Secondary prevention in primary and secondary care for patients following a myocardial infarction

Transcription

1 Secondary prevention in primary and secondary care for patients following a myocardial infarction NICE guideline Draft for consultation, August 00 0 If you wish to comment on this version of the guideline, please be aware that all the supporting information and evidence is contained in the full version. Please put page number and line number for each comment Myocardial infarction: NICE guideline DRAFT (August 00) Page of

2 0 0 0 Contents Introduction... Patient-centred care... Key priorities for implementation... Guidance.... Lifestyle.... Cardiac rehabilitation...0. Drug therapy.... Coronary revascularisation.... Selected patient subgroups... Notes on the scope of the guidance... Implementation in the NHS... Research recommendations.... Optimal duration of treatment with the combination of aspirin and clopidogrel... The clinical and cost effectiveness of long term secondary prevention treatment with ACE inhibitors Spironolactone compared with eplerenone Uptake and adherence to comprehensive cardiac rehabilitation.... Maintaining exercise and dietary changes after comprehensive cardiac rehabilitation... Other versions of this guideline...0. Full guideline...0. Quick reference guide...0. Understanding NICE guidance...0 Related NICE guidance... Updating the guideline... Appendix A: The Guideline Development Group... Members of the GDG from the NCC-PC... Appendix B: The Guideline Review Panel... Appendix C: The algorithms... Myocardial infarction: NICE guideline DRAFT (August 00) Page of

3 0 Introduction In the UK, about,000 men and,000 women have had a myocardial infarction (MI) at some point in their lives. This guideline contains recommendations on secondary prevention for patients in primary and secondary care after an MI. It updates the existing NICE guideline Prophylaxis for patients who have experienced a myocardial infarction (NICE inherited guideline A, April 00) for use in the NHS in England and Wales. The guideline is based on the best available evidence of clinical and cost effectiveness. These guidelines will support the implementation of the Coronary Heart Disease National Service Framework (NSF). The statements in that NSF reflected the evidence that was used at the time it was published. This guideline updates the framework with regard to post-mi secondary prevention. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

4 0 0 0 Patient-centred care This guideline offers best practice advice on secondary prevention for patients following a myocardial infarction (post-mi) in primary and secondary care. Treatment and care should take into account patients individual needs and preferences. Patients following a myocardial infarction should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If patients do not have the capacity to make decisions, healthcare professionals should follow the Department of Health guidelines Reference guide to consent for examination or treatment (00) (available from From April 00 healthcare professionals will need to follow a code of practice accompanying the Mental Capacity Act (summary available from Good communication between healthcare professionals and patients is essential. It should be supported by evidence-based written information tailored to the patient s needs. Treatment and care, and the information patients are given about it, should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English. Healthcare professionals should also make efforts to encourage concordance with cardiac rehabilitation programmes, which should take into account people s wider health and social needs. This may entail identifying and addressing economic, welfare, housing or social support issues. This may be a particular challenge with people from more deprived communities. Rehabilitation services should assess the likely scale of these needs when planning their services for their local population. Carers and relatives should have the opportunity to be involved in decisions about the patient s care and treatment, unless the patient specifically excludes them. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

5 Carers and relatives should also be given the information and support they need. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

6 0 0 Key priorities for implementation Exercise programmes should be tailored to individual ability and, where safely possible, exercise should aim to increase heart rate up to 0 % of peak heart rate and should be performed at least twice a week. [...] All patients after a myocardial infarction (MI) who smoke should be advised to quit.[...] Patients after an MI should be advised to eat a Mediterranean-style diet (more bread, fruit and vegetables, and fish; less meat; and replacing butter and cheese with products based on vegetable and plant oils). [...] Cardiac rehabilitation that includes an exercise component should be equally accessible and relevant to all patients after an MI, explicitly including those from groups that currently are less likely to access this service. These include those from black and minority ethnic groups, older people, those from lower socioeconomic groups, women, those from rural communities and those with mental and physical health comorbidities. [...] All patients who have had an acute MI should be offered treatment with the following drugs: [...] ACE (angiotensin-converting enzyme) inhibitor aspirin beta blocker statin. Patients soon after an MI who have symptoms and/or signs of heart failure and left ventricular systolic dysfunction should be offered treatment with a licensed aldosterone antagonist within to days of the acute MI, after ACE inhibitor therapy. [...] Myocardial infarction: NICE guideline DRAFT (August 00) Page of

7 0 The combination of aspirin and clopidogrel is not recommended for routine use for any longer than months after the acute phase, unless there are other indications to do so (for example recent coronary stenting). [...0] Patients after an MI should be considered for treatment with gram per day of omega- fatty acids, initiated within months of the MI. [...] All patients after an MI should be offered a cardiological assessment to consider the appropriateness of coronary revascularisation, taking into account comorbidity. [...] Myocardial infarction: NICE guideline DRAFT (August 00) Page of

