Author Listing of Relationships With Industry and Other Entities (Relevant) ACC/AHA/SCAI/AMA-Convened PCPI/ NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Intervention Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Brahmajee K. Nallamothu, Co-Chair Ann Arbor VAMC Center for Clinical Management Research University of Michigan Associate Professor Prescription Solutions* None None BCBS Foundation of Michigan* Abbott Vascular None Carl L. Tommaso, Co-Chair NorthShore University HealthSystem Associate Professor, Rush Medical College Physician None None None None None None H. Vernon Anderson University of Texas Health Science Center Houston Professor, Department of Medicine None Bristol-Myers Squibb Sanofi-Aventis None MedPace (DSMB) DCRI Novartis Eli Lilly None None Jeffrey L. Anderson Intermountain Medical Center Associate Chief of Cardiology AstraZeneca Sanofi-Aventis None None Atherotech GlaxoSmithKline None None Joseph C. Cleveland, Jr. University of Colorado at Denver Professor of Surgery and Surgical Director, Cardiac Transplant and MCS Baxter Biosurgery None None None None None R. Adams Dudley Institute for Health Policy Studies Professor of Medicine and Health Policy None None None None None None Peter Louis Duffy FirstHealth of the Carolinas Medical Director, Cardiovascular Service Line at Reid Heart Center, Interventional Cardiology None Volcano None Volcano None None David P. Faxon Brigham and Women s Hospital Vice Chair of Medicine, Cardiology Johnson & Johnson None Reva Medical Biotronik (DSMB) Medtronic (DSMB) Direct Flow (DSMB) Boston Scientific (DSMB) None None Hitinder S. Gurm University of Michigan Cardiovascular Center Associate Professor None None None BCBS of Michigan * None None (Continued) Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 943 Appendix A. Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Lawrence A. Hamilton Kaiser Permanente, Northern California Regional Director, Cardiac and Renal Services None None None None None None Neil C. Jensen United Healthcare Director, Cardiology Network None None None None None None Richard A. Josephson University Hospitals of Cleveland Medical Group Professor of Medicine, Case Western Reserve University School of Medicine None None None None None None David J. Malenka Dartmouth- Hitchcock Medical Center Professor of Medicine, Division of Cardiology Wellpoint* None None Abbott Vascular None None Calin V. Maniu Bon Secours Health System, Suffolk, Virginia Physician None None None None None None Kevin W. McCabe S.C. Johnson & Son, Inc. Director of Occupational and Preventive Medicine None None None None None None James D. Mortimer Jim Mortimer Consulting Consultant None None None None None None Manesh R. Patel Duke University Medical Center Assistant Professor of Medicine None None None Genzyme None None Stephen D. Persell Feinberg School of Medicine, Northwestern University Assistant Professor of Medicine None None None None None None John S. Rumsfeld U.S. Veterans Health Administration National Director of Cardiology; Chief Science Officer, National Cardiovascular Data Registry United Healthcare* None None None None None (Continued) Appendix A.


Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Lawrence A. Hamilton Kaiser Permanente, Northern California Regional Director, Cardiac and Renal Services None None None None None None Neil C. Jensen United Healthcare Director, Cardiology Network None None None None None None Richard A. Josephson University Hospitals of Cleveland Medical Group Professor of Medicine, Case Western Reserve University School of Medicine None None None None None None David J. Malenka Dartmouth- Hitchcock Medical Center Professor of Medicine, Division of Cardiology Wellpoint* None None Abbott Vascular None None Calin V. Maniu Bon Secours Health System, Suffolk, Virginia Physician None None None None None None Kevin W. McCabe S.C. Johnson & Son, Inc. Director of Occupational and Preventive Medicine None None None None None None James D. Mortimer Jim Mortimer Consulting Consultant None None None None None None Manesh R. Patel Duke University Medical Center Assistant Professor of Medicine None None None Genzyme None None Stephen D. Persell Feinberg School of Medicine, Northwestern University Assistant Professor of Medicine None None None None None None John S. Rumsfeld U.S. Veterans Health Administration National Director of Cardiology; Chief Science Officer, National Cardiovascular Data Registry United Healthcare* None None None None None (Continued) Appendix A. Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Kendrick A. Shunk San Francisco VA Medical Center Director of Interventional Cardiology Revascular Therapeutics None Revascular Therapeutics Siemens Medical Systems Abbott Vascular IntraRedx Gilead None None Sidney C. Smith, Jr. University of North Carolina at Chapel Hill Professor of Medicine None None None None None None Stephen J. Stanko The Mended Hearts, Inc. National Cath Patient Outreach Chair None None None None None None Brook Watts Louis Stokes Cleveland VA Medical Center Associate Professor of Medicine, Case Western Reserve University 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.


Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Kendrick A. Shunk San Francisco VA Medical Center Director of Interventional Cardiology Revascular Therapeutics None Revascular Therapeutics Siemens Medical Systems Abbott Vascular IntraRedx Gilead None None Sidney C. Smith, Jr. University of North Carolina at Chapel Hill Professor of Medicine None None None None None None Stephen J. Stanko The Mended Hearts, Inc. National Cath Patient Outreach Chair None None None None None None Brook Watts Louis Stokes Cleveland VA Medical Center Associate Professor of Medicine, Case Western Reserve University None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted.


Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACC/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *At the time that this committee was convened, third-party payers were not deemed relevant. Dr. Nallamothu's relationship with Abbott Vascular (attended training for MitraClip) was added shortly before finalization of the performance measures, so it was not relevant during the development of the measures. No financial relationship. Recused from voting on measure 7. Significant (greater than $10000) relationship. Recused from voting on measures 9 and 11. ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; BCBS, Blue Shield Blue Cross; DCRI, Duke Clinical Research Institute; DSMB, Data Safety Monitoring Board; NCQA, National Committee for Quality Assurance; SCAI, Society for Cardiovascular Angiography and Interventions; VA, Veterans Affairs.


ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; BCBS, Blue Shield Blue Cross; DCRI, Duke Clinical Research Institute; DSMB, Data Safety Monitoring Board; NCQA, National Committee for Quality Assurance; SCAI, Society for Cardiovascular Angiography and Interventions; VA, Veterans Affairs. Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 945 Appendix B. Reviewer Relationships With Industry and Other Entities (Relevant) ACC/AHA/SCAI/AMA-Convened PCPI/NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Interventions Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Nancy Albert Content Reviewer ACC/AHA Task Force on Performance Measures Merck* BG Medicine Medtronic None None None None None Joseph M. Allen Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Steven R. Bailey Content Reviewer ACC Appropriate Use Criteria Task Force None None Biostar Palmaz Scientific Boston Scientific (DSMB) None None Justin M. Bachmann Official Reviewer ACC Board of Governors None None None None None None Biykem Bozkurt Content Reviewer ACC/AHA Task Force on Data Standards None None None Forest Pharmaceuticals PI NIH PI NIH Co-Investigator None Nakela L. Cook Organizational Reviewer NHLBI None None None None None None Pamela S. Douglas Content Reviewer ACC Appropriate Use Criteria Task Force Pappas Ventures None None Roche* Bristol-Myers Squib* Abiomed* Novartis* Miracor* Edwards Lifesciences* Atritech* None None Thomas C. Gerber Content Reviewer ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee Content Reviewer AHA None None None None None None Robert C. Hendel Content Reviewer ACC Appropriate Use Criteria Task Force Bayer Adenosine Therapeutics None None None None None Kalon K.L.


Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 945 Appendix B. Reviewer Relationships With Industry and Other Entities (Relevant) ACC/AHA/SCAI/AMA-Convened PCPI/NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Interventions Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Nancy Albert Content Reviewer ACC/AHA Task Force on Performance Measures Merck* BG Medicine Medtronic None None None None None Joseph M. Allen Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Steven R. Bailey Content Reviewer ACC Appropriate Use Criteria Task Force None None Biostar Palmaz Scientific Boston Scientific (DSMB) None None Justin M. Bachmann Official Reviewer ACC Board of Governors None None None None None None Biykem Bozkurt Content Reviewer ACC/AHA Task Force on Data Standards None None None Forest Pharmaceuticals PI NIH PI NIH Co-Investigator None Nakela L. Cook Organizational Reviewer NHLBI None None None None None None Pamela S. Douglas Content Reviewer ACC Appropriate Use Criteria Task Force Pappas Ventures None None Roche* Bristol-Myers Squib* Abiomed* Novartis* Miracor* Edwards Lifesciences* Atritech* None None Thomas C. Gerber Content Reviewer ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee Content Reviewer AHA None None None None None None Robert C. Hendel Content Reviewer ACC Appropriate Use Criteria Task Force Bayer Adenosine Therapeutics None None None None None Kalon K.L. Ho Official Reviewer SCAI Content Reviewer ACC NCDR Science and Quality Oversight Committee None None None None Boston Scientific* None Hani Jneid Content Reviewer AHA None None None None None None Christopher M. Kramer Content Reviewer ACC Appropriate Use Criteria Task Force Synarc None None Novartis Siemens None None Carl J. Lavie Jr.


Ho Official Reviewer SCAI Content Reviewer ACC NCDR Science and Quality Oversight Committee None None None None Boston Scientific* None Hani Jneid Content Reviewer AHA None None None None None None Christopher M. Kramer Content Reviewer ACC Appropriate Use Criteria Task Force Synarc None None Novartis Siemens None None Carl J. Lavie Jr. Organizational Reviewer AACVPR Abbott Boehringer Ingelheim GlaxoSmithKline Pfizer Upsher Smith Amarin* AstraZeneca None None None None None Alice M. Mascette Organizational Reviewer NHLBI None None None None None None (Continued) Appendix B.


