Values	Previous	Current	Current
Age:	NaN	NaN
Total Cholesterol (mg/dL) (mmol/L)
HDL Cholesterol (mg/dL) (mmol/L)
LDL Cholesterol (mg/dL) (mmol/L)
Systolic Blood Pressure (mm Hg)
Diastolic Blood Pressure (mm Hg)
Diabetes:	No	No
Smoker:
Treatment for Hypertension:	No	No
Aspirin Therapy:
Statin:

Patient Scenario

Initial visit: A 70-year-old black man presents for an initial visit to consider prevention of atherosclerotic cardiovascular disease (ASCVD). A friend recently had a stroke and he is concerned that he may be at risk as well.

Past medical history: Bleeding duodenal ulcer 10 years ago.
ASCVD risk factors: Current smoker, ½ pack per day for 50 years; no history of diabetes mellitus.
Current medications: None.
Physical examination: Systolic blood pressure 160 mm Hg; no signs of ASCVD.
Lab data: Total cholesterol 240 mg/dL, HDL-cholesterol 40 mg/dL, triglycerides 150 mg/dL, LDL-cholesterol 170 mg/dL.

The clinician engages him in a discussion regarding his risks for ASCVD, and the potential for risk reduction. The clinician begins by estimating the patient’s 10-year risk for ASCVD based on his current risk profile. After entering the patient’s current data in the Estimate screen of the ASCVD Risk Estimator Plus app, the clinician and patient review the fact that the estimated 10-year risk is 30.8%. The clinician explains that this means that if we had 100 men like him, at the end of 10 years, about 31 of them will have had or died from a heart attack or stroke. This is considered to be a high-risk scenario by current clinical practice guidelines. The patient expresses a desire to lower his risk.
The clinician provides important information to the patient about pursuing therapeutic lifestyle changes using the Lifestyle table on the Advice tab, including a heart healthy diet and regular physical activity. He agrees to focus on reducing calorie intake, limiting sodium intake, and to start a walking program for 20 minutes daily. Together, they review options for smoking cessation.
Using the Therapy Impact tab in the ASCVD Risk Estimator Plus app, they review medications that may help reduce the patient’s risk. They note that, on average, starting a moderate intensity statin or blood pressure lowering therapy alone, or stopping smoking for 2 years, would each reduce his 10-year risk to about 23%, whereas aspirin alone would reduce the risk to about 28% (with possible risk of bleeding, in light of his history). Starting a statin and blood pressure lowering therapy plus smoking cessation could cut his 10-year risk to as little as 12%. The clinician and patient review the bar graph on the advice tab to visualize all these options together.
The patient is uncertain about whether he is ready to adhere to all of these interventions concurrently. Given the patient’s particular interest in reducing stroke risk, and his current hypertension, the patient and clinician decide to pursue blood pressure lowering therapy with a calcium channel blocker, and to pursue smoking cessation with pharmacological assistance. They agree to discuss the use of aspirin or statins at a future visit, which is scheduled.

Follow-up Visit: One year later, the patient returns for a follow-up visit, having had an interim visit at which his blood pressure regimen was adjusted with the addition of a thiazide diuretic. He successfully stopped smoking 8 months ago. His lipids are unchanged from baseline. His systolic blood pressure today is 140 mm Hg.
However, with his greater than expected blood pressure reduction and successful smoking cessation, the clinician calculates the patient’s updated risk by entering both the patient’s initial visit and follow up data into the app’s Estimate tab, and determines his risk is now 11.4%. The clinician congratulates the patient, and asks whether he would like to consider initiating moderate-intensity statin therapy. They consider the pros and cons and the patient’s preferences, and elect to pursue a moderate intensity statin, with plans to assess the patient’s LDL-cholesterol response in 3 months. The clinician emails themselves a summary of the visit and the patient’s progress to keep in their record, using the button on the Advice tab.

Understanding Cardiovascular Risk

10-Year ASCVD Risk

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The 10-year calculated ASCVD risk is a quantitative estimation of absolute risk based upon data from representative population samples.
The 10-year risk estimate for "optimal risk factors" is represented by the following specific risk factor numbers for an individual of the same age, sex and race: Total cholesterol of ≤ 170 mg/dL, HDL-cholesterol of ≥ 50 mg/dL, untreated systolic blood pressure of ≤ 110 mm Hg, no diabetes history, and not a current smoker.
While the risk estimate is applied to individuals, it is based on group averages.
Just because two individuals have the same estimated risk does not mean that they will or will not have the same event of interest.
Example: If the 10-year ASCVD risk estimate is 10%, this indicates that among 100 patients with the entered risk factor profile, 10 would be expected to have a heart attack or stroke in the next 10 years.

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Lifetime ASCVD Risk

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The lifetime calculated ASCVD risk represents a quantitative estimation of absolute risk for a 50 year old man or woman with the same risk profile.
This estimation of risk is based on the grouping of risk factor levels into 5 strata.
- All risk factors are optimal*
- ≥1 risk factors are not optimal†
- ≥1 risk factors are elevated‡
- 1 major risk factor§
- ≥2 major risk factors§
The division of lifetime risk by these 5 strata leads to thresholds in the data with large apparent changes in lifetime risk estimates.
Example: An individual that has all optimal risk factors except for a systolic blood pressure of 119 mm Hg has a lifetime ASCVD risk of 5%. In contrast, a similar individual that has all optimal risk factors except for a systolic blood pressure of 120 mm Hg has a lifetime ASCVD risk of 36%. This substantial difference in lifetime risk is due to the fact that they are in different stratum.

*Optimal risk levels for lifetime risk are represented by the simultaneous presence of all of the following: Untreated total cholesterol <180 mg/dL, untreated blood pressure <120/<80 mm Hg, no diabetes history, and not a current smoker

†Nonoptimal risk levels for lifetime risk are represented by 1 or more of the following: Untreated total cholesterol of 180 to 199 mg/dL, untreated systolic blood pressure of 120 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg, and no diabetes history and not a current smoker

‡Elevated risk levels for lifetime risk are represented by 1 or more of the following: Untreated total cholesterol of 200 to 239 mg/dL, untreated systolic blood pressure of 140 to 159 mm Hg or diastolic blood pressure of 90 to 99 mm Hg, and no diabetes history and not a current smoker

§Major risk levels for lifetime risk are represented by any of the following: Total cholesterol ≥240 mg/dL or treated, systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg or treated, or diabetes, or current smoker

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Lifestyle Recommendations

Diet recommendations for LDL-C lowering

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To reduce ASCVD risk in all patients:
- - A diet emphasizing intake of vegetables, fruits, legumes, nuts, whole grains, and fish is recommended (I, B-R). A diet containing reduced amounts of cholesterol and sodium can be beneficial (IIa, B-NR).
- - Replacement of saturated fat with dietary mono- and poly-unsaturated fats can be beneficial (IIa, B-NR).
- - Minimizing the intake of trans fats, processed meats, refined carbohydrates, and sweetened beverages as part of a heart healthy diet is reasonable (IIa, B-NR).
For adults with type 2 diabetes mellitus:
- - A tailored nutrition plan focusing on a heart-healthy dietary pattern is recommended to improve glycemic control, achieve weight loss (if needed), and improve other ASCVD risk factors (I, A).

