2010NICE 不稳定型心绞痛/NSTEMI:不稳定型心绞痛和非ST段抬高型心肌梗死的早期管理

其他 心血管内科· 冠心病与冠脉疾病 · 2010

Guideline Title

Unstable angina and NSTEMI: the early management of unstable angina and non-ST-segment-elevation myocardial infarction.

# Bibliographic Source(s)

National Clinical Guideline Centre for Acute and Chronic Conditions. Unstable angina and NSTEMI: the early management of unstable angina and non-ST-segment-elevation myocardial infarction. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Mar. 26 p. (Clinical guideline; no. 94).

Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI)

Note: The guideline does not cover the management of STEMI or specific complications of unstable angina and NSTEMI such as cardiac arrest or acute heart failure.

Guideline Category

Counseling

Management

Risk Assessment

Treatment

Clinical Specialty

Cardiology

Critical Care

Emergency Medicine

Family Practice

Internal Medicine

Preventive Medicine

Thoracic Surgery

Intended Users

Advanced Practice Nurses

Emergency Medical Technicians/Paramedics

Nurses

Patients

Physical Therapists

Physician Assistants

Physicians

Guideline Objective(s)

To provide a user-friendly, clinical, evidence-based guideline for the National Health Service (NHS) in England and Wales that:

$\bullet$ Offers best clinical advice for the management and treatment of acute coronary syndromes (ACS) in adults in primary and secondary care

$\bullet$ Is based on best published clinical and economics evidence, alongside expert consensus

$\bullet$ Takes into account patient choice and informed decision-making

$\bullet$ Defines the major components of NHS care provision for ACS

$\bullet$ Details areas of uncertainty or controversy requiring further research

$\bullet$ Provides a choice of guideline versions for different audiences

Target Population

Adults (18 years and older), with a diagnosis of unstable angina or non-ST elevation MI (NSTEMI)

Interventions and Practices Considered

Management/Treatment

1. Provision of information

$\bullet$ Offer patients clear information about the risks and benefits of the treatments offered

2. Assessment of a patient's risk of future adverse cardiovascular events, including:

$\bullet$ Full clinical history

$\bullet$ Physical examination

* Resting 12-lead electrocardiography (ECG)

$\bullet$ Blood tests

3. Use risk assessment to guide clinical management

4. Antiplatelet therapy

$\bullet$ Aspirin

* Clopidogrel

$\bullet$ Glycoprotein IIb/IIIa inhibitors (GPI)

5. Antithrombin therapy

$\bullet$ Fondaparinux

* Unfractionated heparin

6. Early invasive versus conservative management

7. Percutaneous coronary intervention versus coronary artery bypass grafting

8. Testing for ischaemia

9. Assessing left ventricular function

10. Rehabilitation and discharge planning

Major Outcomes Considered

$\bullet$ Thirty-day survival

$\bullet$ Reinfarction

$\bullet$ Left ventricular (LV) function

$\bullet$ Revascularisation

$\bullet$ Quality of life

$\bullet$ Serious complications

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)

Hand-searches of Published Literature (Secondary Sources)

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Developing Evidence Based Questions

The technical team drafted a series of clinical questions that covered the guideline scope. The guideline development group (GDG) and Project Executive (PE) refined and approved these questions, which are shown in Appendix F (See the "Availability of Companion Documents" field for the full version of the original guideline document.)

Searching For and Identifying the Relevant Evidence

The Information Scientist developed a search strategy for each question. Key words for the search were identified by the GDG.

Systematic literature searches were undertaken to identify evidence within published literature in order to answer the clinical questions. Clinical databases were searched using relevant medical subject headings, free-text terms and study

type filters: Non-English studies were not reviewed and were therefore excluded from searches.

Each database was searched up to 18th June 2009. One initial search was performed for the whole guideline topic which looked for systematic reviews, guidelines and economic papers in the non-ST elevation myocardial infarction (non-STEMI) acute coronary syndrome populations.

The clinical questions were formulated using the PICO (Population, Intervention, Comparison, and Outcome) format and this was used as a basis for constructing a search strategy. Quality assurance of search strategies was approached by checking relevant key papers and amending search strategies if appropriate. The questions, the study types applied, the databases searched and the years covered can be found in Appendix F in the full version of the original guideline document.