Organizational Reviewer AACVPR Abbott Boehringer Ingelheim GlaxoSmithKline Pfizer Upsher Smith Amarin* AstraZeneca None None None None None Alice M. Mascette Organizational Reviewer NHLBI None None None None None None (Continued) Appendix B. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Frederick A. Masoudi Content Reviewer ACC NCDR Science and Quality Oversight Committee Content Reviewer AHA None None None None None None Laura Mauri Official Reviewer AHA Abbott Cordis Johnson & Johnson Medtronic None None Abbott Abiomed Boston Scientific Bristol-Myers Squibb Cordis Daiichi Sankyo Eli Lilly Johnson & Johnson Medtronic Sanofi-Aventis Harvard Clinical Research Institute None None James K. Min Content Reviewer ACC Appropriate Use Criteria Task Force None GE Healthcare TC3* Phillips Healthcare* Arineta* None None Manesh R. Patel Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Eric D. Peterson Official Reviewer ACC/AHA Task Force on Performance Measures Boehringer Ingelheim Genentech Janssen Pharmaceuticals Johnson & Johnson Merck None None Eli Lilly Johnson & Johnson Janssen Pharmaceuticals DCRI None Sunil V. Rao Official Reviewer SCAI AstraZeneca Bristol-Myers Squibb Cordis Daiichi Sankyo Terumo Medical The Medicines Company None None Sanofi-Aventis Abbott Vascular* None None Matthew T. Roe Content Reviewer ACC NCDR Science and Quality Oversight Committee KAI Pharmaceuticals Daiichi Sankyo GlaxoSmithKline Janssen Pharmaceuticals Eli Lilly Bristol-Myers Squibb Sanofi-Aventis None AstraZeneca Bristol-Myers Squibb Eli Lilly Merck Roche Pharmaceuticals Sanofi-Aventis AstraZeneca* AstraZeneca lectures performed within DCRI None Frank Rybicki Content Reviewer ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee None None None Bracco Diagnostics Toshiba Medical Systems None None Leslee Shaw Content Reviewer ACC Appropriate Use Criteria Task Force None None None Bracco Diagnostics None None Marc Shelton Content Reviewer ACC Board of Governors None None None None None None John Spertus Content Reviewer ACC Appropriate Use Criteria Coronary Revascularization Genentech United Healthcare Scientific Advisory Board Amgen None None Eli Lilly CV Outcomes* None (Continued) Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 947 Appendix B.


Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Frederick A. Masoudi Content Reviewer ACC NCDR Science and Quality Oversight Committee Content Reviewer AHA None None None None None None Laura Mauri Official Reviewer AHA Abbott Cordis Johnson & Johnson Medtronic None None Abbott Abiomed Boston Scientific Bristol-Myers Squibb Cordis Daiichi Sankyo Eli Lilly Johnson & Johnson Medtronic Sanofi-Aventis Harvard Clinical Research Institute None None James K. Min Content Reviewer ACC Appropriate Use Criteria Task Force None GE Healthcare TC3* Phillips Healthcare* Arineta* None None Manesh R. Patel Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Eric D. Peterson Official Reviewer ACC/AHA Task Force on Performance Measures Boehringer Ingelheim Genentech Janssen Pharmaceuticals Johnson & Johnson Merck None None Eli Lilly Johnson & Johnson Janssen Pharmaceuticals DCRI None Sunil V. Rao Official Reviewer SCAI AstraZeneca Bristol-Myers Squibb Cordis Daiichi Sankyo Terumo Medical The Medicines Company None None Sanofi-Aventis Abbott Vascular* None None Matthew T. Roe Content Reviewer ACC NCDR Science and Quality Oversight Committee KAI Pharmaceuticals Daiichi Sankyo GlaxoSmithKline Janssen Pharmaceuticals Eli Lilly Bristol-Myers Squibb Sanofi-Aventis None AstraZeneca Bristol-Myers Squibb Eli Lilly Merck Roche Pharmaceuticals Sanofi-Aventis AstraZeneca* AstraZeneca lectures performed within DCRI None Frank Rybicki Content Reviewer ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee None None None Bracco Diagnostics Toshiba Medical Systems None None Leslee Shaw Content Reviewer ACC Appropriate Use Criteria Task Force None None None Bracco Diagnostics None None Marc Shelton Content Reviewer ACC Board of Governors None None None None None None John Spertus Content Reviewer ACC Appropriate Use Criteria Coronary Revascularization Genentech United Healthcare Scientific Advisory Board Amgen None None Eli Lilly CV Outcomes* None (Continued) Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 947 Appendix B. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Raymond F. Stainback Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Eric Stecker Content Reviewer ACC Clinical Quality Committee None None None Biotronik Medtronic Boston Scientific None None James E. Tcheng Content Reviewer ACC/AHA Task Force on Data Standards None None None Philips Medical Systems None None Randal J. Thomas Organizational Reviewer AACVPR None None None None None None Thomas T. Tsai Content Reviewer ACC NCDR Science and Quality Oversight Committee None None None None None None Thad Waites Official Reviewer ACC Board of Trustees None None None None None None Tracy Y. Wang Content Reviewer ACC/AHA Task Force on Data Standards AstraZeneca Medco Health Solutions None None Bristol-Myers Squibb Canyon Pharmaceuticals Daiichi Sankyo Eli Lilly Heartscape Merck Sanofi-Aventis The Medicines Company Gilead None None Michael J. Wolk Content Reviewer ACC Appropriate Use Criteria Task Force 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.


Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Raymond F. Stainback Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Eric Stecker Content Reviewer ACC Clinical Quality Committee None None None Biotronik Medtronic Boston Scientific None None James E. Tcheng Content Reviewer ACC/AHA Task Force on Data Standards None None None Philips Medical Systems None None Randal J. Thomas Organizational Reviewer AACVPR None None None None None None Thomas T. Tsai Content Reviewer ACC NCDR Science and Quality Oversight Committee None None None None None None Thad Waites Official Reviewer ACC Board of Trustees None None None None None None Tracy Y. Wang Content Reviewer ACC/AHA Task Force on Data Standards AstraZeneca Medco Health Solutions None None Bristol-Myers Squibb Canyon Pharmaceuticals Daiichi Sankyo Eli Lilly Heartscape Merck Sanofi-Aventis The Medicines Company Gilead None None Michael J. Wolk Content Reviewer ACC Appropriate Use Criteria Task Force 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. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition.


A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACCF/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *No financial relationship. Significant (greater than $10000) relationship. DCRI has numerous grants and contracts sponsored by industry.


Significant (greater than $10000) relationship. DCRI has numerous grants and contracts sponsored by industry. These include the following: Aastrom Biosciences ; Abbott ; Abiomed ; Acom Cardiovascular ; Adolor Corp. ; Advanced Cardiovascular Systems ; Advanced Stent Technologies ; Adynnx; Aijnomoto ; Allergan ; Amgen ; Alnylam Pharma ; Alpharma ; Amylin Pharmaceuticals ; Anadys ; Anesiva ; Angel Medical Systems ; ANGES MG ; Angiomedtrix ; APT Nidus Center ; ASCA Biopharma ; Astellas Pharma ; Asklepios ; AstraZeneca ; Atritech ; Attention Therapeutics ; Aventis ; Baxter ; Bayer ; Berlex ; BG Medicine ; Biogen ; Biolex Therapeutics ; Biomarker Factory ; Biosite ; Boehringer Ingelheim Biogen ; Boston Scientific ; Bristol-Myers Squibb ; BMS Pfizer ; Carbomed ; CardioDx ; CardioKinetix ; Cardiovascular Systems ; Cardiovax ; Celsion Corp. ; Centocor ; Cerexa ; Chase Medical ; Conatus Pharmaceuticals ; Conor Medsystems ; Cortex ; Corgentech ; CSL Behring ; CV Therapeutics ; Daiichi Pharmaceuticals ; Daiichi Sankyo ; Daiichi Sankyo Lilly ; Datascope; Dendreon ; Dainippon ; Dr. Reddy s Laboratories; Eclipse Surgical Technologies ; Edwards Lifesciences ; Eisai ; Endicor ; EnteroMedics ; Enzon Pharmaceuticals ; Eli Lilly ; Ethicon ; Ev3 ; Evalve ; F2G ; Flow Cardia ; Fox Hollow Pharmaceuticals ; Fujisawa ; Genetech ; General Electric ; General Electric Co. ; General Electric Healthcare ; General Electric Medical Systems ; Genzyme Corp. ; Genome Canada ; Gilead Sciences ; GlaxoSmithKline ; Guidant Corp. ; Heartscape Technologies ; Hoffman-LaRoche ; Hospira ; Idera Pharmaceuticals ; Ikaria ; Imcor Pharmaceuticals ; Immunex ; INFORMD ; Inimex ; Inspire Pharmaceuticals ; Ischemix ; Janssen ; Johnson and Johnson ; Jomed ; Juventus Therapeutics ; KAI Pharmaceuticals ; King Pharmaceuticals ; Kyowa Pharma ; Luitpold ; Mardil ; MedImmune ; Medscape ; Medtronic Diabetes ; Medtronic ; Medtronic Vascular ; Merck Group ; MicroMed Technology ; Millennium Pharmaceuticals ; Mitsubishi Tanabe ; Momenta ; Nabriva ; Neuron Pharmaceuticals ; NitroMed; NovaCardia Inc ; Novartis AG Group ; Novartis Pharmaceuticals ; Oncura ; Orexigen ; Ortho-McNeil-Janssen ; OSI Eyetech ; OSI Pharmaceuticals ; Pfizer ; Pharmacyclics ; Pharmasset ; Pharmos ; Phyxius Pharmaceuticals; Pharsight ; Pluristen Therapeutics ; Portola Pharmaceuticals ; Proventys ; Radiant ; Regado Biosciences ; Rengeneron Pharmaceuticals ; Roche Molecular Systems ; Roche Group ; Roche Diagnostic ; Salix Pharmaceuticals ; Sanofi-Pasteur, Inc; Sanofi-aventis ; Santaris Pharmaceuticals ; Schering-Plough ; Scios ; Siemens ; Southwest Oncology Group ; Spectranetics ; Summit ; Sunovion Pharmaceuticals ; TAP Pharmaceutical Products ; Tengion ; The Medicines Company ; Theravance ; TherOx ; Tethys Bioscience ; Theregen ; Three Rivers Pharmaceuticals ; The EMMES Corporation ; UCB ; Valentis ; Valleylab ; Vertex ; Viacor ; and Wyeth .


AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; ACC, American College of Cardiology; ACR, American College of Radiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; CV, Cardiovascular; DCRI, Duke Clinical Research Institute; DSMB, Data Safety Monitoring Board; NCDR, National Cardiovascular Data Registry; NCQA, National Committee for Quality Assurance; NHLBI, National Heart, Lung, and Blood Institute; SCAI, Society for Cardiovascular Angiography and Interventions. Appendix C. ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 Percutaneous Coronary Interventions Performance Measures: Summary Analysis Table Completely Fulfills Attribute* Partially Fulfills or Does Not Fulfill Attribute* Summary Comments Measures included in the performance measure set Comprehensive Documentation of PCI 1,2,3,4 Appropriate Indication for Elective PCI 1,2,3b,4 3a Lack of existing data on use in test populations makes it difficult to know whether the current measure accurately captures appropriateness (as opposed to encouraging gaming) or whether it will lead to unintended consequences by punishing providers. Assessment of Candidacy for Dual- Antiplatelet Therapy 1,2,4 3 ACCF National Cardiovascular Data Registry CathPCI Registry is unable to measure this. It will require additional chart documentation and abstraction. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Disease 2,3b,4 1b, 3a The guideline Class of Recommendation is 1, and Level of Evidence is only B. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedure 2,3,4 1 There are few potential unintended consequences, given that there are no thresholds specified in this measure. However, evidence indicates that doses are inconsistently documented. Therefore, although this measure is expected to have limited impact because it requires only documentation, it is an intermediate step to a more meaningful performance measure. Radiation Dose Documented 2,3,4 1 There are few potential unintended consequences given that there are no thresholds specified in this measure.


Radiation Dose Documented 2,3,4 1 There are few potential unintended consequences given that there are no thresholds specified in this measure. However, evidence indicates that doses are inconsistently documented. Therefore, although this measure is expected to have limited impact because it requires only documentation, it is an intermediate step to a more meaningful performance measure. Postprocedural Optimal Medical Therapy Composite 1,2,3,4 Registry data are currently limited, making it unfeasible to capture specific medical, patient, or system exceptions. Cardiac Rehabilitation Patient Referral 1,2,3,4 Regional or National PCI Registry Participation 2,3,4 1 The guideline Class of Recommendation is 1, but Level of Evidence is only C. Annual Operator PCI Volume 2,3b 1,3a,4 There are potential unintended consequences because operators might be more inclined to intervene when the procedure is not indicated. This measure could pose a feasibility challenge if a person works at multiple sites. Annual Hospital PCI Volume 2,3 1,4 Smaller hospitals might be more inclined to intervene when the procedure is not indicated, to achieve higher volumes. Measures considered but not included in the performance measure set Assessment of patient knowledge of benefits and risks of PCI 1,4b 2,3,4a Limited availability of validated surveys. Limited existing literature on patient education or actionable methods to improve it. Postprocedural dialysis 1 2,3,4 Dialysis might not be related to PCI. Long measurement period is needed to capture data, given it is a rare event. Postprocedural blood transfusion 1 3,4 Bleeding might occur outside interventionalists locus of control. Measurement of cardiac biomarkers N/A 1,2,3,4 Evidence is still controversial. Periprocedural angina assessment 1,2 3,4 This is a potentially high-impact area with validated instruments, yet little data exist on how to best incorporate validated instruments into routine practice without excessive effort or costs.


Periprocedural angina assessment 1,2 3,4 This is a potentially high-impact area with validated instruments, yet little data exist on how to best incorporate validated instruments into routine practice without excessive effort or costs. Aspirin/thienopyridine at discharge 3,4 1,2 There is little room for major impact or improvement, given existing evidence of already high compliance rates. *Corresponding numbers and letters are linked to the ACC/AHA Task Force on Performance Measures Attributes for Performance Measures. Numbers indicate the entire attribute, and letters indicate specific attribute subcriteria. These measures are performance measures. Indicated in shading, these measures have been designated quality metrics. Quality metric are designated for use in internal quality-improvement programs only. These measures are not appropriate for any other purpose (eg, pay-for-performance, physician ranking, or public reporting programs). Where applicable, the writing committee provided summary comments about why certain measures were included or not included in the final measure set. For all attributes noted as partially or does not fulfill attribute, the writing committee provided summary comments. ACCF indicates American College of Cardiology Foundation; AHA, American Heart Association; GFR, glomerular filtration rate; and PCI, percutaneous coronary intervention. Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 949 Attributes and subcriteria key: 1. Evidence based: For structural measures, the structure should be closely linked to a meaningful process of care that in turn is linked to a meaningful patient outcome. For process measures, the scientific basis for the measure is well established, and the process should be closely linked to a meaningful patient outcome. For outcome measures, the outcome should be clini- cally meaningful. If appropriate, performance mea- sures based on outcomes should adjust for relevant clinical characteristics through the use of appropri- ate methodology and high-quality data sources. 2.


If appropriate, performance mea- sures based on outcomes should adjust for relevant clinical characteristics through the use of appropri- ate methodology and high-quality data sources. 2. Measure selection: The patient group to whom the measure applies (denominator) and the patient group for whom con- formance is achieved (numerator) are clearly defined and clinically meaningful. Exceptions and exclusions are supported by evidence. The measure is reproducible across organizations and delivery settings. Face validity The measure appears to assess what it is intended to. 2e. Content validity The measure captures most mean- ingful aspects of care. Construct validity The measure correlates well with other measures of the same aspect of care. 3. Measure feasibility: The data required for the measure can be obtained with reasonable effort and cost. The data required for the measure can be obtained within the period allowed for data collection. Actionable Those held accountable can affect the care process or outcome. The likelihood of negative unintended consequences with the measure is low.


*ACC/AHA Representative. Lay Representative. ACC/AHA Task Force on Clinical Practice Guidelines Liaison. Task Force Performance Measures Representative. The American Heart Association requests that this document be cited as follows: Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Mu oz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140:e596 e646.


2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140:e596 e646. DOI: 10.1161/ WRITING COMMITTEE MEMBERS Donna K. Arnett, PhD, MSPH, FAHA, Co-Chair Roger S. Blumenthal, MD, FACC, FAHA, Co-Chair Michelle A. Albert, MD, MPH, FAHA* Andrew B. Buroker, Esq Zachary D. Goldberger, MD, MS, FACC, FAHA Ellen J. Hahn, PhD, RN* Cheryl Dennison Himmelfarb, PhD, RN, ANP, FAHA* Amit Khera, MD, MSc, FACC, FAHA* Donald Lloyd-Jones, MD, SCM, FACC, FAHA* J. William McEvoy, MBBCh, MEd, MHS* Erin D. Michos, MD, MHS, FACC, FAHA* Michael D. Miedema, MD, MPH* Daniel Mu oz, MD, MPA, FACC* Sidney C. Smith Jr, MD, MACC, FAHA* Salim S. Virani, MD, PhD, FACC, FAHA* Kim A. Williams Sr, MD, MACC, FAHA* Joseph Yeboah, MD, MS, FACC, FAHA* Boback Ziaeian, MD, PhD, FACC, FAHA 2019 by the American College of Cardiology Foundation and the American Heart Association, Inc. ACC/AHA CLINICAL PRACTICE GUIDELINE 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines Circulation https://www.ahajournals.org/journal/circ ACC/AHA Task Force Members, see page e623 Endorsed by the American Associa- tion of Cardiovascular and Pulmo- nary Rehabilitation, the American Geriatrics Society, the American Society of Preventive Cardiology, and the Preventive Cardiovascular Nurses Association Key Words: AHA Scientific Statements guidelines antihypertensive agents aspirin atherosclerosis atherosclerotic cardiovascular disease atrial fibrillation behavior modification behavior therapy blood cholesterol blood pressure body mass index cardiovascular team-based care cardiovascular cardiovascular disease cholesterol chronic kidney disease coronary artery calcium score coronary disease coronary heart disease cost diet dietary patterns dietary fats dietary sodium dyslipidemia e-cigarettes exercise healthcare disparities health services accessibility heart failure hypertension LDL cholesterol diabetes mellitus lifestyle lipids measurement myocardial infarction nicotine nonpharmacological treatment nutrition physical activity prejudice primary prevention psychosocial deprivation public health quality indicators quality measurement risk assessment risk-enhancing factors risk factors risk reduction risk reduction discussion risk treatment discussion secondhand smoke sleep smoking smoking cessation social determinants of health socioeconomic factors statin therapy systems of care tobacco tobacco smoke pollution treatment adherence treatment outcomes type 2 diabetes mellitus waist circumference weight loss CLINICAL STATEMENTS AND GUIDELINES TABLE OF CONTENTS Top 10 Take-Home Messages for the Primary Prevention of Cardiovascular Disease e597 Preamble e597 1.


Introduction e598 1.1. Methodology and Evidence Review e599 1.2. Organization of the Writing Committee e599 1.3. Document Review and Approval e599 1.4. Scope of the Guideline e599 1.5. Class of Recommendation and Level of Evidence e600 1.6. Abbreviations e601 2. Overarching Recommendations for ASCVD Prevention Efforts e601 2.1. Patient-Centered Approaches to Comprehensive ASCVD Prevention e601 2.2. Assessment of Cardiovascular Risk e602 3. Lifestyle Factors Affecting Cardiovascular Risk e605 3.1. Nutrition and Diet e605 3.2. Exercise and Physical Activity e607 4. Other Factors Affecting Cardiovascular Risk e609 4.1. Adults With Overweight and Obesity e609 4.2. Adults With Type 2 Diabetes Mellitus e610 4.3. Adults With High Blood Cholesterol e612 4.4. Adults With High Blood Pressure or Hypertension e616 4.5. Treatment of Tobacco Use e618 4.6. Aspirin Use e621 5. Cost and Value Considerations e622 6. Conclusion e623 Appendix 1: Search Criteria e636 Appendix 2: Author Relationships With Industry and Other Entities (Relevant) e641 Appendix 3: Reviewer Relationships With Industry and Other Entities (Comprehensive) e642 References e624 TOP 10 TAKE-HOME MESSAGES FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE 1. The most important way to prevent atherosclerotic vascular disease, heart failure, and atrial fibrillation is to promote a healthy lifestyle throughout life. 2. A team-based care approach is an effective strat- egy for the prevention of cardiovascular disease. Clinicians should evaluate the social determinants of health that affect individuals to inform treat- ment decisions. 3. Adults who are 40 to 75 years of age and are being evaluated for cardiovascular disease prevention should undergo 10-year atherosclerotic cardio- vascular disease (ASCVD) risk estimation and have a clinician patient risk discussion before starting on pharmacological therapy, such as antihyper- tensive therapy, a statin, or aspirin.


