• No results found

Assessment and Management summary

Policy change: System change to support practice of AR

Appendix 4: Assessment and Management summary

Risk Assessment and Management Algorithm:

Aboriginal and Torres Straight Islander adults aged 35 and over without known history of CVD

EBR: Evidence-based recommendation (Graded A-D), CBR: Consensus-based recommendation, PP: Practice Point

Already known to be at increased risk?

Adults with any of the following conditions do not require absolute CVD risk assessment using the Framingham Risk Equation because they are already known to be at clinically determined high risk of CVD: (EBR: Grade D)

Diabetes and age >60 years

Diabetes with microalbuminuria (>20 mcg/min or urinary albumin:creatinine ratio >2.5 mg/mmol for males, >3.5 mg/

mmol for females)

Moderate or severe CKD (persistent proteinuria or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2)

A previous diagnosis of familial hypercholesterolaemia

Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg

Serum total cholesterol >7.5 mmol/L

Aboriginal and Torres Strait Islander adults aged over 74 (CBR)

Conduct formal absolute risk assessment

NO YES

High: greater than 15%

risk of CVD within the next 5 years (includes clinically determined high risk) (PP)

Calculate risk level using Framingham Risk Equation (EBR: Grade B):

Australian cardiovascular risk charts

Web calculator www.cvdcheck.org.au

Moderate: 10-15% risk of CVD within the next 5

years (PP) Low: less than 10% risk of CVD

within the next 5 years (PP)

Provide lifestyle advice and support (CBR)

Provide lifestyle advice (CBR)

• Identify all other risk factors

• Continue with lifestyle intervention (CBR)

• Treat for BP and/or lipid-lowering (CBR)

Provide frequent and sustained lifestyle advice, support and follow-up (CBR)

Monitor individual risk factor response to treatment Monitor individual risk factor (PP)

response to treatment (PP)

Treat BP (CBR)

Continue

with lifestyle advice (CBR)

Review absolute risk according to clinical

context (PP)

Review absolute risk in

6-12 months (PP) Review absolute risk in

2 years (PP) Monitor

response (PP)

Commence BP + lipid lowering therapy

unless contraindicated or clinically inappropriate

(EBR: Grade B)

YES

NO

Is BP persistently ≥160/100mmHg?

CVD risk Lifestyle

Pharmacotherapy

Targets Monitoring

High risk

Clinically determined Diabetes and age

>60 years Diabetes with microalbuminuria (>20 mcg/min or UACR >2.5 mg/

mmol for males,

>3.5 mg/mmol for females)

Moderate or severe CKD (persistent proteinuria or eGFR <45 mL/

min/1.73 m2) A previous diagnosis of FH SBP ≥180 mmHg or DPB ≥110 mmHg

Serum TC >7.5 mmol/L

A&TSI adults aged

>74 years or calculated using FRE as

>15% AR of CVD events over 5 years

Frequent and sustained specific advice and support regarding diet and physical activity.

Appropriate advice, support and pharmacotherapy for smoking cessation.

Advice given simultaneously with blood pressure and lipid lowering pharmacotherapy

Treat

simultaneously with lipid lowering unless contraindicated or clinically inappropriate.

Consider other treatable causes for raised BP before starting therapy.

Commence with ACE inhibitor OR angiotensin receptor blocker OR CCB OR Low dose thiazide or thiazide-like diuretic.

For diabetes or CKD commence with ACE inhibitor or angiotensin receptor blocker.

Add second or third agent from different class as needed towards target.

Consider withdrawal of therapy for people who make profound lifestyle changes.

Treat

simultaneously with BP lowering unless contraindicated or clinically inappropriate.

Consider other treatable causes for dyslipidaemia before starting therapy.

Commence with a statin.

Add ezetimibe, bile acid binding resin or nicotinic acid if LDL-C levels not sufficiently reduced or required dose of statin not tolerated. Use these agents as monotherapy if statins not tolerated at all.

Add fenofibrate, nicotinic acid or fish oil to statin if TG levels not sufficiently reduced.