8 0 0 Guidance The following guidance is based on the best available evidence. The full guideline ([add hyperlink]) gives details of the methods and the evidence used to develop the guidance (see section for details).. Lifestyle.. Changing dietary regime... Patients after a myocardial infarction (MI) should be advised not to take supplements containing beta-carotene.... Patients after an MI should not be advised to take antioxidant supplements (Vitamin E and/or C) to reduce cardiovascular risk.... Patients after an MI should be advised to increase their consumption of oily fish.... Patients after an MI should be advised to consume two to four portions of oily fish per week.... Patients after an MI should not be advised to take folic acid to reduce cardiovascular risk.... Patients after an MI should be advised to eat a Mediterranean-style diet (more bread, fruit and vegetables, and fish; less meat; and replacing butter and cheese with products based on vegetable and plant oils)... Delivery of dietary advice... Consistent dietary advice tailored to individuals needs should be given. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

9 Dietary advice should involve discussion of eating habits and education about improvement in diets on a one-to-one basis with a healthcare professional... Alcohol consumption... Low-to-moderate alcohol consumption, within current guidelines, may be continued and should not be discouraged in male patients after an MI.... Low-to-moderate alcohol consumption, within current guidelines, may be continued in female patients after an MI.... Patients after an MI who drink alcohol should be advised to keep weekly consumption within safe limits (no more than units per week for men, or units per week for women) and to avoid binge drinking... Regular physical activity... Patients after an MI should be advised to exercise regularly according to their individual ability.... For patients after an MI, advice on physical activity should involve discussion of current and past activity levels and preferences. The benefit of exercise may be enhanced by a prescription of an exercise programme by a suitably qualified healthcare professional.... Exercise programmes should be tailored to individual ability and, where safely possible, exercise should aim to increase heart rate up to 0 % of peak heart rate and should be performed at least twice a week.... People who cannot safely exercise at this level should be encouraged to exercise at their maximum safe capacity. In patients who are very debilitated or deconditioned, lowintensity exercise may improve functional capacity. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

10 0 0.. Smoking cessation... All patients after an MI who smoke should be advised to quit.... All patients after an MI who smoke and who have expressed a desire to quit should be offered appropriate support and advice, and pharmacotherapy in line with the recommendations in the NICE guidance on bupropion and nicotine replacement therapy for smoking cessation (NICE technology appraisal guidance )... Weight management... All patients after an MI who are overweight or obese should be offered appropriate advice and support to achieve and maintain a healthy weight in line with the NICE guideline Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children (due to be published November 00).. Cardiac rehabilitation.. Comprehensive cardiac rehabilitation... All patients after an MI should be given advice about and offered a cardiac rehabilitation programme with an exercise component.... Programmes should provide a menu of options and patients should be encouraged to attend all those appropriate to their clinical needs. They should not be excluded from the entire programme if they choose not to attend certain components.... If a patient has cardiac or other clinical conditions that may worsen during exercise, these should be treated before the patient is offered the exercise component of cardiac rehabilitation. Myocardial infarction: NICE guideline DRAFT (August 00) Page 0 of

11 Patients with left ventricular systolic dysfunction who are stable can safely be offered the exercise component of cardiac rehabilitation.... The exercise component of cardiac rehabilitation can safely be offered to patients regardless of age... Patient engagement... Cardiac rehabilitation that includes an exercise component should be equally accessible and relevant to all patients after an MI, explicitly including those from groups that currently are less likely to access this service. These include those from black and minority ethnic groups, older people, those from lower socioeconomic groups, women, those from rural communities and those with mental and physical health comorbidities.... All those healthcare professionals involved in providing care for patients after an MI should actively promote cardiac rehabilitation.... Reminders such as: telephone calls telephone calls in combination with direct contact by a professional motivational letters should be used to improve uptake of cardiac rehabilitation.... Interventions within programmes should be culturally sensitive, and bilingual peer educators or cardiac rehabilitation assistants who reflect the diversity of the local population should be considered. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

12 Healthcare professionals should establish a patient s health beliefs and level of health literacy before offering appropriate lifestyle advice.... Family-centred dietary interventions should be offered where appropriate.... Healthcare professionals should assess the patient s preferences as to whether cardiac rehabilitation is most appropriately delivered in single-sex classes or mixed classes, for example women may prefer women-only exercise classes.... Healthcare professionals should facilitate concordance with the programme in the context of an understanding of the patient's wider health and social needs, which may require identifying and addressing economic, welfare rights, housing or social support issues. This may be a particular issue for patients in more deprived situations, and rehabilitation services should assess the likely scale of these needs when planning how their services meet local population need.... Cardiac rehabilitation programmes should consider providing exercise classes specifically designed to meet the needs of older patients or those with significant comorbidity, for whom transport issues may be a particular problem... Education and information needs... Comprehensive cardiac rehabilitation programmes should include a health educational and stress management component.... A self-help programme incorporating education, exercise and stress management components with follow-ups by a trained facilitator (such as The Edinburgh Heart Manual; see Myocardial infarction: NICE guideline DRAFT (August 00) Page of

