SIGN 149 • Risk estimation and the prevention of ...

SIGN 149 ? Risk estimation and the prevention of cardiovascular disease

A national clinical guideline

June 2017

Evidence

KEY TO EVIDENCE STATEMENTS AND RECOMMENDATIONS

LEVELS OF EVIDENCE

1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias

High-quality systematic reviews of case-control or cohort studies

2++ H igh-quality case-control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+

Well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2 - Case-control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3 Non-analytic studies, eg case reports, case series 4 Expert opinion RECOMMENDATIONS

Some recommendations can be made with more certainty than others. The wording used in the recommendations in this guideline denotes the certainty with which the recommendation is made (the `strength' of the recommendation).

The `strength' of a recommendation takes into account the quality (level) of the evidence. Although higher-quality evidence is more likely to be associated with strong recommendations than lower-quality evidence, a particular level of quality does not automatically lead to a particular strength of recommendation.

Other factors that are taken into account when forming recommendations include: relevance to the NHS in Scotland; applicability of published evidence to the target population; consistency of the body of evidence, and the balance of benefits and harms of the options.

For `strong' recommendations on interventions that `should' be used, the guideline development group is confident that, for

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the vast majority of people, the intervention (or interventions) will do more good than harm. For `strong' recommendations on interventions that `should not' be used, the guideline development group is confident that, for the vast majority of people, the

intervention (or interventions) will do more harm than good.

For `conditional' recommendations on interventions that should be `considered', the guideline development group is confident

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that the intervention will do more good than harm for most patients. The choice of intervention is therefore more likely to vary depending on a person's values and preferences, and so the healthcare professional should spend more time discussing the

options with the patient.

GOOD-PRACTICE POINTS

Recommended best practice based on the clinical experience of the guideline development group.

NICE has accredited the process used by Scottish Intercollegiate Guidelines Network to produce clinical guidelines. The accreditation term is valid until 31 March 2020 and is applicable to guidance produced using the processes described in SIGN 50: a guideline developer's handbook, 2015 edition (sign.ac.uk/sign-50.html More information on accreditation can be viewed at .uk/accreditation

Healthcare Improvement Scotland (HIS) is committed to equality and diversity and assesses all its publications for likely impact on the six equality groups defined by age, disability, gender, race, religion/belief and sexual orientation.

SIGN guidelines are produced using a standard methodology that has been equality impact assessed to ensure that these equality aims are addressed in every guideline. This methodology is set out in the current version of SIGN 50, our guideline manual, which can be found at sign.ac.uk/sign-50.html The EQIA assessment of the manual can be seen at sign.ac.uk/pdf/sign50eqia.pdf The full report in paper form and/or alternative format is available on request from the Healthcare Improvement Scotland Equality and Diversity Officer.

Every care is taken to ensure that this publication is correct in every detail at the time of publication. However, in the event of errors or omissions corrections will be published in the web version of this document, which is the definitive version at all times. This version can be found on our web site sign.ac.uk

This document is produced from elemental chlorine-free material and is sourced from sustainable forests.

Scottish Intercollegiate Guidelines Network

Risk estimation and the prevention of cardiovascular disease

A national clinical guideline

July 2017

Risk estimation and the prevention of cardiovascular disease

Scottish Intercollegiate Guidelines Network Gyle Square, 1 South Gyle Crescent Edinburgh EH12 9EB sign.ac.uk First published July 2017 ISBN 978 1 909103 52 8 Citation text

Scottish Intercollegiate Guidelines Network (SIGN). Risk estimation and the prevention of cardiovascular disease. Edinburgh: SIGN; 2017.

(SIGN publication no. 149). [July 2017]. Available from URL:

SIGN consents to the photocopying of this guideline for the purpose of implementation in NHSScotland.