When looking for health economic evidence a whole guideline search looking for economic evidence relating to an acute coronary syndrome (ACS) population was undertaken on the National Health Service (NHS) Economic Evaluation Database (EED) and Health Technology Assessment (HTA) databases with no date restrictions. Additionally, it was run, with a specific economic filter, on Medline and Embase from 2007 to present, to ensure recent publications that may have not yet been indexed by these databases were identified. This was supplemented by an additional search that looked for economic papers specifically relating to revascularisation (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) on the NHS EED and HTA database as it became apparent that some papers in this area were not being identified through the first search. Additionally, ad hoc searches were carried out for individual questions as required.

Titles and abstracts of retrieved papers were reviewed by the Research Fellow or Health Economist and full papers were ordered for studies potentially relevant to each clinical question. The full papers were reviewed against pre-specified inclusion and exclusion criteria.

Where the guideline updated Technology Appraisals (TAs) on clopidogrel or glycoprotein IIb/IIIa inhibitors, the inclusion criteria for clinical evidence was RCTs published at the beginning of 2003 (update of clopidogrel TA) or 2002 (update of glycoprotein IIb/IIIa inhibitors TA) with a sample size ≥250 and at least 60% of the people enrolled given the diagnosis of unstable angina or non-ST-segment-elevation ACS. Where possible, results were reported in the subgroup of patients with unstable angina/non-STEMI. In addition, the trial should report on the six key clinical outcomes agreed for this guideline (30 day survival, reinfarction, left ventricular [LV] function, revascularisation, quality of life, and serious complications). Review papers were checked for additional relevant studies which were then ordered. Additional papers identified by the GDG were ordered and reviewed.

For the remainder of the guideline, inclusion criteria were as above, except there was no restriction on sample size. For areas in which there were no RCTs, other evidence (observational studies, diagnostic studies) were included.

From a health economic perspective studies were prioritised for inclusion if they were from a UK perspective, based intervention effectiveness on data from one or more RCT and these met the clinical data population cut offs (e.g. >60% unstable angina [UA]/NSTEMI population). A judgement was made on a question by question basis regarding whether to include studies from a non-UK perspective$^{a}$, that used observational evidence or that used data that did not meet the clinical data population cut-offs, depending on the availability and quality of the other evidence.

Full economic evaluations (cost-effectiveness, cost-utility and cost-benefit analyses), cost-consequence analyses and comparative costing studies that addressed the clinical question and included UA/NSTEMI adult patients were included.

Studies that only reported cost per hospital (not per patient), or only report average cost effectiveness without disaggregated costs and effects were excluded. Abstracts, posters, reviews, letters/editorials, foreign language publications and unpublished studies were excluded. Studies judged to have an applicability rating of 'not applicable' were excluded. A judgement was made on a question basis regarding whether to include studies with a quality rating of 'very serious limitations,' although these would usually be excluded.

Any publication date cut-offs applied to the clinical evidence were also applied to the economic evidence.

Exclusion lists were generated for each question together with the rationale for the exclusion. The exclusion lists were presented to the GDĞ.

ª Healthcare processes, and therefore resource use, vary between countries as does the cost of healthcare resources. Due to this, and potentially other factors, the applicability and generalisability of non-UK economic studies may be limited. Studies were prioritised by relevance of setting: 1 = UK; 2 = other primarily public healthcare systems in Organisation for Economic Cooperation and Development (OECD) countries (e.g. EU, Canada, Australia); 3 = primarily private healthcare systems in OECD countries (e.g. US, Switzerland). 4 = non-OECD countries – this was an exclusion criteria.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Expert Consensus

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Levels of Evidence for Intervention Studies

|Level|Type of Evidence| |---|---| |1++|High-quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias| |1+|Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias| |1-|Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias*| |2++|High-quality systematic reviews of case-control or cohort studies|

||High-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal| |---|---| |2+|Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal| |2-|Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal*| |3|Non-analytical studies (for example, case reports, case series)| |4|Expert opinion, formal consensus|

*Studies with a level of evidence '-' should not be used as a basis for making a recommendation (see section 7.4 of guideline development manual)

