Class III: No Bene t Routine aspiration thrombectomy before primary PCI is not useful (33 37). (Level of Evidence: A) New recommendation ( Class III: No Bene t added for routine aspiration thrombectomy before PCI). PCI indicates percutaneous coronary intervention; and LD, limited data. Levine et al. J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 potential bene t of a strategy of selective or bailout aspiration thrombectomy (Class IIb, LOE C-LD). Bailout aspiration thrombectomy is de ned as thrombectomy that was initially unplanned but was later used during the procedure because of unsatisfactory initial result or procedural complication, analogous to the de nition of bailout glycoprotein IIb/IIIa use. It should be noted that the preceding recommenda- tions and text apply only to aspiration thrombectomy; no clinical bene t for routine rheolytic thrombectomy has been demonstrated in patients with STEMI undergoing primary PCI (30,43,44). PRESIDENTS AND STAFF American College of Cardiology Kim A. Williams, Sr, MD, FACC, FAHA, President Shalom Jacobovitz, Chief Executive Of cer 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 Brad eld, 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 Of cer Rose Marie Robertson, MD, FAHA, Chief Science Of cer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Of ce of Science Operations JodyHundley,ProductionManager,Scienti cPublications, Of ce of Science Operations R E F E R E N C E S 1. ACCF/AHA Task Force on Practice Guidelines.


PRESIDENTS AND STAFF American College of Cardiology Kim A. Williams, Sr, MD, FACC, FAHA, President Shalom Jacobovitz, Chief Executive Of cer 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 Brad eld, 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 Of cer Rose Marie Robertson, MD, FAHA, Chief Science Of cer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Of ce of Science Operations JodyHundley,ProductionManager,Scienti cPublications, Of ce of Science Operations R E F E R E N C E S 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 Trust- worthy Clinical Practice Guidelines, Institute of Medi- cine (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). Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: National Academies Press, 2011. 4. 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/Amer- ican Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:2304 22. 5. Arnett DK, Goodman RA, Halperin JL, et al.


2014;63:2304 22. 5. Arnett DK, Goodman RA, Halperin JL, et al. AHA/ ACC/HHS strategies to enhance application of clinical practice guidelines in patients with cardiovascular disease and comorbid conditions: from the American Heart Association, American College of Cardiology, and U.S. Department of Health and Human Services. J Am Coll Cardiol. 2014;64:1851 6. 6. Jacobs AK, Kushner FG, Ettinger SM, et al. ACCF/AHA clinical practice guideline methodology summit report: a report of the American College of Cardiology Founda- tion/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61:213 65. 7. Jacobs AK, Anderson JL, Halperin JL. The evolution and future of ACC/AHA clinical practice guidelines: a 30- year journey: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64:1373 84. 8. Halperin JL, Levine GN, Al-Khatib SM, et al. Further evolution of the ACC/AHA clinical practice guideline recommendation classi cation system: a report of the American College of Cardiology/American Heart Asso- ciation Task Force on Clinical Practice Guidelines [published online ahead of print September 23, 2015]. J Am Coll Cardiol. 2015, http://dx.doi.org/10.1016/ j.jacc.2015.09.001. 9. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the American College of Car- diology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Car- diovascular Angiography and Interventions. J Am Coll Cardiol. 2011;58:e44 122. 10. O Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61:e78 140. 11. Hannan EL, Samadashvili Z, Walford G, et al.


2013;61:e78 140. 11. Hannan EL, Samadashvili Z, Walford G, et al. Culprit vessel percutaneous coronary intervention versus multivessel and staged percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel disease. J Am Coll Cardiol Intv. 2010;3:22 31. 12. Toma M, Buller CE, Westerhout CM, et al. Non- culprit coronary artery percutaneous coronary inter- vention during acute ST-segment elevation myocardial infarction: insights from the APEX-AMI trial. Eur Heart J. 2010;31:1701 7. 13. Vlaar PJ, Mahmoud KD, Holmes DR Jr., et al. Culprit vessel only versus multivessel and staged percuta- neous coronary intervention for multivessel disease in patients presenting with ST-segment elevation myocardial infarction: a pairwise and network meta- analysis. J Am Coll Cardiol. 2011;58:692 703. 14. Cavender MA, Milford-Beland S, Roe MT, et al. Prevalence, predictors, and in-hospital outcomes of non-infarct artery intervention during primary percuta- neous coronary intervention for ST-segment elevation myocardial infarction (from the National Cardiovascular Data Registry). Am J Cardiol. 2009;104:507 13. 15. Corpus RA, House JA, Marso SP, et al. Multivessel percutaneous coronary intervention in patients with multivessel disease and acute myocardial infarction. Am Heart J. 2004;148:493 500. 16. Dziewierz A, Siudak Z, Rakowski T, et al. Impact of multivessel coronary artery disease and noninfarct- related artery revascularization on outcome of patients with ST-elevation myocardial infarction transferred for primary percutaneous coronary inter- vention (from the EUROTRANSFER Registry). Am J Cardiol. 2010;106:342 7. 17. Engstr m T, Kelb k H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI 3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386:665 71. 18. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel Disease: the CvLPRIT trial.


Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel Disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963 72. 19. Kornowski R, Mehran R, Dangas G, et al. Prognostic impact of staged versus one-time multivessel percutaneous intervention in acute myocardial infarc- tion: analysis from the HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial. J Am Coll Cardiol. 2011;58: 704 11. 20. Manari A, Varani E, Guastaroba P, et al. Long-term outcome in patients with ST segment elevation myocardial infarction and multivessel disease treated with culprit-only, immediate, or staged multivessel percutaneous revascularization strategies: insights J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Levine et al. from the REAL registry. Catheter Cardiovasc Interv. 2014;84:912 22. 21. Politi L, Sgura F, Rossi R, et al. A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up. Heart. 2010;96:662 7. 22. Roe MT, Cura FA, Joski PS, et al. Initial experience with multivessel percutaneous coronary intervention during mechanical reperfusion for acute myocardial infarction. Am J Cardiol. 2001;88:170 3, A6. 23. Varani E, Balducelli M, Aquilina M, et al. Single or multivessel percutaneous coronary intervention in ST-elevation myocardial infarction patients. Catheter Cardiovasc Interv. 2008;72:927 33. 24. Wald DS, Morris JK, Wald NJ, et al. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013;369:1115 23. 25. Sorajja P, Gersh BJ, Cox DA, et al. Impact of mul- tivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction. Eur Heart J. 2007;28:1709 16. 26. Park D-W, Clare RM, Schulte PJ, et al.


2007;28:1709 16. 26. Park D-W, Clare RM, Schulte PJ, et al. Extent, loca- tion, and clinical signi cance of non-infarct-related cor- onary artery disease among patients with ST-elevation myocardial infarction. JAMA. 2014;312:2019 27. 27. Hlinomaz O. Multivessel coronary disease diagnosed at the time of primary PCI for STEMI: complete revas- cularization versus conservative strategy. PRAGUE 13 trial. Available at: http://sbhci.org.br/wp-content/ September 10, 2015. 28. Vlaar PJ, Mahmoud KD, Holmes DR Jr., et al. Culprit vessel only versus multivessel and staged percutaneous coronary intervention for multivessel disease in patients presenting with ST-segment elevation myocardial infarction: a pairwise and network meta-analysis. J Am Coll Cardiol. 2011;58:692 703. 29. Vlaar PJ, Svilaas T, van der Horst IC, et al. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008;371:1915 20. 30. Bavry AA, Kumbhani DJ, Bhatt DL. Role of adjunctive thrombectomy and embolic protection devices in acute myocardial infarction: a comprehen- sive meta-analysis of randomized trials. Eur Heart J. 2008;29:2989 3001. 31. Sardella G, Mancone M, Bucciarelli-Ducci C, et al. Thrombus aspiration during primary percutaneous cor- onary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, ran- domized trial. J Am Coll Cardiol. 2009;53:309 15. 32. Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration during primary percutaneous coronary inter- vention. N Engl J Med. 2008;358:557 67. 33. Elgendy IY, Huo T, Bhatt DL, et al. Is aspiration thrombectomy bene cial in patients undergoing pri- mary percutaneous coronary intervention? Meta- analysis of randomized trials. Circ Cardiovasc Interv. 2015;8:e002258. 34. Fr bert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med.


Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013;369: 1587 97. 35. Jolly SS, Cairns JA, Yusuf S, et al. Randomized trial of primary PCI with or without routine manual throm- bectomy. N Engl J Med. 2015;372:1389 98. 36. Lagerqvist B, Fr bert O, Olivecrona GK, et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med. 2014;371:1111 20. 37. Stone GW, Maehara A, Witzenbichler B, et al. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012;307: 1817 26. 38. Napodano M, Dariol G, Al Mamary AH, et al. Thrombus burden and myocardial damage during primary percutaneous coronary intervention. Am J Cardiol. 2014;113:1449 56. 39. Sianos G, Papafaklis MI, Daemen J, et al. Angio- graphic stent thrombosis after routine use of drug- eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007;50:573 83. 40. Yip HK, Chen M-C, Chang H-W, et al. Angiographic morphologic features of infarct-related arteries and timely reperfusion in acute myocardial infarction: predictors of slow- ow and no-re ow phenomenon. Chest. 2002;122:1322 32. 41. Brener SJ, Dambrink J-H, Maehara A, et al. Bene ts of optimising coronary ow before stenting in primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from INFUSE-AMI. EuroIntervention. 2014;9:1195 201. 42. Costa RA, Abizaid A, Lotan C, et al. Impact of thrombus burden on outcomes after standard versus mesh-covered stents in acute myocardial infarction (from the MGuard for acute ST elevation reperfusion trial). Am J Cardiol. 2015;115:161 6. 43. Ali A, Cox D, Dib N, et al. Rheolytic thrombectomy with percutaneous coronary intervention for infarct size reduction in acute myocardial infarction: 30-day results from a multicenter randomized study. J Am Coll Cardiol. 2006;48:244 52. 44.


Rheolytic thrombectomy with percutaneous coronary intervention for infarct size reduction in acute myocardial infarction: 30-day results from a multicenter randomized study. J Am Coll Cardiol. 2006;48:244 52. 44. Migliorini A, Stabile A, Rodriguez AE, et al. Com- parison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010;56: 1298 306. KEY WORDS ACC/AHA Clinical Practice Guideline, culprit vessel, focused update, multivessel, myocardial infarction, primary PCI, thrombectomy Levine et al. J A C C V O L . 6 7 , N O .


J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Committee Member Employer/Title Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Voting Recusals by Section* Glenn N. Levine, Chair Baylor College of Medicine Professor of Medicine; Director, Cardiac Care Unit None None None None None None None Eric R. Bates, Vice Chair University of Michigan Professor of Medicine  Merck  Sano -aventis None None None None None 2 and 3 James C. Blankenship, Vice Chair Geisinger Medical Center Director of Cardiology and Cardiac Catheterization Laboratories None None None  Abbott Vascular  Abiomed  Boston Scienti c  Volcano None None 2 and 3 Steven R. Bailey University of Texas Medical Center Professor of Medicine and Radiology None None None None None None None John A. Bittl Munroe Heart Interventional Cardiologist None None None None None None None Bojan Cercek Cedars-Sinai Medical Center Director, Coronary Care Unit None None None None None None None Charles E. Chambers Penn State Milton S. Hershey Medical Center Professor of Medicine and Radiology None None None None None None None Stephen G. Ellis Cleveland Clinic Foundation Section Head, Invasive and Interventional Cardiology  Abbott  Boston Scienti c  Medtronic None None None None None 2 and 3 Robert A. Guyton Emory Clinic, Inc.


1 0 , 2 0 1 6 Committee Member Employer/Title Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Voting Recusals by Section* Glenn N. Levine, Chair Baylor College of Medicine Professor of Medicine; Director, Cardiac Care Unit None None None None None None None Eric R. Bates, Vice Chair University of Michigan Professor of Medicine  Merck  Sano -aventis None None None None None 2 and 3 James C. Blankenship, Vice Chair Geisinger Medical Center Director of Cardiology and Cardiac Catheterization Laboratories None None None  Abbott Vascular  Abiomed  Boston Scienti c  Volcano None None 2 and 3 Steven R. Bailey University of Texas Medical Center Professor of Medicine and Radiology None None None None None None None John A. Bittl Munroe Heart Interventional Cardiologist None None None None None None None Bojan Cercek Cedars-Sinai Medical Center Director, Coronary Care Unit None None None None None None None Charles E. Chambers Penn State Milton S. Hershey Medical Center Professor of Medicine and Radiology None None None None None None None Stephen G. Ellis Cleveland Clinic Foundation Section Head, Invasive and Interventional Cardiology  Abbott  Boston Scienti c  Medtronic None None None None None 2 and 3 Robert A. Guyton Emory Clinic, Inc. Professor and Chief, Division of Cardiothoracic Surgery  Medtronic None None None None None 2 and 3 Steven M. Hollenberg Cooper Medical School of Rowan University Professor of Medicine None None None None None None None Umesh N. Khot Cleveland Clinic Vice Chairman, Department of Cardiovascular Medicine  AstraZeneca None None None None None None Richard A. Lange Texas Tech University Health Sciences Center El Paso President None None None None None None None Laura Mauri Brigham & Women s Hospital Associate Professor of Medicine, Harvard Medical School  Medtronic  St. Jude Medical None None None  Abbott  Boston Scienti c  Bristol-Myers Squibb  Cordis  Medtronic Cardiovascular  Sano -aventis Roxana Mehran Columbia University Medical Center Associate Professor of Medicine; Director, Data Coordinating Analysis Center  Abbott Vascular  Boston Scienti c  Janssen (John- son & Johnson)  Merck  Sano -aventis None None  BMS/Sano - aventis  Regado  STENTYS None None 2 and 3 Issam D. Moussa University of Central Florida College of Medicine Professor of Medicine; First Coast Cardiovascular Institute Chief Medical Of cer None None None None None None None Continued on the next page APPENDIX 1.


Professor and Chief, Division of Cardiothoracic Surgery  Medtronic None None None None None 2 and 3 Steven M. Hollenberg Cooper Medical School of Rowan University Professor of Medicine None None None None None None None Umesh N. Khot Cleveland Clinic Vice Chairman, Department of Cardiovascular Medicine  AstraZeneca None None None None None None Richard A. Lange Texas Tech University Health Sciences Center El Paso President None None None None None None None Laura Mauri Brigham & Women s Hospital Associate Professor of Medicine, Harvard Medical School  Medtronic  St. Jude Medical None None None  Abbott  Boston Scienti c  Bristol-Myers Squibb  Cordis  Medtronic Cardiovascular  Sano -aventis Roxana Mehran Columbia University Medical Center Associate Professor of Medicine; Director, Data Coordinating Analysis Center  Abbott Vascular  Boston Scienti c  Janssen (John- son & Johnson)  Merck  Sano -aventis None None  BMS/Sano - aventis  Regado  STENTYS None None 2 and 3 Issam D. Moussa University of Central Florida College of Medicine Professor of Medicine; First Coast Cardiovascular Institute Chief Medical Of cer None None None None None None None Continued on the next page APPENDIX 1. AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT) 2015 ACC/AHA/SCAI FOCUSED UPDATE ON PRIMARY PERCUTANEOUS CORONARY INTERVENTION FOR PATIENTS WITH ST-ELEVATION MYOCARDIAL INFARCTION (PERCUTANEOUS CORONARY INTERVENTION WRITING COMMITTEE) (NOVEMBER J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Levine et al. APPENDIX 1.


1 0 , 2 0 1 6 Levine et al. APPENDIX 1. CONTINUED Committee Member Employer/Title Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Voting Recusals by Section* Debabrata Mukherjee Texas Tech University Chief, Cardiovascular Medicine None None None None None None None Henry H. Ting New York Presbyterian Hospital, The University Hospital of Columbia and Cornell Senior Vice President and Chief Quality Of cer 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 re ect relationships with industry at the time of publication. A person is deemed to have a signi cant interest in a business if the interest represents ownership of $5% of the voting stock or share of the business entity, or ownership of $$5,000 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 nancial bene t are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted.


Relationships that exist with no nancial bene t 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 nancial, professional, or other personal gain or loss as a result of the issues/content addressed in the document. *Writing group members are required to recuse themselves from voting on sections to which their speci c relationships with industry and other entities may apply. No nancial bene t. Signi cant relationship. ACC indicates American College of Cardiology; AHA, American Heart Association; and SCAI, Society for Cardiovascular Angiography and Interventions. Levine et al. J A C C V O L . 6 7 , N O .


J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Voting Recusals by Section* Patrick T. O Gara, Chair Harvard Medical School Professor of Medicine None None None None None None None Frederick G. Kushner, Vice Chair Tulane University School of Medicine Clinical Professor of Medicine; Heart Clinic of Louisiana Medical Director None None None None None None None Deborah D. Ascheim Mount Sinai School of Medicine Associate Professor; InCHOIR Clinical Director of Research None None None None None None None Ralph G. Brindis UCSF Philip R. Lee Institute for Health Policy Studies Clinical Professor of Medicine None None None None None None None Donald E. Casey, Jr. Thomas Jefferson College of Population Health Adjunct Faculty; Alvarez & Marsal and Founder None None None None None None None Mina K. Chung Cleveland Clinic Foundation Professor of Medicine  Boston Scienti c  Medtronic  St. Jude Medical None None  Biosense Webster  Boston Scienti c  Medtronic  St. Jude Medical None None 2 and 3 James A. de Lemos UT Southwestern Medical Center Professor of Medicine  Abbott Diagnostics  Novo Nordisc  St. Jude Medical None None  Abbott Diagnostics None None 2 and 3 Deborah B. Diercks UT Southwestern Medical Center Audre and Bernard Rapoport Distinguished Chair in Clinical Care and Research; Department of Emergency Medicine Professor and Chair None None None None None None None James C. Fang University of Utah Cardiovascular Division  Boston Scienti c None None None None None 2 and 3 Barry A. Franklin William Beaumont Hospital Director, Cardiac Rehabilitation and Exercise Laboratories None None None None None None None Christopher B. Granger Duke Clinical Research Institute Director, Cardiac Care Unit; Professor of Medicine None None None  Medtronic Foundation  Merck None None 2 and 3 Harlan M. Krumholz Yale University School of Medicine Professor of Epidemiology and Public Health None None None  Johnson & Johnson  Medtronic None None 2 and 3 Jane A. Linderbaum Mayo Clinic Assistant Professor of Medicine None None None None None None None David A. Morrow Harvard Medical School Professor of Medicine  Abbott  Merck None None  Abbott  GlaxoSmithKline  Johnson & Johnson  Merck None None 2 and 3 L. Kristin Newby Duke University Medical Center, Division of Cardiology Professor of Medicine  Philips None None  Merck None None 2 and 3 Continued on the next page APPENDIX 2.


AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT) 2015 ACC/AHA/SCAI FOCUSED UPDATE ON PRIMARY PERCUTANEOUS CORONARY INTERVENTION FOR PATIENTS WITH ST-ELEVATION MYOCARDIAL INFARCTION (ST-ELEVATION MYOCARDIAL INFARCTION WRITING COMMITTEE) (FEBRUARY 2014) J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Levine et al. APPENDIX 2. CONTINUED Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Voting Recusals by Section* Joseph P. Ornato Department of Emergency Medicine Virginia Commonwealth University Professor and Chairman None None None None None None None Narith Ou Mayo Clinic Pharmacotherapy Coordinator, Cardiology None None None None None None None Martha J. Radford NYU Langone Medical Center Chief Quality Of cer; NYU School of Medicine Professor of Medicine (Cardiology) None None None None None None None Jacqueline E. Tamis- Holland Mount Sinai Saint Luke s Hospital and The Icahn School of Medicine Program Director, Interventional Cardiology Fellowship Program None None None None None None None Carl L. Tommaso Skokie Hospital Director of Catheterization Laboratory; NorthShore University HealthSystems Partner None None None None None None None Cynthia M. Tracy George Washington University Medical Center Associate Director, Division of Cardiology None None None None None None None Y. Joseph Woo Stanford University Professor and Chair, Cardiothoracic Surgery None None None None None None None David X. Zhao Wake Forest Baptist Health Professor of Medicine, Heart and Vascular Center of Excellence Director None None None  St. Jude Medical  Medtronic None None 2 and 3 This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document.


CONTINUED Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Voting Recusals by Section* Joseph P. Ornato Department of Emergency Medicine Virginia Commonwealth University Professor and Chairman None None None None None None None Narith Ou Mayo Clinic Pharmacotherapy Coordinator, Cardiology None None None None None None None Martha J. Radford NYU Langone Medical Center Chief Quality Of cer; NYU School of Medicine Professor of Medicine (Cardiology) None None None None None None None Jacqueline E. Tamis- Holland Mount Sinai Saint Luke s Hospital and The Icahn School of Medicine Program Director, Interventional Cardiology Fellowship Program None None None None None None None Carl L. Tommaso Skokie Hospital Director of Catheterization Laboratory; NorthShore University HealthSystems Partner None None None None None None None Cynthia M. Tracy George Washington University Medical Center Associate Director, Division of Cardiology None None None None None None None Y. Joseph Woo Stanford University Professor and Chair, Cardiothoracic Surgery None None None None None None None David X. Zhao Wake Forest Baptist Health Professor of Medicine, Heart and Vascular Center of Excellence Director None None None  St. Jude Medical  Medtronic None None 2 and 3 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 re ect relationships with industry at the time of publication.


The table does not necessarily re ect relationships with industry at the time of publication. A person is deemed to have a signi cant interest in a business if the interest represents ownership of $5% of the voting stock or share of the business entity, or ownership of $$5,000 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 nancial bene t 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 nancial, professional, or other personal gain or loss as a result of the issues/content addressed in the document. *Writing group members are required to recuse themselves from voting on sections to which their speci c relationships with industry and other entities may apply. Dr. Deborah D. Ascheim accepted a position at Capricor Therapeutics in August 2015, after the writing effort was completed. According to policy, she recused herself from the nal voting process. Signi cant relationship. No nancial bene t. ACC indicates American College of Cardiology; AHA, American Heart Association; NYU, New York University; UCSF, University of California San Francisco; and UT, University of Texas. Levine et al.


No nancial bene t. ACC indicates American College of Cardiology; AHA, American Heart Association; NYU, New York University; UCSF, University of California San Francisco; and UT, University of Texas. Levine et al. J A C C V O L . 6 7 , N O .


J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Elliott M. Antman Of cial Reviewer AHA Harvard Medical School Professor of Medicine, Associate Dean for Clinical and Translational Research None None None None None None Deepak L. Bhatt Of cial Reviewer AHA Harvard Medical School Professor; Interventional Cardiovascular Programs Executive Director None None None  Bristol-Myers Squibb*  Ischemix*  Medtronic*  St. Jude Medical  Regado Biosciences None Christopher P. Cannon Of cial Reviewer AHA Harvard Medical School Professor of Medicine; Brigham and Women s Hospital Senior Investigator, TIMI Study Group, Cardiovascular Division  Bristol-Myers Squibb  Merck  Regeneron/ Sano -aventis* None None  Merck* None None Joaquin E. Cigarroa Of cial Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Oregon Health & Science University Clinical Professor of Medicine None None None None None None George Dangas Of cial Reviewer ACC Board of Trustees Icahn School of Medicine Professor of Cardiology and Vascular Surgery; Mount Sinai Medical Center Director, Cardiovascular Innovation  Abbott  Biosensors  Boston Scienti c  Johnson & Johnson*  Merck  Osprey Medical*  Regado Biosciences None None None  Abbott  Medtronic  Osprey None Charles J. Davidson Of cial Reviewer SCAI Northwestern University Feinberg School of Medicine Professor of Medicine, Director of Cardiac Catheterization Lab None None None  Baxter International None None Kirk N. Garratt Of cial Reviewer SCAI Hofstra University Medical School Associate Chair of Quality and Research; Professor of Medicine  Abbott  Boston Scienti c  The Medicines Company  Daiichi-Sankyo/ Eli Lilly  AstraZeneca None  LifeCuff Technologies  Global Delivery Systems None  Boston Scienti c None Steven L. Goldberg Of cial Reviewer SCAI University of Washington Medical Center Cath Lab Director  Terumo None None None None None Continued on the next page APPENDIX 3.


REVIEWER RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT) 2015 ACC/AHA/SCAI FOCUSED UPDATE ON PRIMARY PERCUTANEOUS CORONARY INTERVENTION FOR PATIENTS WITH ST-ELEVATION MYOCARDIAL INFARCTION (COMBINED PEER REVIEWERS FROM 2011 PCI AND 2013 STEMI GUIDELINES) J A C C V O L . , N O . , Levine et al. M A R C H , : ACC/AHA/SCAI Focused Update on Primary PCI Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness G.B. John Mancini Of cial Reviewer ACC Board of Governors Vancouver Hospital Research Pavilion Professor of Medicine  Merck  Sano -aventis/ Regeneron None None None None None Jonathan M. Tobis Of cial Reviewer SCAI University of California Los Angeles Professor of Medicine and Cardiology  St. Jude Medical None None None None None Jeffrey L. Anderson Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Intermountain Medical Center Associate Chief of Cardiology None None None None None None Thomas M. Bashore Content Reviewer Duke University Professor of Medicine None None None None None None James A. Burke Content Reviewer ACC Interventional Scienti c Council Lehigh Valley Heart Specialists Associate Chief, Division of Cardiology None None None None None None Jeffrey J. Cavendish Content Reviewer ACC Prevention of Cardiovascular Disease Committee Kaiser Permanente Cardiology Interventional Cardiologist None None None None  Abbott None Gregory J. Dehmer Content Reviewer ACC Appropriate Use Criteria Texas A&M College of Medicine Professor of Medicine; Scott & White Healthcare None None None None None None John S. Douglas, Jr.


John Mancini Of cial Reviewer ACC Board of Governors Vancouver Hospital Research Pavilion Professor of Medicine  Merck  Sano -aventis/ Regeneron None None None None None Jonathan M. Tobis Of cial Reviewer SCAI University of California Los Angeles Professor of Medicine and Cardiology  St. Jude Medical None None None None None Jeffrey L. Anderson Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Intermountain Medical Center Associate Chief of Cardiology None None None None None None Thomas M. Bashore Content Reviewer Duke University Professor of Medicine None None None None None None James A. Burke Content Reviewer ACC Interventional Scienti c Council Lehigh Valley Heart Specialists Associate Chief, Division of Cardiology None None None None None None Jeffrey J. Cavendish Content Reviewer ACC Prevention of Cardiovascular Disease Committee Kaiser Permanente Cardiology Interventional Cardiologist None None None None  Abbott None Gregory J. Dehmer Content Reviewer ACC Appropriate Use Criteria Texas A&M College of Medicine Professor of Medicine; Scott & White Healthcare None None None None None None John S. Douglas, Jr. Content Reviewer Emory University Hospital Professor of Medicine None None None  Abbott  Medtronic None None John P. Erwin III Content Reviewer ACC/AHA Task Force on Performance Measures Texas A&M College of Medicine Associate Professor; Scott & White Healthcare Vice Chair of the Department of Medicine None None None None None None T. Bruce Ferguson Content Reviewer ACC Surgeons Scienti c Council East Carolina Institute Brody School of Medicine Professor of Surgery and Physiology None None None None None None Anthony Gershlick Content Reviewer University Hospitals of Leicester, Department of Cardiology  Abbott  Boston Scienti c  Cordis  Medtronic  Abbott None None None None Jonathan L. Halperin Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Mt.