Consider withdrawal of therapy for people who make profound lifestyle changes.

Not routinely

recommended BP: ≤140/90 mmHg in general or people with CKD;

≤130/80 mmHg in all people with diabetes;

≤130/80 mmHg if micro or macro albuminuria (UACR > 2.5 mg/mmol in men and >3.5 mg/mmol in women Lipids: TC <4.0 mmol/L; HDL-C

≥ 1.0 mmol/L;

LDL-C <2.0 mmol/L;

Non HDL-C

<2.5 mmol/L;

TG < 2.0 mmol/L Lifestyle:

Smoking cessation (if smoker);

consume diet rich in vegetables and fruit, low in salt and saturated and trans fats;

at least 30 mins moderate intensity physical activity on most or preferably every day of the week; limit alcohol intake.

BP and lipids monitored at approx 6 weekly intervals until sufficient improvement achieved or maximum tolerated dose reached.

Adjust medication as required.

Review of AR according to clinical context.

lowering BP Lipid

lowering Antiplatelet

Risk Management Summary - High Risk

CVD risk Lifestyle Pharmacotherapy

Targets Monitoring

Moderate risk

Calculated using FRE as 10–15%

AR of CVD events over 5 years

Appropriate, specific advice and support regarding diet and physical activity.

Appropriate advice, support and pharmacotherapy for smoking cessation.

Lifestyle advice given in preference to pharmacotherapy.

Not routinely recommended Consider BP lowering if 3–6 months of lifestyle does not reduce risk.

Consider BP-lowering therapy in addition to lifestyle advice if:

• BP persistently

≥160/100 mmHg

• Family history of premature CVD

• Specific population where the FRE underestimates risk e.g. A&TSI peoples, South Asian, Maori and Pacific Islander, Middle Eastern.

Consider other treatable causes for raised BP before starting therapy.

Commence any agent as for high risk. Add second or third agent from different class as needed to reach target.

Consider withdrawal of therapy for people who make profound lifestyle changes.

Not routinely recommended Consider lipid lowering if 3–6 months of lifestyle does not reduce risk.

Consider lipid-lowering therapy in addition to lifestyle advice if:

• Family history of premature CVD

• Specific population where the FRE underestimates risk e.g. A&TSI peoples, South Asian, Maori and Pacific Islander, Middle Eastern.

Consider other treatable causes for dyslipidaemia before starting therapy.

Commence statin as for high risk.

Consider additional treatment as for high risk if indicated.

Consider withdrawal of therapy for people who make profound lifestyle changes.

Not routinely

recommended BP: ≤140/90 mmHg in general or people with CKD;

≤130/80 mmHg in all people with diabetes;

≤130/80 mmHg if micro or macro albuminuria (UACR > 2.5 mg/mmol in men and >3.5 mg/mmol in women Lipids: TC <4.0 mmol/L; HDL-C

≥1.0 mmol/L;

LDL-C <2.0 mmol/L;

Non HDL-C

<2.5 mmol/L;

TG <2.0 mmol/L Lifestyle:

Smoking cessation (if smoker);

consume diet rich in vegetables and fruit, low in salt and saturated and trans fats;

at least 30 mins moderate intensity physical activity on most or preferably every day of the week; limit alcohol intake.

BP and lipids monitored at approx 6 weekly intervals until sufficient improvement achieved or maximum tolerated dose reached.

Adjust medication as required.

Review of AR every 6-12 months

Risk Management Summary - Moderate Risk

lowering BP Lipid

lowering Antiplatelet

Risk Management Summary - Low Risk

CVD risk Lifestyle Pharmacotherapy

Targets Monitoring

Low risk

Calculated using FRE as <10%

AR of CVD events over 5 years

Brief, general lifestyle advice regarding diet and physical activity.

Appropriate advice, support and pharmacotherapy for smoking cessation

Not routinely recommended.

Consider BP-lowering therapy in addition to specific lifestyle advice if BP persistently

≥160/100 mmHg.

Consider other treatable causes for raised BP before starting therapy.

Commence any agent as for high risk. Add second or third agent from different class as needed to reach target.