Adults who are 40 to 75 years of age and are being evaluated for cardiovascular disease prevention should undergo 10-year atherosclerotic cardio- vascular disease (ASCVD) risk estimation and have a clinician patient risk discussion before starting on pharmacological therapy, such as antihyper- tensive therapy, a statin, or aspirin. In addition, assessing for other risk-enhancing factors can help guide decisions about preventive interventions in select individuals, as can coronary artery calcium scanning. 4. All adults should consume a healthy diet that emphasizes the intake of vegetables, fruits, nuts, whole grains, lean vegetable or animal protein, and fish and minimizes the intake of trans fats, red meat and processed red meats, refined carbohy- drates, and sweetened beverages. For adults with overweight and obesity, counseling and caloric restriction are recommended for achieving and maintaining weight loss. 5. Adults should engage in at least 150 minutes per week of accumulated moderate-intensity physical activity or 75 minutes per week of vigorous-inten- sity physical activity. 6. For adults with type 2 diabetes mellitus, lifestyle changes, such as improving dietary habits and achieving exercise recommendations, are crucial. If medication is indicated, metformin is first-line therapy, followed by consideration of a sodium- glucose cotransporter 2 inhibitor or a glucagon- like peptide-1 receptor agonist. 7. All adults should be assessed at every healthcare visit for tobacco use, and those who use tobacco should be assisted and strongly advised to quit. 8. Aspirin should be used infrequently in the routine primary prevention of ASCVD because of lack of net benefit. 9. Statin therapy is first-line treatment for primary prevention of ASCVD in patients with elevated low-density lipoprotein cholesterol levels ( 190 mg/dL), those with diabetes mellitus, who are 40 to 75 years of age, and those determined to be at sufficient ASCVD risk after a clinician patient risk discussion. 10.


Statin therapy is first-line treatment for primary prevention of ASCVD in patients with elevated low-density lipoprotein cholesterol levels ( 190 mg/dL), those with diabetes mellitus, who are 40 to 75 years of age, and those determined to be at sufficient ASCVD risk after a clinician patient risk discussion. 10. Nonpharmacological interventions are recom- mended for all adults with elevated blood pressure or hypertension. For those requiring pharmaco- logical therapy, the target blood pressure should generally be <130/80 mm Hg. PREAMBLE Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, which are based on systematic meth- ods to evaluate and classify evidence, provide a founda- tion for the delivery of quality cardiovascular care. The ACC and AHA sponsor the development and publica- tion of clinical practice guidelines without commercial support, and members volunteer their time to the writ- ing and review efforts. Clinical practice guidelines provide recommenda- tions applicable to patients with or at risk of developing CLINICAL STATEMENTS AND GUIDELINES cardiovascular disease (CVD). The focus is on medical practice in the United States, but these guidelines are relevant to patients throughout the world. Although guidelines may be used to inform regulatory or payer decisions, the goals are to improve quality of care and align with patients interests. Guidelines are intended to define practices meeting the needs of patients in most but not all circumstances and should not replace clinical judgment. Recommendations for guideline-directed manage- ment and therapy, which encompasses clinical evalua- tion, diagnostic testing, and both pharmacological and procedural treatments, are effective only when adopted by both practitioners and patients.


Recommendations for guideline-directed manage- ment and therapy, which encompasses clinical evalua- tion, diagnostic testing, and both pharmacological and procedural treatments, are effective only when adopted by both practitioners and patients. Adherence to rec- ommendations can be enhanced by shared decision- making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated condi- tions and comorbidities. The ACC/AHA Task Force on Clinical Practice Guide- lines strives to ensure that the guideline writing com- mittee includes requisite expertise and is representative of the broader medical community by selecting experts from a broad array of backgrounds, representing dif- ferent geographic regions, sexes, races, ethnicities, intellectual perspectives/biases, and scopes of clinical practice. The ACC and AHA have rigorous policies and methods to ensure that documents are developed with- out bias or improper influence. The complete policy on relationships with industry and other entities (RWI) can be found online. Beginning in 2017, numerous modifications to the guidelines have been and continue to be implemented to make guidelines shorter and enhance user friendli- ness. Guidelines are written and presented in a modu- lar knowledge chunk format, in which each chunk in- cludes a table of recommendations, a brief synopsis, recommendation-specific supportive text and, when appropriate, flow diagrams or additional tables. Hyper- linked references are provided for each modular knowl- edge chunk to facilitate quick access and review. More structured guidelines including word limits ( tar- gets ) and a web guideline supplement for useful but noncritical tables and figures are 2 such changes. This Preamble is an abbreviated version, with the detailed version available online.


This Preamble is an abbreviated version, with the detailed version available online. Patrick T. O Gara, MD, MACC, FAHA Chair, ACC/AHA Task Force on Clinical Practice Guidelines Although there has been substantial improvement in atherosclerotic cardiovascular disease (ASCVD) out- comes in recent decades, ASCVD remains the leading cause of morbidity and mortality globally.S1-1 S1-3 In the United States, it is also the leading cause of death for people of most racial/ethnic groups, with an estimated cost of >$200 billion annually in healthcare services, medications, and lost productivity. Much of this is at- tributable to suboptimal implementation of preven- tion strategies and uncontrolled ASCVD risk factors in Most Americans who have had a myocardial infarc- tion (MI) had unfavorable levels of at least 1 cardiovas- cular risk factor before their ASCVD event.S1-4 the AHA defined a new model of ideal cardiovascular health, referred to as Life s Simple 7.S1-5 Clinicians will find the 2018 Journal of American College of Cardiol- ogy (JACC) Cardiovascular Health Promotion Series very helpful in approaching the various aspects of preven- tion with patients.S1-6 An increasing number of ideal cardiovascular health factors have been associated with a lower prevalence and incidence of ASCVD events, heart failure, atrial fibrillation, cancer, depression, and Therefore, moving individuals toward ideal cardiovascular health is critically important for prevention of many important health conditions. The ACC/AHA Task Force on Clinical Practice Guide- lines has commissioned this guideline to consolidate existing recommendations and various recent scientific statements, expert consensus documents, and clinical practice guidelines into a single guidance document fo- cused on the primary prevention of ASCVD.


The ACC/AHA Task Force on Clinical Practice Guide- lines has commissioned this guideline to consolidate existing recommendations and various recent scientific statements, expert consensus documents, and clinical practice guidelines into a single guidance document fo- cused on the primary prevention of ASCVD. However, this guideline also includes newly generated recom- mendations for aspirin use, exercise and physical activ- ity, and tobacco use, in addition to recommendations related to team-based care, shared decision-making, and assessment of social determinants of health, to cre- ate a comprehensive yet targeted ACC/AHA guideline on the prevention of ASCVD. This guideline has been formatted in the modular chunk format to facilitate readability and future updating. Prevention strategies occur at the population level but must also engage individual adults to slow the de- velopment of ASCVD. The most important way to pre- vent ASCVD is to promote a healthy lifestyle through- out life. Prevention strategies must include a strong focus on lifestyle optimization (improvements in diet, physical activity, and avoidance of tobacco use and ex- posure to secondhand smoke) to minimize the risk of future ASCVD events. A comprehensive patient-centered approach that addresses all aspects of a patient s lifestyle habits and estimated risk of a future ASCVD event is the first step in deciding on where there may be a need for pharmacotherapy. Even if a blood pressure (BP) reduc- ing medication, lipid-lowering medication, or diabe- tes medication is ultimately prescribed, lifestyle goals should be emphasized on a regular basis. Only when a person s risk is sufficiently high should medications to reduce ASCVD risk be considered as part of a shared CLINICAL STATEMENTS AND GUIDELINES decision-making process for optimal treatment. In sum- mary, clinicians and individuals should focus attention on living a healthy lifestyle by referring to these evi- dence-based recommendations to help prevent ASCVD.


In sum- mary, clinicians and individuals should focus attention on living a healthy lifestyle by referring to these evi- dence-based recommendations to help prevent ASCVD. 1.1. Methodology and Evidence Review This guideline continues the ACC and AHA effort to de- sign a comprehensive yet succinct compilation of practi- cal guidance for the primary prevention of ASCVD and to promote optimal dissemination of information by us- ing concise language and formatting. The recommen- dations listed in this guideline are evidence based and supported by an extensive evidence review. A search for literature derived from research involving human sub- jects, published in English, and indexed in Ovid MED- LINE, PubMed, Cochrane Library, National Institute for Health and Care Excellence (NICE), and other selected databases relevant to this guideline, was conducted be- tween May and July 2018. For specific search terms used and years searched per section, please see Appendix 1. Randomized controlled trials (RCTs), systematic re- views of RCTs, meta-analyses, and large, United States based, high-quality cohort studies, as well as observa- tional studies and systematic reviews of observational studies, were evaluated for their content on the preven- tion of ASCVD outcomes related to the following 9 topic areas: risk assessment, diet, exercise/physical activity, obesity and weight loss, type 2 diabetes mellitus (T2DM), blood cholesterol, hypertension, smoking cessation, and aspirin use. Previous ACC/AHA guidelines, as well as US Preventive Services Task Force (USPSTF) reviews and other guidance relevant to this guideline, were also assessed. The final evidence tables included in the Online Data Supplement summarize the evidence used to formulate recommendations. References selected and published in this document are representative and not all-inclusive. Avalere Health, a healthcare advisory services firm con- tracted by ACC/AHA, served as the document manager for this guideline to facilitate its development process.


