adjunctive Antiplatelet Therapy With Fibrinolysis5374.2.2. Adjunctive Anticoagulant Therapy With Fibrinolysis5374.3. Transfer to a PCI-Capable Hospital After Fibrinolytic Therapy5374.3.1. Transfer of Patients With STEMI to a PCI-Capable Hospital for Coronary Angiography After Fibrinolytic Therapy5375. Delayed Invasive Management: Recommendations5385.1. Coronary Angiography in Patients Who Initially Were Managed With Fibrinolytic Therapy or Who Did Not Receive Reperfusion5385.2. PCI of an Infarct Artery in Patients Who Initially Were Managed With Fibrinolysis or Who Did Not Receive Reperfusion Therapy5395.3. PCI of a Noninfarct Artery Before Hospital Discharge5405.4. Adjunctive Antithrombotic Therapy to Support Delayed PCI After Fibrinolytic Therapy5405.4.1. Antiplatelet Therapy to Support PCI After Fibrinolytic Therapy5405.4.2. Anticoagulant Therapy to Support PCI After Fibrinolytic Therapy5406. Coronary Artery Bypass Graft Surgery: Recommendations5406.1. CABG in Patients With STEMI5406.2. Timing of Urgent CABG in Patients With STEMI in Relation to Use of Antiplatelet Agents5417. Routine Medical Therapies: Recommendations5427.1. Beta Blockers5427.2. Renin-Angiotensin-Aldosterone System Inhibitors5427.3. Lipid Management5428. Complications After STEMI: Recommendations5428.1. Treatment of Cardiogenic Shock5428.2. Implantable Cardioverter-Defibrillator Therapy Before Discharge5428.3. Pacing in STEMI5428.4. Management of Pericarditis After STEMI5438.5. Anticoagulation5439. Risk Assessment After STEMI: Recommendations5439.1. Use of Noninvasive Testing for Ischemia Before Discharge5439.2. Assessment of LV Function5439.3. Assessment of Risk for Sudden Cardiac Death54310. Posthospitalization Plan of Care: Recommendations543References544Appendix 1. Author Relationships With Industry and Other Entities (Relevant)551Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant)554PreambleThe medical profession should play a central role in evaluating the evidence related to drugs, devices, and procedures for the detection, management, and prevention of disease. When properly applied, expert analysis of available data on the benefits and risks of these therapies and procedures can improve the quality of care, optimize patient outcomes, and favorably affect costs by focusing resources on the most effective strategies. An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist physicians in selecting the best management strategy for an individual patient. Moreover, clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools.The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly produced guidelines in the area of cardiovascular disease since 1980. The ACCF/AHA Task Force on Practice Guidelines (Task Force), charged with developing, updating, and revising practice guidelines for cardiovascular diseases and procedures, directs and oversees this effort. Writing committees are charged with regularly reviewing and evaluating all available evidence to develop balanced, patient-centric recommendations for clinical practice.Experts in the subject under consideration are selected by the ACCF and AHA to examine subject-specific data and write guidelines in partnership with representatives from other medical organizations and specialty groups. Writing committees are asked to perform a literature review; weigh the strength of evidence for or against particular tests, treatments, or procedures; and include estimates of expected outcomes where such data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of tests or therapies are considered. When available, information from studies on cost is considered, but data on efficacy and outcomes constitute the primary basis for the recommendations contained herein.In analyzing the data and developing recommendations and supporting text, the writing committee uses evidence-based methodologies developed by the Task Force.1 The Class of Recommendation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective or in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing committee reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinician members of the writing committee is the basis for LOE C recommendations and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR.Table 1. Applying Classification of Recommendation and Level of EvidenceTable 1. Applying Classification of Recommendation and Level of EvidenceAppendix 1. Author Relationships With Industry and Other Entities (Relevant)—2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial InfarctionCommittee MemberEmploymentConsultantSpeaker’s BureauOwnership/ Partnership/ PrincipalPersonal ResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessVoting Recusals by Section*Patrick T. O’Gara, ChairHarvard Medical School—Professor of MedicineNoneNoneNoneNoneNoneNoneNoneFrederick G. Kushner, Vice ChairTulane University School of Medicine—Clinical Professor of Medicine; Heart Clinic of Louisiana—Medical DirectorNoneNoneNoneNone• Novartis†None8.18.2Deborah D. AscheimMount Sinai School of Medicine— Associate Professor; InCHOIR—Clinical Director of ResearchNoneNoneNoneNoneNoneNoneNoneDonald E. Casey, JrAtlantic Health— Chief Medical Officer and Vice President of QualityNoneNoneNoneNoneNoneNoneNoneMina K. ChungCleveland Clinic Foundation—Associate Professor of Medicine• Biotronik†;• Boston Scientific†• Nexcura †• PGx†• Sanofi-aventis†• St. Jude Medical†NoneNone• Biotronik†• Boston Scientific†• GlaxoSmithKline†• Medtronic†• Siemens Medical Solutions†• St. Jude Medical†• ZOLL†• Medtronic†;• Boston Scientific†• St. Jude Medical†None4.4.15.1.47.29.5.2James A. de LemosUT Southwestern Medical School—Professor of Medicine• Johnson & Johnson• Tethys• AstraZeneca• Daiichi-Sankyo• BMS/ Sanofi-aventisNone• Bristol-Myers Squibb (DSMB)• Roche• Merck/Schering-Plough• Daiichi-SankyoNoneNone4.4.14.4.25.1.4.15.1.4.26.4.16.4.27.29.6Steven M. EttingerPenn State Heart & Vascular Institute—Professor of Medicine and RadiologyNoneNoneNone• Medtronic§NoneNone4.3.1James C. FangUniversity Hospitals Case Medical Center—Director, Heart Transplantation• Accorda• Novartis• ThoratecNoneNoneNone• MedtronicNone9.5.4.1Francis M. FesmireHeart Stroke Center—Director• AbbottNoneNoneNoneNone• Plaintiff, Missed ACS, 20108.3Barry A. FranklinWilliam Beaumont Hospital—Director, Cardiac Rehabilitation and Exercise LaboratoriesNoneNoneNoneNoneNoneNoneNoneChristopher B. GrangerDuke Clinical Research Institute—Director, Cardiac Care Unit; Assistant Professor of Medicine• AstraZeneca• Boehringer Ingelheim‡• Bristol-Myers Squibb• GlaxoSmithKline• Hoffman La Roche• Novartis• Sanofi-aventis‡• The Medicines CompanyNoneNone• Astellas• AstraZeneca• Boehringer Ingelheim‡• Bristol-Myers Squibb• Eli Lilly• GlaxoSmithKline• Medtronic• Merck• Sanofi-aventis‡• The Medicines CompanyNoneNone4.4.16.4.29.7.1Harlan M. KrumholzYale University School of Medicine— Professor of Medicine• United HealthCare (Science Advisory Group)NoneNoneNoneNoneNoneNoneJane A. LinderbaumMayo Clinic—Assistant Professor of MedicineNoneNoneNoneNoneNoneNoneNoneDavid A. MorrowHarvard Medical School—Associate Professor of Medicine• Beckman-Coulter• Boehringer Ingelheim• Daiichi-Sankyo• Eli Lilly• Genentech• Merck• Novartis• OrthoClinical Diagnostics/Johnson & Johnson• Roche Diagnostics• Sanofi-aventis• Schering-Plough Research Institute• Siemens Medical SolutionsNoneNone• AstraZeneca‡• Beckman-Coulter‡• Daiichi-Sankyo‡• Eli Lilly‡• GlaxoSmithKline‡• Merck‡• Nanosphere‡• Novartis‡• Roche Diagnostics‡• Sanofi-aventis‡• Schering-Plough Research Institute‡• Siemens Medical Solutions‡• Singulex‡• AstraZeneca‡None3.24.4.14.4.25.15.1.4.16.4.16.4.27.28.28.39.6L. Kristin NewbyDuke University Medical Center, Division of Cardiology— Professor of Medicine• Amgen‡• AstraZeneca• BioVascular• Johnson & Johnson• NovartisNoneNone• BG Medicine• Bristol-Myers Squibb• diaDexus‡• Eli Lilly• GlaxoSmithKline‡• Johnson & Johnson• Merck‡• Regado• Schering-Plough‡NoneNone4.4.17.2Joseph P. OrnatoDepartment of Emergency MedicineVirginia Commonwealth University— Professor and Chairman• European Resuscitation Council‡• ZOLL CirculationNoneNone• NIH/NINDS Neurological Emergency Treatment Trials Consortium—‡NoneNoneNoneNarith OuMayo Clinic—Pharmacotherapy Coordinator, CardiologyNoneNoneNoneNoneNoneNoneNoneMartha J. RadfordNYU Langone Medical Center—Chief Quality Officer; NYU School of Medicine— Professor of Medicine (Cardiology)NoneNoneNoneNoneNoneNoneNoneJacqueline E. Tamis-HollandSt Luke’s-Roosevelt Hospital Center—Director, Interventional Cardiology Fellowship Program; Columbia University, College of Physicians and Surgeons— Assistant Professor of Clinical MedicineNoneNoneNoneNoneNoneNoneNoneCarl L. TommasoSkokie Hospital—Director of Catheterization Laboratory; North Shore University Health SystemsNoneNoneNoneNoneNoneNoneNoneCynthia M. TracyGeorge Washington University Medical Center—Associate Director, Division of CardiologyNoneNoneNoneNoneNoneNoneNoneY. Joseph WooHospital of the University of Pennsylvania— Associate Professor of SurgeryNoneNoneNoneNoneNoneNoneNoneDavid X. ZhaoVanderbilt University Medical Center—Director, Cardiac Catheterization and Interventional CardiologyNoneNoneNone• Abbot Vascular• Accumetrics• AGA Medical• Osiris• VolcanoNoneNone4.3.1This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted.According to the ACCF/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.*Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities could apply. Section numbers apply to the full-text guideline.†No financial benefit.‡Significant relationship.§Dr. Ettinger’s relationship with Medtronic was added just before balloting of the recommendations, so it was not relevant during the writing stage; however, the addition of this relationship makes the writing committee out of compliance with the minimum 50% no relevant RWI requirement.ACS indicates acute coronary syndromes; DSMB, data safety monitoring board; NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health; and PI, principal investigator.A new addition to this methodology is separation of the Class III recommendations to delineate whether the recommendation is determined to be of “no benefit” or is associated with “harm” to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another are included for COR I and IIa, LOE A or B only.In view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline-recommended therapies (primarily Class I). This new term, GDMT, will be used throughout subsequent guidelines.Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing committee reviews the potential influence of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation.The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise for which deviations from these guidelines may be appropriate. Clinical decision making should involve consideration of the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas are identified within each respective guideline when appropriate.Prescribed courses of treatment in accordance with these recommendations are effective only if followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient’s active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and should be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower.The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of relationships with industry and other entities (RWI) among the members of the writing committee. All writing committee members and peer reviewers of the guideline are required to disclose all current healthcare related relationships, including those existing 12 months before initiation of the writing effort. In December 2009, the ACCF and AHA implemented a new RWI policy that requires the writing committee chair plus a minimum of 50% of the writing committee to have no relevant RWI. (Appendix 1 includes the ACCF/AHA definition of relevance.) These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing committee, and members provide updates as changes occur. All guideline recommendations require a confidential vote by the writing committee and must be approved by a consensus of the voting members. Members may not draft or vote on any text or recommendations pertaining to their RWI. Members who recused themselves from voting are indicated in the list of writing committee members, and specific section recusals are noted in Appendix 1. Authors’ and peer reviewers’ RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. In addition, to ensure complete transparency, writing committee members’ comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at http://www.cardiosource.org/ACC/About-ACC/Who-We-Are/Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of writing committees is supported exclusively by the ACCF and AHA without commercial support. Writing committee members volunteered their time for this activity.In an effort to maintain relevance at the point of care for practicing physicians, the Task Force continues to oversee an ongoing process improvement initiative. As a result, in response to pilot projects, several changes to these guidelines will be apparent, including limited narrative