Patients received concomitant anticoagulant and aspirin and were randomized to 6 weeks versus 6 months of clopidogrel. There was no difference between the 2 groups in terms of the primary composite endpoint of death, MI, definite stent thrombosis, stroke, or TIMI major bleeding or in terms of the secondary bleeding endpoint of TIMI major bleeding at 9 The Bern PCI RegistryS7.4-10 is a pro- spective registry of consecutive patients who have undergone PCI for stable coronary artery disease or ACS at Bern University Hospital since 2009. Among patients who were discharged on triple therapy, there was no difference between 1 month versus >1 month of triple therapy in the primary composite endpoint of cardiac death, MI, stroke, definite stent thrombosis, or TIMI major bleeding at 1 year.S7.4-10 Although both the ISAR-TRIPLE trial and the Bern PCI Registry have limitations, the consistent find- ing in both patients with ACS and patients with stable ischemic heart disease suggests that with current drug-eluting stents, selecting bare metal stents to shorten the duration of DAPT is no longer indicated. Of the patients treated with triple therapy for 1 month in the Bern PCI Registry, 60% were treated with a current-gen- eration drug-eluting stent. 7.12. Device Detection of AF and Atrial Flutter (New) Recommendations for Device Detection of AF and Atrial Flutter Referenced studies that support new recommendations are summarized in Online Data Supplement 9.


Device Detection of AF and Atrial Flutter (New) Recommendations for Device Detection of AF and Atrial Flutter Referenced studies that support new recommendations are summarized in Online Data Supplement 9. COR LOE Recommendations I B-NR In patients with cardiac implantable electronic devices (pacemakers or implanted cardioverter-defibrillators), the presence of recorded atrial high-rate episodes (AHREs) should prompt further evaluation to document clinically relevant AF to guide IIa B-R In patients with cryptogenic stroke (ie, stroke of unknown cause) in whom external ambulatory monitoring is inconclusive, implantation of a cardiac monitor (loop recorder) is reasonable to optimize detection of silent AF.S7.12-6 Recommendation-Specific Supportive Text (New) 1. Patients with AHREs detected by implanted devices are at increased risk of stroke and abun- dant data now link device-detected atrial tachy- cardia or AF (or AHREs) with the development of thromboembolic events.S7.12-1 S7.12-5 Remote monitoring with AHRE alerts increases the likeli- hood of detecting silent AF. However, it is unclear whether patients with AHREs benefit from oral anticoagulation. Careful review of stored electro- grams may confirm the presence of AF and rule out false positive events. Occasionally, the addi- tion of extended external electrocardiographic monitoring may be needed if data from the implanted device are uncertain. Prospective clini- cal trials of prophylactic anticoagulation based on device-detected AF are under way but have not been completed. Although increased duration of AHREs is associated with increased stroke risk, the threshold duration of AHREs that warrants anticoagulation is unclear. Current approaches factor in the duration of device-detected AF and the patient s stroke risk profile, bleeding risk, and preferences to determine whether to initiate long-term anticoagulation. 2. The cause of ischemic stroke remains unknown in 20% to 40% of patients, leading to a diag- nosis of cryptogenic stroke.


The cause of ischemic stroke remains unknown in 20% to 40% of patients, leading to a diag- nosis of cryptogenic stroke. Prolonged electrocar- diogram monitoring with an implantable cardiac monitor in these patients (age >40 years) has the advantage of increasing the likelihood of detect- ing silent AF that would escape detection with short-term monitoring. A recent RCT established CLINICAL STATEMENTS AND GUIDELINES the superiority of an implantable cardiac monitor over conventional monitoring for detecting silent AF, a finding with major clinical ramifications for A role in screening for silent AF may also exist for remote electrocardiographic acquisition and transmission with a smart worn or handheld WiFi-enabled device with remote 7.13. Weight Loss (New) Recommendation for Weight Loss in Patients with AF Referenced studies that support the new recommendation are summarized in Online Data Supplement 10. COR LOE Recommendation I B-R For overweight and obese patients with AF, weight loss, combined with risk factor modification, is recommended.S7.13-1 S7.13-3 NEW: New data demonstrate the beneficial effects of weight loss and risk factor modification on controlling AF. Recommendation-Specific Supportive Text (New) 1. Obesity is associated with atrial electrostructural One RCT dem- onstrated that a structured weight management program for obese patients (body mass index >27) with symptomatic AF reduced symptom burden and severity and reduced the number of AF episodes and their cumulative duration when compared with attempts to optimally manage risk factors alone.S7.13-1 Risk factor modification included assessment and treatment of underly- ing sleep apnea, hypertension, hyperlipidemia, glucose intolerance, and alcohol and tobacco use.


Obesity is associated with atrial electrostructural One RCT dem- onstrated that a structured weight management program for obese patients (body mass index >27) with symptomatic AF reduced symptom burden and severity and reduced the number of AF episodes and their cumulative duration when compared with attempts to optimally manage risk factors alone.S7.13-1 Risk factor modification included assessment and treatment of underly- ing sleep apnea, hypertension, hyperlipidemia, glucose intolerance, and alcohol and tobacco use. A second nonrandomized observational study reported improved outcomes of AF catheter abla- tion among obese patients who enrolled in a weight loss program.S7.13-2 Observational studies have revealed that the degree of improvement in the AF type and symptoms were related to the degree of weight loss.S7.13-3,S7.13-8 Taken together, these studies support a treatment approach that addresses the risk factors for AF.