Levels of Evidence for Diagnostic Studies

|Level|Type of Evidence| |---|---| |Ia|Systematic review (with homogeneity)$^{a}$ of level-1 $studies^{b}$| |Ib|Level-1 $studies^{b}$| |II|Level-2 $studies^{c}$| |III|Systematic reviews of level-2 studies| |III|Level-3 $studies^{d}$ Systematic reviews of level-3 studies| |IV|Consensus, expert committee reports or opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or 'first principles'|

ª Homogeneity means there are no or minor variations in the directions and degrees of results between individual studies that are included in the systematic review.

b Level-1 studies are studies:

$\bullet$ That use a blind comparison of the test with a validated reference standard (gold standard)

$\bullet$ In a sample of patients that reflects the population to whom the test would apply

c Level-2 studies are studies that have only one of the following:

$\bullet$ Narrow population (the sample does not reflect the population to whom the test would apply)

$\bullet$ Use a poor reference standard (defined as that where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference')

$\bullet$ The comparison between the test and reference standard that is not blind

$\bullet$ Case-control studies

d Level-3 studies are studies that have at least two or three of the features listed for level-2 studies

Methods Used to Analyze the Evidence

Meta-Analysis of Randomized Controlled Trials

Review of Published Meta-Analyses

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Appraising the Evidence

The Research Fellow or Health Economist, as appropriate, critically appraised the full papers. In general, no formal contact was made with authors however there were ad hoc occasions when this was required in order to clarify specific details. Critical appraisal checklists were compiled for each full paper. One Research Fellow undertook the critical appraisal and data extraction. The evidence was considered carefully by the guideline development group (GDG) for accuracy and completeness.

All procedures are fully compliant with the:

$\bullet$ National Institute for Health and Clinical Excellence (NICE) methodology as detailed in the 'Guideline Development Methods - Information for National Collaborating Centres (NCC) and Guideline Developers' Manual

$\bullet$ National Collaborating Centre for Chronic Conditions (NCC-CC) Quality assurance document and systematic review chart

Distilling and Synthesising the Evidence and Developing Recommendations

The evidence from each full paper was distilled into an evidence table and synthesised into evidence statements before being presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations.

Evidence tables are available on the NICE website.

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

The guideline development group (GDG) employed formal consensus techniques to:

$\bullet$ Ensure that the recommendations reflected the evidence-base

$\bullet$ Approve recommendations based on lesser evidence or extrapolations from other situations

$\bullet$ Reach consensus recommendations where the evidence was inadequate

$\bullet$ Debate areas of disagreement and finalise recommendations

The GDG also reached agreement on the following:

$\bullet$ Recommendations as key priorities for implementation

$\bullet$ Key research recommendations

$\bullet$ Algorithms

In prioritising key recommendations for implementation, the GDG took into account the following criteria:

* High clinical impact

* High impact on reducing variation in practice

* More efficient use of National Health Service (NHS) resources

* Allowing the patient to reach critical points in the care pathway more quickly

Audit criteria for this guideline will be produced for National Institute for Health and Clinical Excellence (NICE) following publication in order to provide suggestions of areas for audit in line with the key recommendations for implementation.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Assessing the Cost-Effectiveness of Interventions

It is important to investigate whether healthcare interventions are cost effective as well as clinically effective. That is they offer good value for money. This helps to get the most health gain from available National Health Service (NHS) resources. In any healthcare system resources are finite and choices must be made about how best to spend limited budgets. The guideline developers want to prioritise interventions that provide a high health gain relative to their cost.

Cost-effective analysis compares the costs and health outcomes of two or more alternative healthcare interventions. The criteria applied to an intervention to be considered cost effective were either:

a. The intervention dominated other relevant strategies – that is, it is both less costly in terms of resource use and more clinically effective when compared to other relevant strategies.

b. The intervention cost less than £20,000 per quality-adjusted life-year (QALY) gained compared with the next best strategy

Where health outcomes were not expressed in QALYs or economic evidence was not available the Guideline Development Group (GDG) made a judgement based on the available evidence.

The GDG agreed a priority area for original health economic modelling for the guideline. The analysis undertaken looked at alternative combined antiplatelet and antithrombin strategies. See Appendix C in the full version of the original guideline document for the full report. A summary of relevant results is also included in each relevant chapter of the guideline.