text, a focus on summary and evidence tables (with references linked to abstracts in PubMed), and more liberal use of summary recommendation tables (with references that support LOE) to serve as a quick reference.In April 2011, the Institute of Medicine released 2 reports: Finding What Works in Health Care: Standards for Systematic Reviews and Clinical Practice Guidelines We Can Trust.2,3 It is noteworthy that the IOM cited ACCF/AHA practice guidelines as being compliant with many of the proposed standards. A thorough review of these reports and of our current methodology is under way, with further enhancements anticipated.The recommendations in this guideline are considered current until they are superseded by a focused update or the full-text guideline is revised. The reader is encouraged to consult the full-text guideline4 for additional guidance and details about the care of the patient with ST-elevation myocardial infarction (STEMI), because the Executive Summary contains only the recommendations. Guidelines are official policy of both the ACCF and AHA.Jeffrey L. Anderson, MD, FACC, FAHAChair, ACCF/AHA Task Force on Practice Guidelines1. Introduction1.1. Methodology and Evidence ReviewThe recommendations listed in this document are, whenever possible, evidence based. The current document constitutes a full revision and includes an extensive evidence review which was conducted through November 2010, with additional selected references added through August 2012. Searches were limited to studies conducted in human subjects and reviews and other evidence pertaining to human subjects; all were published in English. Key search words included but were not limited to: acute coronary syndromes, percutaneous coronary intervention, coronary artery bypass graft, myocardial infarction, ST-elevation myocardial infarction, coronary stent, revascularization, anticoagulant therapy, antiplatelet therapy, antithrombotic therapy, glycoprotein IIb/IIIa inhibitor therapy, pharmacotherapy, proton-pump inhibitor, implantable cardioverter-defibrillator therapy, cardiogenic shock, fibrinolytic therapy, thrombolytic therapy, nitrates, mechanical complications, arrhythmia, angina, chronic stable angina, diabetes, chronic kidney disease, mortality, morbidity, elderly, ethics, and contrast nephropathy. Additional searches cross-referenced these topics with the following subtopics: percutaneous coronary intervention, coronary artery bypass graft, cardiac rehabilitation, and secondary prevention. Additionally, the committee reviewed documents related to the subject matter previously published by the ACCF and AHA. References selected and published in this document are representative and not all inclusive.The focus of this guideline is the management of patients with STEMI. Updates to the 2004 STEMI guideline were published in 2007 and 2009.5–7 Particular emphasis is placed on advances in reperfusion therapy, organization of regional systems of care, transfer algorithms, evidence-based antithrombotic and medical therapies, and secondary prevention strategies to optimize patient-centered care. By design, the document is narrower in scope than the 2004 STEMI Guideline, in an attempt to provide a more focused tool for practitioners. References related to management guidelines are provided whenever appropriate, including those pertaining to percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), heart failure (HF), cardiac devices, and secondary prevention.1.2. Organization of the Writing CommitteeThe writing committee was composed of experts representing cardiovascular medicine, interventional cardiology, electrophysiology, HF, cardiac surgery, emergency medicine, internal medicine, cardiac rehabilitation, nursing, and pharmacy. The American College of Physicians, American College of Emergency Physicians, and Society for Cardiovascular Angiography and Interventions assigned official representatives.1.3. Document Review and ApprovalThis document was reviewed by 2 outside reviewers each nominated by the ACCF and the AHA, as well as 2 reviewers each from the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions and 22 individual content reviewers (including members from the ACCF Interventional Scientific Council and ACCF Surgeons’ Scientific Council). All reviewer RWI information was distributed to the writing committee and is published in this document (Appendix 2).Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant)—2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial InfarctionReviewerRepresentationConsultantSpeaker’s BureauOwnership/ Partnership/ PrincipalPersonal ResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessElliott M. AntmanOfficial Reviewer—ACCF Board of TrusteesNoneNoneNone• Accumetrics• AstraZeneca• Beckman Coulter• Bristol-Myers Squibb Pharmaceutical Research Institute• Daiichi-Sankyo*• Eli Lilly*• GlaxoSmithKline• Merck• Millennium Pharmaceuticals• Novartis Pharmaceuticals• Ortho-Clinical Diagnostics• Sanofi-Synthelabo Recherche• Schering-Plough Research InstituteNoneNoneGary J. BaladyOfficial Reviewer—AHANoneNoneNoneNoneNoneNoneChristopher P. CannonOfficial Reviewer—AHA• Novartis†NoneNone• Accumetrics*• AstraZeneca*• Bristol-Myers Squibb†• GlaxoSmithKline• Merck*• GlaxoSmithKline• Merck (DSMB)NoneJudith S. HochmanOfficial Reviewer—ACCF/AHA Task Force on Practice Guidelines• BMS/Sanofi• Eli Lilly• GlaxoSmithKlineNoneNoneNone• Johnson & Johnson Pharmaceutical Research & Development (DSMB)• Merck/Schering Plough (DSMB)NoneAustin H. KutscherOfficial Reviewer—ACCF Board of GovernorsNoneNoneNoneNoneNoneNoneCharles J. DavidsonOrganizational Reviewer—SCAI• Abbott*• Abbott VascularNoneNone• Edwards Lifesciences*NoneNoneDeborah B. DiercksOrganizational Reviewer—ACEP• Abbott Cardiovascular• Daiichi-SankyoNoneNone• Beckman Coulter†• Nanosphere†NoneNoneJonathan M. TobisOrganizational Reviewer—SCAINone• AGA Medical• Boston ScientificNone• AGA Medical*NoneNoneJeffrey L. AndersonContent Reviewer— ACCF/AHA Task Force on Practice GuidelinesNoneNoneNone• Toshiba†• AstraZeneca (DSMB)Defendant, Postoperative Ablation Case, 2010James C. BlankenshipContent ReviewerNoneNoneNone• AstraZeneca†• Boston Scientific†• Novartis†• Schering-Plough†NoneNoneJeffrey J. CavendishContent Reviewer—ACCF Prevention of Cardiovascular Disease CommitteeNoneNoneNoneNoneNoneNoneHarold L. DauermanContent ReviewerNoneNoneNoneNoneNoneNoneJohn S. Douglas, Jr.Content ReviewerNoneNoneNone• Abbott†• Medtronic†• The Medicines Company†NoneNoneStephen G. EllisContent Reviewer• Abbott Vascular• Boston Scientific†NoneNoneNoneNoneNoneJoseph FrediContent Reviewer—ACCF Surgeons’ Scientific Council• AGA Medical†NoneNon
HomeCirculationVol. 127, No. 232012 ACCF/AHA Focused Update Incorporated Into the ACCF/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplementary MaterialsFree AccessResearch ArticlePDF/EPUB2012 ACCF/AHA Focused Update Incorporated Into the ACCF/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial InfarctionA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 2007 WRITING COMMITTEE MEMBERS Jeffrey L. Anderson, MD, FACC, FAHA, Cynthia D. Adams, RN, PhD, FAHA, Elliott M. Antman, MD, FACC, FAHA, Charles R. Bridges, MD, ScD, FACC, FAHA, Robert M. Califf, MD, MACC, Donald E. CaseyJr, MD, MPH, MBA, FACP, William E. ChaveyII, MD, MS, Francis M. Fesmire, MD, FACEP, Judith S. Hochman, MD, FACC, FAHA, Thomas N. Levin, MD, FACC, FSCAI, A. Michael Lincoff, MD, FACC, Eric D. Peterson, MD, MPH, FACC, FAHA, Pierre Theroux, MD, FACC, FAHA, Nanette K. Wenger, MD, MACC, FAHA and R. Scott Wright, MD, FACC, FAHA Presidents and Staff American College of Cardiology Foundation William A. Zoghbi, MD, FACC, Thomas E. ArendJr, Esq, CAE, William J. Oetgen, MD, MBA, FACC, Charlene May, American College of Cardiology Foundation/American Heart Association Lisa Bradfield, CAE, Sue Keller, BSN, MPH, Ezaldeen RamadhanIII, American Heart Association Gordon F. Tomaselli, MD, FAHA, Nancy Brown, Rose Marie Robertson, MD, FAHA, Gayle R. Whitman, PhD, RN, FAHA, FAAN, Judy L. Bezanson, DSN, RN, CNS-MS, FAHA and Jody Hundley 2007 WRITING COMMITTEE MEMBERS , Jeffrey L. AndersonJeffrey L. Anderson , Cynthia D. AdamsCynthia D. Adams , Elliott M. AntmanElliott M. Antman , Charles R. BridgesCharles R. Bridges , Robert M. CaliffRobert M. Califf , Donald E. CaseyJrDonald E. CaseyJr , William E. ChaveyIIWilliam E. ChaveyII , Francis M. FesmireFrancis M. Fesmire , Judith S. HochmanJudith S. Hochman , Thomas N. LevinThomas N. Levin , A. Michael LincoffA. Michael Lincoff , Eric D. PetersonEric D. Peterson , Pierre TherouxPierre Theroux , Nanette K. WengerNanette K. Wenger and R. Scott WrightR. Scott Wright Presidents and Staff , American College of Cardiology Foundation , William A. ZoghbiWilliam A. Zoghbi , Thomas E. ArendJrThomas E. ArendJr , William J. OetgenWilliam J. Oetgen , Charlene MayCharlene May , American College of Cardiology Foundation/American Heart Association , Lisa BradfieldLisa Bradfield , Sue KellerSue Keller , Ezaldeen RamadhanIIIEzaldeen RamadhanIII , American Heart Association , Gordon F. TomaselliGordon F. Tomaselli , Nancy BrownNancy Brown , Rose Marie RobertsonRose Marie Robertson , Gayle R. WhitmanGayle R. Whitman , Judy L. BezansonJudy L. Bezanson and Jody HundleyJody Hundley Originally published29 Apr 2013https://doi.org/10.1161/CIR.0b013e31828478acCirculation. 2013;127:e663–e828is corrected byCorrectionOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2013: Previous Version 1 Table of ContentsPreamble (UPDATED) e6661. Introduction (UPDATED) e6691.1. Organization of Committee and Evidence Review (UPDATED) e6691.2. Document Review and Approval (UPDATED) e6691.3. Purpose of These Guidelines e6691.4. Overview of the Acute Coronary Syndromes e6701.4.1. Definition of Terms e6701.4.2. Pathogenesis of UA/NSTEMI e6721.4.3. Presentations of UA and NSTEMI e6731.5. Management Before UA/NSTEMI and Onset of UA/NSTEMI e6731.5.1. Identification of Patients at Risk of UA/NSTEMI e6731.5.2. Interventions to Reduce Risk of UA/NSTEMI e6741.6. Onset of UA/NSTEMI e6751.6.1. Recognition of Symptoms by Patient e6751.6.2. Silent and Unrecognized Events e6752. Initial Evaluation and Management e6752.1. Clinical Assessment e6752.1.1. Emergency Department or Outpatient Facility Presentation e6792.1.2. Questions to Be Addressed at the Initial Evaluation e6812.2. Early Risk Stratification e6812.2.1. Estimation of the Level of Risk e6822.2.2. Rationale for Risk Stratification e6822.2.3. History e6822.2.4. Anginal Symptoms and Anginal Equivalents e6822.2.5. Demographics and History in Diagnosis and Risk Stratification e6832.2.6. Estimation of Early Risk at Presentation e6842.2.6.1. Electrocardiogram e6862.2.6.2. Physical Examination e6872.2.7. Noncardiac Causes of Symptoms and Secondary Causes of Myocardial Ischemia e6872.2.8. Cardiac Biomarkers of Necrosis and the Redefinition of AMI e6882.2.8.1. Creatine Kinase-MB e6882.2.8.2. Cardiac Troponins e6892.2.8.2.1. Clinical Use e6892.2.8.2.1.1. Clinical Use of Marker Change Scores e6912.2.8.2.1.2. Bedside Testing for Cardiac Markers e6912.2.8.3. Myoglobin and CK-MB Subforms Compared With Troponins e6912.2.8.4. Summary Comparison of Biomarkers of Necrosis: Singly and in Combination e6922.2.9. Other Markers and Multimarker Approaches e6922.2.9.1. Ischemia e6932.2.9.2. Coagulation e6932.2.9.3. Platelets e6932.2.9.4. Inflammation e6932.2.9.5. B-Type Natriuretic Peptides e6932.3. Immediate Management e6932.3.1. Chest Pain Units e6942.3.2. Discharge From ED or Chest Pain Unit e6953. Early Hospital Care e6963.1. Anti-Ischemic and Analgesic Therapy e6973.1.1. General Care e6993.1.2. Use of Anti-Ischemic Therapies e6993.1.2.1. Nitrates e6993.1.2.2. Morphine Sulfate e7013.1.2.3. Beta-Adrenergic Blockers e7013.1.2.4. Calcium Channel Blockers e7033.1.2.5. Inhibitors of the Renin-Angiotensin-Aldosterone System e7043.1.2.6. Other Anti-Ischemic Therapies e7043.1.2.7. Intra-Aortic Balloon Pump Counterpulsation e7053.1.2.8. Analgesic Therapy e7053.2. Recommendations for Antiplatelet/Anticoagulant Therapy in Patients for Whom Diagnosis of UA/NSTEMI Is Likely or Definite (UPDATED) e7053.2.1. Antiplatelet Therapy: Recommendations (UPDATED) e7053.2.2. Anticoagulant Therapy: Recommendations e7073.2.3. Additional Management Considerations for Antiplatelet and Anticoagulant Therapy: Recommendations (UPDATED) e7073.2.3.1. Antiplatelet/Anticoagulant Therapy in Patients for Whom Diagnosis of UA/NSTEMI Is Likely or Definite (NEW SECTION) e7093.2.3.1.1. Newer P2Y12 Receptor Inhibitors e7093.2.3.1.2. Choice of P2Y12 Receptor Inhibitors for PCI in UA/NSTEMI e7113.2.3.1.2.1. Timing of Discontinuation of P2Y12 Receptor Inhibitor Therapy for Surgical Procedures e7113.2.3.1.3. Interindividual Variability in Responsiveness to Clopidogrel e7123.2.3.1.4. Optimal Loading and Maintenance Dosages of Clopidogrel e7133.2.3.1.5. Proton Pump Inhibitors and Dual Antiplatelet Therapy for ACS e7133.2.3.1.6. Glycoprotein IIb/IIIa Receptor Antagonists (Updated to Incorporate Newer Trials and Evidence) e7143.2.4. Older Antiplatelet Agents and Trials (Aspirin, Ticlopidine, Clopidogrel) e7153.2.4.1. Aspirin e7153.2.4.2. Adenosine Diphosphate Receptor Antagonists and Other Antiplatelet Agents e7173.2.5. Anticoagulant Agents and Trials e7203.2.5.1. Unfractionated Heparin e7213.2.5.2. Low-Molecular-Weight Heparin e7223.2.5.3. LMWH Versus UFH e7223.2.5.3.1. Extended Therapy with LMWHs e7253.2.5.4. Direct Thrombin Inhibitors e7263.2.5.5. Factor Xa Inhibitors e7283.2.5.6. Long-Term Anticoagulation e7293.2.6. Platelet GP IIb/IIIa Receptor Antagonists e7303.2.7. Fibrinolysis e7353.3. Initial Conservative Versus Initial Invasive Strategies (UPDATED) e7353.3.1. General Principles e7353.3.2. Rationale for the Initial Conservative Strategy e7363.3.3. Rationale for the Invasive Strategy e7363.3.3.1. Timing of Invasive Therapy (NEW SECTION) e7363.3.4. Immediate Angiography e7373.3.5. Deferred Angiography e7383.3.6. Comparison of Early Invasive and Initial Conservative Strategies e7383.3.7. Subgroups e7413.3.8. Care Objectives e7413.4. Risk Stratification Before Discharge e7433.4.1. Care Objectives e7443.4.2. Noninvasive Test Selection e7443.4.3. Selection for Coronary Angiography e7463.4.4. Patient Counseling e7464. Coronary Revascularization e7464.1. Recommendations for Revascularization With PCI and CABG in Patients With UA/NSTEMI (UPDATED) e7465. Late Hospital Care, Hospital Discharge, and Post-Hospital Discharge Care e7465.1. Medical Regimen and Use of Medications e7465.2. Long-Term Medical Therapy and Secondary Prevention e7485.2.1. Convalescent and Long-Term Antiplatelet Therapy (UPDATED) e7495.2.2. Beta Blockers e7495.2.3. Inhibition of the Renin-Angiotensin-Aldosterone System e7505.2.4. Nitroglycerin e7505.2.5. Calcium Channel Blockers e7505.2.6. Warfarin Therapy (UPDATED) e7505.2.7. Lipid Management e7515.2.8. Blood Pressure Control e7535.2.9. Diabetes Mellitus e7535.2.10. Smoking Cessation e7535.2.11. Weight Management e7545.2.12. Physical Activity e7545.2.13. Patient Education e7555.2.14. Influenza e7555.2.15. Depression e7555.2.16. Nonsteroidal Anti-Inflammatory Drugs e7555.2.17. Hormone Therapy e7555.2.18. Antioxidant Vitamins and Folic Acid e7565.3. Postdischarge Follow-Up e7565.4. Cardiac Rehabilitation e7575.5. Return to Work and Disability e7585.6. Other Activities e7595.7. Patient Records and Other Information Systems e7596. Special Groups e7606.1. Women e7606.1.1. Profile of UA/NSTEMI in Women e7616.1.2. Management e7616.1.2.1. Pharmacological Therapy e7616.1.2.2. Coronary Artery Revascularization e7616.1.2.3. Initial Invasive Versus Initial Conservative Strategy e7626.1.3. Stress Testing e7646.1.4. Conclusions e7646.2. Diabetes Mellitus (UPDATED) e7646.2.1. Profile and Initial Management of Diabetic and Hyperglycemic Patients With UA/NSTEMI e7646.2.1.1. Intensive Glucose Control (NEW SECTION) e7656.2.2. Coronary Revascularization e7666.2.3. Conclusions e7676.3. Post-CABG Patients e7676.3.1. Pathological Findings e7676.3.2. Clinical Findings and Approach e7686.3.3. Conclusions e7686.4. Older Adults e7686.4.1. Pharmacological Management e7696.4.2. Functional Studies e7696.4.3. Percutaneous Coronary Intervention in Older Patients e7696.4.4. Contemporary Revascularization Strategies in Older Patients e7706.4.5. Conclusions e7706.5. Chronic Kidney Disease (UPDATED) e7706.5.1. Angiography in Patients With CKD (NEW SECTION) e7716.6. Cocaine and Methamphetamine Users e7736.6.1. Coronary Artery Spasm With Cocaine Use e7736.6.2. Treatment e7736.6.3. Methamphetamine Use and UA/NSTEMI e7736.7. Variant (Prinzmetal's) Angina e7756.7.1. Clinical Picture e7756.7.2. Pathogenesis e7756.7.3. Diagnosis e7756.7.4. Treatment e7766.7.5. Prognosis e7766.8. Cardiovascular "Syndrome X" e7766.8.1. Definition and Clinical Picture e7776.8.2. Treatment e7786.9. Takotsubo Cardiomyopathy e7787. Conclusions and Future Directions e7787.1. Recommendations for Quality of Care and Outcomes for UA/NSTEMI (NEW SECTION) e7797.1.1. Quality Care and Outcomes (NEW SECTION) e780References e780Appendix 1. Author Relationships With Industry and Other Entities e806Appendix 2. Reviewer Relationships With Industry and Other Entities e811Appendix 3. Abbreviation List e816Appendix 4. 2012 Author Relationships With Industry and Other Entities (NEW) e819Appendix 5. 2012 Reviewer Relationships With Industry and Other Entities (NEW) e821Appendix 6. Selection of Initial Treatment Strategy: Invasive Versus Conservative Strategy (NEW) e824Appendix 7. Dosing Table for Antiplatelet and Anticoagulant Therapy to Support PCI in UA/NSTEMI (NEW) e825Appendix 8. Comparisons Among Orally Effective P2Y12 Inhibitors (NEW) e827Appendix 9. Flowchart for Class I and Class IIa Recommendations for Initial Management of UA/NSTEMI (NEW) e828Preamble (UPDATED)It is important that the medical profession play a significant role in critically evaluating the use of diagnostic procedures and therapies as they are introduced and tested in the detection, management, or prevention of disease states. Rigorous and expert analysis of the available data documenting absolute and relative benefits and risks of those procedures and therapies can produce helpful guidelines that improve the effectiveness of care, optimize patient outcomes, and favorably affect the overall cost of care by focusing resources on the most effective strategies.The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly engaged in the production of such guidelines in the area of cardiovascular disease since 1980. The ACCF/AHA Task Force on Practice Guidelines (Task Force), whose charge is to develop, update, or revise practice guidelines for important cardiovascular diseases and procedures, directs this effort. Writing committees are charged with the task of performing an assessment of the evidence and acting as an independent group of authors to develop, update, or revise written recommendations for clinical practice.Experts in the subject under consideration have been selected from both organizations to examine subject-specific data and write guidelines. The process includes additional representatives from other medical practitioner and specialty groups when appropriate. Writing committees are specifically charged to perform a literature review, weigh the strength of evidence for or against a particular treatment or procedure, and include estimates of expected health outcomes where data exist. Patient-specific modifiers and comorbidities and issues of patient preference that may influence the choice of particular tests or therapies are considered, as well as frequency of follow-up and cost-effectiveness. When available, information from studies on cost will be considered; however, review of data on efficacy and clinical outcomes will constitute the primary basis for preparing recommendations in these guidelines.The guidelines will be reviewed annually by the Task Force and will be considered current unless they are updated, revised, or sunsetted and withdrawn from distribution. Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the Task Force has created a "focused update" process to revise the existing guideline recommendations that are affected by evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care.For the 2012 focused update, the standing guideline writing committee along with the parent Task Force identified trials and other key data through October 2011 that may impact guideline recommendations, specifically in response to the approval of new oral antiplatelets, and to provide guidance on how to incorporate these agents into daily practice (Section 1.1, "Methodology and Evidence"). Now that multiple agents are available, a comparison of their use in various settings within clinical practice is provided. This iteration replaces the sections in the 2007 ACC/AHA Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction that were updated by the 2011 ACCF/AHA Focused Update of the Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction.1,2 The focused update is not intended to be based on a complete literature review from the date of the previous guideline publication but rather to include pivotal new evidence that may affect changes to current recommendations. See the 2012 focused update for the complete preamble and evidence review period.3In analyzing the data and developing recommendations and supporting text, the writing group uses evidence-based methodologies developed by the Task Force.4 The Class of Recommendation (COR) is an estimate of the size of the treatment effect, with consideration given to risks versus benefits, as well as evidence and/or agreement that a given treatment or procedure is or is not useful/effective and in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing group reviews and ranks evidence supporting each recommendation, with the weight of evidence ranked as LOE A, B, or C, according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized, as appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing group is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology for the 2012 focused update is separation of the Class III recommendations to delineate whether the recommendation is determined to be of "no benefit" or is associated with "harm" to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another have been added for COR I and IIa, LOE A or B only.Table 1. Applying Classification of Recommendations and Level of EvidenceTable 1. Applying Classification of Recommendations and Level of EvidenceTable 2. Guidelines for the Identification of ACS Patients by ED Registration Clerks or Triage NursesRegistration/clerical staff Patients with the following chief complaints require immediate assessment by the triage nurse and should be referred for further evaluation: Chest pain, pressure, tightness, or heaviness; pain that radiates to neck, jaw, shoulders, back, or 1 or both armsIndigestion or "heartburn"; nausea and/or vomiting associated with chest discomfortPersistent shortness of breathWeakness, dizziness, lightheadedness, loss of consciousnessTriage nursePatients with the following symptoms and signs require immediate assessment by the triage nurse for the initiation of the ACS protocol: Chest pain or severe epigastric pain, nontraumatic in origin, with components typical of myocardial ischemia or MI: Central/substernal compression or crushing chest painPressure, tightness, heaviness, cramping, burning, aching sensationUnexplained indigestion, belching, epigastric painRadiating pain in neck, jaw, shoulders, back, or 1 or both armsAssociated dyspneaAssociated nausea and/or vomitingAssociated diaphoresisIf these symptoms are present, obtain stat ECG.Medical historyThe triage nurse should take a brief, targeted, initial history with an assessment of current or past history of: CABG, PCI, CAD, angina on effort, or MINTG use to relieve chest discomfortRisk factors, including smoking, hyperlipidemia, hypertension, diabetes mellitus, family history, and cocaine or methamphetamine useRegular and recent medication useThe brief history must not delay entry into the ACS protocol.Special considerationsWomen may present more frequently than men with atypical chest pain and symptoms.Diabetic patients may have atypical presentations due to autonomic dysfunction.Elderly patients may have atypical symptoms such as generalized weakness, stroke, syncope, or a change in mental status.Adapted from National Heart Attack Alert Program. Emergency Department: rapid identification and treatment of patients with acute myocardial infarction. Bethesda, MD: US Department of Health and Human Services. US Public Health Service. National Institutes of Health. National Heart, Lung and Blood Institute, September 1993. NIH Publication No. 93-3278.6ACS = acute coronary syndrome; CABG = coronary artery bypass graft surgery; CAD = coronary artery disease; ECG = electrocardiogram; ED = emergency department; MI = myocardial infarction; NTG = nitroglycerin; PCI = percutaneous coronary intervention.Table 3. Causes of UA/NSTEMI*Thrombus or thromboembolism, usually arising on disrupted or eroded plaque Occlusive thrombus, usually with collateral vessels†Subtotally occlusive thrombus on pre-existing plaqueDistal microvascular thromboembolism from plaque-associated thrombusThromboembolism from plaque erosion Non–plaque-associated coronary thromboembolismDynamic obstruction (coronary spasm‡ or vasoconstriction) of epicardial and/or microvascular vesselsProgressive mechanical obstruction to coronary flowCoronary arterial inflammationSecondary UACoronary artery dissection§*These causes are not mutually exclusive; some patients have 2 or more causes. †DeWood MA, Stifter WF, Simpson CS, et al. Coronary arteriographic findings soon after non–Q-wave myocardial infarction. N Engl J Med 1986;315:417–23.13‡May occur on top of an atherosclerotic plaque, producing missed-etiology angina or UA/NSTEMI. §Rare. Modified with permission from Braunwald E. Unstable angina: an etiologic approach to management. Circulation 1998;98:2219–22.12UA = unstable angina; UA/NSTEMI = unstable angina/non–ST-elevation myocardial infarction.Table 4. Three Principal Presentations of UAClassPresentationRest angina*Angina occurring at rest and prolonged, usuallygreater than 20 minNew-onset anginaNew-onset angina of at least CCS class III severityIncreasing anginaPreviously diagnosed angina that has becomedistinctly more frequent, longer in duration, or lower in threshold (ie, increased by 1 or more CCS class to at least CCS class III severity)*Patients with non–ST-elevated myocardial infarction usually present with angina at rest. Adapted with permission from Braunwald E. Unstable angina: a classification. Circulation 1989;80:410–4.14CCS = Canadian Cardiovascular Society classification; UA = unstable angina.Table 5. Grading of Angina Pectoris According to CCS ClassificationClassDescription of StageI"Ordinary physical activity does not cause… angina," such aswalking or climbing stairs. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation.II"Slight limitation of ordinary activity." Angina occurs on walking orclimbing stairs rapidly; walking uphill; walking or stair climbing after meals; in cold, in wind, or under emotional stress; or only during the few hours after awakening. Angina occurs on walking more than 2 blocks on the level and climbing more than 1 flight of ordinary stairs at a normal pace and under normal conditions.III"Marked limitations of ordinary physical activity." Angina occurson walking 1 to 2 blocks on the level and climbing 1 flight of stairs under normal conditions and at a normal pace.IV"Inability to carry on any physical activity without discomfort— anginal symptoms may be present at rest."Adapted with permission from Campeau L. Grading of angina pectoris (letter). Circulation 1976;54:522–3.15CCS = Canadian Cardiovascular Society.Table 6. Likelihood That Signs and Symptoms Represent an ACS Secondary to CADFeatureHigh Likelihood Any of the following:Intermediate Likelihood Absence of high-likelihood features andpresence of any of the following:Low Likelihood Absence of high- or intermediate-likelihood features but may have:HistoryChest or left arm pain or discomfort as chief symptom reproducing prior documented anginaKnown history of CAD, including MIChest or left arm pain or discomfort as chief symptom Age greater than 70 yearsMale sexDiabetes mellitusProbable ischemic symptoms in absenceof any of the intermediate likelihood characteristicsRecent cocaine useExaminationTransient MR murmur, hypotension,diaphoresis, pulmonary edema, or ralesExtracardiac vascular diseaseChest discomfort reproduced by palpationECGNew, or presumably new, transient ST-segmentdeviation (1 mm or greater) or T-wave inversion in multiple precordial leadsFixed wavesST depression 0.5 to 1 mm or T-wave inversiongreater than 1 mmT-wave flattening or inversion less than1 mm in leads with dominant wavesNormal ECGCardiac markersElevated cardiac TnI, TnT, or CK-MBNormalNormalModified with permission from Braunwald E, Mark DB, Jones RH, et al. Unstable angina: diagnosis and management. Rockville, MD: Agency for Health Care Policy and Research and the National Heart, Lung, and Blood Institute, U.S. Public Health Service, U.S. Department of Health and Human Service, 1994. AHCPR publication no. 94-0602.124ACS = acute coronary syndrome; CAD = coronary artery disease; CK-MB = MB fraction of creatine kinase; ECG = electrocardiogram; MI = myocardial infarction; MR = mitral regurgitation; TnI = troponin I; TnT = troponin T.In view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline (primarily Class I)–recommended therapies. This new term, GDMT, is incorporated into the 2012 focused update and will be used throughout all future guidelines.Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation.The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment about care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise in which deviations from these guidelines may be appropriate. Clinical decision making should consider the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate.Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and should be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower.The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing group. All writing group members and peer reviewers of the guideline are required to disclose all current healthcare–related relationships, including those existing 12 months before initiation of the writing effort.For the 2007 guidelines, all members of the writing committee, as well as peer reviewers of the document, were asked to provide disclosure statements of all such relationships that may be perceived as real or potential conflicts of interest. Writing committee members are also strongly encouraged to declare a previous relationship with industry that may be perceived as relevant to guideline development.In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing group chair plus a minimum of 50% of the writing group to have no relevant RWI (Appendix 4 includes the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing group and are updated as changes occur. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the voting members. Members are not permitted to draft or vote on any text or recommendations pertaining to their RWI. The 2012 members who recused themselves from voting are indicated in the list of writing group members, and specific section recusals are noted in Appendix 4. 2007 and 2012 authors' and peer reviewers' RWI pertinent to this guideline are disclosed in Appendixes 1, 2, 4, and 5, respectively. Additionally, to ensure complete transparency, writing group members' comprehensive disclosure informationincluding RWI not pertinent to this documentis available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at www.cardiosource.org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the 2012 writing group is supported exclusively by the ACCF, and AHA, without commercial support. Writing group members volunteered their time for this activity.In April 2011, the Institute of Medicine released 2 reports: Finding What Works in Health Care: Standards
HomeCirculationVol. 127, No. 92013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUB2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery DiseaseA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Acute Coronary Syndromes and Coronary Artery Disease Clinical Data Standards) Christopher P. Cannon, MD, FACC, Ralph G. Brindis, MD, MPH, FACC, Bernard R. Chaitman, MD, FACC, David J. Cohen, MD, MSC, J. Thomas CrossJr, MD, MPH, Joseph P. DrozdaJr, MD, FACC, Francis M. Fesmire, MD, FACEP, Dan J. Fintel, MD, FACC, Gregg C. Fonarow, MD, FACC, FAHA, Keith A. Fox, MB, ChB, Darryl T. Gray, MD, ScD, FAHA, Robert A. Harrington, MD, FACC, FAHA, Karen A. Hicks, MD, FACC, Judd E. Hollander, MD, FACEP, Harlan Krumholz, MD, SM, FACC, Darwin R. Labarthe, MD, MPH, PhD, Janet B. Long, MSN, ACNP, FAHA, Alice M. Mascette, MD, FACC, FAHA, FACP, Connie Meyer, MICT, AAS, Eric D. Peterson, MD, FACC, FAHA, Martha J. Radford, MD, FACC, FAHA, Matthew T. Roe, MD, MHS, FACC, James B. Richmann, RN, BS, MHA, CEN, Harry P. Selker, MD, MSPH, FAHA, David M. Shahian, MD, FACC, FAHA, Richard E. Shaw, MA, PhD, FACC, FAHA, Sharon Sprenger, RHIA, CPHQ, MPA, Robert Swor, DO, FACEP, James A. Underberg, MD, Frans Van de Werf, MD, FACC, Bonnie H. Weiner, MD, MSEC, MBA and William S. Weintraub, MD, FACC, FAHA Christopher P. CannonChristopher P. Cannon , Ralph G. BrindisRalph G. Brindis , Bernard R. ChaitmanBernard R. Chaitman , David J. CohenDavid J. Cohen , J. Thomas CrossJrJ. Thomas CrossJr *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Joseph P. DrozdaJrJoseph P. DrozdaJr *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Francis M. FesmireFrancis M. Fesmire *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Dan J. FintelDan J. Fintel *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Gregg C. FonarowGregg C. Fonarow , Keith A. FoxKeith A. Fox , Darryl T. GrayDarryl T. Gray *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Robert A. HarringtonRobert A. Harrington , Karen A. HicksKaren A. Hicks *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Judd E. HollanderJudd E. Hollander *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Harlan KrumholzHarlan Krumholz , Darwin R. LabartheDarwin R. Labarthe *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Janet B. LongJanet B. Long *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Alice M. MascetteAlice M. Mascette *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Connie MeyerConnie Meyer *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Eric D. PetersonEric D. Peterson , Martha J. RadfordMartha J. Radford , Matthew T. RoeMatthew T. Roe , James B. RichmannJames B. Richmann *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Harry P. SelkerHarry P. Selker *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , David M. ShahianDavid M. Shahian *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Richard E. ShawRichard E. Shaw , Sharon SprengerSharon Sprenger *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Robert SworRobert Swor *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , James A. UnderbergJames A. Underberg *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Frans Van de WerfFrans Van de Werf , Bonnie H. WeinerBonnie H. Weiner *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ and William S. WeintraubWilliam S. Weintraub Originally published28 Jan 2013https://doi.org/10.1161/CIR.0b013e3182831a11Circulation. 2013;127:1052–1089Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2013: Previous Version 1 Table of ContentsPreamble 10531. Introduction 10542. Methodology 10552.1. Writing Committee Composition 10552.2. Relationships With Industry and Other Entities 10552.3. Review of Literature and Existing Data Definitions 10552.4. Defining Data Elements 10552.5. Relation to Other Standards 10562.6. Consensus Development 10562.7. Peer Review, Public Review, and Board Approval 10562.8. Considerations for ACS and CAD Data Standards 10563. ACS and CAD Clinical Data Standard Elements and Definitions 10593.1. Demographic and Admission Data Elements 10593.2. History and Risk Factors Data Elements 10593.3. Clinical Presentation Data Elements 10633.4. Diagnostic Procedure Data Elements 10653.5. Invasive Therapeutic Intervention Data Elements 10653.6. Medications Table of Data Elements 10653.7. Outcomes Data Elements 1065References 1084Appendix 1. Author Relationships With Industry and Other Entities 1086Appendix 2. Peer Review Relationships With Industry and Other Entities 1089PreambleThe American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) support their members’ goal to improve the prevention and care of cardiovascular diseases through professional education, research, and development of guidelines and standards and by fostering policy that supports optimal patient outcomes. The ACCF and AHA recognize the importance of the use of clinical data standards for patient management, assessment of outcomes, and conduct of research, and the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, or quality-improvement initiatives.Hence, clinical data standards strive to define and standardize data relevant to clinical topics in cardiology, with the primary goal of assisting data collection by providing a platform of data elements and definitions applicable to various conditions. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across studies to promote interoperability of electronic health records (EHRs) and to assess the applicability of research to clinical practice. The increasing national focus on adoption of certified EHRs along with financial incentives for providers to demonstrate “meaningful use” of those EHRs to improve healthcare quality render even more imperative and urgent the need for such definitions and standards. Therefore, the ACCF and AHA have undertaken to define and disseminate clinical data standards—sets of standardized data elements and corresponding definitions—to collect data relevant to cardiovascular conditions. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary to accomplish the ACCF/AHA mission of fostering optimal cardiovascular care and disease prevention and building healthier lives, free of cardiovascular diseases and stroke.The specific goals of clinical data standards areTo establish a consistent, interoperable, and universal clinical vocabulary as a foundation for both clinical care and clinical researchTo promote the ubiquitous use of EHRs and facilitate the exchange of data across systems through harmonized, standardized definitions of key data elementsTo facilitate the further development of clinical registries, quality- and performance-improvement programs, outcomes evaluations, and clinical research, including the comparison of results within and across these initiativesThe key elements and definitions are a compilation of variables intended to facilitate the consistent, accurate, and reproducible capture of clinical concepts; standardize the terminology used to describe cardiovascular diseases and procedures; create a data environment conducive to the assessment of patient management and outcomes for quality and performance improvement and clinical and translational research; and increase opportunities for sharing data across disparate data sources. The ACCF/AHA Task Force on Clinical Data Standards selects cardiovascular conditions and procedures that will benefit from creation of a data standard set. Experts in the subject are selected to examine/consider existing standards and develop a comprehensive, yet not exhaustive, data standard set. When undertaking a data collection effort, only a subset of the elements contained in a clinical data standards listing may be needed, or conversely, users may want to consider whether it may be necessary to collect some elements not listed. For example, in the setting of a randomized clinical trial of a new drug, additional information would likely be required regarding study procedures and drug therapiesThe ACCF and AHA recognize that there are other national efforts to establish clinical data standards, and every attempt is made to harmonize newly published standards with existing standards. Writing committees are instructed to consider adopting or adapting existing nationally recognized data standards if the definitions and characteristics are useful and applicable to the set under development. In addition, the ACCF and AHA are committed to continually expanding their portfolio of data standards and will create new standards and update existing standards as needed to maintain their currency and promote harmonization with other standards as health information technology and clinical practice evolve.The Health Insurance Portability and Accountability Act privacy regulations, which went into effect in April 2003, have heightened all practitioners’ awareness of our professional commitment to safeguard our patients’ privacy. The Health Insurance Portability and Accountability Act privacy regulations1 specify which information elements are considered “protected health information.” These elements may not be disclosed to third parties (including registries and research studies) without the patient’s written permission. Protected health information may be included in databases used for healthcare operations under a data use agreement. Research studies using protected health information must be reviewed by an institutional review board or a privacy board.We have included identifying information in all clinical data standards to facilitate uniform collection of these elements when appropriate. For example, a longitudinal clinic database may contain these elements because access is restricted to the patient’s caregivers. Conversely, registries may not contain protected health information unless specific permission is granted by each patient. These fields are indicated as protected health information in the data standards.The ACCF/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing committee were required to submit a disclosure form showing all such relationships that might be perceived as real or potential conflicts of interest. These statements were reviewed by the ACCF/AHA Task Force on Clinical Data Standards, reported orally to all members of the writing panel at the first meeting, and updated as changes occur.In clinical care, caregivers communicate with each other through a common vocabulary. In an analogous fashion, the integrity of clinical research depends on firm adherence to prespecified procedures for patient enrollment and follow-up; these procedures are guaranteed through careful attention to definitions enumerated in the study design and case report forms. When data elements and definitions are standardized across studies, comparison, pooled analysis, and meta-analysis are enabled, thus deepening our understanding of individual studies.The recent development of quality-performance measurement initiatives, particularly those for which the comparison of providers is an implicit or explicit aim, has further raised awareness about the importance of data standards. Indeed, a wide audience, including nonmedical professionals such as payers, regulators, and consumers, may draw conclusions about care and outcomes. To understand and compare care patterns and outcomes, the data elements that characterize them must be clearly defined, consistently used, and properly interpreted, now more than ever before.Robert C. Hendel, MD, FACC, FAHA Chair, ACCF/AHA Task Force on Clinical Data Standards1. IntroductionIn the field of cardiology, large-scale clinical trials and registries have provided a wealth of data on the treatment and outcomes for hundreds of thousands of patients. Many of these efforts have focused on patients with acute coronary syndromes (ACS), which range from ST-segment elevation myocardial infarction (STEMI) to non–ST-segment elevation myocardial infarction (NSTEMI) to unstable angina (UA). These data have been used to evaluate the effectiveness of the pharmacological and interventional management of these patients, define new therapies, and guide clinical care through evaluation of both the process and the quality of care and outcomes for patients with ACS.The ACCF and AHA, in conjunction with other professional medical organizations and government agencies, recognize the importance of using clinical data and, to that end, have aimed to establish a series of datasets in the major areas of cardiology.2–7 In 2001, a dataset was established for the field of ACS; a working group developed a list of key data elements to characterize patients with ACS. This document served as the basis for data definitions for many data elements in the ACTION Registry–Get With The Guidelines (AR-G), Get With The Guidelines–CAD (GWTG-CAD), and other trials and registries. To date, this document has been cited in 255 publications.Given the overlap of ACS and coronary artery disease (CAD), it was decided to update this list of data elements and expand it to include CAD. The current group of organizations also has been expanded to include as many organizations with an interest in clinical data standards for ACS/CAD as could be identified. In addition, the cardiac catheterization/percutaneous coronary intervention (Cath/PCI) registry of the National Cardiovascular Data Registry also includes patients with ACS and CAD, and as such the elements overlap as well. Thus, the goal was to create definitions that could serve registries in all these areas and in particular those that matched between AR-G and Cath/PCI.The writing committee hopes that this set of data elements and definitions for patients with ACS and CAD will help facilitate research and assessment of quality of care, thereby advancing the practice of medicine.2. Methodology2.1. Writing Committee CompositionThe process undertaken in developing these clinical data standards began with the ACCF/AHA Task Force on Clinical Data Standards, which identified ACS as an important area in which to standardize definitions and registries. A writing committee was formed that included a select group of physicians who have been involved in large-scale ACS clinical trials or registries and who are recognized experts in the field. The committee also included members who are considered to be experts in the diagnosis and treatment of stable CAD. Additionally, the writing committee includes several international members to ensure balance in the data elements and the type of practice worldwide that would be reflected by the data collected in this dataset. The writing committee also included representatives from the American College of Chest Physicians, American College of Emergency Physicians, American College of Physicians, American College of Preventive Medicine, American Medical Association, Emergency Nurses Association, National Association of Emergency Medical Technicians, National Association of EMS Physicians, Preventive Cardiovascular Nurses Association, Society for Academic Emergency Medicine, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Patient Care, Society of General Internal Medicine, and Society of Thoracic Surgeons.2.2. Relationships With Industry and Other EntitiesDisclosure of all relationships with industry and other entities (RWI) is required of every member of ACCF/AHA data standards writing committees and peer reviewers. This writing effort was initiated before the implementation of the updated ACCF and AHA policy on relationships with industry and other entities, which requires that a majority of the writing committee plus the writing committee chair have no relationships with industry and other entities relevant to the document. Relevant relationships disclosed by writing committee members and peer reviewers are listed in Appendixes 1 and 2, respectively. The work of the writing committee was supported exclusively by the ACCF and AHA (and the other partnering organizations) without commercial support. Writing committee members volunteered their time for this effort. Meetings of the writing committee were confidential and attended only by committee members and staff.Appendix 1. Author Relationships With Industry and Other Entities—2013 Accf/Aha Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery DiseaseCommittee MemberEmployer/TitleConsultantSpeakerOwnership/ Partnership/ PrincipalResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessChristopher P. Cannon, ChairBrigham and Women’s Hospital—Principal Investigator, TIMI Study Group• Alnylam• Automedics Medical Systems• Bristol-Myers Squibb• CSL Behring• PfizerNone• Automedics Medical Systems• Accumetrics• AstraZeneca• Aventis-Bristol-Myers Squibb• Essentialis• GlaxoSmithKline• Merck• Merck-Schering Plough• Regeneron/Sanofi• Schering Plough• TakedaNoneNoneRalph G. BrindisOakland Kaiser Medical Center—Senior Regional Advisor for Cardiovascular DiseasesNoneNoneNoneNoneNoneNoneBernard R. ChaitmanSt. Louis University School of Medicine–Core ECG Laboratory—Director, Cardiovascular Research• AstraZeneca• CV Therapeutics• Eli Lilly• Merck• Pfizer• Sanofi-aventis• AstraZeneca• CV Therapeutics• PfizerNone• CV Therapeutics• MerckNoneNoneDavid J. CohenSt. Luke’s Medical Center—Director, Cardiovascular Research• Boehringer Ingelheim• Eli Lilly• Medtronic• Daiichi Sankyo• Eli LillyNone• AstraZeneca• Boston Scientific• Daiichi Sankyo• Edwards Lifesciences• Eli Lilly• Medtronic• St. Jude MedicalNoneNoneJ. Thomas Cross, JrMedStudy Corporation—Director of Medical EducationNoneNoneNoneNoneNoneNoneJoseph P. Drozda, JrMercy Health—Director of Outcomes ResearchNoneNoneNoneNoneNoneNoneFrancis M. FesmireUniversity of Tennessee Health Science Center—Associate ProfessorNoneNoneNoneNoneNoneNoneDan J. FintelNorthwestern University Feinberg School of Medicine—Professor of Medicine• Merck-Schering Plough• Sanofi-aventis• Schering Plough• AstraZeneca• Merck-Schering Plough• Sanofi-aventis• Schering PloughNoneNone• Merck-Schering Plough• Sanofi-aventis• Schering PloughNoneGregg C. FonarowAhmanson-UCLA Cardiomyopathy Center Division of CardiologyNone• AstraZeneca• Aventis Bristol-Myers Squibb• Bristol-Myers Squibb Sanofi• GlaxoSmithKline• Guidant• Medtronic• Merck-Schering Plough• Nitromed• Pfizer• St. JudeNone• GlaxoSmithKline• MedtronicNoneNoneKeith A. FoxEdinburgh University Chancellor’s Building—President, British Cardiac SocietyNoneNoneNoneNoneNoneNoneDarryl T. GrayAgency for Healthcare Research Quality—Medical OfficerNoneNoneNoneNoneNoneNoneRobert A. HarringtonDuke Clinical Research Institute, Duke University Medical Center—Professor of Medicine, DirectorNoneNoneNoneNoneNoneNoneKaren A. HicksUS Food and Drug Administration—Medical OfficerNoneNoneNoneNoneNoneNoneJudd E. HollanderUniversity of Pennsylvania Department of Emergency MedicineNoneNoneNone• Abbott• Allere• Brahms• Nanosphere• SiemensNoneNoneHarlan KrumholzYale University School of Medicine—Professor of Medicine• Alere• Amgen• United Health• VHA, IncNoneNone• American College of Cardiology• Colorado Foundation for Medical CareNoneNoneDarwin R. LabartheCenters for Disease Control and Prevention—retiredNoneNoneNoneNoneNoneNoneJanet B. LongRhode Island Cardiology Center—Nurse PractitonerNone• AstraZenecaNoneNoneNoneNoneAlice M. MascetteNational Heart, Lung, and Blood Institute Division of Cardiovascular Sciences—Senior Clinical Science AdvisorNoneNoneNoneNoneNoneNoneConnie MeyerJohnson County Med-Act (Olathe, KS)—Emergency Medical Services CaptainNoneNoneNoneNoneNoneNoneEric D. PetersonDuke Clinical Research Institute, Duke University Medical Center—Professor of Medicine; Director, Cardiovascular OutcomesNoneGenentechNone• Aventis-Bristol-Myers Squibb• Corgentech• CV Therapeutics• Merck• Schering PloughNoneNoneMartha J. RadfordNew York University Hospitals Center—Professor of Medicine, Chief Quality OfficerNoneNoneNoneNoneNoneNoneMatthew T. RoeDuke Clinical Research Institute, Duke University Medical Center—Associate Professor of Medicine• Genentech• Novartis• Aventis-Bristol-Myers Squibb• Daiichi Sankyo• KAI Pharmaceuticals• Schering PloughNone• Aventis-Bristol-Myers Squibb• Daiichi Sankyo• Eli Lilly• KAI Pharmaceuticals• Schering PloughNoneNoneJames B. RichmannBluejay