A second nonrandomized observational study reported improved outcomes of AF catheter abla- tion among obese patients who enrolled in a weight loss program.S7.13-2 Observational studies have revealed that the degree of improvement in the AF type and symptoms were related to the degree of weight loss.S7.13-3,S7.13-8 Taken together, these studies support a treatment approach that addresses the risk factors for AF. ACC/AHA TASK FORCE MEMBERS Glenn N. Levine, MD, FACC, FAHA, Chair; Patrick T. O Gara, MD, MACC, FAHA, Chair-Elect; Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair*; Sana M. Al-Khatib, MD, MHS, FACC, FAHA; Joshua A. Beckman, MD, MS, FAHA; Kim K. Birtcher, PharmD, MS, AACC; Biykem Bozkurt, MD, PhD, FACC, FAHA*; Ralph G. Brindis, MD, MPH, MACC*; Joaquin E. Cigarroa, MD, FACC; Lesley H. Curtis, PhD, FAHA*; Anita Deswal, MD, MPH, FACC, FAHA; Lee A. Fleisher, MD, FACC, FAHA; Federico Gentile, MD, FACC; Samuel Gidding, MD, FAHA*; Zachary D. Goldberger, MD, MS, FACC, FAHA; Mark A. Hlatky, MD, FACC, FAHA; John Ikonomidis, MD, PhD, FAHA*; Jos A. Joglar, MD, FACC, FAHA; Laura Mauri, MD, MSc, FAHA*; Mariann R. Piano, RN, PhD, FAAN, FAHA; Susan J. Pressler, PhD, RN, FAHA*; Barbara Riegel, PhD, RN, FAHA*; Duminda N. Wijeysundera, MD, PhD PRESIDENTS AND STAFF American College of Cardiology C. Michael Valentine, MD, FACC, President Timothy W. Attebery, DSc, MBA, FACHE, Chief Execu- tive Officer William J. Oetgen, MD, MBA, FACC, FACP, Executive Vice President, Science, Education, Quality, and Pub- lishing MaryAnne Elma, MPH, Senior Director, Science, Educa- tion, Quality, and Publishing Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing American College of Cardiology/ American Heart Association Katherine A. Sheehan, PhD, Director, Guideline Strat- egy and Operations Abdul R. Abdullah, MD, Senior Manager, Guideline Science Thomas S. D. Getchius, Manager, Guideline Science Zainab Shipchandler, MPH, Associate Guideline Advisor American Heart Association Ivor J. Benjamin, MD, President Nancy Brown, Chief Executive Officer Rose Marie Robertson, MD, FAHA, Chief Science and Medicine Officer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations Anne Leonard, MPH, RN, CCRC, FAHA, Senior Science and Medicine Advisor, Office of Science Operations Jody Hundley, Production and Operations Manager, Sci- entific Publications, Office of Science Operations ARTICLE INFORMATION This document was approved by the American College of Cardiology Clinical Policy Approval Committee, the American Heart Association Science Advisory and Coordinating Committee, and the Heart Rhythm Society Board of Trustees *Former Task Force member; current member during the writing effort.


CLINICAL STATEMENTS AND GUIDELINES in September 2018, and the American Heart Association Executive Committee in January 2019. Supplemental materials are available with this article at https://www. ahajournals.org/doi/suppl/10.1161/CIR.0000000000000665. This article has been copublished in the Journal of the American College of Cardiology and HeartRhythm. Copies: This document is available on the websites of the American College of Cardiology (www.acc.org), the American Heart Association (professional. heart.org), and the Heart Rhythm Society (www.hrsonline.org). A copy of the document is also available at https://professional.heart.org/statements by selecting the Guidelines & Statements button. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. The expert peer review of AHA-commissioned documents (eg, scientific statements, clinical practice guidelines, systematic reviews) is conducted by the AHA Office of Science Operations. For more on AHA statements and guide- lines development, visit https://professional.heart.org/statements. Select the Guidelines & Statements drop-down menu near the top of the web page, then click Publication Development. Permissions: Multiple copies, modification, alteration, enhancement, and/ or distribution of this document are not permitted without the express permis- sion of the American Heart Association. Instructions for obtaining permission are located at https://www.heart.org/permissions. A link to the Copyright Per- missions Request Form appears in the second paragraph (https://www.heart. org/en/about-us/statements-and-policies/copyright-request-form). REFERENCES PREAMBLE P-1. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, Institute of Medicine (US). Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. P-2. Committee on Standards for Systematic Reviews of Comparative Effectiveness Research, Institute of Medicine (US). Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: National Academies Press; 2011. P-3. Anderson JL, Heidenreich PA, Barnett PG, et al. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. Circulation.


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Long-term effect of goal-directed weight management in an atrial fibrillation cohort: a long-term follow-up study (LEGACY). J Am Coll Cardiol. 2015;65:2159 69. S7.13-4. Abed HS, Samuel CS, Lau DH, et al. Obesity results in progressive atrial structural and electrical remodeling: implications for atrial fibrillation. Heart Rhythm. 2013;10:90 100. S7.13-5. Wang TJ, Parise H, Levy D, et al. Obesity and the risk of new-onset atrial fibrillation. JAMA. 2004;292:2471 7. S7.13-6. Wong CX, Ganesan AN, Selvanayagam JB. Epicardial fat and atrial fibrillation: current evidence, potential mechanisms, clinical implica- tions, and future directions. Eur Heart J. 2017;38:1294 302. S7.13-7. Wong CX, Abed HS, Molaee P, et al. Pericardial fat is associated with atrial fibrillation severity and ablation outcome. J Am Coll Cardiol. 2011;57:1745 51. S7.13-8. Middeldorp ME, Pathak RK, Meredith M, et al. PREVEntion and regReSsive Effect of weight-loss and risk factor modification on Atrial Fibrillation: the REVERSE-AF study. Europace. 2018;20:1929 35. CLINICAL STATEMENTS AND GUIDELINES Appendix 1.