The following general principles were adhered to:

$\bullet$ The GDG was consulted during the construction and interpretation of the model.

$\bullet$ The model was based on clinical evidence identified from the systematic review of clinical evidence.

$\bullet$ Model inputs and assumptions were reported fully and transparently.

$\bullet$ Sensitivity analysis was used to explore uncertainties in model inputs and methods.

$\bullet$ Costs were estimated from an NHS perspective.

Method of Guideline Validation

External Peer Review

Internal Peer Review

Description of Method of Guideline Validation

The guideline was validated through two consultations.

1. The first draft of the guideline (the Full guideline, National Institute for Health and Clinical Excellence [NICE] guideline, and Quick Reference Guide) were consulted with Stakeholders and comments were considered by the Guideline Development Group (GDG)

2. The final consultation draft of the Full guideline, the NICE guideline, and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

Recommendations

Major Recommendations

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGGCASS) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Provision of Information

Offer patients clear information about the risks and benefits of the treatments offered so that they can make informed choices about management strategies. Information should be appropriate to the patient's underlying risk of a future adverse cardiovascular event and any co morbidities.

Assessment of a Patient's Risk of Future Adverse Cardiovascular Events

As soon as the diagnosis of unstable angina or non ST-elevation myocardial infarction (NSTEMI) is made, and aspirin and antithrombin therapy have been offered, formally assess individual risk of future adverse cardiovascular events using an established risk scoring system that predicts 6-month mortality (for example, Global Registry of Acute Cardiac Events [GRACE]).

Include in the formal risk assessment:

* A full clinical history (including age, previous myocardial infarction [MI] and previous percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG])

$\bullet$ A physical examination (including measurement of blood pressure and heart rate)

* Resting 12-lead electrocardiography (ECG) (looking particularly for dynamic or unstable patterns that indicate myocardial ischaemia)

$\bullet$ Blood tests (such as troponin I or T, creatinine, glucose and haemoglobin).

$\bullet$ Record the results of the risk assessment in the patient's care record.

* Use risk assessment to guide clinical management, and balance the benefit of a treatment against any risk of related adverse events in the light of this assessment.

* Use predicted 6-month mortality to categorise the risk of future adverse cardiovascular events as follows:*

|Predicted 6-month Mortality|Risk of Future Adverse Cardiovascular Events| |---|---| |1.5% or below|Lowest| |>1.5 to 3.0%|Low| |>3.0 to 6.0%|Intermediate| |>6.0 to 9.0%|High| |Over 9.0%|Highest|

Categories of risk are derived from the Myocardial Ischaemia National Audit Process (MINAP) database. More details are in the full guideline (see the "Availability of Companion Documents" field).

Antiplatelet Therapy

Aspirin

$\bullet$ Offer aspirin as soon as possible to all patients and continue indefinitely unless contraindicated by bleeding risk or aspirin hypersensitivity.

$\bullet$ Offer patients a single loading dose of 300 mg aspirin as soon as possible unless there is clear evidence that they are allergic to it.

$\bullet$ For patients with aspirin hypersensitivity, clopidogrel monotherapy should be considered as an alternative treatment. (This recommendation is from MI: secondary prevention (see the National Guideline Clearinghouse [NGC] summary of the National Institute for Health and Clinical Excellence [NICE] clinical guideline).

Clopidogrel

Recommendations in this section update and replace recommendations for the early management of unstable angina

and NSTEMI from Clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome [X] (NICE technology appraisal [TA] guidance 80).

$\bullet$ As soon as the risk of adverse cardiovascular events has been assessed, offer a loading dose of 300 mg clopidogrel in addition to aspirin to patients with a predicted 6-month mortality of more than 1.5% and no contraindications (for example, an excessive bleeding risk)

$\bullet$ Offer a 300 mg loading dose of clopidogrel to all patients with no contraindications who may undergo PCI within 24 hours of admission to hospital. , †

$\bullet$ It is recommended that treatment with clopidogrel in combination with low-dose aspirin should be continued for

12 months after the most recent acute episode of non-ST-segment-elevation acute coronary syndrome (ACS). Thereafter, standard care, including treatment with low-dose aspirin alone, is recommended. (This recommendation has been incorporated from TA 80.)