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Weight Management Recommendations

Physical Activity Recommendations

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To reduce ASCVD risk, adults should:
- - Be routinely counseled to optimize a physically active lifestyle (I, B-R).
- - Engage in at least 150 minutes per week of accumulated moderate intensity or 75 minutes per week of vigorous intensity aerobic physical activity (or an equivalent combination of moderate and vigorous activity) (I, B-NR). This includes adults with type 2 diabetes mellitus (I, A).
- - Decrease sedentary behavior (IIb, C-LD).

For adults unable to meet the minimum physical activity recommendations:

- Engaging in some moderate or vigorous intensity physical activity, even if less than this recommended amount, can be beneficial to reduce ASCVD risk (IIa, B-NR).

Intensity	METS	Examples
Sedentary Behavior^*	1-1.5	Sitting, reclining, or lying; watching TV
Light	1.6-2.9	Walking slowly, cooking, light house work
Moderate	3.0-5.9	Brisk walking (2.4-4mph), biking 5-9mph, ballroom dancing, active yoga, recreational swimming
Vigorous	≥6	Jogging/running, biking ≥10mph, singles tennis, swimming laps

^*Sedentary behavior is defined as any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents (METs), while in a sitting, reclining, or lying posture. Standing is a sedentary activity in that it involves ≤1.5 METs, but is not considered a component of sedentary behavior; mph indicates miles per hour

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Standards for Adult Immunization Practice

Why Focus on Adult Immunizations?

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ACC is part of a consortium of medical specialty societies - Specialty Societies Advancing Adult Immunization - funded through CDC and supported by CMSS to provide vaccination resources to cardiovascular clinicians, including education and learning opportunities, clinical practice guidance, and quality improvement initiatives.

Why focus on adult immunizations?

Adult vaccination rates are extremely low.
Most adults are NOT aware that they need vaccines.
Recommendation from their healthcare professional is the strongest predictor of whether patients get vaccinated.
There are many missed opportunities for vaccination because many healthcare professionals are not routinely assessing vaccination status.

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Standard Steps for All Healthcare Professionals

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The National Vaccine Advisory Committee (NVAC) revised the a Standards for Adult Immunization Practice in 2013. View the most recent Standards for Adult Immunization Practice on the CDC website. These updated standards call on ALL healthcare professionals — whether they provide vaccinations or not — to take steps to help ensure that their adult patients are fully immunized. These steps are as follows:

Assess immunization status of all your patients at every clinical encounter.

All healthcare providers are called upon to help ensure that their adult patients are fully immunized:

Stay informed. Get the latest CDC recommendations for immunization of adults.
Implement protocols and policies. Ensure that patients’ vaccine needs are routinely reviewed, and patients get reminders about vaccines they need.

Assessment is the critical first step in ensuring that your adult patients get the vaccines they need for protection against serious vaccine-preventable diseases.
Your patients’ vaccination needs will change over time based on factors such as:

Age
health conditions
lifestyle
travel
occupation

Adults think immunization is important, but most are not aware of all the vaccines they need. They rely on you to tell them which vaccines are recommended for them.

Whether you provide vaccines or not, assess immunization status at every clinical encounter.

Administer or Refer your patients to a vaccination provider.

Download the Vaccine Administration factsheet.

There are a number of steps you can take to improve vaccine administration in your office and better protect your patients from vaccine-preventable diseases.

Recommend and offer vaccines at the same visit. Research shows that when patients receive a vaccine recommendation and are offered the vaccine at the same time, they are more likely to get vaccinated.
- For vaccines you don't stock, REFER patients to a local immunization provider that can vaccinate.
- There is an expanding network of immunization providers. For details, download this Vaccine Referral factsheet.
Train and educate your staff on vaccine administration. Help improve vaccine delivery and ensure patient safety.
Use standing orders or protocols (where allowed by state law) for vaccine administration. Authorizing nurses, pharmacists, and other healthcare professionals to assess patient vaccine status and administer needed vaccinations without examination or direct order from the attending provider can save time and reduce missed opportunities for vaccination.
Properly store and handle vaccines. This critical step can reduce wastage. Review CDC recommendations and guidelines on vaccine storage and handling practices.
Distribute Vaccine Information Statements (VIS) to patients. Help your patients make informed decisions about vaccinations.
Ensure proper care for patients. Minimize potential risks to your patients by following safety protocols.
Follow standard precautions to control infection. Minimize the risks of spreading disease when administering vaccines. Review the CDC Guide to Infection Prevention for Outpatient Care.
Be aware of and prepared for potential adverse reactions. All vaccines have the potential to cause adverse reactions. Most are minor (e.g., itching, soreness) but severe reactions (e.g., anaphylaxis), while rare, can occur. Make sure you and your staff are prepared to handle severe reactions.
- Review IAC's Chart of Medical Management of Vaccine Reactions in Adult Patients Procedures.
- Report any adverse events that occur following vaccination to the Vaccine Adverse Events Reporting System (VAERS).

Document vaccines received by your patients.

Participate in your state's immunization registry. Help your office, your patients, and your patients' other providers know which vaccines your patients have had.
Follow up. Confirm that patients received recommended vaccines that you referred them to get from other immunization providers.

Keep an up-to-date record of the vaccines your patients have received to make sure they have the best protection against vaccine-preventable diseases.
To ensure patients get the vaccines they need and to prevent unnecessary vaccination, you should:

Record vaccination in patients' medical records
Provide documentation of vaccines received to patients for their personal records.
Document vaccinations in immunization information systems (IIS)

Immunization Information Systems (IIS)
IIS are confidential, community-wide, computerized databases that record vaccines administered by participating healthcare professionals.
Documenting vaccines into IIS can benefit your practice by:

Consolidating vaccination records for your patients.
Helping you assess your patients' immunization status.
Reducing chances for unnecessary doses of vaccine or missed opportunities to provide vaccines.
Facilitating use of reminder and recall notifications to send to patients.
Making calculation of your office's immunization coverage rates easier.

Learn more about Immunization Information Systems (IIS) or reach out to your state's main contact regarding questions about your state or local registry.

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External Resource Links

Diabetes Management

The data are incomplete for the use of SGLT2 inhibitors and GLP-1RAs in patients who do not have DKD or established ASCVD, although expert consensus recommends their use for patients with a high burden of 1 risk factors for CV disease.