PREVEntion and regReSsive Effect of weight-loss and risk factor modification on Atrial Fibrillation: the REVERSE-AF study. Europace. 2018;20:1929 35. CLINICAL STATEMENTS AND GUIDELINES Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation (July 2018) Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Voting Recusals by Section* Craig T. January Chair University of Wisconsin- Madison Professor of Medicine, Cardiovascular Medicine Division None None None None None None None L. Samuel Wann Vice Chair Columbia St. Mary s Cardiovascular Physicians Clinical Cardiologist Astellas None None None None None None Hugh Calkins Johns Hopkins Hospital Professor of Medicine, Director of Electrophysiology Abbott AltaThera AtriCure Boehringer Ingelheim King Pharmaceuticals, Inc. (Pfizer) Medtronic St. Jude Medical None None Boehringer Ingelheim Boston Scientific St. Jude Medical Lin Y. Chen University of Minnesota Medical School, Cardiovascular Division Associate Professor of Medicine None None None None None None None Joaquin E. Cigarroa Oregon Health & Science University Professor of Medicine; Clinical Chief of Knight Cardiovascular Institute Division Head of Cardiology None None None None None None None Joseph C. Cleveland, Jr University of Colorado Professor of Surgery; Denver Veteran s Administration Hospital Chief, Cardiac Surgery None None None St. Jude Medical None None 4.4.1, 4.4.2, 6.3.4, Patrick T. Ellinor Massachusetts General Hospital Heart Center, Cardiac Arrhythmia Service Director Bayer None None Bayer None None 4.1.1, 4.2.2.2, 4.3, Michael D. Ezekowitz Sidney Kimmel Medical College at Thomas Jefferson University Professor of Medicine; Lankenau Medical Center, Bryn Mawr Hospital Attending Cardiologist Armetheon Bayer Boehringer Ingelheim Bristol-Myers Squibb Coherex Daiichi-Sankyo Janssen Pharmaceuticals Johnson & Johnson Medtronic Merck Pfizer Portola Pharmaceuticals Sanofi-aventis None None Boehringer Ingelheim (PI) Pfizer (PI) Portola Pharmaceuticals Michael E. Field Medical University of South Carolina and Ralph H. Johnson VA Medical Center Associate Professor of Medicine None None None None None None None Karen L. Furie Rhode Island Hospital, the Miriam Hospital and Bradley Hospital Neurologist-in-Chief; The Warren Alpert Medical School of Brown University Chair of Neurology None None None None None None None Paul A. Heidenreich Stanford VA Palo Alto Health Care System Professor of Medicine None None None None None None None Katherine T. Murray Vanderbilt University School of Medicine, Divisions of Clinical Pharmacology and Cardiology Professor of Medicine None None Metabolic Technologies, Inc. None None None None Julie B. Shea Brigham and Women s Hospital Medtronic St. Jude Medical None None None None None 4.4.1, 4.4.2, 7.4, (Continued) CLINICAL STATEMENTS AND GUIDELINES Cynthia M. Tracy George Washington University Medical Center Associate Director and Professor of Medicine None None None None None None None Clyde W. Yancy Northwestern University, Feinberg School of Medicine Magerstadt Professor of Medicine; Division of Cardiology Chief None None None None None None None This 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 $5000 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 ACC/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. The Atrial Fibrillation Guideline was initiated in September 2016. Over the initial years of the CMS Open Payment System, understandably, there have been many issues related to the accurate reporting of food and beverage payments. For this reason, the ACC and AHA have not considered these minor charges relevant relationships with industry.


For this reason, the ACC and AHA have not considered these minor charges relevant relationships with industry. *Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply. Significant relationship. No financial benefit. CMS reported payments related to medical education from Medtronic Vascular to a third party, University of Minnesota Foundation, under Dr. Chen s name in 2016. Medtronic has confirmed that there was no payment made to Dr. Chen, and the entry was made in error. The sections authored by Dr. Chen have been reviewed, and it was affirmed that there was no implication of any influence of industry. ACC indicates American College of Cardiology; AHA, American Heart Association; CMS, Centers for Medicare & Medicaid Services; HRS, Heart Rhythm Society; PI, principal investigator; and VA, Veterans Affairs. Appendix 1. Continued Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Voting Recusals by Section* CLINICAL STATEMENTS AND GUIDELINES Appendix 2. Abbreviated Reviewer Relationships With Industry and Other Entities 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/ HRS Guideline for the Management of Patients With Atrial Fibrillation (August 2018)* Reviewer Representation Employment Comprehensive RWI? Samuel C. Dudley, Jr Official Reviewer AHA University of Minnesota Director, Cardiology Division Yes Federico Gentile Official Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Centro Cardiologico Gentile No Augustus O.