$\bullet$ Consider discontinuing clopidogrel treatment 5 days before coronary artery bypass graft (CABG) in patients who have a low risk of adverse cardiovascular events.

$\bullet$ For patients at intermediate or higher risk of adverse cardiovascular events, discuss the continuation of clopidogrel before CABG with the cardiac surgeon and base the decision on the balance of ischaemic and bleeding risk.

**In this guideline, clopidogrel refers to clopidogrel hydrogen sulphate.

***In line with Prasugrel for the treatment of acute coronary syndromes with percutaneous coronary intervention (NICE technology appraisal guidance 182) (see the NGC summary of the NICE guideline), prasugrel in combination with aspirin is an option for patients undergoing PCI who have diabetes or have had stent thrombosis with clopidogrel treatment.

†There is emerging evidence about the use of a 600-mg loading dose of clopidogrel for patients undergoing PCI within 24 hours of admission. Clopidogrel does not have UK marketing authorisation for use at doses above 300 mg. The GDG was not able to formally review all the evidence for a 600-mg loading dose and was therefore not able to recommend this at the time of publication (March 2010).

Glycoprotein IIb/IIIa Inhibitors (GPI)

Recommendations in this section update and replace recommendations for the early management of unstable angina and NSTEMI from Guidance on the use of glycoprotein IIb/IIIa inhibitors in the treatment of acute coronary syndrome (NICE technology appraisal (TA) guidance 47).

$\bullet$ Consider intravenous eptifibatide or tirofiban‡ as part of the early management for patients who have an intermediate or higher risk of adverse cardiovascular events (predicted 6-month mortality above 3.0%), and who are scheduled to undergo angiography within 96 hours of hospital admission.

$\bullet$ Consider abciximab as an adjunct to PCI for patients at intermediate or higher risk of adverse cardiovascular events who are not already receiving a GPI.

$\bullet$ Balance the potential reduction in a patient's ischaemic risk with any increased risk of bleeding, when determining whether a GPI should be offered.

*Eptifibatide and tirofiban are licensed for use with aspirin and unfractionated heparin. They do not have UK marketing authorisation for use with copidogrel. This recommendation is therefore for an off-label use of these drugs. Informed consent should be obtained and documented before they are used in combination with clopidogrel.

Antithrombin Therapy

$\bullet$ Offer fondaparinux to patients who do not have a high bleeding risk, unless coronary angiography is planned within 24 hours of admission.

* Offer unfractionated heparin as an alternative to fondaparinux to patients who are likely to undergo coronary angiography within 24 hours of admission.

* Carefully consider the choice and dose of antithrombin in patients who have a high risk of bleeding associated with any of the following:

$\bullet$ Advancing age

$\bullet$ Known bleeding complications

$\bullet$ Renal impairment

$\bullet$ Low body weight

$\bullet$ Consider unfractionated heparin, with dose adjustment guided by monitoring of clotting function, as an alternative to fondaparinux for patients with significant renal impairment (creatinine above 265 micromoles per litre).

$\bullet$ Offer systemic unfractionated heparin (50–100 units/kg) in the cardiac catheter laboratory to patients receiving fondaparinux who are undergoing PCI.§

$\bullet$ As an alternative to the combination of a heparin plus a GPI, consider bivalirudin for patients who:

$\bullet$ Are at intermediate or higher risk of adverse cardiovascular events (predicted 6-month mortality above 3%), and

$\bullet$ Are not already receiving a GPI or fondaparinux, and

$\bullet$ Are scheduled to undergo angiography (with follow-on PCI if indicated) within 24 hours of admission

$\bullet$ As an alternative to the combination of a heparin plus a GPI, consider bivalirudin for patients undergoing PCI who:

$\bullet$ Are at intermediate or higher risk of adverse cardiovascular events, and

$\bullet$ Are not already receiving a GPI or fondaparinux.

§Infractionated heparin is not licensed for use during angiography and PCI. Such use is an off-label use. Informed consent should be obtained and documented before it is used during angiography and PCI.