Consider withdrawal of therapy for people who make profound lifestyle changes.

Not routinely

recommended Not routinely

recommended BP: ≤140/90 mmHg in general or people with CKD;

≤130/80 mmHg in all people with diabetes;

≤130/80 mmHg if micro or macro albuminuria (UACR >2.5 mg/mmol in men and >3.5 mg/mmol in women Lipids: TC <4.0 mmol/L; HDL-C

≥1.0 mmol/L;

LDL-C <2.0 mmol/L;

Non HDL-C

<2.5 mmol/L;

TG <2.0 mmol/L Lifestyle:

Smoking cessation (if smoker);

consume diet rich in vegetables and fruit, low in salt and saturated and trans fats;

at least 30 mins moderate intensity physical activity on most or preferably every day of the week; limit alcohol intake.

BP monitored at approx 6 weekly intervals until sufficient improvement achieved or maximum tolerated dose reached.

Adjust medication as required.

Review AR every 2 years.

Blood test results within 5 years can be used.

A&TSI: Aboriginal and Torres Strait Islander peoples; BP: Blood Pressure; CKD: Chronic Kidney Disease; DBP: Diastolic Blood Pressure; FH: Familial Hypercholesterolaemia; FRE: Framingham Risk Equation; HDL-C: High Desity Lipoprotein Cholesterol; LDL-C: Low Density Lipoprotein Cholesterol;

SBP: Systolic Blood Pressure; TC: Total Cholesterol; TG: Triglycerides.

lowering BP Lipid

lowering Antiplatelet

The recommendations in these guidelines have been developed from the current evidence base, using methodology from NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines (2009) to appraise and evaluate the quality of the evidence. However, these guidelines are based on an AR approach rather than assessing individual risk factors.

Almost all of the research reviewed during the development process selected study participants based on one or more factors (but not on a formal comprehensive risk assessment considering a number of factors together). This has meant a larger number of practice points are provided compared with previous guidelines which have used a single risk factor approach. This difference in single verses AR highlights major gaps in evidence for this approach. Hence a list of future research priorities has been included here. Research priorities should be based on consideration of the burden of disease, the potential to conduct high quality research in the area and the potential impact on health outcomes.

Assessment tools

• Validation of the FRE or other tools in populations including the aged and adults aged 18- 30 years and determination of the optimum age for risk assessment.

• Investigation of the extra predictive value of significant risk factors that are not currently included in the FRE such as obesity, physical inactivity, family history of CVD, socioeconomic status and psychosocial factors.

• Comparison of the predictive value of emerging biomarkers with current risk assessment tools.

• Development of a risk assessment equation for people already on pharmacotherapy for blood pressure or lipid lowering.

Absolute risk prediction in specific subpopulations

• Investigation of new or modified tools for absolute CVD risk assessment based on risk equations specific to the Australian population, especially the indigenous population.

• Determination of the best predictive tool for people with diabetes and/or CKD.

Treatment

• Clinical trials for pharmacotherapy to lower blood pressure or lipids to be conducted and analysed using AR selection criteria.

• Clinical trials of the value of including aspirin for management of CVD risk using an AR approach in combination with blood pressure and/or lipid lowering therapy.

• New combination therapies such as various versions of the Polypill to be investigated for effect on population AR reduction.

Appendix 5:

Recommendations for future research

• Studies of lifestyle measures to be conducted with more methodological rigour, such as statistically significant sample sizes, exclusion of people with CVD at baseline, and appropriate time for follow-up.

Cost effectiveness of absolute risk

• Detailed local study of the cost effectiveness of various AR assessment tools compared to current practice to determine whether AR improves outcomes and reduces health care costs;

• Study of the cost effectiveness of various health system models for identification and management of chronic diseases.

Patient adherence

• High quality study comparing different interventions for improvement of patient adherence to medication.

• Communication of risk information to consumers

• Development of an effective method for communication to consumers of AR status and the potential impact of management strategies.

Glossary of terms

Abdominal obesity

Excess body fat predominantly around the waist.