Samuel C. Dudley, Jr Official Reviewer AHA University of Minnesota Director, Cardiology Division Yes Federico Gentile Official Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Centro Cardiologico Gentile No Augustus O. Grant Official Reviewer AHA Duke University School of Medicine Professor of Medicine; Vice Dean, Faculty Enrichment No Eric Stecker Official Reviewer ACC Science and Quality Committee OHSU Associate Professor of Medicine, Division of Cardiovascular Medicine, School of Medicine Yes Eugene Yang Official Reviewer ACC Board of Governors University of Washington School of Medicine Yes James R. Edgerton Organizational Reviewer STS The Heart Hospital Baylor Director of Education Yes Fred Morady Organizational Reviewer HRS University of Michigan McKay Professor of Cardiovascular Disease and Professor of Medicine Yes Hakan Oral Organizational Reviewer HRS University of Michigan Hospital Frederick G. L. Huetwell Professor of Cardiovascular Medicine; Director, Cardiac Arrhythmia Service Yes Sana M. Al-Khatib Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Duke Clinical Research Institute Professor of Medicine Yes Joseph S. Alpert Content Reviewer University of Arizona Health Sciences Center Professor of Medicine; Head, Department of Medicine Yes Anastasia L. Armbruster Content Reviewer ACC Surgeons Council St. Louis College of Pharmacy Associate Professor, Department of Pharmacy Practice No Nisha Bansal Content Reviewer University of Washington Associate Professor, Division of Nephrology; Associate Program Director, Nephrology Fellowship Yes Coletta Barrett Content Reviewer AHA/ACC Lay Reviewer Our Lady of the Lake Regional Medical Center Vice President, Mission No Kim K. Birtcher Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines University of Houston College of Pharmacy Clinical Professor Yes John A. Bittl Content Reviewer Ocala Heart Institute; Munroe Regional Medical Center No Yong-Mei Cha Content Reviewer Mayo Clinic, Division of Cardiovascular Diseases No Jamie B. Conti Content Reviewer University of Florida Professor of Medicine (Cardiology); Chief, Division of Cardiovascular Diseases, Department of Medicine Yes Anita Deswal Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Baylor College of Medicine Professor of Medicine; Michael E. DeBakey VA Medical Center Chief of Cardiology Yes Michael S. Firstenberg Content Reviewer ACC Surgeons Council The Summa Health System Yes Zachary D. Goldberger Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines University of Wisconsin School of Medicine and Public Health Associate Professor of Medicine, Division of Cardiovascular Medicine/Electrophysiology No Maya E. Guglin Content Reviewer ACC HF and Transplant Section Leadership Council University of Kentucky Professor of Medicine; Director, Mechanical Assisted Circulation, Gill Heart Institute Yes Jonathan L. Halperin Content Reviewer Mount Sinai Medical Center Professor of Medicine Yes Jos A. Joglar Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines UT Southwestern Medical Center University Associate Professor of Internal Medicine No Gautam Kumar Content Reviewer ACC Interventional Section Leadership Council Emory University; Atlanta VA Medical Center Yes Valentina Kutyifa Content Reviewer ACC EP Section Leadership Council University of Rochester Medical Center Associate Professor of Medicine Yes Glenn N. Levine Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Baylor College of Medicine Professor of Medicine; Michael E. DeBakey Medical Center Director, Cardiac Care Unit Yes Grace Lin Content Reviewer ACC HF and Transplant Section Leadership Council Mayo Clinic; Mayo Foundation Yes Gregory Y. H. Lip Content Reviewer University of Birmingham Centre For Cardiovascular Sciences Yes (Continued) CLINICAL STATEMENTS AND GUIDELINES Patrick T. O Gara Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Harvard Medical School Prof of Medicine; Brigham and Women s Hospital Director, Strategic Planning Yes Ratika Parkash Content Reviewer Dalhousie University and Nova Scotia Health Authority Professor of Medicine, Division of Cardiology (Arrhythmia); Director of Research, Division of Cardiology Yes Mariann Piano Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Vanderbilt University School of Nursing Nancy and Hilliard Travis Professor of Nursing; Senior Associate Dean for Research Yes Win-Kuang Shen Content Reviewer Mayo Clinic Arizona, Phoenix Campus Professor of Medicine; Consultant No Giuseppe Stabile Content Reviewer Clinica Mediterranea, Naples, Italy Yes William G. Stevenson Content Reviewer Vanderbilt Medical Center Director, Director of Arrhythmia Research Yes James Tisdale Content Reviewer AHA Purdue University Professor, College of Pharmacy; Indiana University School of Medicine Adjunct Professor Yes Shane Tsai Content Reviewer ACC Adult Congenital and Pediatric Cardiology Section Leadership Council University of Nebraska Medical Center Assistant Professor, Internal Medicine and Pediatrics, Division of Cardiovascular Medicine; Section Chief, Electrophysiology Yes Kathryn Wood Content Reviewer AHA Emory University Associate Professor, Nell Hodgson Woodruff School of Nursing No This table represents all relationships of reviewers with industry and other entities that were reported at the time of peer review, including those not deemed to be relevant to this document, at the time this document was under review.


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 $5000 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. Names are listed in alphabetical order within each category of review. Please refer to http://www.acc.org/guidelines/ about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees. *Detailed reviewer disclosures can be found at this link: https://www.ahajournals.org/doi/suppl/10.1161/CIR.0000000000000665. ACC indicates American College of Cardiology; AHA, American Heart Association; EP, electrophysiology; HF, heart failure; HRS, Heart Rhythm Society; OHSU, Oregon Health & Science University; RWI, relationships with industry and other entities; STS, Society of Thoracic Surgeons; UT, University of Texas; and VA, Veterans Affairs. Appendix 2. Continued Reviewer Representation Employment Comprehensive RWI?


2015 ACC/AHA/SCAI Focused Update 2015 by the American College of Cardiology Foundation, the American Heart Association, Inc., and the Society for Cardiovascular Angiography and Interventions. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIR.0000000000000336 *Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry may apply; see Appendixes 1 and 2 for detailed information. ACC/AHA Representative. SCAI Representative. ACC/AHA Task Force on Clinical Practice Guidelines Liaison. Dr. Deborah D. Ascheim accepted a position at Capricor Therapeutics in August 2015, after the writing effort was completed. In accordance with ACC/AHA policy, she recused herself from the final voting process. ACP Representative. #ACEP Representative. **Former Task Force member; current member during the writing effort. This document was approved by the American College of Cardiology Board of Trustees and Executive Committee, the American Heart Association Science Advisory and Coordinating Committee, and the Society of Cardiovascular Angiography and Interventions in September 2015, and by the American Heart Association Executive Committee in October 2015. The online-only Comprehensive RWI Data Supplement table is available with this article at http://circ.ahajournals.org/lookup/suppl/ doi:10.1161/CIR.0000000000000336/-/DC1. The online-only Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000336/-/DC2. TheAmerican HeartAssociation requests that this document be cited as follows: Levine GN, O Gara PT, Bates ER, Blankenship JC, Kushner FG,Ascheim DD, Bailey SR, Bittl JA, Brindis RG, Casey DE Jr, Cercek B, Chambers CE, Chung MK, de Lemos JA, Diercks DB, Ellis SG, Fang JC, Franklin BA, Granger CB, Guyton RA, Hollenberg SM, Khot UN, Krumholz HM, Lange RA, Linderbaum JA, Mauri L, Mehran R, Morrow DA, Moussa ID, Mukherjee D, Newby LK, Ornato JP, Ou N, Radford MJ,Tamis-Holland JE,Ting HH,Tommaso CL,Tracy CM,WooYJ, Zhao DX.