Contents

Contents

1 Introduction.......................................................................................................................................................................1 1.1 The need for a guideline....................................................................................................................................................................... 1 1.2 Remit of the guideline........................................................................................................................................................................... 2 1.3 Risk estimation.......................................................................................................................................................................................... 4 1.4 Statement of intent................................................................................................................................................................................. 5 2 Key recommendations.....................................................................................................................................................7 2.1 Estimating cardiovascular risk............................................................................................................................................................. 7 2.2 Diet................................................................................................................................................................................................................ 7 2.3 Physical activity........................................................................................................................................................................................ 7 2.4 Smoking...................................................................................................................................................................................................... 7 2.5 Antiplatelet therapy................................................................................................................................................................................ 7 2.6 Lipid lowering........................................................................................................................................................................................... 7 3 Cardiovascular risk...........................................................................................................................................................8 3.1 Risk factors................................................................................................................................................................................................. 8 3.2 The concept of risk and why it matters............................................................................................................................................ 8 3.3 Risk scoring systems............................................................................................................................................................................... 9 3.4 What is meant by high risk?................................................................................................................................................................. 9 4 Estimating cardiovascular risk.......................................................................................................................................11 4.1 Assessing risk............................................................................................................................................................................................. 11 4.2 Recording risk factor information ..................................................................................................................................................... 11 4.3 Using risk assessment tools.................................................................................................................................................................. 14 4.4 How to determine cardiovascular risk.............................................................................................................................................. 14 5 Diet......................................................................................................................................................................................16 5.1 Altering dietary fat intake..................................................................................................................................................................... 16 5.2 Reducing dietary salt ............................................................................................................................................................................. 17 5.3 Fruit and vegetable intake.................................................................................................................................................................... 17 5.4 Effect of specific minor dietary components................................................................................................................................. 17 5.5 Dietary patterns........................................................................................................................................................................................ 19 5.6 Giving dietary advice.............................................................................................................................................................................. 20 5.7 Weight reduction and cardiovascular risk...................................................................................................................................... 20 5.8 Metabolic syndrome............................................................................................................................................................................... 21 6 Physical activity.................................................................................................................................................................22 6.1 Definitions.................................................................................................................................................................................................. 22 6.2 Physical activity and cardiovascular risk.......................................................................................................................................... 22 7 Smoking..............................................................................................................................................................................26 7.1 Tobacco exposure and cardiovascular risk..................................................................................................................................... 26 7.2 Smoking cessation interventions....................................................................................................................................................... 27 8 Alcohol................................................................................................................................................................................32 8.1 Alcohol and cardiovascular risk.......................................................................................................................................................... 32 9 Antiplatelet therapy......................................................................................................................................... 35 9.1 Antiplatelet agents for people with established cardiovascular disease............................................................................ 35 9.2 Antiplatelet agents for people without cardiovascular disease............................................................................................. 36 9.3 Antiplatelet agents for people with diabetes................................................................................................................................ 38

Risk estimation and the prevention of cardiovascular disease

9.4 Antiplatelet agents for people with hypertension ..................................................................................................................... 38 9.5 Antiplatelet agents for people with chronic kidney disease .................................................................................................. 38 10 Lipid lowering....................................................................................................................................................................39 10.1 The role of total and low-density lipoprotein cholesterol in cardiovascular disease...................................................... 39 10.2 Measuring lipid levels............................................................................................................................................................................. 39 10.3 Lowering cholesterol to reduce cardiovascular risk.................................................................................................................... 40 10.4 Statin therapy............................................................................................................................................................................................ 40 10.5 Special considerations........................................................................................................................................................................... 48 10.6 Other lipid-lowering agents................................................................................................................................................................. 51 10.7 Management of combined dyslipidaemia..................................................................................................................................... 55 11 Blood pressure lowering.................................................................................................................................................57 11.1 Blood pressure thresholds for intervention with drug therapy.............................................................................................. 57 11.2 Target values for blood pressure lowering..................................................................................................................................... 62 11.3 Selection of antihypertensive therapy............................................................................................................................................. 64 11.4 Multiple risk interventions.................................................................................................................................................................... 67 12 Psychological issues.........................................................................................................................................................68 12.1 The impact of psychological wellbeing on cardiovascular risk............................................................................................... 68 12.2 Interventions for psychological distress.......................................................................................................................................... 69 13 Provision of information.................................................................................................................................................72 13.1 Sources of further information........................................................................................................................................................... 72 13.2 Checklist for provision of information.............................................................................................................................................. 73 14 Implementing the guideline...........................................................................................................................................74 14.1 Implementation strategy...................................................................................................................................................................... 74 14.2 Resource implications of key recommendations......................................................................................................................... 74 14.3 Auditing current practice...................................................................................................................................................................... 74 14.4 Health technology assessment advice for NHSScotland.......................................................................................................... 75 15 The evidence base............................................................................................................................................................76 15.1 Systematic literature review................................................................................................................................................................. 76 15.2 Recommendations for research......................................................................................................................................................... 77 16 Development of the guideline.......................................................................................................................................78 16.1 Introduction............................................................................................................................................................................................... 78 16.2 The guideline development group................................................................................................................................................... 78 16.3 The steering group.................................................................................................................................................................................. 79 16.4 Consultation and peer review............................................................................................................................................................. 80 Abbreviations.................................................................................................................................................................................82 Annexes...........................................................................................................................................................................................85 References......................................................................................................................................................................................99

1 ? Introduction

1 Introduction

1.1 1.1.1

THE NEED FOR A GUIDELINE

Cardiovascular disease (CVD) is an umbrella term that describes a range of conditions caused by blood clots (thrombosis) or build up of fatty deposits inside an artery that cause the artery to harden and narrow (atherosclerosis). The main underlying causes of CVD are coronary heart disease (CHD), stroke, peripheral arterial disease (PAD) and aortic disease.

