Evidence
Surveillance decision
Surveillance decision
This report describes the joint surveillance review of clinical guidelines on the early management of unstable angina and non-ST-elevation myocardial infarction (NSTEMI) NICE guideline CG94 and early management of myocardial infarction with ST-segment elevation (STEMI) NICE guideline CG167.
Following the joint surveillance review of CG94 and CG167 and a recent review of the clinical guideline on management of hyperglycaemia in acute coronary syndromes (CG130), it is proposed that the 3 guidelines should be combined to ensure that recommendations on the management of acute coronary syndromes fall under 1 clinical guideline.
Unstable angina and NSTEMI: early management (CG94)
We will plan an update of the following clinical areas:
1. Antiplatelet therapy
-
Which antiplatelet is most effective for managing patients with unstable angina (UA) or NSTEMI? (Note: this clinical question has been amended after reviewing new evidence on antiplatelet therapy.)
2. Management strategies
-
In adults with UA or non-ST elevation myocardial infarction (MI) does early invasive investigation (that is, angiography) with intent to assess for (and in those patients deemed suitable, to perform) revascularisation improve outcomes in comparison with initial conservative treatment, with or without later angiography?
We propose adding the following new question to the guideline:
-
What is the clinical and cost effectiveness of drug-eluting stents in patients with unstable angina or NSTEMI undergoing percutaneous coronary intervention (PCI)?
Myocardial infarction with ST-segment elevation: acute management (CG167)
We will plan an update of the clinical question relating to culprit versus complete revascularisation:
-
What is the clinical and cost effectiveness of multivessel PCI compared to culprit-only primary PCI (PPCI) in people with STEMI and multivessel coronary disease undergoing PPCI?
We propose adding the following new questions to the guideline:
-
What is the clinical and cost effectiveness of PPCI using drug-eluting stents in people with STEMI?
-
What is the clinical and cost effectiveness of antithrombins (such as bivalirudin) in patients with STEMI undergoing PPCI?
We propose that the combined guideline incorporates recommendations from NICE technology appraisal guidance that was developed after the clinical guideline was published: prasugrel with percutaneous coronary intervention for treating acute coronary syndromes. Recommendations will be incorporated subject to the outcome of a technology appraisal review proposal (expected in 2017).
Reason for the decision
We found 132 new studies through surveillance: 8 new studies for CG94 and 124 new studies for CG167.
Unstable angina and NSTEMI: early management (CG94)
Although none of the identified new evidence was thought to impact recommendations, topic experts, including those who helped to develop the guideline, advised us that the following sections of the guideline should be updated.
Antiplatelet therapy
-
Which antiplatelet is most effective for managing patients with UA or NSTEMI? (Note: this clinical question has been amended after reviewing new evidence on antiplatelet therapy.)
There was a strong indication from topic experts that the guideline needed to be updated. Experts stated that although no new evidence has been identified from literature searches, clinical practice indicates that ticagrelor and prasugrel are more potent and predictable antiplatelets than clopidogrel, but they also carry an increased risk of bleeding. As a result, cardiologists need to consider the predicted ischaemic risk and the estimated risk of bleeding. A further consideration is the duration of dual antiplatelet therapy. Experts stated that European Society of Cardiology and American Heart Association guidelines incorporated these issues into their revised guideline, which makes the prescription of antiplatelet therapy more individualised.
Decision: This review question should be updated.
Management strategies
-
In adults with UA or non-ST elevation MI does early invasive investigation (that is, angiography) with intent to assess for (and in those patients deemed suitable, to perform) revascularisation improve outcomes in comparison with initial conservative treatment, with or without later angiography?
Topic experts stated that there is an ongoing debate about whether angiography centres should have 24/7 capabilities for interventional procedures (angioplasty). They felt that this presents a substantive question about the structure of service provision. Some experts suggested that early angiography results in less radiation to the patient, less renal nephropathy, reduced tariff and shorter length of stay. They suggested that this is likely to have an impact on health economic modelling. Another topic expert suggested that patients with suspected non-ST elevation acute coronary syndromes are increasingly being offered coronary angiography (invasive strategy) and systematic use of risk stratification is not widely used. Furthermore, experts felt that evidence highlights that patients who are at highest risk of ischaemia benefit most from early angiography; however, data from registries suggests that cardiologists do not always select these patients
Decision: This review question should be updated.
New question: Drug-eluting stents
-
What is the clinical and cost effectiveness of drug-eluting stents in patients with UA or NSTEMI undergoing PCI? (Note: this question was derived from technology appraisal guidance on drug-eluting stents for the treatment of coronary artery disease.)
During the 6-year surveillance review of CG94, 1 new study on drug-eluting stents was identified; however, it was considered not to have an impact on guideline recommendations. A considerable amount of new evidence was identified from randomised controlled trials (RCTs) during the 2‑year surveillance review of CG167 (see below). The new evidence indicated that CG167 needed updating. Because both guidelines are due to be combined, it is proposed that this clinical question should be added to ensure that the combined guideline covers the use of drug-eluting stents for different types of acute coronary syndromes.
Decision: This review question should be added.
Myocardial infarction with ST-segment elevation: acute management (CG167)
New evidence that could affect recommendations was identified. Topic experts, including those who helped to develop the guideline, advised us about whether the following sections of the guideline should be updated and any new sections added.
Culprit versus complete revascularisation
-
What is the clinical and cost effectiveness of multivessel PCI compared to culprit-only PPCI in people with STEMI and multivessel coronary disease undergoing PPCI?