13 0 0 anual.htm) is recommended to aid comprehensive cardiac rehabilitation.... Most patients who have had an MI can return to work. Any advice should take account of the physical and psychological status of the patient, the nature of the work and the work environment.... Healthcare professionals should be up to date with the latest Driver and Vehicle Licensing Authority guidelines. Regular updates are published on the website ( Patients after an MI without complications can usually undertake air travel within to weeks of MI. Patients who have had a complicated MI need expert individual advice.... Patients after an MI who hold a pilot s licence should seek advice from the Civil Aviation Authority.... Most patients after an MI can return to normal activities of daily living. Any advice about the timing of this should take account of the patient s physical and psychological status, and the type of activity planned.... An estimate of the physical demand of a particular activity, and comparison between activities, can be made using tables of metabolic equivalents (METS) of different activities. Patients should also be advised how to use a perceived exertion scale to help monitor physiological demand. Patients who have had a complicated MI may need expert advice.... Advice on competitive sport may need expert assessment of function and risk, and is dependent on what sport is being discussed and the level of competitiveness. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

14 0 0.. Psychological and social support... For recommendations on the management of patients after an MI who show persistent clinical anxiety and depression following cardiac rehabilitation, refer to the NICE guidelines on anxiety and depression (NICE clinical guidelines and ). Complex psychological interventions over and above stress management, such as cognitive behavioural therapy, should be offered, in addition to comprehensive cardiac rehabilitation, only to selected patients after an MI.... There should be provision to involve partners or carers in the cardiac rehabilitation programme, if the patient wishes... Sexual activity... Patients should be reassured that sexual activity after recovery from an MI presents no greater risk of a subsequent MI than if they had never had an MI.... Patients who have made an uncomplicated recovery following their MI can resume sexual activity when they feel comfortable to do so, usually after about weeks.... The subject of sexual activity should be raised with patients within the context of cardiac rehabilitation and aftercare.... When treating erectile dysfunction, treatment with a PDE (phosphodiesterase ) inhibitor may be considered in patients who had an MI more than months earlier and who are stable.... PDE inhibitors must be avoided in patients treated with nitrates and/or nicorandil. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

15 0 0. Drug therapy.. Overall drug therapy recommendation... All patients who have had an acute MI should be offered treatment with the following drugs: ACE (angiotensin-converting enzyme) inhibitor aspirin beta blocker statin... ACE inhibitors... ACE inhibitors should be offered to all patients early after presentation with an acute MI.... The dose of ACE inhibitor should be increased, as tolerated, to the effective clinical dose.... Assessment of left ventricular function is recommended in all patients after an MI.... In patients with heart failure and/or left ventricular systolic dysfunction, ACE inhibitors should be continued indefinitely.... In patients without heart failure and with preserved left ventricular function, treatment with ACE inhibitors should be continued indefinitely.... Routine prescription of angiotensin receptor blockers (ARBs) after an acute MI is not recommended.... Early after an acute MI, patients with heart failure and/or left ventricular systolic dysfunction should be offered treatment with an ACE inhibitor. In patients who have had to discontinue an ACE inhibitor because of intolerance or allergy, an ARB could be substituted. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

16 Early after an acute MI, patients without heart failure or left ventricular systolic dysfunction should be offered treatment with an ACE inhibitor. In patients who have had to discontinue an ACE inhibitor because of intolerance or allergy, an ARB could be substituted.... Combined treatment with an ACE inhibitor and an ARB in patients early after an acute MI with heart failure and/or left ventricular systolic dysfunction is not recommended for routine use....0 In patients with a proven MI in the past and with heart failure and left ventricular systolic dysfunction, ACE inhibitor and ARB treatment should be managed in line with the NICE guideline on the diagnosis and management of chronic heart failure in primary and secondary care (NICE clinical guideline ).... In patients with a proven MI in the past and with left ventricular systolic dysfunction, who are asymptomatic, ACE inhibitor treatment should be offered and the dose up-titrated as tolerated to the effective clinical dose for patients with heart failure and left ventricular systolic dysfunction.... In patients with a proven MI in the past without heart failure and with preserved left ventricular function, ACE inhibitor treatment should be offered and the dose up-titrated as tolerated to the effective clinical dose.... Measure renal function and serum electrolytes before starting an ACE inhibitor or ARB, again within to weeks of starting treatment, following each dose increase, and then at least annually once the dose has been optimised. More frequent monitoring may be needed in some patients who are at increased risk of deterioration in renal function, and patients with chronic heart failure should be monitored in line Myocardial infarction: NICE guideline DRAFT (August 00) Page of