Avalere Health, a healthcare advisory services firm con- tracted by ACC/AHA, served as the document manager for this guideline to facilitate its development process. As document manager, Avalere facilitated the deliberations of the Writing Committee and led the modified Delphi process for establishing the Class of Recommendation and the Level of Evidence. In parallel, an independent health data and epidemiology expert, Lee Ann Prebil, conducted a systematic evidence review for the key topic of exercise and physical activity and conducted targeted literature searches to support this document s discussion of patient- centered approaches, including team-based care, shared decision-making, and assessment of social determinants of health. A targeted literature search was also conducted for this guideline s cost and value considerations. These searches are available as downloadable Excel files. Recommendations and supportive text relevant to cardiovascular risk, blood cholesterol, and high BP were taken directly from 2 recently released ACC/ AHA guidelines, the 2017 Hypertension Clinical Prac- and the 2018 Cholesterol Clini- cal Practice Guideline,S1.1-2 and were adapted for the present guideline, which aims to provide an overview of the primary prevention of ASCVD among adults. Recommendations that were adapted from previous publications are noted in the recommendation tables, and both the original published recommendation and the adapted version are provided in the guideline. The results of these evidence reviews were evaluat- ed by the writing committee for incorporation into the present guideline. (See Table S1 in the Web Supplement for a list of relevant publications and statements used in support of the guideline s recommendations.) Each topic area was assigned a primary writer, as well as a primary, and sometimes secondary, reviewer. These assignments were based on areas of particular expertise of writing committee members.


These assignments were based on areas of particular expertise of writing committee members. All recommendations were fully reviewed and discussed among the full committee to allow for diverse perspectives and considerations for this guideline. Recommendations were then voted upon, with a modified Delphi process used to reach consensus. 1.2. Organization of the Writing Committee The writing committee consisted of clinicians, cardi- ologists, health services researchers, epidemiologists, internists, nurses, and a lay representative. The writing committee included representatives from the ACC and AHA. Appendix 2 of the present document lists writing committee members relevant RWI. For the purposes of full transparency, the writing committee members com- prehensive disclosure information is available online. 1.3. Document Review and Approval This document was reviewed by 5 official reviewers nominated by the ACC and AHA (1 reviewer from the ACC/AHA Task Force for Practice Guidelines, 2 review- ers from the AHA, and 2 reviewers from the ACC); 3 reviewers on behalf of the American Association of Car- diovascular and Pulmonary Rehabilitation, the American Society for Nutrition, and the American Society of Pre- ventive Medicine; and 23 individual content reviewers. Reviewers RWI information was distributed to the writ- ing committee and is published in this document (Ap- pendix 3). This document was approved for publication by the governing bodies of the ACC and AHA. 1.4. Scope of the Guideline This guideline is intended to be a resource for the clini- cal and public health practice communities. It addresses the primary prevention of CVD in adults ( 18 years of age), focused on outcomes of ASCVD (ie, acute coronary CLINICAL STATEMENTS AND GUIDELINES syndromes, MI, stable or unstable angina, arterial re- vascularization, stroke, transient ischemic attack, or peripheral arterial disease of atherosclerotic origin), as well as heart failure and atrial fibrillation.


It addresses the primary prevention of CVD in adults ( 18 years of age), focused on outcomes of ASCVD (ie, acute coronary CLINICAL STATEMENTS AND GUIDELINES syndromes, MI, stable or unstable angina, arterial re- vascularization, stroke, transient ischemic attack, or peripheral arterial disease of atherosclerotic origin), as well as heart failure and atrial fibrillation. The guide- line presents recommendations to prevent CVD that are related to lifestyle factors (eg, diet and exercise or physical activity), other factors affecting CVD risk (eg, obesity, diabetes, blood cholesterol, high BP, smoking, aspirin use), patient-centered approaches (eg, team- based care, shared decision-making, assessment of so- cial determinants of health), and considerations of the cost and value of primary prevention. 1.5. Class of Recommendation and Level of Evidence Recommendations are designated with both a Class of Recommendation (COR) and a Level of Evidence (LOE). The COR indicates the strength of recommen- dation, encompassing the estimated magnitude and certainty of benefit in proportion to risk. The LOE rates the quality of scientific evidence supporting the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources (Table 1).S1.5-1 Table 1.


The LOE rates the quality of scientific evidence supporting the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources (Table 1).S1.5-1 Table 1. Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care (Updated August 2015) CLINICAL STATEMENTS AND GUIDELINES Abbreviation Meaning/Phrase ASCVD atherosclerotic cardiovascular disease AU Agatston units BMI body mass index BP blood pressure CHD coronary heart disease CKD chronic kidney disease CVD cardiovascular disease DASH Dietary Approaches to Stop Hypertension DBP diastolic blood pressure DM diabetes mellitus ENDS electronic nicotine delivery systems FDA US Food and Drug Administration HDL-C high-density lipoprotein cholesterol LDL-C low-density lipoprotein cholesterol MI myocardial infarction PCE pooled cohort equations RCT randomized controlled trial SBP systolic blood pressure T2DM type 2 diabetes mellitus USPSTF US Preventive Services Task Force 2. OVERARCHING RECOMMENDATIONS FOR ASCVD PREVENTION EFFORTS 2.1. Patient-Centered Approaches to Comprehensive ASCVD Prevention Recommendations for Patient-Centered Approaches to Comprehensive ASCVD Prevention Referenced studies that support recommendations are summarized in Online Data Supplements 1 and 2. COR LOE Recommendations I A A team-based care approach is recommended for the control of risk factors associated with ASCVD.S2.1-1 S2.1-14 I B-R Shared decision-making should guide discussions about the best strategies to reduce ASCVD risk.S2.1-15 S2.1-18 I B-NR Social determinants of health should inform optimal implementation of treatment recommendations for the prevention of Synopsis This 2019 ACC/AHA Guideline on the Primary Preven- tion of CVD aims to promote the delivery of patient- centered care, which the writing committee felt was foundational to the guidance provided throughout. These patient-centered recommendations emphasize the importance of team-based care delivery, shared decision-making, and the evaluation of social determi- nants of health in ASCVD prevention efforts.


These patient-centered recommendations emphasize the importance of team-based care delivery, shared decision-making, and the evaluation of social determi- nants of health in ASCVD prevention efforts. These rec- ommendations apply to all aspects of clinical practice for the primary prevention of ASCVD. Recommendation-Specific Supportive Text 1. Team-based care makes use of multidisciplinary health professionals to improve the quality and maintenance of ASCVD prevention. It is a multi- faceted approach that supports clinical decision- making (ie, treatment algorithms), collaboration among different clinicians, and patient and fam- ily member participation to facilitate the treat- ment goals of patients.S2.1-26 RCTs and systematic reviews with meta-analyses demonstrated greater reduction of ASCVD risk with team-based care than with usual care in patients with hyperten- sion, diabetes, and hyperlipidemia.S2.1-1 S2.1-14 A team-based approach to ASCVD prevention may result in significant improvements in patient out- and often meets patient needs bet- ter than standard care, especially in low-resource settings and among vulnerable populations. In a team-based care model that compared patients enrolled in a preventive cardiology clinic staffed by advanced practice providers with a propensity- matched cohort of patients enrolled in primary care clinics, a reduction in cardiovascular risk was demonstrated through effective risk stratification and preventive management.S2.1-28 Other success- ful interventions that have used team-based care include telehealth monitoring, follow-up support aids, and patient education.S2.1-27 2. Decisions about primary prevention should be collaborative between a clinician and a patient. Shared decision-making occurs when practitioners engage patients in discussions about personal- ized ASCVD risk estimates and their implications for the perceived benefits of preventive strate- gies, including lifestyle habits, goals, and medical therapies. Collaborative decisions are more likely to address potential barriers to treatment options, compared with treatment and guidance offered without patient input.S2.1-15 S2.1-18 3.


Collaborative decisions are more likely to address potential barriers to treatment options, compared with treatment and guidance offered without patient input.S2.1-15 S2.1-18 3. Socioeconomic inequalities are strong determinants of CVD risk internationally.S2.1-21,S2.1-24 Therefore, the clinician should tailor advice to a patient s socioeco- nomic and educational status, as well as cultural, work, and home environments.S2.1-23 The Centers for Medicare & Medicaid Services has developed a CLINICAL STATEMENTS AND GUIDELINES screening tool to assess 5 domains of non health- related measures that affect health outcomes: housing instability, food insecurity, transportation difficulties, utility assistance needs, and interper- ASCVD prevention could ben- efit from such screening. ASCVD risk begins early in life, with heightened susceptibility tied to low Examples of upstream social determinants of health that affect treatment adherence and ASCVD health outcomes include comorbid mental illness, lack of health literacy, exposure to adversity (eg, home/community vio- lence, trauma exposures, safety concerns), finan- cial strain, inadequate housing conditions, lack of food security (ie, access to affordable and nutritious food), and inadequate social support.S2.1-30 Systems of care should evaluate social determinants of health that affect care delivery for the primary pre- vention of ASCVD (eg, transportation barriers, the availability of health services). Important considerations related to socioeco- nomic disadvantage are not captured by existing CVD risk equations.S2.1-31 Addressing unmet social needs improves management of BP and lipids,S2.1-32 which highlights the importance of dietary coun- seling and encouraging physical activity.S2.1-19 More time may be required to address ASCVD preven- tion with adults of low health literacy or disadvan- taged educational backgrounds. Differential cardiovascular outcomes persist by important sociodemographic characteristics that include but are not limited to age, sex, and race/ Failure to address the impact of social determinants of health impedes efficacy of proven prevention recommendations.


Differential cardiovascular outcomes persist by important sociodemographic characteristics that include but are not limited to age, sex, and race/ Failure to address the impact of social determinants of health impedes efficacy of proven prevention recommendations. Table 2 outlines key considerations related to social determinants of health and ASCVD prevention. 2.2. Assessment of Cardiovascular Risk Recommendations for Assessment of Cardiovascular Risk Referenced studies that support recommendations are summarized in Online Data Supplement 3. COR LOE Recommendations I B-NR For adults 40 to 75 years of age, clinicians should routinely assess traditional cardiovascular risk factors and calculate 10-year risk of ASCVD by using the pooled cohort equations (PCE).S2.2-1,S2.2-2 IIa B-NR For adults 20 to 39 years of age, it is reasonable to assess traditional ASCVD risk factors at least every 4 to 6 years.S2.2-1 S2.2-3 IIa B-NR In adults at borderline risk (5% to <7.5% 10-year ASCVD risk) or intermediate risk ( 7.5% to <20% 10-year ASCVD risk), it is reasonable to use additional risk-enhancing factors to guide decisions about preventive interventions (eg, statin therapy).S2.2-4 S2.2-14 IIa B-NR In adults at intermediate risk ( 7.5% to <20% 10-year ASCVD risk) or selected adults at borderline risk (5% to <7.5% 10- year ASCVD risk), if risk-based decisions for preventive interventions (eg, statin therapy) remain uncertain, it is reasonable to measure a coronary artery calcium score to guide clinician patient risk discussion.S2.2-15 S2.2-31 Table 2.