Management Strategies

Early Invasive versus Conservative Management

$\bullet$ Offer coronary angiography (with follow-on PCI if indicated) within 96 hours of first admission to hospital to patients who have an intermediate or higher risk of adverse cardiovascular events (predicted 6-month mortality above 3.0%) if they have no contraindications to angiography (such as active bleeding or comorbidity). Perform angiography as soon as possible for patients who are clinically unstable or at high ischaemic risk.

$\bullet$ Offer conservative management without early coronary angiography to patients with a low risk of adverse cardiovascular events (predicted 6-month mortality 3.0% or less).$\bullet$ Offer coronary angiography (with follow-on PCI if indicated) to patients initially assessed to be at low risk of adverse cardiovascular events (predicted 6-month mortality 3.0% or less) if ischaemia is subsequently experienced or is demonstrated by ischaemia testing.

Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting

$\bullet$ When advising patients about the choice of revascularisation strategy (PCI or CABG), take account of coronary angiographic findings, comorbidities, and the benefits and risks of each intervention.

$\bullet$ When the role of revascularisation or the revascularisation strategy is unclear, resolve this by discussion involving an interventional cardiologist, cardiac surgeon and other healthcare professionals relevant to the needs of the patient. Discuss the choice of revascularisation strategy with the patient.

Testing for Ischaemia

$\bullet$ To detect and quantify inducible ischaemia, consider ischaemia testing before discharge for patients whose condition has been managed conservatively and who have not had coronary angiography.

Assessing Left Ventricular Function

$\bullet$ Assessment of left ventricular function is recommended in all patients who have had an MI. (This recommendation is from MI: secondary prevention (see the NGC summary of the NICE guideline).

$\bullet$ Consider assessing left ventricular function in all patients with unstable angina.

$\bullet$ Record measures of left ventricular function in the patient's care record and in correspondence with the primary healthcare team and the patient.

Rehabilitation and Discharge Planning

* Before discharge offer patients advice and information about:

$\bullet$ Their diagnosis and arrangements for follow-up (in line with MI: secondary prevention, see the NGC summary of the NICE clinical guideline).

$\bullet$ Cardiac rehabilitation (in line with MI: secondary prevention, see the NGC summary of the NICE clinical guideline).

$\bullet$ Management of cardiovascular risk factors and drug therapy for secondary prevention (in line with MI: secondary prevention [NICE clinical guideline 48] and Lipid modification [see the NGC summaries of the NICE clinical guidelines]).

$\bullet$ Lifestyle changes (in line with MI: secondary prevention, NICE clinical guideline 48) (see the NGC summary of the NICE guideline).

$\bullet$ Cardiac rehabilitation should be equally accessible and relevant to all patients after an MI, particularly people from groups that are less likely to access this service. These include people from black and minority ethnic groups, older people, people from lower socioeconomic groups, women, people from rural communities and people with mental and physical health comorbidities. (This recommendation is from MI: secondary prevention [see the NGC summary of the NICE guideline]).

$\bullet$ All patients who smoke should be advised to quit and be offered support and advice, and referral to an intensive support service (for example, the NHS Stop Smoking Services) in line with 'Brief interventions and referral for smoking cessation in primary care and other settings' (see the NGC summary of the NICE clinical guideline Brief interventions and referral for smoking cessation in primary care and other settings). (This recommendation is adapted from MI: secondary prevention, see the NGC summary of the NICE guideline).

Clinical Algorithm(s)

A clinical algorithm is provided in the quick reference version (see "Availability of Companion Documents" field) of the original guideline document: "The early management of unstable angina and NSTEMI."

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

$\bullet$ Appropriate early management of patients with unstable angina and non-ST-elevation myocardial infarction (NSTEMI)

$\bullet$ Prevention of future adverse cardiovascular events

Potential Harms

Clopidogrel

Clopidogrel carries the risk of both major and minor bleeding.

Anticoagulants, Including Heparin

Bleeding (major and minor) and (with use of heparin) a reduced risk of immune-mediated thrombocytopenia.

Glycoprotein IIb/IIIa Inhibitors (GPIs)

Treatment with glycoprotein IIb/IIIa antagonists increases the risk of bleeding. Balance the potential reduction in a patient's ischaemic risk with any increased risk of bleeding, when determining whether a GPI should be offered.