Content Reviewer Emory University Hospital Professor of Medicine None None None  Abbott  Medtronic None None John P. Erwin III Content Reviewer ACC/AHA Task Force on Performance Measures Texas A&M College of Medicine Associate Professor; Scott & White Healthcare Vice Chair of the Department of Medicine None None None None None None T. Bruce Ferguson Content Reviewer ACC Surgeons Scienti c Council East Carolina Institute Brody School of Medicine Professor of Surgery and Physiology None None None None None None Anthony Gershlick Content Reviewer University Hospitals of Leicester, Department of Cardiology  Abbott  Boston Scienti c  Cordis  Medtronic  Abbott None None None None Jonathan L. Halperin Content Reviewer ACC/AHA Task Force on Clinical Practice Guidelines Mt. Sinai Medical Professor of Medicine  Bayer Healthcare  Boston Scienti c  Johnson & Johnson  Medtronic None None None None None Continued on the next page APPENDIX 3. CONTINUED Levine et al. J A C C V O L . , N O .


J A C C V O L . , N O . , ACC/AHA/SCAI Focused Update on Primary PCI M A R C H , : Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Howard C. Herrmann Content Reviewer University of Pennsylvania Perelman School of Medicine Professor of Medicine, Director of Interventional Cardiology Program  Seimens Medical  St. Jude Medical None None  Abbott*  Medtronic  Siemens Medical*  St. Jude Medical None None Morton J. Kern Content Reviewer University of California Irvine Professor of Medicine, Associate Chief of the Division of Cardiology  Acist Medical  Merit Medical*  St. Jude Medical* None None None None Fred M. Kosumoto Content Reviewer Mayo Clinic Director, Pacing and Electrophysiology Service None None None None None None David J. Maron Content Reviewer Stanford University School of Medicine Professor of Medicine and Emergency Medicine None None None None None None Douglass A. Morrison Content Reviewer University of Arizona Professor of Medicine; Southern Arizona VA Health Care System Cardiac Catheterization Laboratories, Director None None None None None None Manesh R. Patel Content Reviewer ACC Appropriate Use Criteria Duke University Medical Center Associate Professor of Medicine  Bayer Healthcare*  Janssen Pharmaceuticals* None None  Johnson & Johnson* None None M. Eugene Sherman Content Reviewer ACC Board of Governors Aurora Denver Cardiology None None None None  Bristol-Myers Squibb*  Hospira* None Daniel I. Simon Content Reviewer University Hospitals Case Medical Center Professor of Cardiovascular Research  Cordis/Johnson & Johnson*  Janssen Pharmaceuticals/ Johnson & Johnson  Medtronic Vascular  Merck  Abbott None None None None Richard W. Snyder Content Reviewer ACC Board of Governors HeartPlace None None None None None None William A. Tansey III Content Reviewer Summit Medical Group Cardiologist None None None None None None David D. Waters Content Reviewer San Francisco General Hospital Chief, Division of Cardiology None None None None  Merck None Continued on the next page APPENDIX 3.


CONTINUED J A C C V O L . , N O . , Levine et al. M A R C H , : ACC/AHA/SCAI Focused Update on Primary PCI Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Patrick L. Whitlow Content Reviewer Cleveland Clinic Foundation Director, Interventional Cardiology None None None  Abbott  Medtronic* David O. Williams Content Reviewer Harvard Medical School Professor of Medicine; Brigham and Women s Hospital None None None None None None Clyde W. Yancy Content Reviewer ACC/AHA Task Force on Practice Guidelines Northwestern University Feinberg School of Medicine Vice Dean for Diversity and Inclusion, Chief of Medicine- Cardiology, Professor None None None None None None Yerem Yeghiazarians Content Reviewer University of California San Francisco Associate Professor None None None None None None This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. It does not necessarily re ect relationships with industry at the time of publication. A person is deemed to have a signi cant interest in a business if the interest represents ownership of $5% of the voting stock or share of the business entity, or ownership of $$5,000 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. A relationship is considered to be modest if it is less than signi cant under the preceding de nition. Relationships that exist with no nancial bene t are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted.


Relationships that exist with no nancial bene t 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. 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 nancial, professional, or other personal gain or loss as a result of the issues/content addressed in the document. *Signi cant relationship. No nancial bene t. ACC indicates American College of Cardiology; AHA, American Heart Association; SCAI, Society for Cardiovascular Angiography and Interventions; STEMI, ST-elevation myocardial infarction; PCI, percutaneous coronary interventions; TIMI, Thrombolysis In Myocardial Infarction; and VA, Veterans Affairs. APPENDIX 3. CONTINUED Levine et al. J A C C V O L . , N O . , ACC/AHA/SCAI Focused Update on Primary PCI M A R C H , :


ACCF/AHA/SCAI Practice Guideline 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions WRITING COMMITTEE MEMBERS* Glenn N. Levine, MD, FACC, FAHA, Chair ; Eric R. Bates, MD, FACC, FAHA, Vice Chair* ; James C. Blankenship, MD, FACC, 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, FSCAI ; Brahmajee K. Nallamothu, MD, FACC ; Henry H. Ting, MD, FACC, FAHA ACCF/AHA TASK FORCE MEMBERS Alice K. Jacobs, MD, FACC, FAHA, Chair; Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect; Nancy Albert, PhD, CCNS, CCRN, FAHA; Mark A. Creager, MD, FACC, FAHA; Steven M. Ettinger, MD, FACC; Robert A. Guyton, MD, FACC; Jonathan L. Halperin, MD, FACC, FAHA; Judith S. Hochman, MD, FACC, FAHA; Frederick G. Kushner, MD, FACC, FAHA; E. Magnus Ohman, MD, FACC; William Stevenson, MD, FACC, FAHA; Clyde W. Yancy, MD, FACC, FAHA *Writing committee members are required to recuse themselves from voting on sections where their specific relationship with industry and other entities may apply; see Appendix 1 for recusal information. ACCF/AHA Representative. Society for Cardiovascular Angiography and Interventions Representative. Joint Revascularization Section Author. ||ACCF/AHA Task Force on Practice Guidelines Liaison. ACCF/AHA Task Force on Performance Measures Liaison.


||ACCF/AHA Task Force on Practice Guidelines Liaison. ACCF/AHA Task Force on Performance Measures Liaison. This document was approved by the American College of Cardiology Foundation Board of Trustees and the American Heart Association Science Advisory and Coordinating Committee in July 2011, and the Society for Cardiovascular Angiography and Interventions in August 2011. The American Heart Association requests that this document be cited as follows: Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124:e574 e651. This article has been copublished in the Journal of the American College of Cardiology and Catherization and Cardiovascular Interventions. Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org) and the American Heart Association (my.americanheart.org). A copy of the document is available at http://my.americanheart.org/statements by selecting either the By Topic link or the By Publication Date link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. Expert peer review of AHA Scientific Statements is conducted at the AHA National Center. For more on AHA statements and guidelines development, visit http://my.americanheart.org/statements and select the Policies and Development link. 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. 2011 by the American College of Cardiology Foundation and the American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIR.0b013e31823ba622 Table of Contents Preamble e576 1. Introduction e578 1.1. Methodology and Evidence Review e578 1.2. Organization of the Writing Committee e579 1.3. Document Review and Approval e579 1.4. PCI Guidelines: History and Evolution e579 2. CAD Revascularization e580 2.1. Heart Team Approach to Revascularization Decisions: Recommendations e580 2.2. Revascularization to Improve Survival: Recommendations e582 2.3. Revascularization to Improve Symptoms: Recommendations e583 2.4. CABG Versus Contemporaneous Medical Therapy e583 2.5. PCI Versus Medical Therapy e584 2.6. CABG Versus PCI e584 2.6.1. CABG Versus Balloon Angioplasty or BMS e584 2.6.2. CABG Versus DES e585 2.7. Left Main CAD e585 2.7.1. CABG or PCI Versus Medical Therapy for Left Main CAD e585 2.7.2. Studies Comparing PCI Versus CABG for Left Main CAD e586 2.7.3. Revascularization Considerations for Left Main CAD e586 2.8. Proximal LAD Artery Disease e587 2.9. Clinical Factors That May Influence the Choice of Revascularization e587 2.9.1. Diabetes Mellitus e587 2.9.2. Chronic Kidney Disease e587 2.9.3. Completeness of Revascularization e587 2.9.4. LV Systolic Dysfunction e588 2.9.5. Previous CABG e588 2.9.6. Unstable Angina/Non ST-Elevation Myocardial Infarction e588 2.9.7. DAPT Compliance and Stent Thrombosis: Recommendation e588 2.10. TMR as an Adjunct to CABG e588 2.11. Hybrid Coronary Revascularization: Recommendations e589 3. PCI Outcomes e589 3.1. Definitions of PCI Success e589 3.1.1. Angiographic Success e589 3.1.2. Procedural Success e589 3.1.3. Clinical Success e589 3.2. Predictors of Clinical Outcome After PCI e590 3.3. PCI Complications e590 4. Preprocedural Considerations e591 4.1. Cardiac Catheterization Laboratory Requirements e591 4.1.1. Equipment e591 4.1.2. Staffing e591 4.1.3. Time-Out Procedures e592 4.2. Ethical Aspects e592 4.2.1. Informed Consent e592 4.2.2.