17 0 0 with NICE guidance on the diagnosis and management of chronic heart failure in primary and secondary care (NICE clinical guideline ).... Patients after an MI who have serum creatinine less than 0 micromol/litre and/or serum potassium less than. mmol/litre should be considered for ACE inhibitor therapy if they do not have severe renal artery stenosis.... Seek specialist advice before initiating ACE inhibitors in patients after an MI who have serum creatinine of 0 micromol/litre or greater and/or serum potassium of. mmol/litre or greater,... Antiplatelet therapy... Aspirin should be offered to all patients after an MI.... In patients after an MI, aspirin should be continued indefinitely.... Clopidogrel should not be offered as a first-line monotherapy after an MI.... Patients with a non-st-segment-elevation MI should be managed in line with NICE technology appraisal 0, Clopidogrel in the treatment of non-st-segment-elevation acute coronary syndrome (as specified in paragraphs... to...).... Clopidogrel, in combination with low-dose aspirin, is recommended for use in the management of non-stsegment-elevation acute coronary syndrome in people who are at moderate to high risk of MI or death.... For the purposes of this guidance, moderate to high risk of MI or death in people presenting with non-st-segmentelevation acute coronary syndrome can be determined by Myocardial infarction: NICE guideline DRAFT (August 00) Page of

18 0 0 clinical signs and symptoms, accompanied by one or both of the following: the results of clinical investigations, such as new ECG changes (other than persistent ST-segment-elevation) indicating ongoing myocardial ischaemia, particularly dynamic or unstable patterns the presence of raised blood levels of markers of cardiac cell damage such as troponin.... It is recommended that treatment with clopidogrel in combination with low-dose aspirin should be continued for months after the most recent acute episode of non-stsegment-elevation acute coronary syndrome. Thereafter standard care, including treatment with low-dose aspirin alone, is recommended.... In patients after an ST-segment-elevation MI who have been treated with a combination of aspirin and clopidogrel during the first of hours after MI, this combination should be continued for at least weeks. Thereafter standard treatment including low-dose aspirin should be continued, unless there are other indications to continue with the combination for longer (for example coronary stenting).... If the patient has not been treated with a combination of aspirin and clopidogrel during the acute phase, this combination should not routinely be initiated....0 The combination of aspirin and clopidogrel is not recommended for routine use for any longer than months after the acute phase, unless there are other indications to do so (for example recent coronary stenting).... For patients with aspirin hypersensitivity, clopidogrel should be considered as an alternative treatment. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

19 In patients with a history of severe indigestion, treatment with a proton pump inhibitor with low-dose aspirin should be considered.... After appropriate treatment, patients with a history of gastrointestinal bleeding should be considered for treatment with full-dose proton pump inhibitor and low-dose aspirin. Cross-refer to the NICE guidance on dyspepsia (NICE clinical guideline ).... Patients with dyspepsia should be considered for treatment with a maintenance dose of a proton pump inhibitor and lowdose aspirin Cross refer to the NICE guidance on dyspepsia (NICE clinical guideline )... Beta blockers... All patients after an acute MI without left ventricular systolic dysfunction or with left ventricular systolic dysfunction (symptomatic or asymptomatic) should be offered treatment with a beta blocker whether or not they have symptoms.... In patients after an MI with left ventricular systolic dysfunction, treatment with a beta blocker licensed for use in heart failure may be preferred.... In general beta blockers should be continued indefinitely in patients treated after acute MI.... All patients with a proven previous MI with left ventricular systolic dysfunction should be offered treatment with a beta blocker whether or not they have symptoms, and those with heart failure plus left ventricular systolic dysfunction should be managed in line with NICE guidance on the management of chronic heart failure in primary and secondary care (NICE clinical guideline ). Myocardial infarction: NICE guideline DRAFT (August 00) Page of

20 Patients with preserved left ventricular function who are asymptomatic and who have had a proven MI in the past (more than year ago) should not be routinely offered treatment with a beta blocker, unless they are identified to be at increased risk of further cardiovascular events or there are other compelling indications for beta blocker treatment.... Beta blockers should be initiated as soon as possible when the patient is clinically stable... Vitamin K antagonists... High-intensity warfarin should not be considered as an alternative to aspirin in first-line treatment in patients after an MI.... In patients after an MI who are intolerant to both aspirin and clopidogrel, treatment with warfarin (INR ) should be considered.... In patients after an MI who are intolerant to clopidogrel and have a low risk of bleeding, treatment with aspirin and warfarin (INR ) combined should be considered.... Patients after an MI should continue warfarin if already being treated for another indication (mechanical valve, recurrent deep vein thrombosis, atrial fibrillation, left ventricular thrombus). In those treated with moderate intensity warfarin (INR ) and who are at low risk of bleeding, the addition of aspirin should be considered.... The combination of warfarin and clopidogrel is not recommended... Calcium channel blockers... Calcium channel blockers should not be used routinely to reduce cardiovascular risk after an MI. Myocardial infarction: NICE guideline DRAFT (August 00) Page 0 of