Coronary Revascularization Procedures

All revascularization procedures carry the risk of intraoperative and postoperative complications, including death.

Qualifying Statements

Qualifying Statements

$\bullet$ National Institute for Health and Clinical Excellence (NICE) clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the National Health Service (NHS) in England and Wales.

$\bullet$ This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgment. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.

$\bullet$ Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

Implementation of the Guideline

Description of Implementation Strategy

National Institute for Health and Clinical Excellence (NICE) has developed tools to help organisations implement this guidance (see the "Availability of Companion Documents" field).

Implementation Tools

Audit Criteria/Indicators

Chart Documentation/Checklists/Forms

Clinical Algorithm

Foreign Language Translations

Patient Resources

Quick Reference Guides/Physician Guides

Resources

Slide Presentation

For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Getting Better

Living with Illness

IOM Domain

Effectiveness

Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)

National Clinical Guideline Centre for Acute and Chronic Conditions. Unstable angina and NSTEMI: the early management of unstable angina and non-ST-segment-elevation myocardial infarction. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Mar. 26 p. (Clinical guideline; no. 94).

Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released

2010 Mar

Guideline Developer(s)

National Clinical Guideline Centre for Acute and Chronic Conditions - National Government Agency [Non-U.S.]

Source(s) of Funding

National Institute for Health and Clinical Excellence

Guideline Committee

Guideline Development Group

Composition of Group That Authored the Guideline

Guideline Development Group: Professor John Camm (Chair), BHF Professor of Clinical Cardiology, St George's, University of London; Dr Huon Gray (Clinical Advisor), National Clinical Guideline Centre for Acute and Chronic Conditions, Consultant Cardiologist, Southampton University Hospital; Mr Sotiris Antoniou, Principal Cardiac Pharmacist, Barts and the London NHS Trust, Lead Pharmacist for North East London Cardiac and Stroke Network; Ms Lina Bakhshi, Senior Information Scientist, National Clinical Guideline Centre for Acute and Chronic Conditions; Ms Jenny Cadman, Cardiac Rehabilitation Service Manager, Senior Nurse in Cardiology, Luton and Dunstable Hospital NHS Trust; Dr Emily Crowe, (from May 2008 to November 2009), Senior Research Fellow, National Clinical Guideline Centre for Acute and Chronic Conditions; Dr Mark de Belder, Consultant Cardiologist, James Cook University Hospital, Middlesbrough; Dr Jose Diaz (until May 2008), Research Fellow, National Clinical Guideline Centre for Acute and Chronic Conditions; Mr David H Geldard, Patient and carer representative, Immediate Past President, Heart Care Partnership (UK); Dr Robert Henderson, Consultant Cardiologist, Nottingham University Hospitals; Ms Marjan Jahangiri, Professor of Cardiac Surgery, St George's University of London; Ms Taryn Krause (from November 2008), Senior Project Manager, National Clinical Guideline Centre for Acute and Chronic Conditions; Miss Kate Lovibond, Health Economist, National Clinical Guideline Centre for Acute and Chronic Conditions; Mr Gavin Maxwell, Patient and carer representative, Patient and Carer Network, Royal College of Physicians, London; Dr Francis Morris, Accident and Emergency Physician, Sheffield Teaching Hospitals NHS Trust; Mr Alun Roebuck, Cardiology Nurse Consultant, Sunderland City Hospital; Ms Nicola Sloan (July 2008 to March 2009), Research Fellow, National Clinical Guideline Centre for Acute and Chronic Conditions; Ms Claire Turner (until November 2008), Senior Project Manager, National Clinical Guideline Centre for Acute and Chronic Conditions; Professor S Richard Underwood, Professor of Cardiac Imaging, Imperial College London; Mr Mark Whitbread, Clinical Practice Manager, Senior Paramedic, Cardiac Lead Medical Directorate, London Ambulance Service NHS Trust

Financial Disclosures/Conflicts of Interest

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site [X].

Availability of Companion Documents

The following are available:

$\bullet$ Unstable angina and NSTEMI: the early management of unstable angina and non-ST-segment-elevation myocardial infarction. Full guideline. London (UK): National Institute for Health and Clinical Excellence; 2010 Mar. 360 p. (Clinical guideline; no. 94). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site [x]. $\bullet$ Unstable angina and NSTEMI. Appendices to the full version. London (UK): National Institute for Health and Clinical Excellence; 2010 Mar. Various p. (Clinical guideline; no. 94). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site [x].