Time-Out Procedures e592 4.2. Ethical Aspects e592 4.2.1. Informed Consent e592 4.2.2. Potential Conflicts of Interest e592 4.3. Radiation Safety: Recommendation e592 4.4. Contrast-Induced AKI: Recommendations e593 4.5. Anaphylactoid Reactions: Recommendations e594 4.6. Statin Treatment: Recommendation e594 4.7. Bleeding Risk: Recommendation e594 4.8. PCI in Hospitals Without On-Site Surgical Backup: Recommendations e594 5. Procedural Considerations e595 5.1. Vascular Access: Recommendation e595 5.2. PCI in Specific Clinical Situations e596 5.2.1. UA/NSTEMI: Recommendations e596 5.2.2. ST-Elevation Myocardial Infarction e597 5.2.2.1. Coronary Angiography Strategies in STEMI: Recommendations e597 5.2.2.2. Primary PCI of the Infarct Artery: Recommendations e598 5.2.2.3. Delayed or Elective PCI in Patients With STEMI: Recommendations e599 5.2.3. Cardiogenic Shock: Recommendations e600 5.2.3.1. Procedural Considerations for Cardiogenic Shock e600 5.2.4. Revascularization Before Noncardiac Surgery: Recommendations e600 5.3. Coronary Stents: Recommendations e601 5.4. Adjunctive Diagnostic Devices e602 5.4.1. FFR: Recommendation e602 5.4.2. IVUS: Recommendations e602 5.4.3. Optical Coherence Tomography e603 5.5. Adjunctive Therapeutic Devices e603 5.5.1. Coronary Atherectomy: Recommendations e603 5.5.2. Thrombectomy: Recommendation e603 5.5.3. Laser Angioplasty: Recommendations e603 5.5.4. Cutting Balloon Angioplasty: Recommendations e603 5.5.5. Embolic Protection Devices: Recommendation e604 5.6. Percutaneous Hemodynamic Support Devices: Recommendation e604 5.7. Interventional Pharmacotherapy e604 5.7.1. Procedural Sedation e604 5.7.2. Oral Antiplatelet Therapy: Recommendations e605 Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e575 5.7.3. IV Antiplatelet Therapy: Recommendations e606 5.7.4. Anticoagulant Therapy e607 5.7.4.1. Use of Parenteral Anticoagulants During PCI: Recommendation e607 5.7.4.2. UFH: Recommendation e607 Recommendations e608 5.7.4.4. Bivalirudin and Argatroban: Recommendations e608 Recommendation e609 5.7.5. No-Reflow Pharmacological Therapies: Recommendation e610 5.8. PCI in Specific Anatomic Situations e610 5.8.1. CTOs: Recommendation e610 5.8.2. SVGs: Recommendations e610 5.8.3. Bifurcation Lesions: Recommendations e611 5.8.4. Aorto-Ostial Stenoses: Recommendations e611 5.8.5. Calcified Lesions: Recommendation e611 5.9. PCI in Specific Patient Populations e612 5.9.1. Elderly e612 5.9.2. Diabetes e612 5.9.3. Women e612 5.9.4. CKD: Recommendation e612 5.9.5.


Diabetes e612 5.9.3. Women e612 5.9.4. CKD: Recommendation e612 5.9.5. Cardiac Allografts e612 5.10. Periprocedural MI Assessment: Recommendations e613 5.11. Vascular Closure Devices: Recommendations e613 6. Postprocedural Considerations e613 6.1. Postprocedural Antiplatelet Therapy: Recommendations e613 6.1.1. PPIs and Antiplatelet Therapy: Recommendations e615 6.1.2. Clopidogrel Genetic Testing: Recommendations e615 6.1.3. Platelet Function Testing: Recommendations e616 6.2. Stent Thrombosis e616 6.3. Restenosis: Recommendations e616 6.3.1. Background and Incidence e616 6.3.2. Restenosis After Balloon Angioplasty e617 6.3.3. Restenosis After BMS e617 6.3.4. Restenosis After DES e617 6.4. Clinical Follow-Up e617 6.4.1. Exercise Testing: Recommendations e617 6.4.2. Activity and Return to Work e618 6.4.3. Cardiac Rehabilitation: Recommendation e618 6.5. Secondary Prevention e618 7. Quality and Performance Considerations e618 7.1. Quality and Performance: Recommendations e618 7.2. Training e619 7.3. Certification and Maintenance of Certification: Recommendation e619 7.4. Operator and Institutional Competency and Volume: Recommendations e619 7.5. Participation in ACC NCDR or National Quality Database e620 8. Future Challenges e620 References e620 Appendix 1. Author Relationships With Industry and Other Entities (Relevant) e643 Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant) e645 Appendix 3. Abbreviation List e648 Appendix 4. Additional Tables/Figures e649 Preamble The medical profession should play a central role in evalu- ating 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.


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 founda- tion 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 Guide- lines (Task Force), charged with developing, updating, and revising practice guidelines for cardiovascular diseases and procedures, directs and oversees this effort. Writing commit- tees are charged with regularly reviewing and evaluating all available evidence to develop balanced, patient-centric rec- ommendations 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 formal 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 consid- ered, but data on efficacy and outcomes constitute the primary basis for the recommendations contained herein.


When available, information from studies on cost is consid- ered, 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 avail- able, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recom- mendations 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 committee is the basis for LOE C recommenda- tions and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides sug- gested phrases for writing recommendations within each COR. A new addition to this methodology is separation of the Table 1. Applying Classification of Recommendations and Level of Evidence A recommendation with Level of Evidence B or C does not imply that the recommendation is weak.


Applying Classification of Recommendations and Level of Evidence A 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. Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e577 Class III recommendations to delineate if the recommenda- tion 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. 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 herein and throughout all future guidelines. Because the ACCF/AHA practice guidelines address pa- tient 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.


Because the ACCF/AHA practice guidelines address pa- tient 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 influ- ence 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 describ- ing a range of generally acceptable approaches to the diag- nosis, 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 guide- lines may be appropriate. Clinical decision making should involve consideration of the quality and availability of exper- tise 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 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.


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, where 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 committee. All writing committee members and peer reviewers of the guideline are asked to disclose all such current relationships, as well as those existing 12 months previously. In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing committee chair plus a minimum of 50% of the writing committee 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 committee and are updated 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 are not permitted to write, and must recuse themselves from voting on, any recommendation or section to which their RWI apply. Members who recused themselves from voting are indicated in the list of writing committee members, and section recusals are noted in Appendix 1. Authors and peer reviewers RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively.


Authors and peer reviewers RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing committee members compre- hensive 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 www.cardiosource.org/ACC/About-ACC/ Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the writing committee was supported exclusively by the ACCF, AHA, and the Society for Cardiovascular Angiography and Interventions (SCAI) without commercial support. Writing com- mittee 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 System- atic Reviews and Clinical Practice Guidelines We Can Trust.2,3 It is noteworthy that the ACCF/AHA guidelines were cited as being compliant with many of the standards that were proposed. A thorough review of these reports and of our current methodology is under way, with further enhance- ments anticipated. The recommendations in this guideline are considered current until they are superseded by a focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and AHA. Alice K. Jacobs, MD, FACC, FAHA, Chair ACCF/AHA Task Force on Practice Guidelines 1.1. Methodology and Evidence Review The recommendations listed in this document are, whenever possible, evidence based.


Methodology and Evidence Review The recommendations listed in this document are, whenever possible, evidence based. An extensive evidence review was conducted through November 2010, as well as selected other references through August 2011. Searches were limited to studies, reviews, and other evidence conducted in human subjects and that were published in English. Key search words included but were not limited to the following: ad hoc angioplasty, angioplasty, balloon angioplasty, clinical trial, coronary stenting, delayed angioplasty, meta-analysis, per- cutaneous transluminal coronary angioplasty, randomized controlled trial (RCT), percutaneous coronary intervention (PCI) and angina, angina reduction, antiplatelet therapy, bare-metal stents (BMS), cardiac rehabilitation, chronic stable angina, complication, coronary bifurcation lesion, coronary calcified lesion, coronary chronic total occlusion (CTO), coronary ostial lesions, coronary stent (BMS and drug-eluting stents [DES]; and BMS versus DES), diabetes, distal embolization, distal protection, elderly, ethics, late stent thrombosis, medical therapy, microembolization, mor- tality, multiple lesions, multi-vessel, myocardial infarction (MI), non ST-elevation myocardial infarction (NSTEMI), no-reflow, optical coherence tomography, proton pump in- hibitor (PPI), return to work, same-day angioplasty and/or stenting, slow flow, stable ischemic heart disease (SIHD), staged angioplasty, STEMI, survival, and unstable angina (UA). Additional searches cross-referenced these topics with the following subtopics: anticoagulant therapy, contrast ne- phropathy, PCI-related vascular complications, unprotected left main PCI, multivessel coronary artery disease (CAD), adjunctive percutaneous interventional devices, percutaneous hemodynamic support devices, 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.