TheAmerican HeartAssociation requests that this document be cited as follows: Levine GN, O Gara PT, Bates ER, Blankenship JC, Kushner FG,Ascheim DD, Bailey SR, Bittl JA, Brindis RG, Casey DE Jr, Cercek B, Chambers CE, Chung MK, de Lemos JA, Diercks DB, Ellis SG, Fang JC, Franklin BA, Granger CB, Guyton RA, Hollenberg SM, Khot UN, Krumholz HM, Lange RA, Linderbaum JA, Mauri L, Mehran R, Morrow DA, Moussa ID, Mukherjee D, Newby LK, Ornato JP, Ou N, Radford MJ,Tamis-Holland JE,Ting HH,Tommaso CL,Tracy CM,WooYJ, Zhao DX. 2015ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: an update of the 2011ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of theAmerican College of Cardiology/American HeartAssociation Task Force on Clinical Practice Guidelines and the Society for CardiovascularAngiography and Interventions. Circulation. 2016;133:1135 1147. This article has been copublished in the Journal of the American College of Cardiology and Catheterization and Cardiovascular Interventions. Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (my.americanheart.org), and the Society for Cardiovascular Angiography and Interventions (www.scai.org). A copy of the document is available at http:// professional.heart.org/statements by using either Search for Guidelines & Statements or the Browse By Topic area. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements. Select the Guidelines & Statements drop-down menu, then click Publication Development. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright- Permission-Guidelines_UCM_300404_Article.jsp.


Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright- Permission-Guidelines_UCM_300404_Article.jsp. A link to the Copyright Permissions Request Form appears on the right side of the page.


A link to the Copyright Permissions Request Form appears on the right side of the page. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions Endorsed by the Latin American Society of Interventional Cardiology PCI WRITING COMMITTEE* Glenn N. Levine, MD, FACC, FAHA, Chair ; Eric R. Bates, MD, FACC, FAHA, FSCAI, Vice Chair* ; James C. Blankenship, MD, FACC, FAHA, FSCAI, Vice Chair* ; Steven R. Bailey, MD, FACC, FSCAI* ; John A. Bittl, MD, FACC ; Bojan Cercek, MD, FACC, FAHA ; Charles E. Chambers, MD, FACC, FSCAI ; Stephen G. Ellis, MD, FACC* ; Robert A. Guyton, MD, FACC ; Steven M. Hollenberg, MD, FACC* ; Umesh N. Khot, MD, FACC* ; Richard A. Lange, MD, FACC, FAHA ; Laura Mauri, MD, MSc, FACC, FSCAI* ; Roxana Mehran, MD, FACC, FAHA, FSCAI* ; Issam D. Moussa, MD, FACC, FAHA, FSCAI ; Debabrata Mukherjee, MD, FACC, FAHA, FSCAI ; Henry H. Ting, MD, FACC, FAHA STEMI WRITING COMMITTEE* Patrick T. O Gara, MD, FACC, FAHA, Chair ; Frederick G. Kushner, MD, FACC, FAHA, FSCAI, Vice Chair ; Deborah D. Ascheim, MD, FACC ; Ralph G. Brindis, MD, MPH, MACC, FSCAI, FAHA ; Donald E. Casey, Jr, MD, MPH, MBA, FAHA ; Mina K. Chung, MD, FACC, FAHA* ; James A. de Lemos, MD, FACC* ; Deborah B. Diercks, MD, MSc#; James C. Fang, MD, FACC, FAHA* ; 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, FSCAI ; Carl L. Tommaso, MD, FACC, FAHA, MSCAI ; Cynthia M. Tracy, MD, FACC, FAHA ; Y. Joseph Woo, MD, FACC, FAHA ; David X. Zhao, MD, FACC* Table of Contents Preamble 1136 1.


Introduction 1137 1.1. Methodology and Evidence Review 1137 1.2. Organization of the GWC 1137 1.3. Review and Approval 1137 2. Culprit Artery Only Versus Multivessel PCI 1137 3. Aspiration Thrombectomy 1139 References 1140 Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 1142 Appendix 2. Author Relationships With Industry and Other Entities (Relevant) 1143 Appendix 3. Reviewer Relationships With Industry and Other Entities (Relevant) 2015 Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction (Combined Peer Reviewers From 2011 PCI and 2013 STEMI Guidelines) 1145 Preamble To ensure that guidelines reflect current knowledge, avail- able treatment options, and optimum medical care, existing clinical practice guideline recommendations are modified and new recommendations are added in response to new data, medications or devices. To keep pace with evolving evidence, the American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Clinical Practice Guidelines ( Task Force ) has issued this focused update to revise guide- line recommendations on the basis of recently published data. This update is not based on a complete literature review from the date of previous guideline publications, but it has been subject to rigorous, multilevel review and approval, similar to the full guidelines. For specific focused update criteria and additional methodological details, please see the ACC/AHA guideline methodology manual.1 Modernization In response to published reports from the Institute of Medicine2,3 and ACC/AHA mandates,4 7 processes have changed leading to adoption of a knowledge byte format. This entails delineation of recommendations addressing specific clinical questions, fol- lowed by concise text, with hyperlinks to supportive evidence.


This entails delineation of recommendations addressing specific clinical questions, fol- lowed by concise text, with hyperlinks to supportive evidence. This approach better accommodates time constraints on busy clinicians, facilitates easier access to recommendations via electronic search engines and other evolving technology (eg, smart phone apps), and supports the evolution of guidelines as living documents that can be dynamically updated as needed. Intended Use Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular dis- ease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organi- zations may have a broader target. Although guidelines may inform regulatory or payer decisions, they are intended to improve quality of care in the interest of patients. Class of Recommendation and Level of Evidence The Class of Recommendation (COR) and Level of Evidence (LOE) are derived independently of one another according to established criteria. The COR indicates the strength of recommendation, encompassing the estimated magnitude and certainty of benefit of a clinical action in proportion to risk. The LOE rates the quality of scientific evidence sup- porting the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources Relationships With Industry and Other Entities The ACC and AHA sponsor the guidelines without commer- cial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with indus- try or other entities (RWI). All Guideline Writing Committee (GWC) members and reviewers are required to disclose current industry relationships or personal interests from 12 months before initiation of the writing effort.