Doses, Indications, Dose Modifications, Contraindications, Cautions, and Adverse Effects of SGLT2 Inhibitors with Demonstrated CV Benefit

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	Canagliflozin	Dapagliflozin	Empagliflozin
Recommended Doses for CV Benefit*	100 mg PO daily	100 mg PO daily	100 mg PO daily
Indications	Improve glycemic control in adults with T2D as an adjunct to diet and exercise Reduce risk of MI, stroke, or CV death in adults with T2D and CV disease Reduce the risk of end-stage kidney disease, doubling of serum creatinine, CV death, and hospitalization for HF in patients with T2D and diabetic nephropathy with albuminuria	eGFR 2: use is not recommended for glycemic control Reduce the risk of hospitalization for HF in adults with T2D and established CV disease or multiple CV risk factors Reduce the risk of CV death and hospitalization for HF in adults with HFrEFa	Improve glycemic control in adults with T2D as an adjunct to diet and exercise Reduce risk of CV death in adults with T2D and established CV disease
Dose Modifications	eGFR 30 to 59 ml/min/1.73m²: max dose 100 mg daily eGFR 2: use is not recommended for glycemic control	eGFR 2: use is not recommended for glycemic control eGFR 2: use is contraindicated	eGFR 2: use is not recommended
Contraindications	History of serious hypersensitivity reaction to drug Pregnancy or breastfeeding On dialysis eGFR 2 (dapagliflozin) ESRD (dapagliflozin and empagliflozin) Severe renal impairment (empagliflozin)
Cautions	If HbA1c well-controlled at baseline, or known history of frequent hypoglycemic events, wean or stop sulfonylurea or glinide and consider reducing total daily insulin dose by ~20% when starting therapy May contribute to intravascular volume contraction; consider stopping or reducing diuretic dose if applicable Use with caution in patients with prior amputation, severe peripheral neuropathy, severe peripheral vascular disease, or active diabetic foot ulcers or soft tissue infections Possible increased risk of bone fractures (canagliflozin)
Adverse Effects to Monitor	Genital fungal infections Urinary tract infections Euglycemic diabetic ketoacidosis Lower limb ulcerations and soft tissue infections

^*Because there is no evidence of a graded dose response regarding CV and renal effects, SGLT2 inhibitors with CV benefit should be initiated at the lowest dose tested in CV and renal outcomes trials. Those doses are listed here. No further dose titration is needed for CV or renal risk reduction. However, dose increases may provide further glucose reduction benefits if indicated

CV = cardiovascular; eGFR = estimated glomerular filtration rate; ESRD= end stage renal disease; HbA1c = hemoglobin A1c; HF= heart failure; PO = “per os", by mouth; SGLT2 = sodium-glucose cotransporter-2; T2D = type 2 diabetes

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Doses, Indications, Dose Modifications, Contraindications, Cautions, and Adverse Effects of GLP-1RAs with Demonstrated CV Benefit

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	Dulaglutide	Exenatide QW	Liraglutide	Lixisenatide	Semaglutide SC	Semaglutide PO
Recommended Doses for CV Benefit	Initiate 0.75 mg SC per week Titrate slowly to 1.5 mg or maximally tolerated dose based on prescribing information	2 mg SC per week	Initiate 0.6 mg SC daily. Titrate slowly to 1.8 mg or maximally tolerated dose based on prescribing information	10 mcg SC daily Titrate as tolerated to 20 mcg daily based on prescribing information.	Initiate 0.25 mg SC per week. Titrate slowly to 1 mg once weekly or maximally tolerated dose based on prescribing information.	Initiate 3 mg PO per day for the first 30 days. Titrate slowly to 14 mg daily or maximally tolerated dose based on prescribing information.
Indications	Improve glycemic control in adults with T2D Reduce MACE for people with T2D with and without established CV disease	Improve glycemic control in adults with T2D	Improve glycemic control in adults with T2D Reduce risk of MI, CVA, or CV death in adults with T2D and CV disease	Improve glycemic control in adults with T2D.	Improve glycemic control in adults with T2D. Reduce risk of MI, CVA, or CV death in adults with T2D and CV disease.	Improve glycemic control in adults with T2D.
Dose Modifications	Up-titrate slowly to reduce nausea and vomiting Discontinue if pancreatitis is suspected and do not restart if pancreatitis is confirmed No dose adjustment necessary with renal or hepatic impairment; data in end-stage renal disease are limited	Discontinue if pancreatitis is suspected and do not restart if pancreatitis is confirmed eGFR <45 mL/min/1.73 m2: Use is not recommended	Up-titrate slowly to reduce nausea and vomiting Discontinue if pancreatitis is suspected and do not restart if pancreatitis is confirmed No dose adjustment is necessary with renal or hepatic impairment	Up-titrate slowly to reduce nausea and vomiting. Discontinue if pancreatitis is suspected, and do not restart if pancreatitis is confirmed . eGFR ≥30 mL/min: No dosage adjustment is required. eGFR 15 to 29 mL/min: Use caution and monitor renal function. eGFR <15 mL/min: Use is not recommended.	Up-titrate slowly to reduce nausea and vomiting. Discontinue if pancreatitis is suspected and do not restart if pancreatitis is confirmed. No dose adjustment is necessary with renal or hepatic impairment.	Up-titrate slowly to reduce nausea and vomiting. Discontinue if pancreatitis is suspected and do not restart if pancreatitis is confirmed. No dose adjustment is necessary with renal or hepatic impairment.
Contraindications	History of serious hypersensitivity reaction to drug Pregnancy or breast feeding Severe renal impairment or end-stage renal failure (exenatide, lixisenatide) Personal or family history of medullary thyroid cancer Personal or family history of MEN2
Cautions	Hypoglycemia risk increased with insulin, sulfonylureas, or glinides May delay gastric emptying; not recommended in patients with clinically meaningful gastroparesis. This effect is usually transient with longer-acting GLP-1RAs Care should be taken in patients with prior gastric surgery, including bariatric surgery Diabetic retinopathy complications were reported with semaglutide (injectable), although it is unclear if this is a direct effect of the drug or due to other factors such as rapid improvement in blood glucose control
Adverse Effects to Monitor	Nausea, vomiting, diarrhea, headache, weakness, or dizziness Hypoglycemia when given with insulin, sulfonylureas, or glinides Weight loss Injection site reactions

CV = cardiovascular; CVA = cerebrovascular accident; eGFR = estimated glomerular filtration rate; GLP-1RA = glucagon-like peptide-1 receptor agonist; MACE = major adverse cardiovascular events; MEN2 = multiple endocrine neoplasia, type 2; MI = myocardial infarction; PO = "per os", by mouth; T2D = type 2 diabetes; SC = subcutaneous; QW = once weekly