In 2015, 15% of adults aged 16 and over had any CVD condition, which represents an estimated 670,000 people living with cardiovascular disease in Scotland. Both incidence and prevalence of CVD are higher amongst men, the elderly and in deprived areas of Scotland.1 Cardiovascular disease caused more than a quarter of all deaths in Scotland in 2015.2

Of particular relevance to Scotland are the effects of socioeconomic status on the risk of developing CVD. The incidence and mortality rates from acute myocardial infarction in those aged under 65 are higher in deprived areas than in more affluent areas.3-6

Cardiovascular disease has a multifactorial aetiology with a number of potentially modifiable risk factors. The established Framingham risk factors of age, sex, cigarette smoking, blood pressure, total cholesterol and high-density lipoprotein (HDL) cholesterol have proved consistent risk factors in every population studied. In addition, this guideline considers and reports on physical activity and sedentary behaviour. Some ethnic groups may show differences in population baseline risk.7 Scotland's ethnic population is growing: at the 2011 census around 4% of the country's 5.3 million people were from minority ethnic backgrounds, double the proportion from the previous census in 2001.8

Recent estimates show that disease incidence rates are falling and, although the reasons for this decline are complex, improvements in the management of risk factors, in particular, a reduction in smoking rates, are significant factors. Between 2005/6 and 2015/6 the age-standardised incidence rate for CVD fell by 13% in men and nearly 16% in women, driven by a significant fall in CHD incidence and a smaller decline in stroke rates.6,9 (ISD Scotland. Personal communication, 13 March 2017).

Recognising CVD as a continuum challenges the traditional concepts of primary and secondary prevention, with healthcare professionals adopting a `high-risk' approach to prevention (one which involves the clinical identification of individuals in that portion of the population at highest risk over a defined time period and their intensive treatment through lifestyle or pharmacological means).10 In fact, most cases of CVD occur in the large number of individuals at lower levels of absolute risk.11 High-risk approaches have been facilitated both by the availability of scoring systems to estimate absolute risk (rather than the traditional use of single risk factors) and by the advent of several treatments, principally statins and antihypertensives, which produce marked and apparently independent reductions in CVD risk in people at high risk.12

The guideline has attempted to devise effective strategies for the reduction of CVD that take a combined approach using both `high-risk' and population approaches.

UPDATING THE EVIDENCE

This guideline updates SIGN 97: Risk estimation and the prevention of cardiovascular disease to reflect the most recent evidence.

Where no new evidence was identified to support an update, text and recommendations are reproduced verbatim from SIGN 97. The original supporting evidence was not re-appraised by the current guideline development group (GDG).

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Risk estimation and the prevention of cardiovascular disease

1.2 1.2.1

1.2.2 1.2.3 1.2.4

REMIT OF THE GUIDELINE

OVERALL OBJECTIVES

This guideline deals with the management of cardiovascular risk, both primary prevention, defined as the potential for intervention prior to the disease presenting through a specified event (any incident linked to critical disruption of blood flow that may cause damage to the heart, brain or peripheral tissues), and secondary prevention, defined as the potential for intervention after an event has occurred. The guideline development group has tried to consider CVD as a continuum from the preclinical to the end-stage disease, potentially offering different opportunities to intervene, both prior to, and after an event, so creating the potential to alter the outcome of the disease process. The guideline development group believes that it is more relevant to consider an individual in terms of whether they have a low or high risk of cardiovascular events rather than in terms of primary or secondary prevention.

The guideline provides recommendations on estimation of cardiovascular risk and interventions to reduce this risk in people with and without established CVD. The guideline does not make specific recommendations for the management of people with chronic heart failure, acute coronary syndrome, stable angina or cardiac arrhythmias as these are contained within other SIGN guidelines.13-16 Cardiac rehabilitation is the subject of a further SIGN guideline.17

TARGET USERS OF THE GUIDELINE

This guideline will be of interest to healthcare professionals involved in the management of patients with cardiovascular disease including cardiologists, dietitians, general practitioners, lipidologists, pharmacists, physiotherapists, practice nurses, psychologists and public health staff, as well as patients, carers, voluntary organisations and policy makers.

PATIENT VERSION A patient version of this guideline is available from the SIGN website, sign.ac.uk

SUMMARY OF UPDATES TO THE GUIDELINE, BY SECTION

1.1 The need for a guideline

1.1.1 Updating the evidence

1.2.1 Overall objectives

1.2.2 Target users of the guideline

1.2.4 Summary of updates to the guideline, by section

1.3.1 Definitions (risk estimation)

1.3.2 Risk scores

1.4 Statement of intent

1.4.1 Influence of financial and other interests

1.4.2 Prescribing of licensed medicines outwith their marketing authorisation

1.4.3 Health technology assessment advice for NHSScotland

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Key recommendations

3.1 Risk factors

3.2 The concept of risk and why it matters

3.3 Risk scoring systems

3.4 What is meant by high risk?

4.1 Assessing risk

4.2 Recording risk factor information

4.3 Using risk assessment tools

4.4 How to determine cardiovascular risk

Updated New Minor update New New Updated Updated Minor update New New Updated New Updated Minor update Completely revised Completely revised Updated Updated Updated Updated

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