21 If beta blockers are contraindicated or must be discontinued, diltiazem or verapamil may be considered for secondary prevention in patients without pulmonary congestion or left ventricular systolic dysfunction, although this is an unlicensed indication for these drugs and specialist advice should be sought.... In patients after an MI who are stable, calcium channel blockers may be used to treat hypertension and/or angina. In those patients with heart failure, amlodipine should be used, and verapamil, diltiazem and short-acting dihydropyridine agents should be avoided (in line with the NICE guidance on the management of chronic heart failure in primary and secondary care [NICE clinical guideline ])... Potassium channel activators... Nicorandil is not recommended to reduce cardiovascular risk in patients after an MI... Aldosterone antagonists in patients with heart failure and left ventricular dysfunction... Patients soon after an MI who have symptoms and/or signs of heart failure and left ventricular systolic dysfunction should be offered treatment with a licensed aldosterone antagonist within to days of the acute MI, after ACE inhibitor therapy.... Patients who have recently had an acute MI and have clinical heart failure and left ventricular systolic dysfunction, but who are already on treatment with an aldosterone antagonist for a concomitant condition (for example, chronic heart failure), should continue with the aldosterone antagonist or an alternative licensed for early post MI treatment. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

22 In patients with proven MI in the past and heart failure due to left ventricular systolic dysfunction, treatment with an aldosterone antagonist should be in line with the NICE guidance on the management of chronic heart failure in primary and secondary care (NICE clinical guideline ).... Patients after an acute MI who have serum creatinine greater than 0 micromol/litre and serum potassium greater than mmol/litre should not routinely be considered for treatment with an aldosterone antagonist.... Renal function and serum potassium should be monitored before and during treatment with an aldosterone antagonist. If hyperkalaemia is a problem, the dose of aldosterone antagonist should be halved or the drug stopped (see the NICE guideline Management of chronic heart failure in adults in primary and secondary care [NICE clinical guideline ] for guidance on the monitoring of patients with chronic heart failure treated with spironolactone)... Omega- fatty acid ethyl esters... Patients after an MI should be considered for treatment with gram per day of omega- fatty acids, initiated within months of the MI...0 Statins and fibrates..0. Statin therapy is recommended for adults with clinical evidence of cardiovascular disease...0. All patients after an MI should be offered treatment with a statin to lower serum cholesterol concentrations either to less than mmol/litre (LDL-C [low-density lipoprotein cholesterol] to less than mmol/litre) or by 0% (whichever is greater). The routine use of statins at maximum dose irrespective of baseline cholesterol is not recommended. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

23 0 0 The treatment of serum cholesterol for patients who have had an MI, have other established vascular disease or are at high cardiovascular risk is being reviewed within the NICE clinical guideline Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (publication expected December 00)...0. At the time of publication of this guideline, the routine use of statins at very high dose, irrespective of baseline cholesterol, is not currently recommended, but this should be revised as appropriate following publication of the NICE clinical guideline Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (publication expected December 00) All patients after an MI should be offered treatment with a statin as soon as possible...0. In patients after an MI who are intolerant of statins, cholesterol absorption inhibitors or fibrates should be considered...0. Routine monitoring of creatine kinase in asymptomatic patients after an MI who are being treated with a statin is not recommended...0. Patients after an MI who are being treated with a statin and who develop muscle symptoms (pain, tenderness or weakness) should be advised to seek medical advice, when creatine kinase should be measured...0. The dose of statins metabolised by CYPA (simvastatin, atorvastatin) may need to be reduced, or in some cases the Myocardial infarction: NICE guideline DRAFT (August 00) Page of

24 0 0 statin temporarily withheld, in patients taking concomitant drugs that inhibit the CYPA enzyme system...0. Baseline liver enzymes should be measured before initiation of a statin in patients after an MI Patients after an MI who have raised liver enzymes should not routinely be excluded from statin therapy...0. Statins should be discontinued in patients who develop a peripheral neuropathy that may be attributable to the statin treatment, and further advice from a specialist should be sought.. Coronary revascularisation... All patients after an MI should be offered a cardiological assessment to consider the appropriateness of coronary revascularisation, taking into account comorbidity.. Selected patient subgroups.. Patients with hypertension... Treat hypertension to the target given in the NICE hypertension guideline (NICE clinical guideline ), currently 0/0 mmhg, or lower, particularly in patients with relevant comorbidities, for example diabetes or renal disease... Patients with left ventricular dysfunction... Patients after an MI who have left ventricular systolic dysfunction should be considered for implantable cardioverter defibrillators in line with the recommendations in NICE technology appraisal, Implantable cardioverter defibrillators for arrhythmias. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