Absolute risk (global risk, total risk)

The numerical probability of an event occurring within a specified period, usually expressed as a percentage. (e.g. 5-year AR of 15% means there is a 15% probability that the individual will experience a cardiovascular event within five years).

Absolute risk reduction

The arithmetic difference between event rates in two groups (e.g. the rates of CVD in a lipid-lowering treatment group subtracted from the rate in the untreated group). For any given relative risk reduction, the AR reduction decreases when event rates are low in the given population.

Albuminuria

The presence of excessive amounts of a protein called albumin in the urine.

Anti-platelet agents

Medicines that reduce the risk of abnormal blood clotting (e.g. aspirin, clopidogrel).

Atrial fibrillation (AF)

Rapid, irregular beating of the heart which can mean that the heart is not pumping efficiently.

Blood pressure (BP)

The pressure of the blood against the inner walls of the arteries as it is pumped around the body by the heart.

Blood pressure varies from moment to moment and is affected by factors such as body position, breathing, emotional state, physical activity and sleep.

Body mass index (BMI)

A calculated number used to identify and measure underweight, overweight or obesity, calculated from a person’s height and weight. BMI = weight (in kg) divided by height (in m) squared.

Cardiovascular disease (CVD)

Group term for all medical conditions affecting the heart or blood vessels (e.g. coronary heart disease, stroke, peripheral arterial disease, some types of kidney disease).

Cardiovascular events

Group of outcomes which may vary between trials but normally includes myocardial infarction, stroke, death from a vascular cause (including coronary, pulmonary embolism, haemorrhage) or any arterial revascularisation procedure.

Cholesterol See lipids.

Chronic heart failure (CHF)

A condition in which the heart does not pump blood effectively, typically resulting in breathlessness and fatigue.

Chronic kidney disease (CKD)

Long-term inability of the kidney/s to function normally, most commonly caused by diabetes, inflammation of the kidneys or high blood pressure.

Cochrane review

A comprehensive systematic review and meta-analysis (where possible).

Cohort studies

A type of medical research in which a selected group of people is studied over time, often over a period of several years.

Glossary and abbreviations

Coronary heart disease (CHD)

A disease in which arteries that surround the heart and supply blood to the heart muscle become partly blocked.

Diabetes mellitus (diabetes)

A long-term disease that affects the way body cells take up and use glucose (sugar) from the blood, resulting in abnormally high levels of glucose in the blood.

Dyslipidaemia

An abnormal amount of lipids (e.g. cholesterol or triglycerides) in the blood, usually abnormally high levels.

Family history of CVD

A family history of premature cardiovascular disease refers to an event that occurs in relatives including parents, grandparents, uncles and/or aunts before the age of 55 years.

Familial hypercholesterolaemia

An inherited condition in which removal of cholesterol from the blood is reduced, causing high blood cholesterol levels and early heart disease in some families.

Framingham Risk Equation

A statistical method of predicting an individual’s likelihood of developing CVD within the next five or 10 years, based on risk factors such as age, sex and blood pressure.

Hypertension

Raised blood pressure.

Lipids

Fatty substances naturally occurring in the blood (cholesterol and triglycerides).

Macroalbuminuria

A raised level of albumin in the urine (more than 300mg of albumin in the urine per day).

Microalbuminuria

A slightly raised level of albumin in the urine (between 30 mg and 300 mg per day).

Myocardial infarction (heart attack)

Temporary loss of blood supply to the heart muscle, typically caused by a blood clot that suddenly blocks a narrowed artery. This can result in heart muscle damage.

Non HDL-C

The cholesterol in low density lipoprotein, intermediate density lipoprotein and very low density lipoprotein.

Numbers needed to treat (NNT)

Average number of patients who need to be treated to prevent one additional bad outcome. The number is the inverse of the absolute risk reduction.

Peripheral arterial disease (PAD)

Disease affecting the arteries other than those of the heart or brain.

Proteinuria

The presence of excessive amounts of protein (>150 mg per day) in the urine. These proteins are typically albumin, but also consist of low molecular weight immunoglobulin, lysozyme, insulin and beta-2 microglobulin.