COR LOE Recommendations I B-NR For adults 40 to 75 years of age, clinicians should routinely assess traditional cardiovascular risk factors and calculate 10-year risk of ASCVD by using the pooled cohort equations (PCE).S2.2-1,S2.2-2 IIa B-NR For adults 20 to 39 years of age, it is reasonable to assess traditional ASCVD risk factors at least every 4 to 6 years.S2.2-1 S2.2-3 IIa B-NR In adults at borderline risk (5% to <7.5% 10-year ASCVD risk) or intermediate risk ( 7.5% to <20% 10-year ASCVD risk), it is reasonable to use additional risk-enhancing factors to guide decisions about preventive interventions (eg, statin therapy).S2.2-4 S2.2-14 IIa B-NR In adults at intermediate risk ( 7.5% to <20% 10-year ASCVD risk) or selected adults at borderline risk (5% to <7.5% 10- year ASCVD risk), if risk-based decisions for preventive interventions (eg, statin therapy) remain uncertain, it is reasonable to measure a coronary artery calcium score to guide clinician patient risk discussion.S2.2-15 S2.2-31 Table 2. Example Considerations for Addressing Social Determinants of Health to Help Prevent ASCVD Events Topic/Domain Example Considerations Cardiovascular risk Adults should be routinely assessed for psychosocial stressors and provided with appropriate counseling.S2.1-31 Health literacy should be assessed every 4 to 6 y to maximize recommendation effectiveness.S2.1-36 Diet In addition to the prescription of diet modifications, body size perception, as well as social and cultural influences, should be Potential barriers to adhering to a heart-healthy diet should be assessed, including food access and economic factors; these factors may be particularly relevant to persons from vulnerable populations, such as individuals residing in either inner-city or rural environments, those at socioeconomic disadvantage, and those of advanced age*.S2.1-39 Exercise and physical activity In addition to the prescription of exercise, neighborhood environment and access to facilities for physical activity should be Obesity and weight loss Lifestyle counseling for weight loss should include assessment of and interventional recommendations for psychosocial stressors, sleep hygiene, and other individualized barriers.S2.1-42 S2.1-44 Weight maintenance should be promoted in patients with overweight/obesity who are unable to achieve recommended weight loss.


Example Considerations for Addressing Social Determinants of Health to Help Prevent ASCVD Events Topic/Domain Example Considerations Cardiovascular risk Adults should be routinely assessed for psychosocial stressors and provided with appropriate counseling.S2.1-31 Health literacy should be assessed every 4 to 6 y to maximize recommendation effectiveness.S2.1-36 Diet In addition to the prescription of diet modifications, body size perception, as well as social and cultural influences, should be Potential barriers to adhering to a heart-healthy diet should be assessed, including food access and economic factors; these factors may be particularly relevant to persons from vulnerable populations, such as individuals residing in either inner-city or rural environments, those at socioeconomic disadvantage, and those of advanced age*.S2.1-39 Exercise and physical activity In addition to the prescription of exercise, neighborhood environment and access to facilities for physical activity should be Obesity and weight loss Lifestyle counseling for weight loss should include assessment of and interventional recommendations for psychosocial stressors, sleep hygiene, and other individualized barriers.S2.1-42 S2.1-44 Weight maintenance should be promoted in patients with overweight/obesity who are unable to achieve recommended weight loss. Diabetes mellitus In addition to the prescription of type 2 diabetes mellitus interventions, environmental and psychosocial factors, including depression, stress, self-efficacy, and social support, should be assessed to improve achievement of glycemic control and adherence to treatment.S2.1-45 S2.1-48 High blood pressure Short sleep duration (<6 h) and poor-quality sleep are associated with high blood pressure and should be considered.S2.1-49 Because other lifestyle habits can impact blood pressure, access to a healthy, low-sodium diet and viable exercise options should also be considered. Tobacco treatment Social support is another potential determinant of tobacco use. Therefore, in adults who use tobacco, assistance and arrangement for individualized and group social support counseling are recommended.S2.1-50,S2.1-51 *Advanced age generally refers to age 75 years.


Therefore, in adults who use tobacco, assistance and arrangement for individualized and group social support counseling are recommended.S2.1-50,S2.1-51 *Advanced age generally refers to age 75 years. ASCVD indicates atherosclerotic cardiovascular disease. CLINICAL STATEMENTS AND GUIDELINES IIb B-NR For adults 20 to 39 years of age and for those 40 to 59 years of age who have <7.5% 10-year ASCVD risk, estimating lifetime or 30-year ASCVD risk may be Synopsis Assessment of ASCVD risk remains the foundation of primary prevention. Although all individuals should be encouraged to follow a heart-healthy lifestyle, estimat- ing an individual s 10-year absolute ASCVD risk enables matching the intensity of preventive interventions to the patient s absolute risk, to maximize anticipated benefit and minimize potential harm from overtreatment. The 10-year ASCVD risk estimate is used to guide decision- making for many preventive interventions, including and BP management;S2.2-37 it should be the start of a conversation with the pa- tient about risk-reducing strategies (the clinician pa- tient discussion ) and not the sole decision factor for the initiation of pharmacotherapy.S2.2-4,S2.2-36,S2.2-38 All risk estimation tools have inherent limitations, and pop- ulation-based risk scores must be interpreted in light of specific circumstances for individual patients. The PCE have been shown to overestimateS2.2-15,S2.2-39 S2.2-47 ASCVD risk for cer- tain subgroups. Thus, after calculation of the PCE, it is reasonable to use additional risk-enhancing factors to guide decisions about preventive interventions for bor- derline- or intermediate-risk adults.S2.2-4 S2.2-14 However, the value of preventive therapy may remain uncertain for many individuals with borderline or intermediate es- timated 10-year risk, and some patients may be reluc- tant to take medical therapy without clearer evidence of increased ASCVD risk.


Thus, after calculation of the PCE, it is reasonable to use additional risk-enhancing factors to guide decisions about preventive interventions for bor- derline- or intermediate-risk adults.S2.2-4 S2.2-14 However, the value of preventive therapy may remain uncertain for many individuals with borderline or intermediate es- timated 10-year risk, and some patients may be reluc- tant to take medical therapy without clearer evidence of increased ASCVD risk. For these individuals, the as- sessment of coronary artery calcium is a reasonable tool to reclassify risk either upward or downward, as part of shared decision-making. For younger adults 20 to 59 years of age, estimation of lifetime risk may be considered. For adults >75 years of age, the clinician and patient should engage in a discussion about the possible benefits of preventive therapies appropriate to the age group in the context of comorbidities and life expectancy. Recommendation-Specific Supportive Text 1. To facilitate decisions about preventive interven- tions, it is recommended to screen for traditional ASCVD risk factors and apply the race- and sex- specific PCE (ASCVD Risk Estimator) to estimate 10-year ASCVD risk for asymptomatic adults 40 to For management of stage 1 hypertension (BP 130 139 / 80 89 mm Hg), adults should be categorized as <10% or >10% 10-year ASCVD risk for therapeutic decisions (see Section 4.4 Figure 4). For management of blood cholesterol, adults should be categorized as having The PCE are best validated among non- Hispanic whites and non-Hispanic blacks living in the United States.S2.2-1,S2.2-39,S2.2-48,S2.2-49,S2.2-52 In other or in some non- the PCE may overestimate or underestimate risk. Therefore, clinicians may consider the use of another risk prediction tool as an alternative to the PCE if the tool was validated in a population with charac- teristics similar to those of the evaluated patient.


Therefore, clinicians may consider the use of another risk prediction tool as an alternative to the PCE if the tool was validated in a population with charac- teristics similar to those of the evaluated patient. Examples include the general Framingham CVD the Reynolds risk scores,S2.2-56,S2.2-57 SCORE (Systematic COronary Risk Evaluation),S2.2-58 and the QRISK/JBS3S2.2-59 tools. Other professional societies have incorporated some of these alterna- tive validated risk scores into their lipid manage- ment guidelines or have considered different risk thresholds for preventive interventions.S2.2-58 S2.2-63 Although slight differences exist across organi- zational guidelines, they are all very similar in their overarching goal of matching the intensity of preventive therapies to the absolute (generally 10-year) risk of the patient.S2.2-58 S2.2-63 2. After age 20 years, it is reasonable to mea- sure traditional risk factors at least every 4 to For adults 20 to 39 years of age, limited data exist on the performance and utility of Because age is a major driver of risk, most in this age range (<40 years) are unlikely to have a sufficiently elevated 10-year risk to warrant pharmacological therapy with a statin (with some exceptions, such as in familial hypercholesterolemia). Nevertheless, peri- odic assessment of risk factors (eg, at least every 4 to 6 years in younger adults 20 to 39 years of age) is important to guide discussions about inten- sity of lifestyle interventions, frequency of risk factor monitoring, treatment of nonlipid risk fac- tors, and consideration of 30-year or lifetime risk 3. No single risk calculator is appropriate for all patients.


Nevertheless, peri- odic assessment of risk factors (eg, at least every 4 to 6 years in younger adults 20 to 39 years of age) is important to guide discussions about inten- sity of lifestyle interventions, frequency of risk factor monitoring, treatment of nonlipid risk fac- tors, and consideration of 30-year or lifetime risk 3. No single risk calculator is appropriate for all patients. In certain populations, the PCE have However, some studies have found underestimation of risk (and potential for undertreatment) among indi- viduals with chronic inflammatory conditions (eg, ) or not Recommendations for Assessment of Cardiovascular Risk (Continued) COR LOE Recommendations CLINICAL STATEMENTS AND GUIDELINES captured in current risk scoring models. Patients with familial hypercholesterolemia are at signifi- cant risk of having an early ASCVD event, and the use of risk calculators is not applicable to these patients.


