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........................................................................................................................................... of time. Total CVD risk expresses the combined effect of a number of risk factors on this risk estimate. In these Guidelines, we address the lipid-related contribution to total CV risk and how to manage it at the clinical level.

4.1.1 Rationale for assessing total cardiovascular disease risk All current guidelines on the prevention of ASCVD in clinical practice recommend the assessment of total CVD risk. Prevention of ASCVD in a given person should relate to his or her total CV risk: the higher the risk, the more intense the action should be. Many risk assessment systems are available and have been comprehensively reviewed (Supplementary Table 1 in the Supplementary Data). Most guidelines use one of these risk assessment systems.68 Ideally, risk charts should be based on country-specific cohort data. These are not available for most countries. The SCORE (Systematic Coronary Risk Estimation) system can be recalibrated for use in different populations by adjusting for secular changes in CVD mortality and risk factor prevalence. Calibrated country-specific versions are available for many European countries and can be found at http:// www.heartscore.org. These are now being updated to provide recalibrated, contemporaneous country-specific charts for all European countries. Other risk estimation systems—using both fatal and nonfatal events—can also be recalibrated, but the process is easier and scientifically more robust for mortality than for total events. The European Guidelines on CVD prevention in clinical practice (both the 20129 and 201610 versions) recommend the use of the SCORE system because it is based on large, representative European cohort data sets and because it is relatively straightforward to recalibrate for individual countries. Persons with documented ASCVD, type 1 or type 2 DM (T1DM and T2DM, respectively), very high levels of individual risk factors, or chronic kidney disease (CKD) are generally at very-high or high total CV risk. No risk estimation models are needed for such persons; they all need active management of all risk factors. For other, apparently healthy people, the use of a risk estimation system such as SCORE, which estimates the 10 year cumulative risk of a first fatal atherosclerotic event, is recommended to estimate total CV risk, since many people have several risk factors that, in combination, may result in high levels of total CV risk. Risk estimates have been produced as charts for high- and low-risk regions in Europe (Figures 1 and 2).11 All International Classification of Diseases codes that are related to deaths from vascular origin caused by atherosclerosis are included. The reasons for retaining a system that estimates fatal as opposed to total fatal þ non-fatal events are that non-fatal events are dependent on definition, developments in diagnostic tests, and methods of ascertainment, all of which can vary, resulting in very variable multipliers to convert fatal to total events. In addition, total event charts, in contrast to those based on mortality, are more difficult to recalibrate to suit different populations. That said, work is in progress to produce regional total event charts.

The SCORE data indicate that the total CVD event risk is about three times higher than the risk of fatal CVD for men, so a SCORE risk of 5% translates into a CVD risk of 15% of total (fatal þ nonfatal) CVD endpoints; the multiplier is higher in women and lower in older people. Clinicians often ask for thresholds to trigger certain interventions. This is problematic since risk is a continuum and there is no threshold at which, for example, a drug is automatically indicated. This is true for all continuous risk factors such as plasma cholesterol or systolic BP (SBP). Therefore, the goals that are proposed in this document reflect this concept. A particular problem relates to young people with high levels of risk factors; a low absolute risk may conceal a very high relative risk requiring at least intensive lifestyle advice. To motivate young people (i.e. aged <40 years) not to delay changing their unhealthy lifestyle, an estimate of their relative risk—illustrating that lifestyle changes can reduce relative risk substantially—may be helpful (Supplementary Figure 1). Another approach to this problem is to use CV risk age. The risk age of a person with several CV risk factors is the age of a person with the same level of risk but with ideal levels of risk factors. Thus, a high-risk 40-year-old would have a risk age >_65 years. Risk age can be estimated visually by looking at the SCORE chart (as illustrated in Supplementary Figure 2). In this chart, the risk age of a person with risk factors is defined as the age at which a person with ideal risk factor levels would reach the same risk level. Ideal risk factors are nonsmoking, total cholesterol (TC) <_4 mmol/L (<_155 mg/dL), and SBP <_120 mmHg. Risk age is also automatically calculated as part of the latest revision of HeartScore (http://www.HeartScore.org). Risk age has been shown to be independent of the CV endpoint used,6,8 can be used in any population regardless of baseline risk or secular changes in mortality, and therefore avoids the need for recalibration. Lifetime risk is another approach to illustrate the impact of risk factors that may be useful in younger people.12 The greater the burden of risk factors, the higher the lifetime risk. This approach produces higher risk figures for younger people because of their longer exposure times. Therefore, it is more useful as a way of illustrating risk than as a guide to treatment, because therapeutic trials have been based on a fixed follow-up period and not on lifetime risk. Another problem relates to older people. In some age categories, the majority of people, especially males, will have estimated 10 year

PCSK9 inhibitors New outcome study data of PCSK9 inhibitors are presented, and updated recommendations for their clinical use are provided. Cost-effectiveness The issue of cost-effectiveness of lipid-modifying interventions is updated in view of changes in the availability of generic products for statins and ezetimibe, and of PCSK9 inhibitors. ACS = acute coronary syndrome; ApoB = apolipoprotein B; ASCVD = atherosclerotic cardiovascular disease; CAC = coronary artery calcium; CHD = coronary heart disease; CT = computed tomography; CV = cardiovascular; CVD = cardiovascular disease; DM = diabetes mellitus; FH = familial hypercholesterolaemia; HDL = high-density lipoprotein; LDL-C = low-density lipoproteins cholesterol; Lp(a) = lipoprotein(a); PCSK9 = proprotein convertase subtilisin/kexin type 9; PUFAs = polyunsaturated fatty acids; RCTs = randomized controlled trials; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus; TGs = triglycerides.

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