Relative risk (RR)

The ratio of the rate of events (e.g. CVD) in the population exposed to a risk factor to the rate among the unexposed population (e.g. the risk of someone developing a CVD event who has a given set of risk factors, compared with the risk in someone of the same age and sex who does not have those risk factors).

Relative risk reduction (RRR)

The difference in event rates between two groups (e.g.

treatment group versus control group), expressed as a proportion of the event rate in the untreated group.

Often remains constant whether event rates are high or low within the population.

Renovascular disease

Cardiovascular disease affecting the blood vessels supplying the kidney.

Risk factor

A characteristic of a person (or people) that is positively associated with a particular disease or condition.

Stroke

Sudden loss of blood supply to the brain (e.g. due to blockage of an artery by a blood clot, or because the artery breaks or bursts).

TC: HDL ratio

Total cholesterol divided by high density lipoprotein. Used in the Framingham Risk Equation.

Transient ischaemic attack (TIA)

Transient episode of neurologic dysfunction caused by loss of blood flow. TIAs share the same underlying cause as stroke and the same symptoms but symptoms resolve within a few minutes or less than 24 hours.

Triglycerides See Lipids.

Abbreviations

ACE: Angiotensin-converting enzyme AF: Atrial fibrillation

APCC: Australian Primary Care Collaboratives AR: Absolute risk

ARB: Angiotensin receptor blocker

A&TSI: Aboriginal and Torres Strait Islander Peoples AUC: Area Under the ROC curve

BP: Blood pressure BMI: Body mass index CAD: Coronary artery disease CCB: Calcium channel blocker CHD: Coronary heart disease CKD: Chronic kidney disease CI: Confidence interval CVD: Cardiovascular disease DALY: Disability adjusted life years DBP: Diastolic blood pressure

DoHA: Department of Health and Ageing ECG: Electrocardiography

EGFR: Estimated glomerular filtration rate

EWG: Expert working group FRE: Framingham Risk Equation GFR: Glomerular filtration rate GP: General practitioner

HDL: High-density lipoprotein cholesterol (also HDL-C) HMG-CoA: 3-hydroxy-3-methylglutaryl-coenzyme A (statin) ICER: Incremental cost-effectiveness ratio

LDL: Low-density lipoprotein cholesterol (also LDL-C) LVH: Left ventricular hypertrophy

MBS: Medicare Benefits Schedule MI: Myocardial infarction

NHMRC: National Health and Medical Research Council NNT: Numbers needed to treat

NVDPA: National Vascular Disease Prevention Alliance OGTT: Oral Glucose Tolerance Test

OR: Odds ratio

PBAC: Pharmaceutical Benefits Advisory Committee PBS: Pharmaceutical Benefits Scheme

QALY: Quality adjusted life year

RACGP: Royal Australian College of General Practitioners RCT: Randomised controlled trial

RR: Relative risk

RRR: Relative risk reduction SBP: Systolic blood pressure

SCORE: Systematic Coronary Risk Evaluation project SR: Systematic review

TC: Total cholesterol TG: Triglyceride

TIA: Transient ischaemic attack UACR: Urinary albumin:creatinine ratio

UKPDS: United Kingdom Prospective Diabetes Study

1. Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8.

2. Jackson R, Lawes CM, Bennett DA, Milne RJ, Rodgers A. Treatment with drugs to lower blood pressure and blood cholesterol based on an individual’s absolute cardiovascular risk. Lancet. 2005 Jan 29-Feb 4;365(9457):434-41.

3. Kannel WB. Some lessons in cardiovascular epidemiology from Framingham. Am J Cardiol. 1976 Feb;37(2):269-82.

4. Australian Institute of Health and Welfare 2011. Health determinants, the key to preventing chronic disease. Cat No. PHE 157. Canberra:

AIHW.

5. Tonkin A, Barter P, Best J, Boyden A, Furler J, Hossack K, et al.

National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand: position statement on lipid management--2005. Heart Lung Circ. 2005 Dec;14(4):275-91.