Patients with familial hypercholesterolemia are at signifi- cant risk of having an early ASCVD event, and the use of risk calculators is not applicable to these patients. In contrast, other studies have found overestimation of risk with the PCE, particularly among those with higher socioeconomic posi- tion and those with continual access to care and preventive services, which could lead to overtreat- ment of individuals less likely to receive net benefit from preventive pharmacotherapies over the next The PCE may be subopti- mally calibrated in more modern populations as compared with the older cohorts from which they Therefore, among adults at bor- derline (5% to <7.5%) and intermediate ( 7.5% to <20%) risk, one may consider additional individual risk-enhancing clinical factors (Table 3) that can be used to revise the 10-year ASCVD risk estimate.S2.2-4 These factors may include having a family history of premature ASCVD,S2.2-5 chronic inflammatory disease [rheumatoid arthritis,S2.2-6 or HIV ], South Asian ancestry,S2.2-13 a history or preterm delivery,S2.2-9 early chronic kidney disease (CKD), metabolic syndrome, per- sistently elevated inflammatory markers,S2.2-14 or elevated lipid biomarkers.S2.2-4 After these clini- cally available risk-enhancing factors have been considered, if there is still uncertainty about the reliability of the risk estimate for individu- als in the borderline- or intermediate-risk cat- egories, further testing to document subclinical coronary atherosclerosis is reasonable to more accurately reclassify the risk estimate upward or 4.


In contrast, other studies have found overestimation of risk with the PCE, particularly among those with higher socioeconomic posi- tion and those with continual access to care and preventive services, which could lead to overtreat- ment of individuals less likely to receive net benefit from preventive pharmacotherapies over the next The PCE may be subopti- mally calibrated in more modern populations as compared with the older cohorts from which they Therefore, among adults at bor- derline (5% to <7.5%) and intermediate ( 7.5% to <20%) risk, one may consider additional individual risk-enhancing clinical factors (Table 3) that can be used to revise the 10-year ASCVD risk estimate.S2.2-4 These factors may include having a family history of premature ASCVD,S2.2-5 chronic inflammatory disease [rheumatoid arthritis,S2.2-6 or HIV ], South Asian ancestry,S2.2-13 a history or preterm delivery,S2.2-9 early chronic kidney disease (CKD), metabolic syndrome, per- sistently elevated inflammatory markers,S2.2-14 or elevated lipid biomarkers.S2.2-4 After these clini- cally available risk-enhancing factors have been considered, if there is still uncertainty about the reliability of the risk estimate for individu- als in the borderline- or intermediate-risk cat- egories, further testing to document subclinical coronary atherosclerosis is reasonable to more accurately reclassify the risk estimate upward or 4. For individuals with intermediate predicted risk ( 7.5% to <20%) by the PCE or for select adults with borderline (5% to <7.5%) predicted risk, coronary artery calcium measurement can be a useful tool in refining risk assessment for preven- tive interventions (eg, statin therapy).S2.2-4 In these groups, coronary artery calcium measurement can reclassify risk upward (particularly if coronary artery calcium score is 100 Agatston units (AU) or 75th age/sex/race percentile) or downward (if coronary artery calcium is zero) in a signifi- cant proportion of individuals.S2.2-15 The extent of reclassification is sufficient to provide confidence that borderline- or intermediate-risk patients with elevated coronary artery calcium will have event rates that clearly exceed benefit thresholds (ie, 7.5% in 10 years) and those with coronary artery calcium scores of zero will have event rates <7.5%, which can help guide shared decision- making about statinsS2.2-15,S2.2-16,S2.2-21 or potentially In observational data, the pres- ence and severity of coronary artery calcium have Table 3.


For individuals with intermediate predicted risk ( 7.5% to <20%) by the PCE or for select adults with borderline (5% to <7.5%) predicted risk, coronary artery calcium measurement can be a useful tool in refining risk assessment for preven- tive interventions (eg, statin therapy).S2.2-4 In these groups, coronary artery calcium measurement can reclassify risk upward (particularly if coronary artery calcium score is 100 Agatston units (AU) or 75th age/sex/race percentile) or downward (if coronary artery calcium is zero) in a signifi- cant proportion of individuals.S2.2-15 The extent of reclassification is sufficient to provide confidence that borderline- or intermediate-risk patients with elevated coronary artery calcium will have event rates that clearly exceed benefit thresholds (ie, 7.5% in 10 years) and those with coronary artery calcium scores of zero will have event rates <7.5%, which can help guide shared decision- making about statinsS2.2-15,S2.2-16,S2.2-21 or potentially In observational data, the pres- ence and severity of coronary artery calcium have Table 3. Risk-Enhancing Factors for Clinician Patient Risk Discussion Risk-Enhancing Factors Family history of premature ASCVD (males, age <55 y; females, age <65 y) Primary hypercholesterolemia (LDL-C, 160 189 mg/dL [4.1 4.8 mmol/L]; non HDL-C 190 219 mg/dL [4.9 5.6 mmol/L])* Metabolic syndrome (increased waist circumference [by ethnically appropriate cutpoints], elevated triglycerides [>150 mg/dL, nonfasting], elevated blood pressure, elevated glucose, and low HDL-C [<40 mg/dL in men; <50 mg/dL in women] are factors; a tally of 3 makes the diagnosis) with or without albuminuria; not treated with dialysis or kidney transplantation) Chronic inflammatory conditions, such as psoriasis, RA, lupus, or HIV/AIDS History of premature menopause (before age 40 y) and history of pregnancy-associated conditions that increase later ASCVD risk, such as preeclampsia High-risk race/ethnicity (eg, South Asian ancestry) Lipids/biomarkers: associated with increased ASCVD risk Persistently elevated* primary hypertriglyceridemia ( 175 mg/dL, nonfasting) If measured: Elevated high-sensitivity C-reactive protein ( 2.0 mg/L) Elevated Lp(a): A relative indication for its measurement is family history of premature ASCVD.


Risk-Enhancing Factors for Clinician Patient Risk Discussion Risk-Enhancing Factors Family history of premature ASCVD (males, age <55 y; females, age <65 y) Primary hypercholesterolemia (LDL-C, 160 189 mg/dL [4.1 4.8 mmol/L]; non HDL-C 190 219 mg/dL [4.9 5.6 mmol/L])* Metabolic syndrome (increased waist circumference [by ethnically appropriate cutpoints], elevated triglycerides [>150 mg/dL, nonfasting], elevated blood pressure, elevated glucose, and low HDL-C [<40 mg/dL in men; <50 mg/dL in women] are factors; a tally of 3 makes the diagnosis) with or without albuminuria; not treated with dialysis or kidney transplantation) Chronic inflammatory conditions, such as psoriasis, RA, lupus, or HIV/AIDS History of premature menopause (before age 40 y) and history of pregnancy-associated conditions that increase later ASCVD risk, such as preeclampsia High-risk race/ethnicity (eg, South Asian ancestry) Lipids/biomarkers: associated with increased ASCVD risk Persistently elevated* primary hypertriglyceridemia ( 175 mg/dL, nonfasting) If measured: Elevated high-sensitivity C-reactive protein ( 2.0 mg/L) Elevated Lp(a): A relative indication for its measurement is family history of premature ASCVD. An Lp(a) 50 mg/dL or 125 nmol/L constitutes a risk- enhancing factor, especially at higher levels of Lp(a). Elevated apoB ( 130 mg/dL): A relative indication for its measurement would be triglyceride 200 mg/dL. A level 130 mg/dL corresponds to an LDL-C >160 mg/dL and constitutes a risk-enhancing factor *Optimally, 3 determinations. ABI indicates ankle-brachial index; AIDS, acquired immunodeficiency syndrome; apoB, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; eGFR, estimated glomerular filtration rate; HDL-C, high-density lipoprotein cholesterol; HIV, human immunodeficiency virus; LDL-C, low-density lipoprotein cholesterol; Lp(a), lipoprotein (a); and RA, rheumatoid arthritis. Reproduced with permission from Grundy et al.S2.2-4 Copyright 2018, American Heart Association, Inc., and American College of Cardiology Foundation.


Reproduced with permission from Grundy et al.S2.2-4 Copyright 2018, American Heart Association, Inc., and American College of Cardiology Foundation. CLINICAL STATEMENTS AND GUIDELINES been shown to be associated with the likelihood of benefit from statin therapy for ASCVD risk Coronary artery calcium scoring has superior discrimination and risk reclassification as compared with other subclinical imaging mark- ers or biomarkers.S2.2-22,S2.2-27 In the MESA (Multi- Ethnic Study of Atherosclerosis) trial, the coronary artery calcium score was strongly associated with 10-year ASCVD risk in a graded manner across age, sex, and racial/ethnic groups, independent of traditional risk factors.S2.2-17 Coronary artery cal- cium may even refine ASCVD risk estimates among younger adults (<45 years of age),S2.2-20 and older adults ( 75 years of age),S2.2-26 but more data are needed to support its use in these subgroups. A coronary artery calcium score of zero identifies indi- viduals at lower risk of ASCVD events and death who appear to derive little or no benefit from statins for ASCVD Thus, the absence of coronary artery calcium could reclassify a patient downward into a lower risk group in which preventive interven- tions (eg, statins) could be postponed.S2.2-22 Note that the absence of coronary artery calcium does not rule out noncalcified plaque, and clinical judg- ment about risk should prevail. Coronary artery cal- cium might also be considered in refining risk for selected low-risk adults (<5% 10-year risk), such as those with a strong family history of premature coronary heart disease (CHD).S2.2-23 and Astro-CHARM (Astronaut Cardiovascular Health and Risk Modification)S2.2-29 are risk estimation tools that incorporate both risk factors and coronary artery calcium for estimating 10-year CHD and ASCVD risk, respectively.


Coronary artery cal- cium might also be considered in refining risk for selected low-risk adults (<5% 10-year risk), such as those with a strong family history of premature coronary heart disease (CHD).S2.2-23 and Astro-CHARM (Astronaut Cardiovascular Health and Risk Modification)S2.2-29 are risk estimation tools that incorporate both risk factors and coronary artery calcium for estimating 10-year CHD and ASCVD risk, respectively. Coronary artery calcium measurement is not intended as a screening test for all but rather may be used as a decision aid in select adults to facilitate the clinician patient risk discussion. 5. For adults 20 to 39 years of age (who are not included in the PCE) and those 40 to 59 years of age who are not already at elevated ( 7.5%) 10-year risk, estimating a lifetime or 30-year risk of ASCVD may be considered (ASCVD Risk Younger individuals often have low estimated 10-year risk, but the presence of at least 1 major risk factor by middle age is associated with increased lifetime ASCVD risk and reduced survival free of morbidity compared with those with opti- mal risk factors.S2.2-32 S2.2-34 Calculation of lifetime risk with the ACC/AHA 30-year/lifetime risk esti- mator for those 20 to 59 years of age (not at high short-term risk) may be reasonable to consider as a communication strategy for reinforcing adher- ence to lifestyle recommendations.S2.2-2 3. LIFESTYLE FACTORS AFFECTING CARDIOVASCULAR RISK 3.1. Nutrition and Diet Recommendations for Nutrition and Diet Referenced studies that support recommendations are summarized in Online Data Supplements 4 and 5.