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Opportunities to Initiate an SGLT2 inhibitor or a GLP-1RA with Demonstrated CV or Renal Benefit in Patients with T2D*

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In a patient with T2D and ASCVD (SGLT2 inhibitor or GLP-1RA)

At the time of diagnosis of clinical ASCVD (SGLT2 inhibitor or GLP-1RA), DKD, and/or HF (SGLT2 inhibitor)^†in a patient with T2D on a drug regimen that does not include a SGLT2 inhibitor or GLP-1RA with CV benefit

At the time of diagnosis of T2D in a patient with clinical ASCVD (SGLT2 inhibitor or GLP-1RA), DKD and/or HF (SGLT2 inhibitor)^†^‡

At hospital discharge (with close outpatient follow-up) after admission for an ASCVD (SGLT2 inhibitor or GLP-1RA) or HF (SGLT2 inhibitor) event^§

In a patient with T2D and diabetic kidney disease (SGLT2 inhibitor, alternatively GLP-1RA for eGFR<30 ml/min/1.73 m2) ^‡

In patients determined to be at high risk of ASCVD^|| (SGLT2 inhibitor or GLP-1RA) or HF (SGLT2 inhibitor) ^†‡

*At the time of hospital discharge or in the outpatient setting. Increased vigilance regarding hypoglycemia surveillance is warranted, especially if on background insulin, sulfonylurea, or glinide therapy.

†A minority of patients included in the CANVAS, LEADER, SUSTAIN-6, and EXSCEL trials and a majority of patients in the REWIND trial could be characterized as high-risk primary prevention patients. These patients did not have established ASCVD but did have prespecified ASCVD risk factors.

‡Use clinical judgement when initiating an SGLT2 inhibitor in a patient who will be starting or uptitrating an ACE inhibitor or ARB if the patient’s renal function is impaired.

§Hospitalized patients were not included in most of the CV outcome trials discussed here. There is a lack of practical and safety data regarding in-hospital addition of SGLT2 inhibitors or GLP-1RAs to a patient’s regimen.

^||Consider for patients at very high risk of ASCVD to include patients with end-organ damage such as left ventricular hypertrophy or retinopathy or with multiple CV risk factors (e.g., age, hypertension, smoking, dyslipidemia, obesity).

ACE = angiotensin converting enzyme; ARB = angiotensin reception blocker; ASCVD = atherosclerotic cardiovascular disease; CANVAS = Canagliflozin Cardiovascular Assessment Study; CV = cardiovascular; DKD = diabetic kidney disease; eGFR = estimated glomerular filtration rate; EXSCEL = Exenatide Study of Cardiovascular Event Lowering Trial; GLP-1RA = glucagon-like peptide-1 receptor agonist; HF = heart failure; LEADER = Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results; REWIND = Researching CV Events With a Weekly Incretin in Diabetes; SGLT2 = sodium-glucose cotransporter-2; SUSTAIN-6 = Trial to Evaluate CV and Other Long-term Outcomes With Semaglutide in Subjects With T2D;T2D = type 2 diabetes

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Patient and Clinician Preferences and Priorities for Considering SGLT2 Inhibitors with Demonstrated CV Benefit Versus GLP-1RAs with Demonstrated CV Benefit

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Preference or Priority	Consider using an SGLT2 inhibitor first when patient and clinician priorities include:	Consider using a GLP-1RA first when patient and clinician priorities include:
MACE prevention	+++	+++
HF prevention	+++
Weight loss	+	+++
Renal disease progression prevention	+++	+
Mode of administration	Oral	Subcutaneous
Considerations that may prompt use of an alternative class	Severely reduced kidney function*† History of prior amputation, severe peripheral arterial disease, or active diabetic foot ulcers (caution with canagliflozin) History of recurrent genital candidiasis History of diabetic ketoacidosis History of fracture (caution with canagliflozin) The patient is considering pregnancy The patient is breast feeding	Persistent nausea, despite appropriate dietary education and low doses History of gastroparesis Active gallbladder disease History of MEN2 or medullary thyroid cancer History of proliferative retinopathy (caution with semaglutide or dulaglutide) The patient is considering pregnancy The patient is breast feeding

*eGFR <45 ml/min/1.73 m² is currently a caution due to a decrease in glycemic efficacy (not due to safety), but ongoing studies are testing whether SGLT2 inhibitors offer renal benefits in these patients. The FDA label for canagliflozin allows use of canagliflozin to an eGFR of 30 ml/min/1.73m²specifically for patients with DKD.

†Use clinical judgement when initiating an SGLT2 inhibitor in a patient who will be starting or uptitrating an ACE inhibitor or ARB if the patient’s renal function is impaired

ACE = angiotensin converting enzyme; ARB = angiotensin reception blocker; CV = cardiovascular; DKD = diabetic kidney disease; eGFR = estimated glomerular filtration rate; FDA = Food and Drug Administration; GLP-1RA = glucagon-like peptide-1 receptor agonist; HF = heart failure; MACE = major adverse cardiovascular event; MEN2 = multiple endocrine neoplasia type 2; SGLT2 = sodium-glucose cotransporter-2

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Considerations for Drug Initiation and Monitoring in Patients Starting an SGLT2 Inhibitor with Demonstrated CV Benefit

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If HbA1c is well-controlled at baseline or known history of frequent hypoglycemic events, wean or stop sulfonylurea and consider reducing total daily insulin dose by ~20% when starting therapy.

Educate patients regarding potential for genital mycotic infections and importance of genital hygiene.

Avoid hypovolemia. May need to reduce diuretic dose if the patient has symptoms of dehydration. Educate patients regarding symptoms of dehydration (lightheadedness, orthostasis, weakness) and to hold medication if low oral intake.

Instruct patients to more closely monitor glucose at home for the first 4 weeks of therapy (especially if on insulin, sulfonylurea, and/or glinides). Consider discontinuing any sulfonylurea or glinide. For patients taking insulin, consider modestly reducing total daily insulin dose (by up to 20%).

Educate patients regarding symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, weakness) and that diabetic ketoacidosis can occur even if blood glucose readings are in the 150–250 mg/dL range. If patient experiences diabetic ketoacidosis-like symptoms, he/she should be instructed to seek urgent medical attention.

Educate patients regarding foot care, especially in patients with diabetic neuropathy. Ask patients to report any foot wounds immediately.

CV = cardiovascular; HbA1c = hemoglobin A1c; SGLT2 = sodium-glucose cotransporter-2.

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Considerations for Drug Initiation and Monitoring in Patients Starting a GLP-1RA with Demonstrated CV Benefit

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If HbA1c is well-controlled at baseline or known history of frequent hypoglycemic events, wean or stop sulfonylurea and consider reducing total daily insulin dose by ~20% when starting therapy.