All Guideline Writing Committee (GWC) members and reviewers are required to disclose current industry relationships or personal interests from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced GWC and assuring that the chair and a majority of committee members have no rele- vant RWI (Appendixes 1 and 2). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is also available online. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic ACC/AHA TASK FORCE MEMBERS Jonathan L. Halperin, MD, FACC, FAHA, Chair; Glenn N. Levine, MD, FACC, FAHA, Chair-Elect; Jeffrey L. Anderson, MD, FACC, FAHA, Immediate Past Chair**; Nancy M. Albert, PhD, RN, FAHA**; Sana M. Al-Khatib, MD, MHS, FACC, FAHA; Kim K. Birtcher, PharmD, MS, AACC; Biykem Bozkurt, MD, PhD, FACC, FAHA; Ralph G. Brindis, MD, MPH, MACC; Joaquin E. Cigarroa, MD, FACC; Lesley H. Curtis, PhD, FAHA; Lee A. Fleisher, MD, FACC, FAHA; Federico Gentile, MD, FACC; Samuel Gidding, MD, FAHA; Mark A. Hlatky, MD, FACC; John Ikonomidis, MD, PhD, FAHA; Jose Joglar, MD, FACC, FAHA; Richard J. Kovacs, MD, FACC, FAHA**; E. Magnus Ohman, MD, FACC**; Susan J. Pressler, PhD, RN, FAHA; Frank W. Sellke, MD, FACC, FAHA**; Win-Kuang Shen, MD, FACC, FAHA**; Duminda N. Wijeysundera, MD, PhD Levine et al 2015 ACC/AHA/SCAI Focused Update on Primary PCI 1137 regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators.


The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic ACC/AHA TASK FORCE MEMBERS Jonathan L. Halperin, MD, FACC, FAHA, Chair; Glenn N. Levine, MD, FACC, FAHA, Chair-Elect; Jeffrey L. Anderson, MD, FACC, FAHA, Immediate Past Chair**; Nancy M. Albert, PhD, RN, FAHA**; Sana M. Al-Khatib, MD, MHS, FACC, FAHA; Kim K. Birtcher, PharmD, MS, AACC; Biykem Bozkurt, MD, PhD, FACC, FAHA; Ralph G. Brindis, MD, MPH, MACC; Joaquin E. Cigarroa, MD, FACC; Lesley H. Curtis, PhD, FAHA; Lee A. Fleisher, MD, FACC, FAHA; Federico Gentile, MD, FACC; Samuel Gidding, MD, FAHA; Mark A. Hlatky, MD, FACC; John Ikonomidis, MD, PhD, FAHA; Jose Joglar, MD, FACC, FAHA; Richard J. Kovacs, MD, FACC, FAHA**; E. Magnus Ohman, MD, FACC**; Susan J. Pressler, PhD, RN, FAHA; Frank W. Sellke, MD, FACC, FAHA**; Win-Kuang Shen, MD, FACC, FAHA**; Duminda N. Wijeysundera, MD, PhD Levine et al 2015 ACC/AHA/SCAI Focused Update on Primary PCI 1137 regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. Related Issues For additional information pertaining to the methodol- ogy for grading evidence, assessment of benefit and harm, shared decision making between the patient and clinician, structure of evidence tables and summaries, standardized terminology for articulating recommendations, organi- zational involvement, peer review, and policies for peri- odic assessment and updating of guideline documents, we encourage readers to consult the ACC/AHA guideline The recommendations in this focused update represent the official policy of the ACC and AHA until superseded by pub- lished addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified.


To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles.1 Jonathan L. Halperin, MD, FACC, FAHA Chair, ACC/AHA Task Force on Clinical Practice Guidelines The scope of this focused update is limited to considerations relevant to multivessel percutaneous coronary intervention (PCI) and thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. 1.1. Methodology and Evidence Review Clinical trials presented at the major cardiology organizations 2013 to 2015 annual scientific meetings and other selected reports published in a peer-reviewed format through August 2015 were reviewed by the 2011 PCI and 2013 STEMI GWCs and the Task Force to identify trials and other key data that might affect guideline recommendations. The information considered important enough to prompt updated recommen- dations is included in evidence tables in the Online Data Supplement. Consult the full-text versions of the 2011 PCI and for recommendations in clini- cal areas not addressed in the focused update. The indi- vidual recommendations in this focused update will be incorporated into future revisions or updates of the full-text guidelines. 1.2. Organization of the GWC For this focused update, representative members of the 2011 PCI and 2013 STEMI GWCs were invited to participate. Members were required to disclose all RWI relevant to the topics under consideration. The entire membership of both GWCs voted on the revised recommendations and text. The latter group was composed of experts representing cardiovascular medicine, interventional cardiology, electrophysiology, heart failure, cardiac surgery, emergency medicine, internal medicine, car- diac rehabilitation nursing, and pharmacy. The GWC included representatives from the ACC, AHA, American College of Physicians, American College of Emergency Physicians, and Society for Cardiovascular Angiography and Interventions (SCAI).


The GWC included representatives from the ACC, AHA, American College of Physicians, American College of Emergency Physicians, and Society for Cardiovascular Angiography and Interventions (SCAI). 1.3. Review and Approval This document was reviewed predominantly by the prior reviewers from the respective 2011 and 2013 guidelines. These included 8 official reviewers jointly nominated by the ACC and AHA, 4 official/organizational reviewers nominated by SCAI, and 25 individual content reviewers. Reviewers RWI information was distributed to the GWC and is published in this document (Appendix 3). This document was approved for publication by the govern- ing bodies of theACC, theAHA, and the SCAI and was endorsed by the Latin American Society of Interventional Cardiology. 2. Culprit Artery Only Versus Multivessel PCI (See Section 5.2.2.2 of 2011 PCI guideline and Section 4.1.1 of 2013 STEMI guideline for additional recommendations.) Approximately 50% of patients with STEMI have multi- PCI options for patients with STEMI and multivessel disease include: 1) culprit artery only primary PCI, with PCI of nonculprit arteries only for spontaneous isch- emia or intermediate- or high-risk findings on predischarge noninvasive testing; 2) multivessel PCI at the time of primary PCI; or 3) culprit artery only primary PCI followed by staged PCI of nonculprit arteries. Observational studies, randomized controlled trials (RCTs), and meta-analyses comparing culprit artery only PCI with multivessel PCI have reported conflict- likely because of differing inclusion criteria, study protocols, timing of multivessel PCI, statistical heterogeneity, and variable endpoints (Data Supplement).