Currently, CG167 makes no recommendations on the use of multivessel PCI in people with STEMI and multivessel coronary disease.
One large RCT indicated some benefit of multivessel PCI whereas the remaining identified studies reported no significant differences between multivessel PCI and culprit-only PPCI in people with STEMI and multivessel coronary disease undergoing PPCI. In combination with the opinions of topic experts, the identified new evidence suggests that recommendations on the role of multivessel PCI could inform future clinical practice.
Decision: This review question should be updated.
New question: Drug-eluting stents
-
What is the clinical and cost effectiveness of PPCI using drug-eluting stents in people with STEMI? (Note: this question was derived from NICE's technology appraisal guidance on drug-eluting stents for the treatment of coronary artery disease.)
CG167 makes recommendations on PPCI using bare-metal stents but does not make any recommendations on PPCI using drug-eluting stents in patients with STEMI.
A considerable amount of evidence was identified that assessed the safety and efficacy of drug-eluting stents. The identified new evidence comparing drug-eluting stents and bare-metal stents was inconsistent: some studies indicated that drug-eluting stents were safer and more effective than bare-metal, whereas other studies reported no significant differences between the 2 types of stent. When different types of drug-eluting stents were compared against each other results tended to favour everolimus-eluting stents. Studies also reported that new stent designs conferred better outcomes than older designs. Topic experts highlighted that drug-eluting stent prices have decreased significantly since their initial introduction and bare-metal stents are generally no longer used for patients with STEMI. They felt that this may have cost implications on procurement.
It was considered that an extensive review of the evidence base on drug-eluting stents would ensure that their role in treatment of patients with STEMI is clearly defined.
Decision: This review question should be added.
New question: Antithrombin therapy
-
What is the clinical and cost effectiveness of antithrombins (such as bivalirudin) in patients with STEMI undergoing PPCI?
CG167 incorporates a recommendation from NICE's technology appraisal guidance on bivalirudin for the treatment of ST-segment-elevation myocardial infarction:
1.2.2 Bivalirudin in combination with aspirin and clopidogrel is recommended for the treatment of adults with STEMI undergoing primary PCI.
The new evidence was inconsistent in reporting the direction of the treatment effect of bivalirudin when used during PPCI. Some studies reported that bivalirudin was more effective than other antithrombins; some reported that it was less effective and others reported no difference in outcomes. Topic experts highlighted uncertainties about older studies and felt that new evidence suggests that heparin is superior to bivalirudin. The inconsistent evidence in addition to uncertainties outlined by topic experts indicates that this question should be updated to clarify the role bivalirudin and other antithrombins in patients with STEMI.
Decision: This review question should be added subject to agreement to update the technology appraisal on bivalirudin.
Recommendations from NICE technology appraisals
We identified that NICE technology appraisal guidance on prasugrel with percutaneous coronary intervention for treating acute coronary syndromes was developed after the clinical guideline was published. It was considered that the technology appraisal was a relevant NICE guidance.
Decision: We propose that the clinical guideline incorporates recommendations from the technology appraisal subject to the outcome of a technology appraisal review proposal (expected in 2017).
Other clinical areas
Unstable angina and NSTEMI: early management (CG94)
We found new evidence for CG94 that was not thought to have an effect on current recommendations. This evidence related to the efficacy and safety of adding a glycoprotein inhibitor (GPI; tirofiban, eptifibatide and abciximab) to aspirin and heparin therapy as adjunct therapy to patients with UA/ NSTEMI undergoing primary coronary intervention (PPCI).
We did not find any new evidence related to:
-
Tables, equations, engines or scoring systems for patient-risk stratification.
-
The efficacy and safety of aspirin therapy compared to placebo.
-
The efficacy and safety of adding a low-molecular-weight heparin (LMWH) compound to aspirin (with or without clopidogrel).
-
The efficacy and safety of adding a factor Xa inhibitor (fondaparinux) to aspirin.
-
The efficacy and safety of adding a synthetic pentasaccharide (fondaparinux and enoxaparin) to aspirin as adjunct therapy to patients undergoing PCI.
-
The efficacy and safety of adding a thrombin inhibitor (bivalirudin) to the combination of aspirin, with or without a glycoprotein inhibitor (GPI).
-
The efficacy and safety of adding a thrombin inhibitor (hirudin and bivalirudin) to the combination of aspirin and a GPI as adjunct therapy in patients undergoing PCI.
-
Comparisons between coronary artery bypass grafting and PCI.
-
Intra-aortic balloon pump counterpulsation.
-
Investigation for myocardial ischaemia prior to hospital discharge in patients who do not undergo angiography.
-
Pre-discharge assessment of left ventricular function.
-
Psychosocial and educational interventions, mobilisation and discharge planning (cardiac rehabilitation – phase 1).
Myocardial infarction with ST-segment elevation: acute management (CG167)
We found new evidence related to CG167 that was not thought to have an effect on current recommendations. This evidence related to time to perfusion, pre-hospital versus in-hospital fibrinolysis, facilitated PPCI, radial versus femoral access, thrombus extraction during PPCI, hospital volumes of PPCI, rescue PCI and routine early angiography following fibrinolysis.
We did not find any new evidence related to cardiogenic shock and treatment of people who remain unconscious after a cardiac arrest.
Overall decision
After considering all the new evidence and views of topic experts, we decided that partial updates were necessary for both guidelines.
See how we made the decision for further information.
This page was last updated: 29 September 2016