Instruct patients to more closely monitor glucose at home for the first 4 weeks of therapy. Consider discontinuing any sulfonylurea or glinide. For patients taking insulin, consider modestly reducing total daily insulin dose (by up to 20%).

Discontinue DPP-4 inhibitor before starting.

To mitigate nausea, recommend small portion sizes for meals, start at the lowest dose, and up-titrate as tolerated toward the goal doses used in CV outcome trials.

Advise patients to undergo appropriate, guideline-recommended eye examinations before starting therapy if not done within the last 12 months.

Discuss potential risk of diabetic retinopathy complications (for dulaglutide or injectable semaglutide).

Avoid in patients with diabetic gastroparesis or active gallbladder disease.

CV = cardiovascular; DPP4 = dipeptidyl peptidase-4; GLP-1RA = glucagon-like peptide-1 receptor agonist; HbA1c = hemoglobin A1c.

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Tobacco Cessation

Guideline Recommendations for Tobacco Cessation

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Recommendations for Tobacco Treatment
COR	LOE	Recommendations
I	A	1. All adults should be assessed at every visit for tobacco use and their tobacco use status recorded as a vital sign to facilitate tobacco cessation.
I	A	2. All adults who use tobacco should be firmly advised to quit in order to achieve tobacco abstinence.
I	A	3. In adults who use tobacco, a combination of behavioral interventions plus pharmacotherapy is recommended to maximize quit rates.
I	B-NR	4. In adults who use tobacco, tobacco abstinence is recommended to reduce ASCVD risk.
IIa	B-R	5. It is reasonable to dedicate trained staff to tobacco treatment in every health system to facilitate tobacco cessation.
III: Harm	B-NR	6. All adults and adolescents should avoid secondhand smoke exposure to reduce ASCVD risk.

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Clinician Pharmacotherapy Tool: Tobacco Cessation for Patients with Cardiovascular Disease

Examples of Behavioral Interventions for Nicotine Dependence

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The below table is from the 2018 ACC Expert Consensus Decision Pathway on Tobacco Cessation Treatment.

Examples of Behavioral Interventions for Nicotine Dependence
Treatment	Examples
Cognitive behavioral skills training	Instructions, modeling, rehearsal, and feedback to teach smokers how to change their smoking behavior. Examples include: Self-monitoring to identify triggers for smoking. Smokers are asked to keep a real-time record of the times, places, and situations in which smoking occur. Behavioral rehearsals such as practice quit attempts and practicing how to respond to a lapse back to smoking. Practicing self-control over smoking triggers. Avoiding triggers (e.g., putting away ashtrays, abstaining from alcohol), altering trigger situations (e.g., taking work breaks in a place in which you cannot smoke), using substitutes in place of smoking (e.g., gum, candy, a stress ball, exercise), and refocusing thoughts when cravings arise (e.g., statements of self-determination such as “I can do this”; delay statements such as “wait a minute or 2 and the urge will pass”). Assertiveness training to help smokers better handle social situations likely to trigger cues to smoking. Instruction and training (e.g., deep breathing, yoga, mindfulness training) for handling stress and negative emotions that are often linked to smoking urges. Instructions on how to use medications properly to increase medication adherence and quit rates. Biofeedback to smokers using a simple breath test measuring expired carbon monoxide to educate patients about immediate health risks. from smoking and enhance motivation for cutting down and quitting Facilitated discussion with a group of smokers to share effective behavior change experiences and challenges.
Motivational interviewing	Motivational interviewing is a goal-oriented, client-centered counseling style that aims to elicit behavior change by helping smokers explore and resolve ambivalence about making changes in their behavior. The method relies on the counselor eliciting from the client their own motivations for change, rather than imposing a treatment plan on the smoker.
Incentives	Incentives, usually provided as cash or vouchers, can be used to motivate smokers to try to quit and to reward them for making changes in their smoking behaviors.

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Community-based Behavioral Support Resources to Help Smokers Quit

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The below table is from the 2018 ACC Expert Consensus Decision Pathway on Tobacco Cessation Treatment.

Community-based Behavioral Support Resources to Help Smokers Quit
Resource	Services Provided
Telephone Quitline 1-800-QUIT-NOW (1-800-784-8669)	Counseling by telephone from a trained tobacco coach who offers support via a series of scheduled telephone calls before and after a smoker’s quit date. Many Quitlines also offer text messaging and web coaching support. Many Quitlines also offer a free sample of non-prescription nicotine replacement products. Providers can directly refer to Quitlines using fax or web enrollments. Quitline then contacts smoker directly to offer services.
Smokefree.gov (National Cancer Institute website)	SmokefreeTXT (text messaging program) QuitGuide (mobile phone app) Web-based information about quitting resources
Becomeanex.org (Truth Initiative)	Web-based support program that includes support from experts and an online community to help smokers quit

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Groups that Benefit from Statin Therapy

1. Secondary Prevention: Clinical ASCVD

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Clinical ASCVD includes acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin.

High-intensity statin therapy should be initiated or continued as first-line therapy in women and men ≤75 years of age who have clinical ASCVD, unless contraindicated (I, A).

In individuals with clinical ASCVD in whom high-intensity statin therapy would otherwise be used, when high-intensity statin therapy is contraindicated or when characteristics predisposing to statin-associated adverse effects are present, moderate-intensity statin should be used as the second option if tolerated (I, A).

In individuals with clinical ASCVD >75 years of age, it is reasonable to evaluate the potential for ASCVD risk-reduction benefits and for adverse effects, drug-drug interactions and to consider patient preferences, when initiating a moderate- or high-intensity statin. It is reasonable to continue statin therapy in those who are tolerating it (IIa, B).

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2. Primary Prevention: LDL-C ≥190 mg/dL

3. Primary Prevention: Diabetes and aged 40 to 75 years with LDL-C between 70 - 189 mg/dL

4. Primary Prevention: No diabetes and estimated 10-year ASCVD risk of ≥7.5% who are between 40 to 75 years of age with LDL-C between 70 - 189 mg/dL

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The Pooled Cohort Equations should be used to estimate 10-year ASCVD risk for individuals with LDL-C 70 to 189 mg/dL without clinical ASCVD to guide initiation of statin therapy for the primary prevention of ASCVD (I, B).

Before initiating statin therapy for the primary prevention of ASCVD in adults with LDL-C 70 - 189 mg/dL without clinical ASCVD or diabetes it is reasonable for clinicians and patients to engage in a discussion which considers the potential for ASCVD risk reduction benefits and for adverse effects, for drug-drug interactions, and patient preferences for treatment (IIa, C).

Adults 40 to 75 years of age with LDL-C 70 to 189 mg/dL, without clinical ASCVD or diabetes and an estimated 10-year ASCVD risk ≥7.5% should be treated with moderate- to high-intensity statin therapy (I, A).