Nutrition and Diet Recommendations for Nutrition and Diet Referenced studies that support recommendations are summarized in Online Data Supplements 4 and 5. COR LOE Recommendations I B-R A diet emphasizing intake of vegetables, fruits, legumes, nuts, whole grains, and fish is recommended to decrease ASCVD risk IIa B-NR Replacement of saturated fat with dietary monounsaturated and polyunsaturated fats can be beneficial to reduce ASCVD IIa B-NR A diet containing reduced amounts of cholesterol and sodium can be beneficial to decrease ASCVD risk.S3.1-9,S3.1-14 S3.1-16 IIa B-NR As a part of a healthy diet, it is reasonable to minimize the intake of processed meats, refined carbohydrates, and sweetened beverages to reduce ASCVD risk.S3.1-17 S3.1-24 III: Harm B-NR As a part of a healthy diet, the intake of trans fats should be avoided to reduce Synopsis Approximately 630000 Americans died from heart dis- ease in 2015, of whom 366000 died from coronary ar- tery disease. After 4 decades of decline, heart disease deaths rose in 2015 by 1%.S3.1-28 This trend has been attributed to the obesity epidemic. Healthy nutrition has an important impact on ASCVD and its risk factors (see recommendations in the individual sections), po- tentially reversing or reducing obesity, high cholesterol, diabetes, and hypertension. The cardiovascular nutri- tion literature is limited by the paucity of large-scale prospective randomized trials with ASCVD outcomes. Although RCTs focused on hard endpoints are limited, multiple observational studies have focused on the association of CVD mortality with dietary patterns specifically, sugar, low-calorie sweeteners, high-carbo- hydrate diets, low-carbohydrate diets, refined grains, trans fat, saturated fat, sodium, red meat, and pro- cessed red meat (eg, bacon, salami, ham, hot dogs, Processed meats are any meat pre- served by smoking, curing, or salting, or additional Recommendation-Specific Supportive Text 1.


Although RCTs focused on hard endpoints are limited, multiple observational studies have focused on the association of CVD mortality with dietary patterns specifically, sugar, low-calorie sweeteners, high-carbo- hydrate diets, low-carbohydrate diets, refined grains, trans fat, saturated fat, sodium, red meat, and pro- cessed red meat (eg, bacon, salami, ham, hot dogs, Processed meats are any meat pre- served by smoking, curing, or salting, or additional Recommendation-Specific Supportive Text 1. Plant-based and Mediterranean diets, along with increased fruit, nut, vegetable, legume, and lean vegetable or animal protein (preferably fish) con- sumption, with the inherent soluble and insoluble CLINICAL STATEMENTS AND GUIDELINES vegetable fiber, have consistently been associated with lower risk of all-cause mortality than control or standard dietsS3.1-1 S3.1-10,S3.1-29,S3.1-30 in observa- tional studies. The PREDIMED (Prevenci n con Dieta Mediterr nea) trial randomized participants to a Mediterranean diet supplemented with either extra-virgin olive oil or nuts and demonstrated 30% and 28% reductions, respectively, in the combined endpoint (MI, stroke, or cardiovascular mortality), but the improved outcome was driven largely by the reduction in stroke, with no signifi- cant improvement over the control diet for mor- tality or MI.S3.1-1 When the PREDIMED cohort was reanalyzed post hoc for the provegetarian food pattern (more vegetable consumption versus ani- mal, egg, fish, dairy, or meat product consump- tion), a significant mortality rate reduction (41%) was noted in the 2 quintiles with the highest A comparison of plant and animal protein from the Adventist Health Study-2 similarly indicated that using meat for protein was associated with a 61% increase in mortality rate, whereas replacing meat with nuts and seeds was associated with a 40% reduction in mortality rate. Similarly, the graded risk published by Song et al.


The PREDIMED (Prevenci n con Dieta Mediterr nea) trial randomized participants to a Mediterranean diet supplemented with either extra-virgin olive oil or nuts and demonstrated 30% and 28% reductions, respectively, in the combined endpoint (MI, stroke, or cardiovascular mortality), but the improved outcome was driven largely by the reduction in stroke, with no signifi- cant improvement over the control diet for mor- tality or MI.S3.1-1 When the PREDIMED cohort was reanalyzed post hoc for the provegetarian food pattern (more vegetable consumption versus ani- mal, egg, fish, dairy, or meat product consump- tion), a significant mortality rate reduction (41%) was noted in the 2 quintiles with the highest A comparison of plant and animal protein from the Adventist Health Study-2 similarly indicated that using meat for protein was associated with a 61% increase in mortality rate, whereas replacing meat with nuts and seeds was associated with a 40% reduction in mortality rate. Similarly, the graded risk published by Song et al. indicated that lower mortality rate was associated with replacing animal protein of different origins with plant protein.S3.1-9 The evi- dence is mixed with regard to the effectiveness of dairy intake to reduce ASCVD risk factors, which is why it is not included in the listed foods for this recommendation. Although the DASH (Dietary Approaches to Stop Hypertension) diet, which includes low-fat dairy products, was shown to and the PURE (Prospective Urban Rural Epidemiology) study indicated that dairy intake was associated with a 23% lower mortality Song et al. indicated an 11% increase in cardiovascular mortality rate with dairy consump- tion as compared with vegetable protein S3.1-9). 2.


indicated an 11% increase in cardiovascular mortality rate with dairy consump- tion as compared with vegetable protein S3.1-9). 2. Trans and saturated fats have been associated with a higher risk of total and cause-specific death.S3.1-12 However, observational data from the PURE trial suggested that, when used instead of refined car- bohydrates, saturated and unsaturated fats were associated with reduced stroke and mortality.S3.1-13 3. Dietary sodium reduction was found to reduce BP and cardiovascular events in the DASH trial and in TOHP (Trials of Hypertension Prevention).S3.1-14,S3.1-15 Data from NHANES (National Health and Nutrition suggest that high con- sumption of sodium (>2000 mg daily), red meat (>14 g/d), and sugar-sweetened beverages and processed red meat consumption were associated with cardiovascular death. A prospective cohort study of US healthcare professionalsS3.1-9 with at least 1 risk factor indicated that replacement of animal protein (sources of cholesterol, saturated fat, heme iron and precursors of trimethylamine- N-oxide) with plant protein was associated with reduced cardiovascular mortality rate. In that study, compared with plant protein, poultry and fish were associated with a 6% higher mortality rate, dairy with an 8% higher mortality rate, unprocessed red meat with a 12% higher mortality rate, eggs with a 19% higher mortality rate, and processed red meat with a 34% higher mortality rate. Overall, plant protein was associated with a reduction in mortality rate of 10% for every 3% energy incre- ment replacement of animal protein. 4. Intake of several food products has been shown to be potentially harmful or increase risk of ASCVD.


Intake of several food products has been shown to be potentially harmful or increase risk of ASCVD. Sugar-sweetened and artificially sweetened bev- erages have been correlated with increasing the development of T2DM and with ASCVD risk, with a 20% increase in the frequency of diabetes mellitus with 1 daily serving of these sweetened In large cohort studies, consump- tion of added sugar at >10% of daily calories has been associated with increased mortality However, adults who are habitually high consumers of sugar-sweetened beverages and utilize low calorie sweetened beverages as a replacement strategy that provides a sweet taste while reducing caloric intake may find this use- ful in the transition to water.S3.1-20 In REGARDS (REasons for Geographic and Racial Differences the Southern dietary pattern was identified as substantially increasing health risks, including a 56% higher risk of heart disease and a 30% higher risk of stroke. This pattern con- sisted of more fried food, added fats, organ and processed meats, and sugar-sweetened bev- erages. Consuming a dietS3.1-4 with juices and sweetened beverages, refined grains, potatoes/ fries, and sweets resulted in a greater increase in coronary events than the increase seen with consumption of animal products. Given the addi- tional risk associated with intake of these various food products, clinicians would do well to coun- sel individuals about their associated harm and advise them to avoid these foods when possible. Furthermore, longstanding dietary patterns that focus on low intake of carbohydrates and a high intake of animal fat and protein are associated with increased cardiac and noncardiac mortal- low- carbohydrate diets were associated with a 31% higher risk of all-cause death, with increased cardiac mortality rate.


Furthermore, longstanding dietary patterns that focus on low intake of carbohydrates and a high intake of animal fat and protein are associated with increased cardiac and noncardiac mortal- low- carbohydrate diets were associated with a 31% higher risk of all-cause death, with increased cardiac mortality rate. Population data from the ARIC (Atherosclerosis Risk in Communities) study indicated an 18% increase in mortality rate with CLINICAL STATEMENTS AND GUIDELINES low-carbohydrate diets using animal-derived protein and fat sources (eg, lamb, beef, pork, but plant sources (eg, vegetables, nuts, peanut butter, whole-grain breads) were associated with lower mortality rate. In addition, the ARIC investigators noted a 23% increase in mortality rate associated with high-carbohydrate diets, with the optimal carbohydrate intake observed to be 50% to 55%. 5. Intake of trans fat has been shown to be harm- ful and increase risk of ASCVD. Trans fat was associated with higher all-cause mortality rate in the REGARDS US healthcare professionals cohort Additionally, regulations to curb use of trans fat in the food industry have been associated with a decrease in stroke and Trans fats have adverse effects on lipid and lipoproteins and promote endothelial dys- function, insulin resistance, inflammation, and Since partially hydrogenated oils are optional food additives, their elimination has been a public health priority.S3.1-27 3.2. Exercise and Physical Activity Recommendations for Exercise and Physical Activity Referenced studies that support recommendations are summarized in Online Data Supplements 6 and 7.