25 0 0 Notes on the scope of the guidance NICE guidelines are developed in accordance with a scope that defines what the guideline will and will not cover. The scope of this guideline is available from This guideline is of relevance to those who work in or use the National Health Service (NHS) in England and Wales: healthcare professionals who work within the acute and primary healthcare sectors and who have direct contact with patients following an MI those with responsibilities for commissioning and planning health services such as primary care trust commissioners and Welsh Assembly Government officers public health and trust managers patients who have had an MI, their partners, families and other carers. The guideline does not cover: patients who have had a non-spontaneous MI (for example, a periprocedural MI, which may occur after percutaneous coronary intervention) patients who have had a non-atherosclerotic-induced MI (which is an MI in patients without underlying coronary artery disease). diagnosis of an MI either acutely or restrospectively interventions specific to the early phase of the acute MI, such as thrombolysis different methods of assessment of cardiac status before possible coronary revascularisation symptom control such as the management of angina. The guideline also does not cover the additional management of diabetes and glycaemic control in patients who have had an MI, because this is more appropriately placed in the revisions of the diabetes guidelines. Similarly, the additional management of chronic heart failure, which would be more Myocardial infarction: NICE guideline DRAFT (August 00) Page of

26 appropriately placed in revisions of the chronic heart failure guideline, is not included. How this guideline was developed NICE commissioned the National Collaborating Centre for Primary Care to develop this guideline. The Centre established a Guideline Development Group (see appendix A), which reviewed the evidence and developed the recommendations. An independent Guideline Review Panel oversaw the development of the guideline (see appendix B). There is more information in the booklet: The guideline development process: 0 an overview for stakeholders, the public and the NHS (second edition, published April 00), which is available from or by telephoning 00 (quote reference N). 0 Implementation in the NHS The Healthcare Commission assesses the performance of NHS organisations in meeting core and developmental standards set by the Department of Health in Standards for better health, issued in July 00. Implementation of clinical guidelines forms part of the developmental standard D. Core standard C says that national agreed guidance should be taken into account when NHS organisations are planning and delivering care. NICE has developed tools to help organisations implement this guidance (listed below). These are available on our website ( [NICE to amend list as needed at time of publication] Slides highlighting key messages for local discussion. Costing tools: costing report to estimate the national savings and costs associated with implementation costing template to estimate the local costs and savings involved. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

27 0 0 0 Implementation advice on how to put the guidance into practice and national initiatives which support this locally. Audit criteria to monitor local practice. Research recommendations The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.. Optimal duration of treatment with the combination of aspirin and clopidogrel What is the optimal duration of treatment with the combination of aspirin and clopidogrel, compared with aspirin alone, in patients with ST-segmentelevation MI treated with thrombolysis? Why this is important The addition of clopidogrel to other standard treatment, including aspirin and thrombolysis, in patients presenting with ST-segment-elevation MI has been shown to improve coronary patency and clinical outcome. This effect appears to be mediated by preventing re-occlusion of the open infarct-related artery rather than by facilitating early reperfusion. The trials examining the effects of the addition of clopidogrel in patients with ST-segment-elevation MI were of short duration (about weeks or less). The trial that reported a clinical benefit from treating patients with non-st-segment-elevation MI with the combination of aspirin and clopidogrel, compared with aspirin alone, had a follow-up of up to months, mean months. The optimal duration of treatment with the combination of aspirin and clopidogrel in patients with ST-segment-elevation MI is unknown.. The clinical and cost effectiveness of long term secondary prevention treatment with ACE inhibitors What is the clinical and cost effectiveness of long term secondary prevention treatment with ACE inhibitors in patients after an MI and without left ventricular dysfunction? Myocardial infarction: NICE guideline DRAFT (August 00) Page of

28 0 0 0 Why this is important Most trials of secondary prevention drugs after a myocardial infarction follow up patients for a limited period of time, rarely more than years after the event. In current guidance there is an assumption that the benefit demonstrated in these trials persists indefinitely and therefore, provided they are tolerated, secondary prevention drugs such as beta blockers, statins, aspirin and ACE inhibitors should be continued long term. Further research is needed to test this assumption. It would be ethically and logistically difficult to study withdrawal of drug therapy using the traditional randomised controlled trial design. Alternative designs, such as large cohort studies, based on routinely collected (or enhanced) data would allow comparison of people stopping one or more secondary prevention drugs with a cohort continuing their secondary prevention therapy. Close attention would need to be paid to confounders. This question is particularly pertinent for ACE inhibitors and beta blockers, because it is not clear to what extent patients without significant left ventricular dysfunction benefit from long-term use of these agents after a myocardial infarction.. Spironolactone compared with eplerenone What is the clinical and cost effectiveness of treatment with spironolactone compared with eplerenone in patients with heart failure early after myocardial infarction? Why this is important Heart failure is the major cause of death after the acute phase of myocardial infarction. We know that eplerenone, in addition to conventional treatments, can reduce mortality from heart failure early after myocardial infarction (EPHESUS). Spironolactone, another aldosterone antagonist, is less expensive but is not always well tolerated, particularly in men. We need to know whether spironolactone is as effective as eplerenone in reducing mortality in all grades of heart failure after acute myocardial infarction. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