It is reasonable to offer treatment with a moderate-intensity statin to adults 40 to 75 years of age, with LDL-C 70 to 189 mg/dL, without clinical ASCVD or diabetes and an estimated 10-year ASCVD risk of 5% to <7.5% (IIa, B).

In adults with LDL-C <190 mg/dL who are not otherwise identified in a statin benefit group, or for whom after quantitative risk assessment a risk-based treatment decision is uncertain, additional factors may be considered to inform treatment decision making. In these individuals, statin therapy for primary prevention may be considered after evaluating the potential for ASCVD risk reduction benefits, adverse effects, drug-drug interactions, and discussion of patient preferences (IIb, C).

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Additional Factors

Blood Cholesterol Recommendation Summary

Recommendations REC Click here for Definitions of Statin Intensity	ACC/ AHA ACC/AHA COR	ACC/ AHA ACC/AHA LOE
A. Heart-healthy lifestyle habits should be encouraged for all individuals.
B . The appropriate intensity of statin therapy should be initiated or continued:
1. Clinical ASCVD*
a. Age ≤75 y and no safety concerns: High-intensity statin	I	A
b. Age >75 y or safety concerns: Moderate-intensity statin	I	A
2. Primary prevention – Primary LDL–C ≥190 mg/dL
a. Rule out secondary causes of hyperlipidemia
b. Age ≥21y: High-intensity statin	I	B
c. Achieve at least a 50% reduction in LDL–C	IIa	B
d. LDL–C lowering nonstatin therapy may be considered to further reduce LDL–C	IIb	C
3. Primary prevention – Diabetes 40-75 years of age and LDL–C 70-189 mg/dL
a. Moderate-intensity statin	I	A
b. Consider high-intensity statin when ≥7.5% 10-y ASCVD risk using the Pooled Cohort Equations†	IIa	B
4. Primary prevention – No diabetes 40-75 years of age and LDL–C 70-189 mg/dL
a. Estimate 10-y ASCVD risk using the Risk Calculator based on the Pooled Cohort Equations† in those NOT receiving a statin; estimate risk every 4-6 y	I	B
b. To determine whether to initiate a statin, engage in a clinician-patient discussion of the potential for ASCVD risk reduction, adverse effects, drug-drug interactions, and patient preferences.	IIa	C
c. Re-emphasize heart-healthy lifestyle habits and address other risk factors.
i. ≥7.5% 10-y ASCVD risk: Moderate- or high-intensity statin	I	A
ii. 5 to <7.5% 10-y ASCVD risk: Consider moderate-intensity statin	IIa	B
iii. Other factors may be considered‡: LDL–C ≥160 mg/dL, family history of premature cardiovascular disease, hs-CRP ≥2.0 mg/L, CAC score ≥300 Agaston units, ABI <0.9 or lifetime ASCVD risk	IIb	C
5. Primary prevention when LDL–C <190 mg/dL and age <40 or >75 y, or <5% 10-y ASCVD risk
a. Statin therapy may be considered in selected individuals‡	IIb	C
6. Statin therapy is not routinely recommended for individuals with NYHA class II-IV heart failure or who are receiving maintenance hemodialysis
C. Regularly monitor adherence to lifestyle and drug therapy with lipid and safety assessments.
1. Assess adherence, response to therapy, and adverse effects within 4-12 wk following statin initiation or change in therapy.	I	A
a. Measure a fasting lipid panel	I	A
b. Do not routinely monitor ALT or CK unless symptomatic	IIa	C
c. Screen and treat type 2 diabetes according to current practice guidelines. Heart-healthy lifestyle habits should be encouraged to prevent progression to diabetes	I	B
d. Anticipated therapeutic response approximately ≥50% reduction in LDL–C from baseline for high-intensity statin and 30% to <50% for moderate-intensity statin	IIa	B
i. Insufficient evidence for LDL–C or non-HDL-C treatment targets from RCTs
ii. For those with unknown baseline LDL–C, an LDL–C <100 mg/dL was observed in RCTs of high-intensity statin therapy
e. Less than anticipated therapeutic response:
i. Reinforce improved adherence to lifestyle and drug therapy	I	A
ii. Evaluate for secondary causes of hyperlipidemia if indicated	I	A
iii. Increase statin intensity, or if on maximally-tolerated statin intensity, consider addition of nonstatin therapy in selected high-risk individuals§	IIb	C
f. Regularly monitor adherence to lifestyle and drug therapy every 3-12 mo once adherence has been established. Continued assessment of adherence for optimal ASCVD risk reduction and safety.	I	A
D. In individuals intolerant of the recommended intensity of statin therapy, use the maximally-tolerated intensity of statin.	I	B
1. If there are muscle or other symptoms, establish that they are related to the statin	IIa	B
2. For specific recommendations on managing muscle symptoms (see Statin Safety Recommendations)

* Clinical ASCVD includes acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin.

† Estimated 10-year or "hard" ASCVD risk includes first occurrence of nonfatal MI, CHD death, and nonfatal and fatal stroke as used by the Risk Assessment Work Group in developing the Pooled Cohort Equations.

‡ These factors may include primary LDL–C ≥160 mg/dL or other evidence of genetic hyperlipidemias; family history of premature ASCVD with onset <55 years of age in a first-degree male relative or <65 years of age in a first-degree female relative; hs-CRP ≥2 mg/L; CAC score ≥300 Agatston units or ≥75 ^th percentile for age, sex, and ethnicity; ABI <0.9; or lifetime risk of ASCVD. Additional factors that might aid in individual risk assessment could be identified in the future.

§ High-risk individuals include those with clinical ASCVD, an untreated LDL–C ≥190 mg/dL suggesting genetic hypercholesterolemia, or diabetes.

ABI indicates ankle-brachial index; ACC, American College of Cardiology; AHA, American Heart Association; ALT, alanine aminotransferase, a test of hepatic function; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; CHD, coronary heart disease; CK, creatine kinase, a test of muscle injury; COR, Class of Recommendation; HDL-C, high-density lipoprotein cholesterol; hs-CRP, high-sensitivity C-reactive protein; LDL–C, low-density lipoprotein cholesterol; LOE, Level of Evidence; NHLBI, National Heart, Lung, and Blood Institute; NYHA, New York Heart Association; RCTs, randomized controlled trials; and TIA, transient ischemic attack.

Primary Prevention of ASCVD - Summary

apoB indicates apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; HIV, human immunodeficiency virus; hsCRP, high-sensitivity C-reactive protein; LDL-C, low-density lipoprotein cholesterol; and Lp(a), lipoprotein (a).