Consulting—ConsultantNoneNoneNoneNoneNoneNoneHarry P. SelkerTufts Medical Center—Executive Director of the Institute for Clinical Research and Health Policy Studies; Tufts University—Dean of Tufts Clinical and Translational Science InstituteNoneNoneNoneNoneNoneNoneDavid M. ShahianMassachusetts General Hospital—Associate Director of the Codman Center for Clinical Effectiveness in SurgeryNoneNoneNoneNoneNoneNoneRichard E. ShawCalifornia Pacific Medical Center—Director–Research, Quality and EducationNoneNoneNone• Duke Clinical Research Institute• Schering PloughNoneNoneSharon SprengerThe Joint CommissionNoneNoneNoneNoneNoneNoneRobert SworWilliam Beaumont HospitalNoneNoneNoneNoneNoneNoneJames A. UnderbergNYU Langone Center for Cardiovascular Disease Prevention; Bellevue Hospital Lipid Clinic—Director• Genzyme• Liposcience• Aboott• AstraZeneca• Daiichi Sankyo• DiaDexus• Eli Lilly• GlaxoSmithKline• KowaNone• KowaNoneNoneFrans Van de WerfUniversity Hospitals Leuven—Professor of CardiologyNoneNoneNoneNoneNoneNoneBonnie H. WeinerSt. Vincent Hospital Worcester Medical Center—Director of Interventional Cardiology ResearchNoneNoneNoneNoneNoneNoneWilliam S. WeintraubChristiana Care Health System—Section Chief, Cardiology• AstraZeneca• Bayer• Bristol-Myers Squibb• Cardionet• Eli Lilly• Pfizer• ShionogiNoneNone• Abbott• AstraZeneca• Bristol-Myers Squibb• Otsuka• Sanofi-aventisNone• 2011—Oral contraceptive litigation—represented defendant for general epidemiologic testimony• 2009—Aprotinin litigation—represented defendant as an expert witness for AprotininThis table represents the relationships of committee members with industry and other entities that were reported by authors to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$10000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted.Appendix 2. Peer Review Relationships With Industry and Other Entities—2013 Accf/Aha Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery DiseasePeer ReviewerRepresentationConsultantSpeakerOwnership/Partnership/PrincipalResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessRobert A. GuytonACCF—Board of TrusteesNoneNoneNone• National Institutes of HealthNone• 2011—Represented defendant—aortic dissection during coronary bypassJafna L. CoxACCF—Board of Governors• AstraZeneca• Bayer• Boehringer-Ingelheim• Sanofi-aventisNoneNoneNone• Heart and Stroke Foundation of Nova ScotiaNoneLloyd KleinAmerican Heart AssociationNoneNoneNoneNoneNoneNoneBiykem BozkurtACCF/AHA Data Standards Task Force Lead ReviewerNoneNoneNone• Forest Pharmaceuticals• Amgen• Corthera• National Institutes of Health• NovartisNoneDarice AllardOfficial Reviewer—Society of Chest Pain Centers and ProvidersNoneNoneNoneNoneNoneNoneLes R. BeckerOfficial Reviewer—National Association of Emergency Medical TechniciansNoneNoneNoneNoneNoneNoneDeborah DiercksOfficial Reviewer—American College of Emergency PhysiciansNoneNoneNoneNoneNoneNoneRobert S. GibsonOfficial Reviewer—American College of PhysiciansNoneNoneNoneNoneNoneNoneDiane GurneyOfficial Reviewer—Emergency Nurses AssociationNoneNoneNoneNoneNoneNoneJane Nelson-WorelOfficial Reviewer—Preventive Cardiovascular Nurses AssociationNoneNoneNoneNoneNoneNoneRichard L. PragerOfficial Reviewer—Society of Thoracic SurgeonsNoneNoneNoneNoneNoneNoneClyde B. SchecterOfficial Reviewer—American College of Preventive MedicineNoneNoneNoneNoneNoneNoneDavid K. TanOfficial Reviewer—National Association of EMS PhysiciansNoneNoneNoneNoneNoneNoneShari TargumOfficial Reviewer—Food and Drug AdministrationNoneNoneNoneNoneNoneNoneMichael D. BrownContent ReviewerNoneNoneNoneNoneNoneNoneAngus JamesonContent ReviewerNoneNoneNoneNoneNoneNoneRobert L. McNamaraContent Reviewer• Boehringer-Ingelheim• Ortho-McNeillNoneNoneNoneNoneNoneMark MenegusContent ReviewerNoneNoneNoneNoneNoneNoneJoyce L. RossContent ReviewerNoneNoneNoneNoneNoneNoneThomas TsaiContent ReviewerNoneNoneNoneNoneNoneNoneThis table represents the relevant relationships with industry and other entities that were disclosed by reviewers at the time of peer review. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Participation in the peer review process does not imply endorsement of this document.2.3. Review of Literature and Existing Data DefinitionsWriting committee members compiled and reviewed case report forms, data elements, and data definitions from national and international ACS registries and previous or ongoing clinical trials to develop an initial set of data elements. Examples of these data sources included in the first round are the NRMI (National Registry of Myocardial Infarction),8 GRACE (Global Registry of Acute Coronary Events),9 TIMI (Thrombolysis in Myocardial Infarction),10–12 and the GUSTO (Global Use of Streptokinase and Tissue Plasminogen Activator to Open Occluded Arteries)13–15 trials, and in this update, the definitions for the Cath/PCI and AR-G, CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress Adverse outcomes with Early implementation of the ACC/AHA Guidelines),16 and ACTION Registry-GWTG17 were reviewed in detail.This document also considered data elements and how they pertain to the emergency department,16 the prehospital setting, and Mission: Lifeline.182.4. Defining Data ElementsThe data elements reflect an ongoing review of the medical literature to focus on new developments. Current scientific evidence provided the basis for the selection and definition of appropriate data elements required to evaluate and manage patients with ACS and stable CAD. Therefore, data elements and definitions were linked whenever possible to evidence-based national guidelines. For the purposes of these clinical data standards, the writing committee chose to review and cite several ACCF/AHA guidelines, including but not limited to the “ACCF/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction”19,20 and the “ACCF/AHA Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction.”21 Data element definitions, particularly in the Outcomes section, were also matched to the upcoming Food and Drug Administration (FDA) definitions for major cardiovascular endpoints. In addition, the writing committee adopted the definition of myocardial infarction (MI) as published in a European Society of Cardiology/ACCF/AHA/World Heart Federation consensus document on the universal definition of MI.22 On a few occasions, data elements and definitions were linked to other national guidelines, such as the National Cholesterol Education Program (NCEP III) guidelines.23The writing committee members reviewed the list of
Maintenance of airway stability is an essential part of critical care management of patients undergoing endovascular treatment for acute stroke. While some patients may undergo endovascular treatment utilizing conscious sedation alone, many patients require deeper sedation and emergent mechanical ventilation due to need to control patient movement, stabilize the airway, and facilitate patient comfort during prolonged procedures (average duration 1.9 hrs). Nine patients undergoing emergent intubation prior to endovascular treatment for acute stroke underwent observational study. Following completion of IRB-approved consent for study participation, patients received arterial line placement and vital signs were collected before, during, and after intubation and throughout endovascular treatment. Intubation was performed by experienced ED physicians using a variety of medications. An immediate and dramatic rise in mean arterial pressure (MAP) was associated with intubation (increased by 172% over baseline) followed by a decrease in the MAP (12% below baseline) in the ED prior to patient transfer to angiography. No consist trend was noted in PaCO2 levels drawn immediately after intubation but prior to initiation of mechanical ventilation. Average MAP in the angiogram suite during endovascular therapy was almost identical to pre-intubation baseline MAP (101% of baseline) despite utilization by interventionalists of a number of sedative medications. Transient decreases in the MAP to a nadir of 75 - 80 were seen during endovascular therapy in 3 patients; more significant drops did not occur. Mean duration of intubation, ICU stay, and total hospitalization was 3 days, 8 days, and 12 days respectively. In conclusion, real-world emergent intubation by ED physicians of acute stroke patients just prior to endovascular treatment is associated with significant fluctuations in MAP. Such fluctuations in either direction may further jeopardize tissue at risk. Recent reports from the national MERCI Registry Database indicate worse outcomes in intubated patients for unclear reasons; this could be due to fluctuations in MAP but might also be due to the effect of anesthesia itself. Assuming that these hemodynamic changes are causal in reducing clinical outcomes, ED intubation and angiographic sedation protocols should be designed to minimize fluctuations in MAP. Further investigations documenting improved MAP control utilizing standardized protocols are needed.
This clinical policy from the American College of Emergency Physicians is the revision of the 2003 Clinical Policy: Critical Issues in the Initial Evaluation and Management of Patients Presenting to the Emergency Department in Early Pregnancy.(1) A writing subcommittee reviewed the literature to derive evidence-based recommendations to help clinicians answer the following critical questions: (1) Should the emergency physician obtain a pelvic ultrasound in a clinically stable pregnant patient who presents to the emergency department (ED) with abdominal pain and/or vaginal bleeding and a beta human chorionic gonadotropin (β-hCG) level below a discriminatory threshold? (2) In patients who have an indeterminate transvaginal ultrasound, what is the diagnostic utility of β-hCG for predicting possible ectopic pregnancy? (3) In patients receiving methotrexate for confirmed or suspected ectopic pregnancy, what are the implications for ED management? Evidence was graded and recommendations were developed based on the strength of the available data in the medical literature. A literature search was also performed for a critical question from the 2003 clinical policy.(1) Is the administration of anti-D immunoglobulin indicated among Rh-negative women during the first trimester of pregnancy with threatened abortion, complete abortion, ectopic pregnancy, or minor abdominal trauma? Because no new, high-quality articles were found, the management recommendations from the previous policy are discussed in the introduction.
WRITING COMMITTEE MEMBERS* Patrick T. O’Gara, MD, FACC, FAHA, Chair†; Frederick G. Kushner, MD, FACC, FAHA, FSCAI, Vice Chair*†; Deborah D. Ascheim, MD, FACC†; Donald E. Casey, Jr, MD, MPH, MBA, FACP, FAHA‡; Mina K. Chung, MD, FACC, FAHA*†; James A. de Lemos, MD, FACC*†; Steven M. Ettinger, MD, FACC*§; James C. Fang, MD, FACC, FAHA*†; Francis M. Fesmire, MD, FACEP* ¶; Barry A. Franklin, PHD, FAHA†; Christopher B. Granger, MD, FACC, FAHA*†; Harlan M. Krumholz, MD, SM, FACC, FAHA†; Jane A. Linderbaum, MS, CNP-BC†; David A. Morrow, MD, MPH, FACC, FAHA*†; L. Kristin Newby, MD, MHS, FACC, FAHA*†; Joseph P. Ornato, MD, FACC, FAHA, FACP, FACEP†; Narith Ou, PharmD†; Martha J. Radford, MD, FACC, FAHA†; Jacqueline E. Tamis-Holland, MD, FACC†; Carl L. Tommaso, MD, FACC, FAHA, FSCAI#; Cynthia M. Tracy, MD, FACC, FAHA†; Y. Joseph Woo, MD, FACC, FAHA†; David X. Zhao, MD, FACC*†
BACKGROUND:Studies have individually reported the relationship of age, cardiac risk factors, and history of preexisting coronary artery disease (CAD) for predicting acute coronary syndromes in chest pain patients undergoing cardiac stress testing. In this study, we investigate the interplay of all these factors on the incidence of acute coronary syndromes to develop a tool that may assist physicians in the selection of appropriate chest pain patients for stress testing.METHODS:Retrospective analysis of a prospectively acquired database of consecutive chest pain patients undergoing nuclear stress testing. Backward stepwise logistic regression was used to develop a model for predicting risk of 30-day acute coronary events (ACE) using information obtained from age, sex, cardiac risk factors, and history of preexisting CAD.RESULTS:A total of 800 chest pain patients underwent nuclear stress testing. ACE occurred in 74 patients (9.3%). Logistic regression analysis found only 6 factors predictive of ACE: age, male sex, preexisting CAD, diabetes, and hyperlipidemia. Area under the receiver operator characteristic curve of this model for predicting ACE was 0.767 (95% confidence interval, 0.719-0.815). There were no cases of ACE in the 173 patients with predicted probability estimates ≤2.5% (95% confidence interval, 0%-2.1%).CONCLUSIONS:A regression model using age, sex, preexisting CAD, diabetes, and hyperlipidemia is predictive of 30-day ACE in chest pain patients undergoing nuclear stress testing. Prospective studies need to be performed to determine whether this model can assist physicians in the selection of appropriate low-to-intermediate risk chest pain patients for nuclear stress testing.