6. Hillier S, Grimmer-Somers K, Merlin T, Middleton P, Salisbury J, Tooher R, et al. FORM: an Australian method for formulating and grading recommendations in evidence-based clinical guidelines. BMC Med Res Methodol. 2011 Feb 28;11:23.

7. Begg SJ, Vos T, Barker B, Stanley L, Lopez AD. Burden of disease and injury in Australia in the new millennium: measuring health loss from diseases, injuries and risk factors. Med J Aust. 2008 Jan 7;188(1):36-40.

8. Australian Institute of Health and Welfare 2011. Cardiovascular disease: Australian facts2011. Cardiovascular disease series. Cat.no.

CVD 53. Canberra: AIHW.

9. Australian Institute of Health and Welfare 2008. Australia’s health 2008. Cat. no. AUS 99. Canberra: AIHW.

10. National Vascular Disease Prevention Alliance. Guidelines for the assessment of absolute cardiovascular disease risk. 2009.

11. National Heart Foundation of Australia (National Blood Pressure and Vascular Disease Advisory Committee). Guide to the management of hypertension for doctors 2008.

12. Colagiuri S, Davies D, Girgis S, Colagiuri R. National Evidence-based Guideline for Case Detection and Diagnosis of Type 2 Diabetes.

Diabetes Australia and the NHMRC, Canberra 2009.

13. Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, et al.

Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study.

Lancet. 2004 Sep 11-17;364(9438):937-52.

14. Scottish Intercollegiate Guidelines Network (SIGN). Risk estimation and the prevention of cardiovascular disease. A national clinical guideline, 2007. Available at: www.sign.ac.uk

15. National Vascular Disease Prevention Alliance (Diabetes Australia, Kidney Health Australia and National Stroke Foundation of Australia).

Consensus statement for the prevention of vascular disease. Aust Family Physician 2004; 33: 234-239.

16. Harris M, Bailey L, Bridges-Webb C, et al. Guidelines for prevention activities in general practice (6th edition). Melbourne; The Royal Australian College of General Practitioners, 2005.

17. National Aboriginal Community Controlled Health Organisation.

National guide to a preventative health assessment in Aboriginal and Torres Strait Islander peoples. South Melbourne; Royal Australian College of General Practitioners, 2005.

18. Grundy SM, Pasternak R, Greenland P, Smith S, Jr., Fuster V.

Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology. Circulation. 1999 Sep 28;100(13):1481-92.

19. Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64.

20. Hall LM, Jung RT, Leese GP. Controlled trial of effect of documented cardiovascular risk scores on prescribing. BMJ. 2003 Feb

1;326(7383):251-2.

21. Lowensteyn I, Joseph L, Levinton C, Abrahamowicz M, Steinert Y, Grover S. Can computerized risk profiles help patients improve their coronary risk? The results of the Coronary Health Assessment Study (CHAS). Prev Med. 1998 Sep-Oct;27(5 Pt 1):730-7.

22. Manuel DG, Lim J, Tanuseputro P, Anderson GM, Alter DA, Laupacis A, et al. Revisiting Rose: strategies for reducing coronary heart disease. BMJ. 2006 Mar 18;332(7542):659-62.

23. Manuel DG, Kwong K, Tanuseputro P, Lim J, Mustard CA, Anderson GM, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease:

modelling study. BMJ. 2006 Jun 17;332(7555):1419.

24. Marshall T. Evaluating national guidelines for prevention of cardiovascular disease in primary care. J Eval Clin Pract. 2005 Oct;11(5):452-61.

25. National Institute of Clinical Studies. Rate or rhythm control for recurrent atrial fibrillation. Canberra: National Health and Medical Research Council; 2008.

26. National Collaborating Centre for Chronic Conditions. Atrial fibrillation:

national clinical guideline for management in primary and secondary care. London: Royal College of Physicians. 2006.

27. New Zealand Guidelines Group; 2005. Available from: www.nzgg.org.

nz

28. Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, et al. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke.

2011 Jan;42(1):227-76.

Bibliography