References selected and published in this document are representative and not all-inclusive. To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published, the abso- lute risk difference and number needed to treat or harm will be provided in the guideline, along with confidence intervals (CIs) and data related to the relative treatment effects such as odds ratio (OR), relative risk, hazard ratio (HR), or incidence rate ratio. The focus of this guideline is the safe, appropriate, and efficacious performance of PCI. The risks of PCI must be balanced against the likelihood of improved survival, symp- toms, or functional status. This is especially important in patients with SIHD. 1.2. Organization of the Writing Committee The committee was composed of physicians with expertise in interventional cardiology, general cardiology, critical care cardiology, cardiothoracic surgery, clinical trials, and health services research. The committee included representatives from the ACCF, AHA, and SCAI. 1.3. Document Review and Approval This document was reviewed by 2 official reviewers nomi- nated by the ACCF, AHA, and SCAI, as well as 21 individual content reviewers (including members of the ACCF Interven- tional Scientific Council and ACCF Surgeons Scientific Council). All information on reviewers RWI was distributed to the writing committee and is published in this document (Appendix 2). This document was approved for publication by the governing bodies of the ACCF, AHA, and SCAI. 1.4. PCI Guidelines: History and Evolution In 1982, a 2-page manuscript titled Guidelines for the Performance of Percutaneous Transluminal Coronary Angio- plasty was published in Circulation.4 The document, which addressed the specific expertise and experience physicians should have to perform balloon angioplasty, as well as laboratory requirements and the need for surgical support, was written by an ad hoc group whose members included Andreas Gru ntzig.


PCI Guidelines: History and Evolution In 1982, a 2-page manuscript titled Guidelines for the Performance of Percutaneous Transluminal Coronary Angio- plasty was published in Circulation.4 The document, which addressed the specific expertise and experience physicians should have to perform balloon angioplasty, as well as laboratory requirements and the need for surgical support, was written by an ad hoc group whose members included Andreas Gru ntzig. In 1980, the ACC and the AHA estab- lished the Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures, which was charged with the development of guidelines related to the role of new therapeutic approaches and of specific noninvasive and inva- sive procedures in the diagnosis and management of cardio- vascular disease. The first ACC/AHA Task Force report on guidelines for coronary balloon angioplasty was published in 1988.5 The 18-page document discussed and made recom- mendations about lesion classification and success rates, indications for and contraindications to balloon angioplasty, institutional review of angioplasty procedures, ad hoc angio- plasty after angiography, and on-site surgical backup. Further iterations of the guidelines were published in 1993,6 2001,7 and 2005.8 In 2007 and 2009, focused updates to the guideline were published to expeditiously address new study results and recent changes in the field of interventional cardiology.9,10 The 2009 focused update is notable in that there was direct collaboration between the writing commit- tees for the STEMI guidelines and the PCI guidelines, resulting in a single publication of focused updates on STEMI The evolution of the PCI guideline reflects the growth of knowledge in the field and parallels the many advances and innovations in the field of interventional cardiology, includ- ing primary PCI, BMS and DES, intravascular ultrasound (IVUS) and physiologic assessments of stenosis, and newer antiplatelet and anticoagulant therapies.


Further iterations of the guidelines were published in 1993,6 2001,7 and 2005.8 In 2007 and 2009, focused updates to the guideline were published to expeditiously address new study results and recent changes in the field of interventional cardiology.9,10 The 2009 focused update is notable in that there was direct collaboration between the writing commit- tees for the STEMI guidelines and the PCI guidelines, resulting in a single publication of focused updates on STEMI The evolution of the PCI guideline reflects the growth of knowledge in the field and parallels the many advances and innovations in the field of interventional cardiology, includ- ing primary PCI, BMS and DES, intravascular ultrasound (IVUS) and physiologic assessments of stenosis, and newer antiplatelet and anticoagulant therapies. The 2011 iteration of the guideline continues this process, addressing ethical as- pects of PCI, vascular access considerations, CAD revascu- larization including hybrid revascularization, revasculariza- tion before noncardiac surgery, optical coherence tomography, advanced hemodynamic support devices, no- reflow therapies, and vascular closure devices. Most of this document is organized according to patient flow, consisting of preprocedural considerations, procedural considerations, and postprocedural considerations. In a major undertaking, the STEMI, PCI, and coronary artery bypass graft (CABG) surgery guidelines were written concurrently, with additional collaboration with the SIHD guideline writing committee, allowing greater collaboration between the different writing committees on topics such as PCI in STEMI and revascular- ization strategies in patients with CAD (including unpro- tected left main PCI, multivessel disease revascularization, and hybrid procedures). In accordance with direction from the Task Force and feedback from readers, in this iteration of the guideline, the text has been shortened, with an emphasis on summary Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e579 statements rather than detailed discussion of numerous indi- vidual trials.


In accordance with direction from the Task Force and feedback from readers, in this iteration of the guideline, the text has been shortened, with an emphasis on summary Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e579 statements rather than detailed discussion of numerous indi- vidual trials. Online supplemental evidence and summary tables have been created to document the studies and data considered for new or changed guideline recommendations. 2. CAD Revascularization Recommendations and text in this section are the result of extensive collaborative discussions between the PCI and CABG writing committees, as well as key members of the SIHD and UA/NSTEMI writing committees. Certain issues, such as older versus more contemporary studies, primary analyses versus subgroup analyses, and prospective versus post hoc analyses, have been carefully weighed in designating COR and LOE; they are addressed in the appropriate corre- sponding text. The goals of revascularization for patients with CAD are to 1) improve survival and/or 2) relieve symptoms. Revascularization recommendations in this section are predominantly based on studies of patients with symptomatic SIHD and should be interpreted in this context. As discussed later in this section, recommendations on the type of revas- cularization are, in general, applicable to patients with UA/ NSTEMI. In some cases (eg, unprotected left main CAD), specific recommendations are made for patients with UA/ NSTEMI or STEMI. Historically, most studies of revascularization have been based on and reported according to angiographic criteria. Most studies have defined a significant stenosis as 70% diameter narrowing; therefore, for revascularization decisions and recommendations in this section, a significant stenosis has been defined as 70% diameter narrowing ( 50% for left main CAD). Physiological criteria, such as an assessment of fractional flow reserve (FFR), has been used in deciding when revascularization is indicated.


Physiological criteria, such as an assessment of fractional flow reserve (FFR), has been used in deciding when revascularization is indicated. Thus, for recommenda- tions about revascularization in this section, coronary steno- ses with FFR 0.80 can also be considered to be As noted, the revascularization recommendations have been formulated to address issues related to 1) improved survival and/or 2) improved symptoms. When one method of revascularization is preferred over the other for improved survival, this consideration, in general, takes precedence over improved symptoms. When discussing options for revascu- larization with the patient, he or she should understand when the procedure is being performed in an attempt to improve symptoms, survival, or both. Although some results from the SYNTAX (Synergy be- tween Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) study are best characterized as subgroup analyses and hypothesis generating, SYNTAX nonetheless represents the latest and most comprehensive comparison of PCI and CABG.13,14 Therefore, the results of SYNTAX have been considered appropriately when formulating our revas- cularization recommendations. Although the limitations of using the SYNTAX score for certain revascularization rec- ommendations are recognized, the SYNTAX score is a reasonable surrogate for the extent of CAD and its complex- ity and serves as important information that should be considered when making revascularization decisions. Recom- mendations that refer to SYNTAX scores use them as surrogates for the extent and complexity of CAD. Revascularization recommendations to improve survival and symptoms are provided in the following text and are summarized in Tables 2 and 3. References to studies com- paring revascularization with medical therapy are presented when available for each anatomic subgroup. See Online Data Supplements 1 and 2 for additional data regarding the survival and symptomatic benefits with CABG or PCI for different anatomic subsets. 2.1.


See Online Data Supplements 1 and 2 for additional data regarding the survival and symptomatic benefits with CABG or PCI for different anatomic subsets. 2.1. Heart Team Approach to Revascularization Decisions: Recommendations Class I 1. A Heart Team approach to revascularization is recommended in patients with unprotected left main or complex CAD.14 16 (Level of Evidence: C) Class IIa 1. Calculation of the Society of Thoracic Surgeons (STS) and SYNTAX scores is reasonable in pa- tients with unprotected left main and complex CAD.13,14,17 22 (Level of Evidence: B) One protocol used in RCTs14 16,23 often involves a multidis- ciplinary approach referred to as the Heart Team. Composed of an interventional cardiologist and a cardiac surgeon, the Heart Team 1) reviews the patient s medical condition and coronary anatomy, 2) determines that PCI and/or CABG are technically feasible and reasonable, and 3) discusses revas- cularization options with the patient before a treatment strategy is selected. Support for using a Heart Team approach comes from reports that patients with complex CAD referred specifically for PCI or CABG in concurrent trial registries have lower mortality rates than those randomly assigned to PCI or CABG in controlled trials.15,16 The SIHD, PCI, and CABG guideline writing committees endorse a Heart Team approach in patients with unprotected left main CAD and/or complex CAD in whom the optimal revascularization strategy is not straightforward. A collabor- ative assessment of revascularization options, or the decision to treat with GDMT without revascularization, involving an interventional cardiologist, a cardiac surgeon, and (often) the patient s general cardiologist, followed by discussion with the patient about treatment options, is optimal.