HomeCirculationVol. 126, No. 72012 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction (Updating the 2007 Guideline and Replacing the 2011 Focused Update) Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUB2012 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction (Updating the 2007 Guideline and Replacing the 2011 Focused Update)A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 2012 Writing Committee Members Hani Jneid, MD, FACC, FAHA, Jeffrey L. Anderson, MD, FACC, FAHA, R. Scott Wright, MD, FACC, FAHA, Cynthia D. Adams, RN, PhD, FAHA, Charles R. Bridges, MD, ScD, FACC, FAHA, Donald E. CaseyJr, MD, MPH, MBA, FACP, FAHA, Steven M. Ettinger, MD, FACC, Francis M. Fesmire, MD, FACEP, Theodore G. Ganiats, MD, A. Michael Lincoff, MD, FACC, Eric D. Peterson, MD, MPH, FACC, FAHA, George J. Philippides, MD, FACC, FAHA, Pierre Theroux, MD, FACC, FAHA, Nanette K. Wenger, MD, MACC, FAHA and James Patrick Zidar, MD, FACC, FSCAI 2012 Writing Committee Members *, †, ‡, §, ∥, ¶, #, **, †† , Hani JneidHani Jneid *, †, ‡, §, ∥, ¶, #, **, †† , Jeffrey L. AndersonJeffrey L. Anderson *, †, ‡, §, ∥, ¶, #, **, †† *, †, ‡, §, ∥, ¶, #, **, †† , R. Scott WrightR. Scott Wright *, †, ‡, §, ∥, ¶, #, **, †† , Cynthia D. AdamsCynthia D. Adams *, †, ‡, §, ∥, ¶, #, **, †† , Charles R. BridgesCharles R. Bridges *, †, ‡, §, ∥, ¶, #, **, †† , Donald E. CaseyJrDonald E. CaseyJr *, †, ‡, §, ∥, ¶, #, **, †† , Steven M. EttingerSteven M. Ettinger *, †, ‡, §, ∥, ¶, #, **, †† , Francis M. FesmireFrancis M. Fesmire *, †, ‡, §, ∥, ¶, #, **, †† , Theodore G. GaniatsTheodore G. Ganiats *, †, ‡, §, ∥, ¶, #, **, †† , A. Michael LincoffA. Michael Lincoff *, †, ‡, §, ∥, ¶, #, **, †† , Eric D. PetersonEric D. Peterson *, †, ‡, §, ∥, ¶, #, **, †† , George J. PhilippidesGeorge J. Philippides *, †, ‡, §, ∥, ¶, #, **, †† , Pierre TherouxPierre Theroux *, †, ‡, §, ∥, ¶, #, **, †† , Nanette K. WengerNanette K. Wenger *, †, ‡, §, ∥, ¶, #, **, †† and James Patrick ZidarJames Patrick Zidar *, †, ‡, §, ∥, ¶, #, **, †† Originally published16 Jul 2012https://doi.org/10.1161/CIR.0b013e318256f1e0Circulation. 2012;126:875–910Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2012: Previous Version 1 Developed in Collaboration With the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic SurgeonsTable of ContentsPreamble. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8761. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .879 1.1. Methodology and Evidence Review. . . . . . . . . .8791.2. Organization of the Writing Group. . . . . . . . . . .8791.3. Document Review and Approval. . . . . . . . . . . .8793. Early Hospital Care. . . . . . . . . . . . . . . . . . . . . . . . . .879 3.2. Antiplatelet/Anticoagulant Therapy in Patients for Whom Diagnosis of UA/NSTEMI Is Likely or Definite: Recommendations. . . . . . . .879 3.2.1. Antiplatelet Therapy: Recommendations. . .8793.2.3. Additional Management of Antiplatelet and Anticoagulant Therapy: Recommendations. .879 3.2.3.1. Antiplatelet/Anticoagulant Therapy in Patients for Whom Diagnosis of UA/NSTEMI Is Likely or Definite. . . . . . . . . .879 3.2.3.1.1. P2Y12 Receptor Inhibitors. . . . . . . . . .8793.2.3.1.2. Choice of P2Y12 Receptor Inhibitors for PCI in UA/NSTEMI. .881 3.2.3.1.2.1. Timing of Discontinuation of P2Y12 Receptor Inhibitor Therapy for Surgical Procedures. . . . . .8823.2.3.1.3. Interindividual Variability in Responsiveness to Clopidogrel. . . . . . . . .8823.2.3.1.4. Optimal Loading and Maintenance Dosages of Clopidogrel. . . . . .8833.2.3.1.5. Proton Pump Inhibitors and Dual Antiplatelet Therapy for ACS. . . .8833.2.3.1.6. Glycoprotein IIb/IIIa Receptor Antagonists. . .8843.3. Initial Invasive Versus Initial Conservative Strategies: Recommendations. . . . . . . . . . . . . . . .885 3.3.3.1. Timing of Invasive Therapy. . . .8855. Late Hospital Care, Hospital Discharge, and Posthospital Discharge Care. . . . . . . . . . . . . . . . . . . .890 5.2. Long-Term Medical Therapy and Secondary Prevention. . . . . . . . . . . . . . . . . . . . .890 5.2.1. Convalescent and Long-Term Antiplatelet Therapy: Recommendations. . . .8905.2.6. Warfarin Therapy: Recommendations. . .8926. Special Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .892 6.2. Diabetes Mellitus: Recommendations. . . . . . . . .892 6.2.1.1. Intensive Glucose Control. . . . .8926.5. Chronic Kidney Disease: Recommendations. . . .893 6.5.1. Angiography in Patients With CKD. . . . .8937. Conclusions and Future Directions. . . . . . . . . . . . . . .895 7.1. Quality of Care and Outcomes for UA/NSTEMI: Recommendation. . . . . . . . . . . . .895 7.1.1. Quality Care and Outcomes. . . . . . . . . . .895Appendix 1. Author Relationships With Industry and Other Entities (Relevant). . . . . . . . . . . . . .901Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant). . . . . . . . . .903Appendix 3. Dosing Table for Antiplatelet and Anticoagulant Therapy Discussed in This Focused Update to Support PCI in UA/NSTEMI. . . . . . . . . . . . . . . . . . . . .906Appendix 4. Comparisons Among Orally Effective P2Y12 Inhibitors. . . . . . . . . . . . . . . . . . . .908Appendix 5. Flowchart for Class I and Class IIa Recommendations for Initial Management of UA/NSTEMI. . . . . . . . . . .909Appendix 6. Selection of Initial Treatment Strategy: Invasive Versus Conservative Strategy. . .910Anderson Jeffrey L., MD, FACC, FAHAPreambleKeeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Task Force on Practice Guidelines (Task Force) has created a “focused update” process to revise the existing guideline recommendations that are affected by the evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence is reviewed at least twice a year, and updates are initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of more than 20 years.These focused updates are prompted following a thorough review of late-breaking clinical trials presented at national and international meetings in addition to other new published data deemed to have an impact on patient care (Section 1.1, Methodology and Evidence Review). Through a broad-based vetting process, the studies included are identified as being important to the relevant patient population. The focused update is not intended to be based on a complete literature review from the date of the previous guideline publication but rather to include pivotal new evidence that may affect changes to current recommendations. Specific criteria/considerations for inclusion of new data include the following: publication in a peer-reviewed journal;large, randomized, placebo-controlled trial(s);nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions, including observational studies and meta-analyses;strength/weakness of research methodology and findings;likelihood of additional studies influencing current findings;impact on current and/or likelihood of need to develop new performance measure(s);request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of industry relationships or other potential bias;number of previous trials showing consistent results; andneed for consistency with a new guideline or guideline updates or revisions.In analyzing the data and developing recommendations and supporting text, the writing group uses evidence-based methodologies developed by the Task Force.1 The Class of Recommendation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective and in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing group reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C using specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing group is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology is separation of the Class III recommendations to delineate whether the recommendation is determined to be of “no benefit” or is associated with “harm” to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment/strategy with respect to another for COR I and IIa, LOE A or B only.Table 1. Applying Classification of Recommendations and Level of EvidenceTable 1. Applying Classification of Recommendations and Level of EvidenceA recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use.†For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.In view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline (primarily Class I) recommended therapies. This new term, GDMT, will be used herein and throughout all future guidelines.Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation.The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise in which deviations from these guidelines may be appropriate. Clinical decision making should consider the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise for which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate.Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower.The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing group. All writing group members and peer reviewers of the guideline are required to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the writing effort. In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing group chair plus a minimum of 50% of the writing group to have no relevant RWI (Appendix 1 for the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing group and are updated as changes occur. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the voting members. Members are not permitted to draft or vote on any text or recommendations pertaining to their RWI. Members who recused themselves from voting are indicated in the list of writing group members, and specific section recusals are noted in Appendix 1. Authors' and peer reviewers' RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing group members' comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at http://www.cardiosource.org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the writing group is supported exclusively by the ACCF and AHA without commercial support. Writing group members volunteered their time for this activity.In an effort to maintain relevance at the point of care for practicing physicians, the Task Force continues to oversee an ongoing process improvement initiative. As a result, in response to pilot projects, several changes to these guidelines will be apparent, including limited narrative text, a focus on summary and evidence tables (with references linked to abstracts in PubMed), and more liberal use of summary recommendation tables (with references that support LOE) to serve as a quick reference.In April 2011, the Institute of Medicine released 2 reports: Clinical Practice Guidelines We Can Trust and Finding What Works in Health Care: Standards for Systematic Reviews.2,3 It is noteworthy that the ACCF/AHA practice guidelines were cited as being compliant with many of the standards that were proposed. A thorough review of these reports and our current methodology is under way, with further enhancements anticipated.The recommendations in this focused update are considered current until they are superseded in another focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and AHA.1. Introduction1.1. Methodology and Evidence ReviewThe standing guideline writing committee along with the parent Task Force identified trials and other key data through October 2011 that may impact guideline recommendations. On the basis of the criteria/considerations noted in the Preamble and the approval of new oral antiplatelets, a focused update was initiated to provide guidance on how to incorporate these agents into daily practice. Now that multiple agents are available, a comparison of their use in various settings within clinical practice is provided. This iteration replaces the sections in the 2007 ACC/AHA Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction4 that were updated by the 2011 ACCF/AHA Focused Update of the Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction.5,6To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published, the absolute risk difference and number needed to treat or harm are provided in the guideline, along with confidence intervals (CI) and data related to the relative treatment effects such as odds ratio (OR), relative risk (RR), hazard ratio (HR), and incidence rate ratio.Consult the full-text version of the 2007 ACC/AHA Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction4 for policy on clinical areas not covered by the current document. Individual recommendations updated in this focused update will be incorporated into future revisions and/or updates of the full-text guidelines.1.2. Organization of the Writing GroupFor this focused update, members of the 2011 Unstable Angina/Non–ST-Elevation Myocardial Infarction (UA/NSTEMI) focused update writing group were invited and all agreed to participate (referred to as the 2012 focused update writing group). Members were required to disclose all RWI relevant to the data under consideration. The writing group included representatives from the ACCF, AHA, American Academy of Family Physicians, American College of Emergency Physicians, American College of Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.1.3. Document Review and ApprovalThis document was reviewed by 2 official reviewers each nominated by the ACCF and the AHA, as well as 1 or 2 reviewers each from the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons, and 29 individual content reviewers, including members of the ACCF Interventional Scientific Council. The information on reviewers' RWI was distributed to the writing group and is published in this document (Appendix 2).This document was approved for publication by the governing bodies of the ACCF and the AHA and endorsed by the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.3. Early Hospital Care3.2. Antiplatelet/Anticoagulant Therapy in Patients for Whom Diagnosis of UA/NSTEMI Is Likely or Definite: Recommendations3.2.1. Antiplatelet Therapy: Recommendations(See Table 2, Appendixes 3, 4, 5, 6, and the Online Data Supplement.)Table 2. Recommendations for Antiplatelet Therapy2012 Focused Update Recommendations2012 CommentsClass I 1. Aspirin should be administered to UA/NSTEMI patients as soon as possible after hospital presentation and continued indefinitely in patients who tolerate it.59–66(Level of Evidence: A)2011 recommendation remains current. 