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June 18/25, 2019 Circulation. 2019;139:e1082–e1143. DOI: 10.1161/CIR.0000000000000625 e1104

CLINICAL STATEMENTS AND GUIDELINES discussion.S4.4.2-13,S4.4.2-26 Required information includes age, sex, and race/ethnicity; presence of diabetes mellitus or cigarette smoking and treated hypertension; and a current blood pressure level and fasting or nonfasting TC and HDL-C levels. The PCE include a stroke endpoint and racespecific coefficients. This identifies, for example, a black woman who with similar risk factors is at much higher risk than her white counterpart. The PCE were externally validated in a high-quality natural history study published shortly after the 2013 ACC/AHA cholesterol guidelines were presented.S4.4.2-11 These equations may underestimate risk in individuals of South Asian ancestry and other high-risk groups and may overestimate risk in selected lower-risk groups.S4.4.2-10 Unlike other risk estimators, the PCE use only fatal and nonfatal stroke and CHD as endpoints. Other risk estimators that include revascularization and additional cardiovascular endpoints provide risk estimates that cannot be compared directly with those given by the PCE. Finally, the potential for errors in estimating ASCVD risk at both ends of the risk curve (low risk and high-risk) as noted for individuals can be reviewed in the clinician– patient risk discussion (Table 6). 4.	 The present guidelines continue to emphasize the importance of a clinician–patient risk discussion.S4.4.2-12–S4.4.2-14,S4.4.2-27,S4.4.2-28 In those with a 10-year ASCVD risk of ≥7.5%, it is recommended that the discussion occur before a statin prescription is written.S4.4.2-26 This frank discussion, as recommended in the 2013 ACC/ AHA cholesterol guidelines,S4.4.2-26 should consider whether ASCVD risk factors have been addressed, evaluate whether an optimal lifestyle has been implemented, and review the potential for statin benefit versus the potential for adverse effects and drug-drug interactions. Then, on the basis of individual characteristics and including an informed patient preference in shared decision-making, a risk decision about statin therapy can be made (Table 7). Clinicians should indicate that as ASCVD risk increases, so does benefit of evidence-based LDL-C–lowering therapy. They may wish to review the drug and safety sections of the present guideline and stay informed on safety information that is essential for a balanced discussion. Importantly, for those at intermediate-risk, especially those >55 years of age, risk-enhancing factors or CAC can be used to clarify risk if the risk decision is uncertain.S4.4.2-16 Risk-enhancing factors, such as family history of premature ASCVD or an LDL-C of 160 to 189 mg/dL (4.1–4.8 mmol/L), identify Table 7.  Checklist for Clinician–Patient Shared Decision-Making for Initiating Therapy

Checklist Item Recommendation ASCVD risk assessment Assign to statin treatment group; use ASCVD Risk Estimator Plus.*

In lower-risk primary-prevention adults 40-75 y of

age with LDL-C ≥70 mg/dL (≥1.8 mmol/L). Not needed in secondary prevention, in those

with LDL-C ≥190 mg/dL (≥4.9 mmol/L), or in those 40-75 y of age with diabetes mellitus. Assess other patient characteristics that influence risk. See Risk-Enhancing Factors (Section 4.4.1.3. and Table 6). Assess CAC (Section 4.4.1.4.) if risk decision is uncertain and additional information is needed to clarify ASCVD risk. Use decision tools to explain risk (eg, ASCVD

Risk Estimator Plus,* Mayo Clinic Statin Choice Decision Aid†).

Lifestyle modifications Review lifestyle habits (eg, diet, physical activity, weight or body mass index, and tobacco use).

Endorse a healthy lifestyle and provide relevant advice, materials, or referrals (eg, CardioSmart‡, AHA Life’s Simple 7§, NLA Patient Tear Sheets‖, PCNA Heart Healthy Toolbox¶, cardiac rehabilitation, dietitian, smoking cessation program).

Potential net clinical benefit of pharmacotherapy Recommend statins as first-line therapy.

Consider the combination of statin and nonstatin therapy in selected patients. Discuss potential risk reduction from lipid-lowering therapy. Discuss the potential for adverse effects or drug– drug interactions.

Cost considerations Discuss potential out-of-pocket cost of therapy to the patient (eg, insurance plan coverage, tier level, copayment). Shared decisionmaking Encourage the patient to verbalize what was heard (eg, patient’s personal ASCVD risk, available options, and risks/benefits).

Invite the patient to ask questions, express values and preferences, and state ability to adhere to lifestyle changes and medications. Refer patients to trustworthy materials to aid in their understanding of issues regarding risk decisions. Collaborate with the patient to determine therapy and follow-up plan.

*ASCVD Risk Predictor Plus is available at: http://tools.acc.org/ASCVD-Risk- Estimator-Plus/#!/calculate/estimate/ and http://static.heart.org/riskcalc/app/ index.html#!/baseline-risk. Accessed September 1, 2018. †Mayo Clinic Statin Decision Aid information is available at: https:// statindecisionaid.mayoclinic.org. ‡CardioSmart health information is available at: https://www.cardiosmart. org/About. §AHA Life's Simple 7 information is available at: https://www.heart.org/en/ healthy-living/healthy-lifestyle/my-life-check–lifes-simple-7. ‖NLA Patient Tear Sheets information is available at: https://www.lipid.org/ practicetools/tools/tearsheets. ¶PCNA Heart Healthy Toolbox information is available at: http://pcna.net/ clinical-tools/tools-for-healthcare-providers/heart-healthy-toolbox. AHA indicates American Heart Association; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; CKD, chronic kidney disease; HIV, human immunodeficiency virus; LDL-C, low-density lipoprotein cholesterol; PCNA, Preventive Cardiology Nurses Association and NLA, National Lipid Association.

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