A collabor- ative assessment of revascularization options, or the decision to treat with GDMT without revascularization, involving an interventional cardiologist, a cardiac surgeon, and (often) the patient s general cardiologist, followed by discussion with the patient about treatment options, is optimal. Particularly in patients with SIHD and unprotected left main and/or complex CAD for whom a revascularization strategy is not straight- forward, an approach has been endorsed that involves termi- nating the procedure after diagnostic coronary angiography is completed: this allows a thorough discussion and affords both the interventional cardiologist and cardiac surgeon the oppor- tunity to discuss revascularization options with the patient. Because the STS score and the SYNTAX score have been shown to predict adverse outcomes in patients undergoing CABG and PCI, respectively, calculation of these scores is often useful in making revascularization decisions.13,14,17 22 Table 2.


Because the STS score and the SYNTAX score have been shown to predict adverse outcomes in patients undergoing CABG and PCI, respectively, calculation of these scores is often useful in making revascularization decisions.13,14,17 22 Table 2. Revascularization to Improve Survival Compared With Medical Therapy Anatomic Setting COR LOE References UPLM or complex CAD CABG and PCI I Heart Team approach recommended C 14 16 CABG and PCI IIa Calculation of STS and SYNTAX scores B 13,14,17 22 UPLM* CABG I B 24 30 PCI IIa For SIHD when both of the following are present Anatomic conditions associated with a low risk of PCI procedural complications and a high likelihood of good long-term outcome (eg, a low SYNTAX score of 22, ostial or trunk left main CAD) Clinical characteristics that predict a significantly increased risk of adverse surgical outcomes (eg, STS-predicted risk of operative mortality 5%) IIa For UA/NSTEMI if not a CABG candidate B 13,36 39,44,45,47 49 IIa For STEMI when distal coronary flow is TIMI flow grade 3 and PCI can be performed more rapidly and safely than CABG IIb For SIHD when both of the following are present Anatomic conditions associated with a low to intermediate risk of PCI procedural complications and an intermediate to high likelihood of good long-term outcome (eg, low-intermediate SYNTAX score of 33, bifurcation left main CAD) Clinical characteristics that predict an increased risk of adverse surgical outcomes (eg, moderate-severe COPD, disability from prior stroke, or prior cardiac surgery; STS-predicted risk of operative mortality 2%) III: Harm For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG 3-vessel disease with or without proximal LAD artery disease* CABG I B 26,30,53 56 IIa It is reasonable to choose CABG over PCI in patients with complex 3-vessel CAD (eg, SYNTAX score 22) who are good candidates for CABG PCI IIb Of uncertain benefit B 26,46,53,56,82 2-vessel disease with proximal LAD artery disease* CABG I B 26,30,53 56 PCI IIb Of uncertain benefit B 26,53,56,82 2-vessel disease without proximal LAD artery disease* CABG IIa With extensive ischemia B 60 63 IIb Of uncertain benefit without extensive ischemia C 56 PCI IIb Of uncertain benefit B 26,53,56,82 1-vessel proximal LAD artery disease CABG IIa With LIMA for long-term benefit B 30,56,69,70 PCI IIb Of uncertain benefit B 26,53,56,82 1-vessel disease without proximal LAD artery involvement CABG III: Harm B 30,53,60,61,94 98 PCI III: Harm B 30,53,60,61,94 98 LV dysfunction CABG IIb EF 35% without significant left main CAD B 30,64 68,83,84 PCI Insufficient data N/A Survivors of sudden cardiac death with presumed ischemia-mediated VT CABG I B 57 59 PCI I C 57 No anatomic or physiologic criteria for revascularization CABG III: Harm B 30,53,60,61,94 98 PCI III: Harm B 30,53,60,61,94 98 *In patients with multivessel disease who also have diabetes, it is reasonable to choose CABG (with LIMA) over PCI62,74 81 (Class IIa; LOE: B).


CABG indicates coronary artery bypass graft; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; COR, class of recommendation; EF, ejection fraction; LAD, left anterior descending; LIMA, left internal mammary artery; LOE, level of evidence; LV, left ventricular; N/A, not applicable; PCI, percutaneous coronary intervention; SIHD, stable ischemic heart disease; STEMI, ST-elevation myocardial infarction; STS, Society of Thoracic Surgeons; SYNTAX, Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery; TIMI, Thrombolysis in Myocardial Infarction; UA/NSTEMI, unstable angina/non ST-elevation myocardial infarction; UPLM, unprotected left main disease; and VT, ventricular tachycardia. Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e581 2.2. Revascularization to Improve Survival: Recommendations Left Main CAD Revascularization Class I 1. CABG to improve survival is recommended for patients with significant (>50% diameter stenosis) left main coronary artery stenosis.24 30 (Level of Evidence: B) Class IIa 1. PCI to improve survival is reasonable as an alterna- tive to CABG in selected stable patients with signif- icant (>50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low risk of PCI procedural complications and a high likelihood of good long-term outcome (eg, a low SYNTAX score [<22], ostial or trunk left main CAD); and 2) clinical characteristics that predict a significantly increased risk of adverse surgical out- comes (eg, STS-predicted risk of operative mortality >5%).13,17,19,23,31 48 (Level of Evidence: B) 2. PCI to improve survival is reasonable in patients with UA/NSTEMI when an unprotected left main coronary artery is the culprit lesion and the patient is not a candidate for CABG.13,36 39,44,45,47 49 (Level of Evidence: B) 3.


PCI to improve survival is reasonable in patients with UA/NSTEMI when an unprotected left main coronary artery is the culprit lesion and the patient is not a candidate for CABG.13,36 39,44,45,47 49 (Level of Evidence: B) 3. PCI to improve survival is reasonable in patients with acute STEMI when an unprotected left main coronary artery is the culprit lesion, distal coronary flow is less than TIMI (Thrombolysis In Myocardial Infarction) grade 3, and PCI can be performed more rapidly and safely than CABG.33,50,51 (Level of Evi- dence: C) Class IIb 1. PCI to improve survival may be reasonable as an alternative to CABG in selected stable patients with significant (>50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associ- ated with a low to intermediate risk of PCI proce- dural complications and an intermediate to high likelihood of good long-term outcome (eg, low- intermediate SYNTAX score of <33, bifurcation left main CAD); and 2) clinical characteristics that predict an increased risk of adverse surgical out- comes (eg, moderate-severe chronic obstructive pul- monary disease, disability from previous stroke, or previous cardiac surgery; STS-predicted risk of operative mortality >2%).13,17,19,23,31 48,52 (Level of Evidence: B) Class III: HARM 1. PCI to improve survival should not be performed in stable patients with significant (>50% diameter stenosis) unprotected left main CAD who have un- favorable anatomy for PCI and who are good can- didates for CABG.13,17,19,24 32 (Level of Evidence: B) Non Left Main CAD Revascularization Class I 1. CABG to improve survival is beneficial in patients with significant (>70% diameter) stenoses in 3 major coronary arteries (with or without involve- ment of the proximal left anterior descending [LAD] artery) or in the proximal LAD plus 1 other major coronary artery.26,30,53 56 (Level of Evidence: B) 2.


CABG to improve survival is beneficial in patients with significant (>70% diameter) stenoses in 3 major coronary arteries (with or without involve- ment of the proximal left anterior descending [LAD] artery) or in the proximal LAD plus 1 other major coronary artery.26,30,53 56 (Level of Evidence: B) 2. CABG or PCI to improve survival is beneficial in survivors of sudden cardiac death with presumed ischemia-mediated ventricular tachycardia caused by significant (>70% diameter) stenosis in a major coronary artery. (CABG Level of Evidence: B57 59; PCI Level of Evidence: C57) Class IIa 1. CABG to improve survival is reasonable in patients with significant (>70% diameter) stenoses in 2 major coronary arteries with severe or extensive Table 3.