Format (PDF) from the NICE Web site [x].

$\bullet$ Unstable angina and NSTEMI. Quick reference guide. London (UK): National Institute for Health and Clinical Excellence; 2010 Mar. 8 p. (Clinical guideline; no. 94). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site [x].

$\bullet$ Unstable angina and NSTEMI. Costing statement. London (UK): National Institute for Health and Clinical Excellence; 2010 Mar. 4 p. (Clinical guideline; no. 94). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site [x].

$\bullet$ Unstable angina and NSTEMI. Audit support. London (UK): National Institute for Health and Clinical Excellence; 2010 Mar. 13 p. (Clinical guideline; no. 94). Electronic copies: Available from the NICE Web site [x].

$\bullet$ Unstable angina and NSTEMI. Slide set. London (UK): National Institute for Health and Clinical Excellence; 2010.

21 p. (Clinical guideline; no. 94). Electronic copies: Available from the NICE Web site [x].

* Unstable angina and NSTEMI. Patient questionnaire. London (UK): National Institute for Health and Clinical

* Unstable angina and NSTEMI. Patient questionnaire. London (UK): National Institute for Health and Clinical

* Unstable angina and NSTEMI. Patient questionnaire. London (UK): National Institute for Health and Clinical

Excellence; 2010. 7 p. (Clinical guideline; no. 94). Electronic copies: Available from the NICE Web site [x].

Excellence; 2010. 7 p. (Clinical guideline; no. 94). Electronic copies: Available from the NICE Web site [x].

* Unstable angina and NSTEMI. Baseline assessment. London (UK): National Institute for Health and Clinical

Excellence; 2010. Various p. (Clinical guideline; no. 94). Electronic copies: Available from the NICE Web site [x].

* The guidelines manual 2009. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Jan.

* The guidelines manual 2009. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Jan.

$\bullet$ The guidelines manual 2009. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Jan.

Electronic copies: Available from the National Health Service (NHS) Response Line 0845 003 7783 or email

Print copies: Available from the National Health Service (NHS) Response Line 0845 003 7783 or email

publications@nice.org.uk and quote: N2111. MidCity Place, 71 Holborn, London WC1V 6NA

Patient Resources

The following are available:

* Unstable angina and NSTEMI. Understanding NICE guidance - Information for people who use NHS services. London (UK): National Institute for Health and Clinical Excellence. (Clinical guideline; no. 94). Electronic copies:

London (UK): National Institute for Health and Clinical Excellence (NICE) Web site.

Available in English [x] and Welsh [x] from the National Institute for Health and clinical Excellence (NICE) Web site.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on January 4, 2010.

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their Technology Appraisal guidance with the intention of disseminating and facilitating the implementation of that guidance. NICE has not verified this content to confirm that it accurately reflects the original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE technology appraisal guidance is prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk [x].

be found at www.nice.org.uk [x]

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

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Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion-criteria.aspx.

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表 1
LevelType of Evidence
1++High-quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias
1+Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias*
2++High-quality systematic reviews of case-control or cohort studies
表 2
High-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal
2+Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal
2-Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal*
3Non-analytical studies (for example, case reports, case series)
4Expert opinion, formal consensus
表 3
LevelType of Evidence
IaSystematic review (with homogeneity)$^{a}$ of level-1 $studies^{b}$
IbLevel-1 $studies^{b}$
IILevel-2 $studies^{c}$
IIISystematic reviews of level-2 studies
IIILevel-3 $studies^{d}$ Systematic reviews of level-3 studies
IVConsensus, expert committee reports or opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or 'first principles'
表 4
Predicted 6-month MortalityRisk of Future Adverse Cardiovascular Events
1.5% or belowLowest
>1.5 to 3.0%Low
>3.0 to 6.0%Intermediate
>6.0 to 9.0%High
Over 9.0%Highest
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引用 / 出处

2010NICE 不稳定型心绞痛/NSTEMI:不稳定型心绞痛和非ST段抬高型心肌梗死的早期管理. 2010.