2. A loading dose followed by daily maintenance dose of either clopidogrel13,67,68(Level of Evidence: B), prasugrel* (in PCI-treated patients)7(Level of Evidence: C), or ticagrelor†9(Level of Evidence: C) should be administered to UA/NSTEMI patients who are unable to take aspirin because of hypersensitivity or major GI intolerance.2011 recommendation modified (included prasugrel and ticagrelor). 3. Patients with definite UA/NSTEMI at medium or high risk and in whom an initial invasive strategy is selected (Appendix 6) should receive dual antiplatelet therapy on presentation.13,16,45,69(Level of Evidence: A) Aspirin should be initiated on presentation.59,61–66(Level of Evidence: A) The choice of a second antiplatelet therapy to be added to aspirin on presentation includes 1 of the following (note that there are no data for therapy with 2 concurrent P2Y12 receptor inhibitors, and this is not recommended in the case of aspirin allergy):2011 recommendation modified (included ticagrelor). Before PCI: Clopidogrel13,16(Level of Evidence: B); orTicagrelor†9(Level of Evidence: B); orAn IV GP IIb/IIIa inhibitor.45,50,51,70,71(Level of Evidence: A) IV eptifibatide and tirofiban are the preferred GP IIb/IIIa inhibitors.50,51(Level of Evidence: B) At the time of PCI: Clopidogrel if not started before PCI13,16(Level of Evidence: A); orPrasugrel*7(Level of Evidence: B); orTicagrelor†9(Level of Evidence: B); orAn IV GP IIb/IIIa inhibitor.46,50,51(Level of Evidence: A) 4. For UA/NSTEMI patients in whom an initial conservative (ie, noninvasive) strategy is selected, clopidogrel or ticagrelor† (loading dose followed by daily maintenance dose) should be added to aspirin and anticoagulant therapy as soon as possible after admission and administered for up to 12 months.9,10,13(Level of Evidence: B)2011 recommendation modified (included ticagrelor and changed duration of therapy to “up to 12 months”). 5. For UA/NSTEMI patients in whom an initial conservative strategy is selected, if recurrent symptoms/ischemia, heart failure, or serious arrhythmias subsequently appear, then diagnostic angiography should be performed.55,72(Level of Evidence: A) Either an IV GP IIb/IIIa inhibitor (eptifibatide or tirofiban46,50,51[Level of Evidence: A]), clopidogrel (loading dose followed by daily maintenance dose13[Level of Evidence: B]), or ticagrelor† (loading dose followed by daily maintenance dose9[Level of Evidence: B]) should be added to aspirin and anticoagulant therapy before diagnostic angiography (upstream). (Level of Evidence: C)2011 recommendation modified (included ticagrelor). 6. A loading dose of P2Y12 receptor inhibitor therapy is recommended for UA/NSTEMI patients for whom PCI is planned.‡ One of the following regimens should be used:2011 recommendation modified (included ticagrelor and changed loading dose of clopidogrel and associated level of evidence to be concordant with 2011 PCI guideline75). a. Clopidogrel 600 mg should be given as early as possible before or at the time of PCI32,73,74(Level of Evidence: B) or b. Prasugrel* 60 mg should be given promptly and no later than 1 hour after PCI once coronary anatomy is defined and a decision is made to proceed with PCI7(Level of Evidence: B) or c. Ticagrelor† 180 mg should be given as early as possible before or at the time of PCI.9(Level of Evidence: B) 7. The duration and maintenance dose of P2Y12 receptor inhibitor therapy should be as follows:2011 recommendation modified (included ticagrelor; a footnote added pertaining to recommended aspirin maintenance dose). a. In UA/NSTEMI patients undergoing PCI, either clopidogrel 75 mg daily,13,16 prasugrel* 10 mg daily,7 or ticagrelor† 90 mg twice daily9 should be given for at least 12 months. (Level of Evidence: B) b. If the risk of morbidity because of bleeding outweighs the anticipated benefits afforded by P2Y12 receptor inhibitor therapy, earlier discontinuation should be considered. (Level of Evidence: C)Class IIa 1. For UA/NSTEMI patients in whom an initial conservative strategy is selected and who have recurrent ischemic discomfort with aspirin, a P2Y12 receptor inhibitor (clopidogrel or ticagrelor), and anticoagulant therapy, it is reasonable to add a GP IIb/IIIa inhibitor before diagnostic angiography. (Level of Evidence: C)2007 recommendation modified (“clopidogrel” replaced with “P2Y12” receptor inhibitor [clopidogrel or ticagrelor]). 2. For UA/NSTEMI patients in whom an initial invasive strategy is selected, it is reasonable to omit administration of an IV GP IIb/IIIa inhibitor if bivalirudin is selected as the anticoagulant and at least 300 mg of clopidogrel was administered at least 6 hours earlier than planned catheterization or PCI.57,76,77(Level of Evidence: B)2011 recommendation remains current.Class IIb 1. For UA/NSTEMI patients in whom an initial conservative (ie, noninvasive) strategy is selected, it may be reasonable to add eptifibatide or tirofiban to anticoagulant and oral antiplatelet therapy.50,51(Level of Evidence: B)2007 recommendation remains current. 2. Prasugrel* 60 mg may be considered for administration promptly upon presentation in patients with UA/NSTEMI for whom PCI is planned, before definition of coronary anatomy if both the risk for bleeding is low and the need for CABG is considered unlikely.7,8,78(Level of Evidence: C)2011 recommendation remains current. 3. The use of upstream GP IIb/IIIa inhibitors may be considered in high-risk UA/NSTEMI patients already receiving aspirin and a P2Y12 receptor inhibitor (clopidogrel or ticagrelor) who are selected for an invasive strategy, such as those with elevated troponin levels, diabetes, or significant ST-segment depression, and who are not otherwise at high risk for bleeding.50,51,55,56,58(Level of Evidence: B)2011 recommendation modified (“clopidogrel” replaced with “P2Y12” receptor inhibitor [clopidogrel or ticagrelor]). 4. In patients with definite UA/NSTEMI undergoing PCI as part of an early invasive strategy, the use of a loading dose of clopidogrel of 600 mg, followed by a higher maintenance dose of 150 mg daily for 6 days, then 75 mg daily may be reasonable in patients not considered at high risk for bleeding.32(Level of Evidence: B)2011 recommendation remains current.Class III: No Benefit 1. Abciximab should not be administered to patients in whom PCI is not planned.46,71(Level of Evidence: A)2007 recommendation remains current. 2. In UA/NSTEMI patients who are at low risk for ischemic events (eg, TIMI risk score ≤2) or at high risk of bleeding and who are already receiving aspirin and a P2Y12 receptor inhibitor, upstream GP IIb/IIIa inhibitors are not recommended.56,57,78(Level of Evidence: B)2011 recommendation modified (“clopidogrel” replaced with “P2Y12 receptor inhibitor”).Class III: Harm 1. In UA/NSTEMI patients with a prior history of stroke and/or TIA for whom PCI is planned, prasugrel* is potentially harmful as part of a dual antiplatelet therapy regimen.7(Level of Evidence: B)2011 recommendation remains current.*Patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10-mg once-daily maintenance dose. Consideration should be given to lowering the maintenance dose to 5 mg in patients who weigh <60 kg, although the effectiveness and safety of the 5-mg dose have not been studied prospectively. For post-PCI patients, a daily maintenance dose should be given for at least 12 months for patients receiving DES and up to 12 months for patients receiving BMS unless the risk of bleeding outweighs the anticipated net benefit afforded by a P2Y12 receptor inhibitor. Do not use prasugrel in patients with active pathological bleeding or a history of TIA or stroke. In patients age ≥75 years, prasugrel is generally not recommended because of the increased risk of fatal and intracranial bleeding and uncertain benefit except in high-risk situations (patients with diabetes or a history of prior myocardial infarction), in which its effect appears to be greater and its use may be considered. Do not start prasugrel in patients likely to undergo urgent CABG. When possible, discontinue prasugrel at least 7 days before any surgery.8 Additional risk factors for bleeding include body weight <60 kg, propensity to bleed, and concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, or chronic use of nonsteroidal anti-inflammatory drugs).8†The recommended maintenance dose of aspirin to be used with ticagrelor is 81 mg daily.11 Ticagrelor's benefits were observed irrespective of prior therapy with clopidogrel. 9 When possible, discontinue ticagrelor at least 5 days before any surgery.12 Issues of patient compliance may be especially important. Consideration should be given to the potential and as yet undetermined risk of intracranial hemorrhage in patients with prior stroke or TIA.‡Applies to patients who were not treated chronically with these medications.BMS indicates bare-metal stent; CABG, coronary artery bypass graft; DES, drug-eluting stent; GI, gastrointestinal; GP, glycoprotein; IV, intravenous; PCI, percutaneous coronary intervention; TIA, transient ischemic attack; TIMI, Thrombolysis In Myocardial Infarction; and UA/NSTEMI, unstable
BACKGROUND:The HEART score uses elements from patient History, Electrocardiogram, Age, Risk Factors, and Troponin to obtain a risk score on a 0- to 10-point scale for predicting acute coronary syndromes (ACS). This investigation seeks to improve on the HEART score by proposing the HEARTS(3) score, which uses likelihood ratio analysis to give appropriate weight to the individual elements of the HEART score as well as incorporating 3 additional "S" variables: Sex, Serial 2-hour electrocardiogram, and Serial 2-hour delta troponin during the initial emergency department valuation. METHODS:This is a retrospective analysis of a prospectively acquired database consisting of 2148 consecutive patients with non-ST-segment elevation chest pain. Interval analysis of likelihood ratios was performed to determine appropriate weighting of the individual elements of the HEART(3) score. Primary outcomes were 30-day ACS and myocardial infarction. RESULTS:There were 315 patients with 30-day ACS and 1833 patients without ACS. Likelihood ratio analysis revealed significant discrepancies in weight of the 5 individual elements shared by the HEART and HEARTS(3) score. The HEARTS(3) score outperformed the HEART score as determined by comparison of areas under the receiver operating characteristic curve for myocardial infarction (0.958 vs 0.825; 95% confidence interval difference in areas, 0.105-0.161) and for 30-day ACS (0.901 vs 0.813; 95% confidence interval difference in areas, 0.064-0.110). CONCLUSION:The HEARTS(3) score reliably risk stratifies patients with chest pain for 30-day ACS. Prospective studies need to be performed to determine if implementation of this score as a decision support tool can guide treatment and disposition decisions in the management of patients with chest pain.
This document has been developed as an Expert Consensus Document (ECD) by the American College of Cardiology Foundation (ACCF), American Association for Clinical Chemistry (AACC), American College of Chest Physicians (ACCP), American College of Emergency Physicians (ACEP), American College of