Intensities of Statin Therapy

High-, Moderate-, and Low-Intensity Statin Therapy

	High-Intensity	Moderate-Intensity	Low-Intensity
LDL-C Lowering §	≥ 50%	30% to 49%	< 30%
Primary Statins	Atorvastatin (40†)-80 mg Rosuvastatin 20 (40) mg	Atorvastatin 10 (20) mg Rosuvastatin (5) 10 mg Simvastatin 20-40 mg‡	Simvastatin 10 mg
Other Statins	-	Pravastatin 40 (80) mg Lovastatin 40 (80) mg Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 1-4 mg	Pravastatin 10-20 mg Lovastatin 20 mg Fluvastatin 20-40 mg

Percent LDL-C reductions with the primary statin medications used in clinical practice (atorvastatin, rosuvastatin, simvastatin) were estimated using the median reduction in LDL-C from the VOYAGER database. Reductions in LDL-C for other statin medications (fluvastatin, lovastatin, pitavastatin, pravastatin) were identified according to FDA approved product labeling in adults with hyperlipidemia, primary hypercholesterolemia and mixed dyslipidemia.

Boldface type indicates specific statins and doses that were evaluated in RCTs, and the Cholesterol Treatment Trialists 2010 meta-analysis. All these RCTs demonstrated a reduction in major cardiovascular events.

Italic type indicates statins and doses that have been approved by the FDA but were not tested in the RCTs reviewed.

§ LDL-C lowering that should occur with the dosage listed below each intensity

‡ Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis

* Percent reductions are estimates from data across large populations. Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice.

† Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study.

BID indicates twice daily; FDA, Food and Drug Administration; LDL-C, low-density lipoprotein cholesterol; and RCTs, randomized controlled trials.

Recommendations to Monitor Response to LDL-C Lowering Therapy

Recommendations to Monitor Response to LDL-C Lowering Therapy
COR	LOE	Recommendations
I	A	1. Adherence to changes in lifestyle and effects of LDL-C–lowering medication should be assessed by measurement of fasting lipids and appropriate safety indicators 4 to 12 weeks after statin initiation or dose adjustment and every 3 to 12 months thereafter based on need to assess adherence or safety.

Statin Safety Recommendations

Recommendations for Statin Safety and Statin-Associated Side Effects
COR	LOE	Recommendations
I	A	1. A clinician–patient risk discussion is recommended before initiation of statin therapy to review net clinical benefit, weighing the potential for ASCVD risk reduction against the potential for statin-associated side effects, statin–drug interactions, and safety, while emphasizing that side effects can be addressed successfully.
I	A	2. In patients with statin-associated muscle symptoms (SAMS), a thorough assessment of symptoms is recommended, in addition to an evaluation for nonstatin causes and predisposing factors.
I	B-R	3. In patients with indication for statin therapy, identification of potential predisposing factors for statin-associated side effects, including new-onset diabetes mellitus and SAMS, is recommended before initiation of treatment.
I	B-R	4. In patients with statin-associated side effects that are not severe, it is recommended to reassess and to rechallenge to achieve a maximal LDL-C lowering by modified dosing regimen, an alternate statin or in combination with nonstatin therapy.
I	B-R	5. In patients with increased diabetes mellitus risk or new-onset diabetes mellitus, it is recommended to continue statin therapy, with added emphasis on adherence, net clinical benefit, and the core principles of regular moderate-intensity physical activity, maintaining a healthy dietary pattern, and sustaining modest weight loss.
I	C-LD	6. In patients treated with statins, it is recommended to measure creatine kinase levels in individuals with severe statin-associated muscle symptoms, objective muscle weakness, and to measure liver transaminases (aspartate aminotransferase, alanine aminotransferase) as well as total bilirubin and alkaline phosphatase (hepatic panel) if there are symptoms suggesting hepatotoxicity.
I	B-R	7. In patients at increased ASCVD risk with chronic, stable liver disease (including non-alcoholic fatty liver disease) when appropriately indicated, it is reasonable to use statins after obtaining baseline measurements and determining a schedule of monitoring and safety checks.
IIa	B-R	8. In patients at increased ASCVD risk with severe statin-associated muscle symptoms or recurrent statin-associated muscle symptoms despite appropriate statin rechallenge, it is reasonable to use RCT proven nonstatin therapy that is likely to provide net clinical benefit.
III: No Benefit	B-R	9. Coenzyme Q10 is not recommended for routine use in patients treated with statins or for the treatment of SAMS.
III: No Benefit	C-LD	10. In patients treated with statins, routine measurements of creatine kinase and transaminase levels are not useful.

Oral Antihypertensive Drug Dosing and Usage

Nonpharmacologic Hypertension Interventions

Statin

Terms and Concepts

ASCVD:atherosclerotic cardiovascular disease, defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke

ABCS Therapies: Aspirin therapy in appropriate patients, Blood pressure control, Cholesterol management, and Smoking cessation

Initial Visit:

- First time a patient undergoes an ASCVD risk assessment with a particular clinician and initiates a discussion regarding the benefits of starting (or intensifying) therapy with aspirin, blood pressure lowering medication, cholesterol lowering medication, and/or smoking/tobacco cessation (ABCS) as part of a risk-reduction plan. The 10-year ASCVD risk determined at the initial visit should also be used as a benchmark with which to compare updated risk at follow-up visit.

- The patient may have already initiated any of the ABCS therapies prior to the initial visit, individually or in combination.

10-year ASCVD risk calculated at the initial visit, without comparison to a previous visit:

- The initial 10-year ASCVD Risk serves as a baseline or reference-point risk. The patient parameters used to calculate are also needed to calculate a representative follow-up risk, and the initial risk value itself serves as a comparison point for follow up risk.

Follow Up Visit:Any visit after the established initial visit at which an updated 10-year ASCVD risk is calculated based on updated clinical and laboratory values.

Optimal Risk:Predicted 10-year ASCVD risk for someone with the same age and race/ethnicity category who has an optimal risk factor profile (total cholesterol, 170 mg/dL; HDL-cholesterol, 60 mg/d; SBP, 110 mm Hg; nonsmoker; non-diabetic; and no blood pressure–lowering drugs).

Smokers:For the purposed of this app, smokers are defined as cigarette smokers in accordance with the patient populations studied in the relevant clinical trials used to develop the tool. Clinical judgement should be exercised in the case of patient’s who use e-cigarettes and other nicotine and tobacco products.

Lifestyle:AHA/ACC guidelines stress the importance of lifestyle modifications as the foundation to lowering cardiovascular disease risk. These include eating a heart-healthy diet, regular aerobic exercises, maintenance of desirable body weight and avoidance of tobacco products. The evidence base for this specific tool focused on average patient responses to the ABCS therapies (aspirin when appropriate, blood pressure control, cholesterol management, and smoking cessation). Evidence for quantification of benefit from individual therapeutic lifestyle interventions is currently lacking and was out of the scope for this tool. However, the tool is intended to guide decision-making around ABCS in the context of, and in addition to, recommended lifestyle interventions. Benefit from lifestyle intervention is reflected in the app’s updated 10-year risk calculation at a follow up visit through the “credit” given for improvement of patient’s LDL-C and/or systolic blood pressure, regardless of how that improvement was achieved.