CABG to improve survival is reasonable in patients with significant (>70% diameter) stenoses in 2 major coronary arteries with severe or extensive Table 3. Revascularization to Improve Symptoms With Significant Anatomic (>50% Left Main or >70% Non Left Main CAD) or Physiological (FFR <0.80) Coronary Artery Stenoses Clinical Setting COR LOE References 1 significant stenoses amenable to revascularization and unacceptable angina despite GDMT I CABG I PCI 1 significant stenoses and unacceptable angina in whom GDMT cannot be implemented because of medication contraindications, adverse effects, or patient preferences IIa CABG IIa PCI C N/A Previous CABG with 1 significant stenoses associated with ischemia and unacceptable angina despite GDMT IIa PCI C 86,89,92 IIb CABG C 93 Complex 3-vessel CAD (eg, SYNTAX score 22) with or without involvement of the proximal LAD artery and a good candidate for CABG IIa CABG preferred over PCI B 32,46,56,71,72 Viable ischemic myocardium that is perfused by coronary arteries that are not amenable to grafting IIb TMR as an adjunct to CABG No anatomic or physiologic criteria for revascularization III: Harm CABG III: Harm PCI C N/A CABG indicates coronary artery bypass graft; CAD, coronary artery disease; COR, class of recommendation; FFR, fractional flow reserve; GDMT, guideline-directed medical therapy; LOE, level of evidence; N/A, not applicable; PCI, percutaneous coronary intervention; SYNTAX, Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery; and TMR, transmyocardial laser revascularization. myocardial ischemia (eg, high-risk criteria on stress testing, abnormal intracoronary hemodynamic eval- uation, or >20% perfusion defect by myocardial perfusion stress imaging) or target vessels supplying a large area of viable myocardium.60 63 (Level of Evidence: B) 2.


myocardial ischemia (eg, high-risk criteria on stress testing, abnormal intracoronary hemodynamic eval- uation, or >20% perfusion defect by myocardial perfusion stress imaging) or target vessels supplying a large area of viable myocardium.60 63 (Level of Evidence: B) 2. CABG to improve survival is reasonable in patients with mild-moderate left ventricular (LV) systolic dysfunction (ejection fraction [EF] 35% to 50%) and significant (>70% diameter stenosis) multi-vessel CAD or proximal LAD coronary artery stenosis, when viable myocardium is present in the region of intended revascularization.30,64 68 (Level of Evi- dence: B) 3. CABG with a left internal mammary artery (LIMA) graft to improve survival is reasonable in patients with significant (>70% diameter) stenosis in the proximal LAD artery and evidence of extensive ischemia.30,56,69,70 (Level of Evidence: B) 4. It is reasonable to choose CABG over PCI to im- prove survival in patients with complex 3-vessel CAD (eg, SYNTAX score >22), with or without involvement of the proximal LAD artery who are good candidates for CABG.32,46,56,71,72 (Level of Evi- dence: B) 5. CABG is probably recommended in preference to PCI to improve survival in patients with multivessel CAD and diabetes mellitus, particularly if a LIMA graft can be anastomosed to the LAD artery.62,74 81 (Level of Evidence: B) Class IIb 1. The usefulness of CABG to improve survival is uncertain in patients with significant (>70%) diam- eter stenoses in 2 major coronary arteries not involv- ing the proximal LAD artery and without extensive ischemia.56 (Level of Evidence: C) 2. The usefulness of PCI to improve survival is uncer- tain in patients with 2- or 3-vessel CAD (with or without involvement of the proximal LAD artery) or 1-vessel proximal LAD disease.26,53,56,82 (Level of Evidence: B) 3.


The usefulness of PCI to improve survival is uncer- tain in patients with 2- or 3-vessel CAD (with or without involvement of the proximal LAD artery) or 1-vessel proximal LAD disease.26,53,56,82 (Level of Evidence: B) 3. CABG might be considered with the primary or sole intent of improving survival in patients with SIHD with severe LV systolic dysfunction (EF <35%) whether or not viable myocardium is present.30,64 68,83,84 (Level of Evidence: B) 4. The usefulness of CABG or PCI to improve survival is uncertain in patients with previous CABG and extensive anterior wall ischemia on noninvasive test- ing.85 93 (Level of Evidence: B) Class III: HARM 1. CABG or PCI should not be performed with the primary or sole intent to improve survival in pa- tients with SIHD with 1 or more coronary stenoses that are not anatomically or functionally significant (eg, <70% diameter non left main coronary artery stenosis, FFR >0.80, no or only mild ischemia on noninvasive testing), involve only the left circumflex or right coronary artery, or subtend only a small area of viable myocardium.30,53,60,61,94 98 (Level of Evidence: B) 2.3. Revascularization to Improve Symptoms: Recommendations Class I 1. CABG or PCI to improve symptoms is beneficial in patients with 1 or more significant (>70% diameter) coronary artery stenoses amenable to revasculariza- tion and unacceptable angina despite GDMT.82,99 108 (Level of Evidence: A) Class IIa 1. CABG or PCI to improve symptoms is reasonable in patients with 1 or more significant (>70% diameter) coronary artery stenoses and unacceptable angina for whom GDMT cannot be implemented because of medication contraindications, adverse effects, or pa- tient preferences. (Level of Evidence: C) 2.


CABG or PCI to improve symptoms is reasonable in patients with 1 or more significant (>70% diameter) coronary artery stenoses and unacceptable angina for whom GDMT cannot be implemented because of medication contraindications, adverse effects, or pa- tient preferences. (Level of Evidence: C) 2. PCI to improve symptoms is reasonable in patients with previous CABG, 1 or more significant (>70% diameter) coronary artery stenoses associated with ischemia, and unacceptable angina despite GDMT.86,89,92 (Level of Evidence: C) 3. It is reasonable to choose CABG over PCI to im- prove symptoms in patients with complex 3-vessel CAD (eg, SYNTAX score >22), with or without involvement of the proximal LAD artery who are good candidates for CABG.32,46,56,72,73 (Level of Evi- dence: B) Class IIb 1. CABG to improve symptoms might be reasonable for patients with previous CABG, 1 or more signif- icant (>70% diameter) coronary artery stenoses not amenable to PCI, and unacceptable angina despite GDMT.93 (Level of Evidence: C) 2. Transmyocardial laser revascularization (TMR) performed as an adjunct to CABG to improve symptoms may be reasonable in patients with viable ischemic myocardium that is perfused by arteries that are not amenable to grafting.109 113 (Level of Evidence: B) Class III: HARM 1. CABG or PCI to improve symptoms should not be performed in patients who do not meet anatomic (>50% diameter left main or >70% non left main stenosis diameter) or physiological (eg, abnormal FFR) criteria for revascularization. (Level of Evi- dence: C) 2.4.


CABG or PCI to improve symptoms should not be performed in patients who do not meet anatomic (>50% diameter left main or >70% non left main stenosis diameter) or physiological (eg, abnormal FFR) criteria for revascularization. (Level of Evi- dence: C) 2.4. CABG Versus Contemporaneous Medical Therapy In the 1970s and 1980s, 3 RCTs established the survival benefit of CABG compared with contemporaneous (although minimal by current standards) medical therapy without revas- cularization in certain subjects with stable angina: the Veter- Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e583 ans Affairs Cooperative Study,114 European Coronary Sur- gery Study,55 and CASS (Coronary Artery Surgery Study).115 Subsequently, a 1994 meta-analysis of 7 studies that random- ized a total of 2649 patients to medical therapy or CABG30 showed that CABG offered a survival advantage over medi- cal therapy for patients with left main or 3-vessel CAD. The studies also established that CABG is more effective than medical therapy for relieving anginal symptoms. These stud- ies have been replicated only once during the past decade. In MASS II (Medicine, Angioplasty, or Surgery Study II), patients with multivessel CAD who were treated with CABG were less likely than those treated with medical therapy to have a subsequent MI, need additional revascularization, or experience cardiac death in the 10 years after Surgical techniques and medical therapy have improved substantially during the intervening years. As a result, if CABG were to be compared with GDMT in RCTs today, the relative benefits for survival and angina relief observed several decades ago might no longer be observed. Con- versely, the concurrent administration of GDMT may sub- stantially improve long-term outcomes in patients treated with CABG in comparison with those receiving medical therapy alone.


Con- versely, the concurrent administration of GDMT may sub- stantially improve long-term outcomes in patients treated with CABG in comparison with those receiving medical therapy alone. In the BARI 2D (Bypass Angioplasty Revas- cularization Investigation 2 Diabetes) trial of patients with diabetes mellitus, no significant difference in risk of mortality in the cohort of patients randomized to GDMT plus CABG or GDMT alone was observed, although the study was not powered for this endpoint, excluded patients with significant left main CAD, and included only a small percentage of patients with proximal LAD artery disease or LV ejection fraction (LVEF) 0.50.116 The PCI and CABG guideline writing committees endorse the performance of the ISCH- EMIA (International Study of Comparative Health Effective- ness with Medical and Invasive Approaches) trial, which will provide contemporary data on the optimal management strat- egy (medical therapy or revascularization with CABG or PCI) of patients with SIHD, including multivessel CAD, and moderate to severe ischemia. 2.5. PCI Versus Medical Therapy Although contemporary interventional treatments have low- ered the risk of restenosis compared with earlier techniques, meta-analyses have failed to show that the introduction of BMS confers a survival advantage over balloon angio- plasty117 119 or that the use of DES confers a survival advantage over BMS.119,120 No study to date has demonstrated that PCI in patients with SIHD improves survival rates.26,53,56,82,116,119,121 124 Neither COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation)82 nor BARI 2D,116 which treated all patients with contemporary optimal medical ther- apy, demonstrated any survival advantage with PCI, although these trials were not specifically powered for this endpoint.