Observational studies, randomized controlled trials (RCTs), and meta-analyses comparing culprit artery only PCI with multivessel PCI have reported conflict- likely because of differing inclusion criteria, study protocols, timing of multivessel PCI, statistical heterogeneity, and variable endpoints (Data Supplement). Previous clinical practice guidelines recommended against PCI of nonculprit artery stenoses at the time of primary PCI in hemodynamically stable patients with STEMI.9,10 Planning for routine, staged PCI of noninfarct artery stenoses on the basis of the initial angiographic findings was not addressed in these previous guidelines, and noninfarct artery PCI was considered only in the limited context of spontaneous isch- emia or high-risk findings on predischarge noninvasive test- ing. The earlier recommendations were based in part on safety concerns, which included increased risks for procedural com- plications, longer procedural time, contrast nephropathy, and stent thrombosis in a prothrombotic and proinflammatory and in part on the findings from many observational studies and meta-analyses of trends toward or statistically sig- nificant worse outcomes in those who underwent multivessel Four RCTs have since suggested that a strategy of multi- vessel PCI, either at the time of primary PCI or as a planned, staged procedure, may be beneficial and safe in selected patients with STEMI17,18,24,27 (Data Supplement). In the PRAMI (Preventive Angioplasty in Acute Myocardial Infarction) trial the composite primary outcome of cardiac death, nonfatal myocardial infarction (MI), or refractory angina occurred in 21 patients (9%) treated with multivessel primary PCI, compared with 53 patients (22%) treated with culprit artery only PCI (HR: 0.35; 95% CI: 0.21 to 0.58; P<0.001). In the CvLPRIT (Complete Versus Culprit-Lesion Only Primary PCI) trial,18 296 patients were randomized to culprit artery only or multivessel PCI during the index hospitaliza- tion (72% underwent multivessel primary PCI).


In the CvLPRIT (Complete Versus Culprit-Lesion Only Primary PCI) trial,18 296 patients were randomized to culprit artery only or multivessel PCI during the index hospitaliza- tion (72% underwent multivessel primary PCI). The compos- ite primary outcome of death, reinfarction, heart failure, and ischemia-driven revascularization at 12 months occurred in 15 patients (10%) who underwent multivessel PCI, compared with 31 patients (21%) receiving culprit artery only PCI (HR: PRIMULTI (Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction) the composite primary outcome of all-cause death, nonfatal MI, or ischemia-driven revascularization of non- culprit artery disease occurred in 40 of 314 patients (13%) who underwent multivessel staged PCI guided by angiogra- phy and fractional flow reserve before discharge, versus 68 of 313 patients (22%) treated with culprit artery only PCI (HR: (Primary Angioplasty in Patients Transferred From General Community Hospitals to Specialized PTCA Units With or Without Emergency Thrombolysis) trial,27 214 patients with Table 1. Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care* (Updated August 2015) Levine et al 2015 ACC/AHA/SCAI Focused Update on Primary PCI 1139 STEMI were randomized to staged (3 to 40 days after the index procedure) revascularization of all 70% diameter stenosis noninfarct lesions or culprit-only PCI. Preliminary results at 38 months mean follow-up showed no between-group differ- ences in the composite primary endpoint of all-cause death, nonfatal MI, and stroke. On the basis of these findings,17,18,24,27 the prior Class III (Harm) recommendation with regard to multivessel primary PCI in hemodynamically stable patients with STEMI has been upgraded and modified to a Class IIb recommendation to include consideration of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure.


On the basis of these findings,17,18,24,27 the prior Class III (Harm) recommendation with regard to multivessel primary PCI in hemodynamically stable patients with STEMI has been upgraded and modified to a Class IIb recommendation to include consideration of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure. The writ- ing committee emphasizes that this change should not be interpreted as endorsing the routine performance of multives- sel PCI in all patients with STEMI and multivessel disease. Rather, when considering the indications for and timing of multivessel PCI, physicians should integrate clinical data, lesion severity/complexity, and risk of contrast nephropathy to determine the optimal strategy. The preceding discussion and recommendations apply to the strategy of routine PCI of noninfarct related arteries in hemodynamically stable patients. Recommendations in the 2013 STEMI guideline with regard to PCI of a non infarct- related artery at a time separate from primary PCI in patients who have spontaneous symptoms and myocardial ischemia or who have intermediate- or high-risk findings on noninva- sive testing (Section 6.3 of that guideline) remain operative. Although several observational studies19,20 and a network have suggested that multivessel staged PCI may be associated with better outcome than multivessel primary PCI, there are insufficient observational data and no randomized data at this time to inform a recommenda- tion with regard to the optimal timing of nonculprit vessel PCI. Additional trial data that will help further clarify this issue are awaited. Issues related to the optimal method of evaluating nonculprit lesions (eg, percent diameter stenosis, fractional flow reserve) are beyond the scope of this focused update. 3. Aspiration Thrombectomy (See Section 5.5.2 of the 2011 PCI guideline and Section 4.2 of the 2013 STEMI guideline for additional recommendations.)


Aspiration Thrombectomy (See Section 5.5.2 of the 2011 PCI guideline and Section 4.2 of the 2013 STEMI guideline for additional recommendations.) Class IIa recommendation for aspiration thrombectomy before primary PCI was based on the results of 2 RCTs29,31,32 and 1 meta-anal- and was driven in large measure by the results of TAPAS (Thrombus Aspiration During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction Study), a single- center study that randomized 1071 patients with STEMI to aspiration thrombectomy before primary PCI or primary PCI Three multicenter trials, 2 of which enrolled signifi- cantly more patients than prior aspiration thrombectomy tri- als, have prompted reevaluation of this recommendation. In the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial of 452 patients with anterior STEMI due to proximal or mid-left anterior descending occlusion, infarct size was not reduced by aspiration thrombectomy before primary PCI. The TASTE (Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction) trial (n=7244) incorporated a unique design that allowed randomization within an exist- ing national registry, resulting in enrollment of a remarkably high proportion of eligible patients.34,36 No significant 30-day or 1-year differences were found between the group that received aspiration thrombectomy before primary PCI and the group that received primary PCI only with regard to death, reinfarc- tion, stent thrombosis, target lesion revascularization, or a com- posite of major adverse cardiac events. The TOTAL (Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI) trial randomized 10,732 patients with STEMI to aspiration thrombectomy before primary PCI or pri- mary PCI only.35 Bailout thrombectomy was performed in 7.1% of the primary PCI only group, whereas the rate of crossover from aspiration thrombectomy before primary PCI to primary PCI only was 4.6%.