How are the different risk values in the app calculated?

Lifetime ASCVD Risk:

Estimates of lifetime risk for ASCVD are provided for adults 20 through 59 years of age and are shown as the lifetime risk for ASCVD for a 50-year old without ASCVD who has the risk factor values entered at the initial visit. Because the primary use of these lifetime risk estimates is to facilitate the very important discussion regarding risk reduction through lifestyle change, the imprecision introduced is small enough to justify proceeding with lifestyle change counseling informed by these results.

Estimated 10 Year ASCVD Risk

At Initial Visit (without comparison to a previous visit): Calculated using the ACC/AHA 2013 Pooled Cohort Equation, which predict the absolute 10-year risk for an ASCVD for a patient with the profile entered at initial visit. This is the same as the previous version of the ASCVD Risk Estimator app.

At Follow-up visit (with comparison to a previous visit): Updated 10-year risk for ASCVD is a function of the initial visit risk, the follow-up age, and the interim change in therapies and risk factor levels, which are themselves a function of response to therapy and adherence. The confidence of the updated on-treatment risk estimate is improved by scaling the risk reduction to the amount of change in SBP or LDL-cholesterol or duration of smoking cessation. The values for the actual updated 10-year ASCVD risk estimate also have floor and ceiling values applied. The floor value is calculated as the predicted 10-year ASCVD risk for someone with optimal risk factor levels at the follow-up age. A patient’s 10-year risk at follow up will not be calculated to a value below this floor value. The ceiling value is the predicted 10-year ASCVD risk calculated from the actual updated risk factor profile, including use of medications.

Projected 10 Year ASCVD Risk on the Therapy Impact Tab

Numbers on Therapy Impact mode represent the projected 10-year ASCVD risk that would be associated with institution of specific preventive therapies as designated for each row by the scenarios selected by the user. These estimates are a function of the initial visit predicted 10-year risk from for the patient and the expected average relative risk reduction associated with a given therapy experienced by participants in randomized clinical trials, using systematic review data described in the original Million Hearts Longitudinal ASCVD Risk Assessment Tool manuscript. In instances where a therapy is not advised or relevant for a given patient based on the profile entered (smoking cessation for a patient who has never smoked), the forecasted risk for this therapy will be displayed as “NA”. See below for more information about individual therapies.

What effect do the different ABCS therapies and related risk factors have on the calculations in the app?

Systolic Blood Pressure and Blood Pressure Medications

Risk reduction estimates related to blood pressure medication come from randomized controlled trials that have tended to last for 3 to 5 years, so it is assumed that patients who would start a blood pressure medication would stay on it for at least that period of time, and adhere to the therapy similarly to participants in the trials.
If follow up risk is estimated for a patient who has not yet initiated blood pressure medication, and then a forecasted risk is calculated with the initiation of BP meds, the user may see the patient’s risk actually increase. This is because the app is forecasting what the patient’s risk would be if they had achieved the same blood pressure reduction they’ve already achieved, but with the aid of medication, and the calculation gives more “credit” for blood pressure reduction without the aid of medication than with. This same principle applies to the initial visit 10-year risk calculation.
In terms for forecasting, for patients already taking blood pressure–lowering drugs, one can estimate the expected effect of additional medication. However, if a patient has an initial visit SBP <120 mm Hg, or <130 mm Hg with diabetes mellitus, no additional benefit of SBP lowering is assumed.

LDL-C and Statin Therapy

As an update to the original ASCVD Risk Estimator, “Initial 10 year ASCVD risk may be calculated for patients who have already initiated statin therapy because recent evidence suggests a patient’s cholesterol values have the same the impact on ASCVD risk regardless of whether current values were achieved with or without the aid of statin therapy. However, the specific LDL-C value and statin use status at initial visit does still does not affect the initial visit 10-year risk calculation itself. They are only collected at initial visit to provide context for the forecasted risk reduction and to provide baseline values for updating ASCVD risk at follow-up visits.
Patients with LDL-cholesterol of at least 190 mg/dL may have familial hypercholesterolemia and should be evaluated and considered for statin therapy regardless of age and estimated 10-year ASCVD risk.
Risk reduction estimates related to statin therapy come from randomized controlled trials that have tended to last for 3 to 5 years, so it is assumed that patients who would start satin therapy would stay on it for at least that period of time, and adhere to the therapy similarly to participants in the trials.
For patients with estimated 10-year ASCVD risk below 5%, users will see “NA” appear in initial visit forecast scenarios where statin use or intensification would be added, given that the guidelines do not recommend consideration of statin therapy for this group.

Aspirin Use

Aspirin use status does not affect the initial visit 10-year risk calculation itself, but is collected at initial visit to provide context for the forecasted risk reduction and to provide baseline values for updating ASCVD risk at follow-up visits.
If the patient is taking aspirin therapy at initial visit, the expected risk reduction for continuing aspirin is assumed to be the same as starting aspirin de novo, because it is uncertain how to quantify any increase in risk associated with aspirin cessation.
For initial visit forecasting, patients with estimated 10- year ASCVD risk below 10%, users will see “NA” appear in rows where aspirin would be started because guidelines do not typically recommend consideration of aspirin therapy for patients with 10-year risk <10%.

Smokers and Smoking Cessation

The app calculations are based on studies that estimated the time-dependent effects of successful smoking cessation on ASCVD risk reduction (See the original Million Hearts Longitudinal ASCVD Risk Assessment Tool manuscript). As a result, the combined estimates for risk reduction associated with smoking cessation are 15% at 1 year, 27% at 2 years, 38% at 3 years, and 47% at 4 years. Because the risk reduction estimates for aspirin, blood pressure–lowering, and statins were based on trials with typical follow-up exceeding 2 years, the app uses the 2-year estimate for smoking cessation as the basis for prospective risk reduction estimation.
For the purposed of this app, smokers are defined as cigarette smokers in accordance with the patient populations studied in the relevant clinical trials used to develop the tool. Clinical judgement should be exercised in the case of patient’s who use e-cigarettes and other nicotine and tobacco products.
Counseling and efforts aimed at smoking cessation should be considered for all current smokers.

Class of Recommendation and Level of Evidence Table

Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care (Updated August 2015)

Recommendations are designated with both a class of recommendation (COR) and a level of evidence (LOE). The class of recommendation indicates the strength of recommendation, encompassing the estimated magnitude and certainty of benefit in proportion to risk. The level of evidence 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.