29 Uptake and adherence to comprehensive cardiac rehabilitation What strategies are effective in improving the uptake and adherence to comprehensive cardiac rehabilitation in people who have had an MI, including those from under-represented groups such as minority ethnic groups, women, the elderly and those on low incomes or with physical or mental comorbidities? Why this is important Participation of patients after an MI in cardiac rehabilitation has been shown to reduce all-cause mortality and cardiac mortality when compared with usual care. The National Service Framework for Coronary Heart Disease states that more than % of people discharged from hospital with a primary diagnosis of acute MI or after coronary revascularisation should be offered cardiac rehabilitation. However, less than a third of all patients with a prior MI and those who have undergone coronary revascularisation attend comprehensive cardiac rehabilitation, and uptake is particularly poor among certain groups including minority ethnic groups, women, the elderly and those on low incomes or with physical or mental comorbidities. Studies investigating methods to improve uptake of and adherence to comprehensive cardiac rehabilitation have been small and limited to individual programmes or geographical locations and have not evaluated interventions specifically for underrepresented patient groups. Consequently, the ability of NICE to provide specific recommendations in this area is limited, because the most clinically and cost effective strategies are unknown.. Maintaining exercise and dietary changes after comprehensive cardiac rehabilitation What encourages the maintenance of regular exercise and a Mediterraneanstyle diet beyond the period of comprehensive cardiac rehabilitation? Why this is important Long term regular exercise and following a Mediterranean-style diet have been shown to reduce all cause and cardiovascular mortality in patients after Myocardial infarction: NICE guideline DRAFT (August 00) Page of

30 0 an MI. A Mediterranean-style diet has also been shown to reduce recurrent MI. Maintenance of these lifestyle changes in patients after an MI has been shown to decline following the end of the patient s participation in coordinated comprehensive cardiac rehabilitation. The strategies that are effective in maintaining these lifestyle activities are unknown. Other versions of this guideline. Full guideline The full guideline, Secondary prevention in primary and secondary care for patients following a myocardial infarction, contains details of the methods and evidence used to develop the guideline. It is published by the National Collaborating Centre for Primary Care, and is available from [NCC website details to be added], our website ( and the National Library for Health ( [Note: these details will apply to the published full guideline.]. Quick reference guide A quick reference guide for healthcare professionals is also available from For printed copies, phone the NHS Response Line on 00 (quote reference number NXXXX). [Note: these details will apply when the 0 guideline is published.]. Understanding NICE guidance Information for patients and carers ( Understanding NICE guidance ) is available from For printed copies, phone the NHS Response Line on 00 (quote reference number NXXX). [Note: these details will apply when the guideline is published.] Myocardial infarction: NICE guideline DRAFT (August 00) Page 0 of

31 0 0 Related NICE guidance Hypertension: management of hypertension in adult patients in primary care. NICE clinical guideline no. (00). Available from Chronic heart failure: management of chronic heart failure in adults in primary and secondary care NICE clinical guideline no.. (00). Available from Brief interventions and referral for smoking cessation in primary care and other settings. NICE public health intervention guidance no. (00). Available from Implantable cardioverter defibrillators (ICDs) for the treatment of arrhythmias. NICE technology appraisal guidance no. (00). Available from Statins for the prevention of cardiovascular events in patients at increased risk of developing cardiovascular disease or those with established cardiovascular disease. NICE technology appraisal guidance no. (00) Available from Clopidogrel and dipyridamole for the prevention of artherosclerotic events. NICE technology appraisal guidance no. 0 (00). Available from Clopidogrel in the treatment of non-st-segment-elevation acute coronary syndrome. NICE technology appraisal guidance no. 0 (00). Available from Myocardial perfusion scintigraphy for the diagnosis and management of angina and myocardial infarction. NICE technology appraisal guidance no. (00). Available from The clinical effectiveness and cost effectiveness of bupropion (Zyban) and nicotine replacement therapy for smoking cessation. NICE technology appraisal guidance no. (00). Available from Myocardial infarction: NICE guideline DRAFT (August 00) Page of

32 0 NICE is developing the following guidance (details available from Obesity: the prevention, identification, evaluation, treatment and weight maintenance of overweight and obesity in adults. NICE clinical gudeline. (Publication expected November 00.) Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. NICE clinical guideline. (Publication expected December 00.) Familial hypercholesterolaemia: identification and management. NICE clinical guideline. (Publication date to be confirmed.) Updating the guideline NICE clinical guidelines are updated as needed so that recommendations take into account important new information. We check for new evidence and years after publication, to decide whether all or part of the guideline should be updated. If important new evidence is published at other times, we may decide to do a more rapid update of some recommendations. Myocardial infarction: NICE guideline DRAFT (August 00) Page of