The TOTAL (Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI) trial randomized 10,732 patients with STEMI to aspiration thrombectomy before primary PCI or pri- mary PCI only.35 Bailout thrombectomy was performed in 7.1% of the primary PCI only group, whereas the rate of crossover from aspiration thrombectomy before primary PCI to primary PCI only was 4.6%. There were no differences between the 2 treatment groups, either in the primary composite endpoint of cardiovascular death, recurrent MI, cardiogenic shock, or New York Heart Association class IV heart failure at 180 days, or in the individual components of the primary endpoint, stent thrombosis, or target-vessel revascularization. There was a small but statistically significant increase in the rate of stroke in Recommendation 2015 Focused Update Recommendation Comment Class III: Harm Class IIb PCI should not be performed in a noninfarct artery at the time of primary PCI in patients with STEMI who are hemodynamically (Level of Evidence: B) PCI of a noninfarct artery may be considered in selected patients with STEMI and multivessel disease who are hemodynamically stable, either at the time of primary PCI or as a planned staged (Level of Evidence: B-R) Modified recommendation (changed class from III: Harm to IIb and expanded time frame in which multivessel PCI could be performed). PCI indicates percutaneous coronary intervention; and STEMI, ST-elevation myocardial infarction. Recommendation 2015 Focused Update Recommendations Comments Class IIa Class IIb Manual aspiration thrombectomy is reasonable for patients undergoing (Level of Evidence: B) The usefulness of selective and bailout aspiration thrombectomy in patients undergoing primary PCI is not well established.33 37 (Level of Evidence: C-LD) Modified recommendation (Class changed from IIa to IIb for selective and bailout aspiration thrombectomy before PCI).


Recommendation 2015 Focused Update Recommendations Comments Class IIa Class IIb Manual aspiration thrombectomy is reasonable for patients undergoing (Level of Evidence: B) The usefulness of selective and bailout aspiration thrombectomy in patients undergoing primary PCI is not well established.33 37 (Level of Evidence: C-LD) Modified recommendation (Class changed from IIa to IIb for selective and bailout aspiration thrombectomy before PCI). Class III: No Benefit Routine aspiration thrombectomy before primary PCI is not (Level of Evidence: A) New recommenda- tion ( Class III: No Benefit added for routine aspiration thrombectomy before PCI). PCI indicates percutaneous coronary intervention; and LD, limited data. the aspiration thrombectomy group. An updated meta-analysis that included these 3 trials among a total of 17 trials (n=20960) found no significant reduction in death, reinfarction, or stent thrombosis with routine aspiration thrombectomy. Aspiration thrombectomy was associated with a small but nonsignificant increase in the risk of stroke.33 Several previous studies have found that higher thrombus burden in patients with STEMI is independently associated with higher risks of distal embolization, no-reflow phenom- enon, transmural myocardial necrosis, major adverse cardiac events, stent thrombosis, and death.38 42 However, subgroup analyses from the TASTE and TOTAL trials did not suggest rel- ative benefit from aspiration thrombectomy before primary PCI in patients with higher thrombus burden or in patients with ini- tial Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 1 or left anterior descending artery/anterior infarction.34,35 On the basis of the results of these studies, the prior Class IIa recommendation for aspiration thrombectomy has been changed. Routine aspiration thrombectomy before primary PCI is now not recommended (Class III: No Benefit, LOE A). There are insufficient data to assess the potential benefit of a strategy of selective or bailout aspiration thrombectomy (Class IIb, LOE C-LD).


There are insufficient data to assess the potential benefit of a strategy of selective or bailout aspiration thrombectomy (Class IIb, LOE C-LD). Bailout aspiration thrombectomy is defined as thrombectomy that was initially unplanned but was later used during the procedure because of unsatisfactory initial result or procedural complication, analogous to the defi- nition of bailout glycoprotein IIb/IIIa use. It should be noted that the preceding recommendations and text apply only to aspiration thrombectomy; no clini- cal benefit for routine rheolytic thrombectomy has been demonstrated in patients with STEMI undergoing primary Presidents and Staff American College of Cardiology Kim A. Williams, Sr, MD, FACC, FAHA, President Shalom Jacobovitz, Chief Executive Officer William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publications Amelia Scholtz, PhD, Publications Manager, Science, Education, and Quality American College of Cardiology/American Heart Association Lisa Bradfield, CAE, Director, Science and Clinical Policy Abdul R. Abdullah, MD, Associate Science and Medicine Advisor Allison Rabinowitz, Project Manager, Science and Clinical Policy American Heart Association Mark A. Creager, MD, FAHA, FACC, President Nancy Brown, Chief Executive Officer Rose Marie Robertson, MD, FAHA, Chief Science Officer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations Jody Hundley, Production Manager, Scientific Publications, Office of Science Operations References 1. ACCF/AHA Task Force on Practice Guidelines. Methodology Manual and Policies From the ACCF/AHA Task Force on Practice Guidelines. American College of Cardiology and American Heart Association. 2010. Available at: http://assets.cardiosource.com/Methodology_Manual_ for_ACC_AHA_Writing_Committees.pdf and http://my.americanheart. org/idc/groups/ahamah-public/@wcm/@sop/documents/downloadable/ ucm_319826.pdf. Accessed January 23, 2015. 2. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, Institute of Medicine (US). Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. 3. Committee on Standards for Systematic Reviews of Comparative Effectiveness Research, Institute of Medicine (US).