33 0 0 Appendix A: The Guideline Development Group Professor Gene Feder (Chairman) Professor of Primary Care Research and Development, Barts and the London Queen Mary's School of Medicine and Dentistry, London Dr Jane Skinner (Clinical Advisor) Consultant Community Cardiologist, the Newcastle upon Tyne Hospitals NHS Foundation Trust Dr Keith MacDermott General Practitioner, York Dr Rubin Minhas General Practitioner, Primary Care CHD Lead, Kent Dr Chris Packham Director of Public Health, Nottingham City Primary Care Trust Mrs Helen Squires Superintendent Physiotherapist, Luton and Dunstable Hospital NHS Trust, Bedfordshire Mr David Thomson Patient representative, Buckinghamshire Professor Adam Timmis Professor of Clinical Cardiology, Barts and the London Queen Mary's School of Medicine and Dentistry, London Mr John Walsh Patient representative, Swindon Ms Helen Williams Pharmacy Team Leader for Cardiac Services and London Region CHD Advisor for Clinical Pharmacy, King's College Hospital, London Myocardial infarction: NICE guideline DRAFT (August 00) Page of

34 0 Ms Anne White British Heart Foundation Cardiac Specialist Nurse, Addenbrooke's Hospital and Cambridge City and South Cambridgeshire PCTs, Cambridge Members of the GDG from the NCC-PC Ms Nancy Turnbull Guideline Lead and Chief Executive Dr Angela Cooper Senior Health Services Research Fellow Gabrielle Shaw (until December 00) Project Manager Dr Meeta Kathoria (from May 00) Project Manager Mr Leo Nherera Health Economist Myocardial infarction: NICE guideline DRAFT (August 00) Page of

35 0 Appendix B: The Guideline Review Panel The Guideline Review Panel is an independent panel that oversees the development of the guideline and takes responsibility for monitoring adherence to NICE guideline development processes. In particular, the panel ensures that stakeholder comments have been adequately considered and responded to. The Panel includes members from the following perspectives: primary care, secondary care, lay, public health and industry. [NICE to add] [Name; style = Unnumbered bold heading] [job title and location; style = NICE normal] Myocardial infarction: NICE guideline DRAFT (August 00) Page of

36 Patient with MI within the last year Appendix C: The algorithms MI in the past year Assess secondary prevention management and manage as described below 0 0 SECONDARY PREVENTION DRUG TREATMENT Optimise long term secondary prevention drug therapy, if no contraindications: Aspirin Beta blockers ACE inhibitors Statin Omega PUFA supplements Identify whether treated with clopidogrel as well as aspirin, and if so what the planned duration of combined therapy is. Treat with eplerenone if within days of MI with symptoms and or signs of heart failure, and left ventricular systolic dysfunction (LVEF 0%) (if no contraindications) Measure blood pressure and optimise management of hypertension SPECIALIST CARDIOLOGICAL ASSESSMENT Arrange specialist cardiological assessment if not been seen since this event Assess left ventricular function Consider the need for coronary revascularisation Consider the need for ICD implantation (refer to NICE technology appraisal guidance Implantable cardioverter defibrillators for arrhythmias ) Make arrangements for appropriate monitoring. Refer to the NICE clinical guideline on the diagnosis and management of chronic heart failure for the long term management of patients with left ventricular systolic dysfunction who develop Myocardial infarction: NICE guideline DRAFT (August 00) Page of chronic heart failure LIFESTYLE CHANGES AND CARDIAC REHABILITATION Offer lifestyle advice Diet Alcohol consumption Physical activity Weight management Smoking (offer help to stop at every opportunity, combine pharmacotherapy with an appropriate support programme) Offer cardiac rehabilitation with the following components: Exercise (except in those with contraindications, until these are controlled) Information and education Stress management Involve partners or carers in accordance with the patient s wishes Make appropriate arrangements to help patients achieve and maintain lifestyle changes Screen for anxiety and depression and arrange appropriate treatment

37 Proven MI in the past Patient with proven MI in the past (> year ago) Assess secondary prevention management and manage as described below SECONDARY PREVENTION DRUG TREATMENT Optimise long term secondary prevention drug therapy, if no contraindications: Aspirin Beta blockers ACE inhibitors Statin Omega PUFA supplements Make arrangements for appropriate monitoring. Measure blood pressure and optimise management of hypertension. Refer to the NICE guidelines for the diagnosis and management of chronic heart failure in primary and secondary care for the long term management of patients with left ventricular systolic dysfunction and chronic heart failure. SPECIALIST CARDIOLOGICAL ASSESSMENT Consider the need for specialist cardiological assessment; LV function Coronary revascularisation ICD implantation (refer to refer to NICE technology appraisal guidance Implantable cardioverter defibrillators for arrhythmias ) LIFESTYLE CHANGES AND CARDIAC REHABILITATION Offer lifestyle advice Diet Alcohol consumption Physical activity Weight management Smoking (offer help to stop at every opportunity, combine pharmacotherapy with an appropriate support programme) Offer cardiac rehabilitation with the following components if patients have specific needs to be addressed: Exercise (except in those with contraindications, until these are controlled) Information and education Stress management Involve partners or carers in accordance with the patient s wishes Make appropriate arrangements to help patients achieve and maintain lifestyle changes Myocardial infarction: NICE guideline DRAFT (August 00) Page of Screen for anxiety and depression and arrange appropriate treatment