NICE draft guidance recommends new "clot-busting" drug to treat acute coronary syndromes

NICE draft guidance recommends new "clot-busting" drug to treat acute coronary syndromes
In draft guidance published today (30 June) NICE has recommended ticagrelor (Brilique, Astrazeneca) in combination with aspirin as an option to treat adults with acute coronary syndromes.

Acute coronary syndromes refer to a group of heart problems ranging from myocardial infarction (heart attacks) to unstable angina, which occur due to narrowed coronary arteries. They are usually caused by coronary heart disease where cholesterol-rich deposits, or plaques, form within the walls of coronary arteries (atherosclerosis). This can cause the coronary artery to become progressively narrowed, and blood supply to the heart is affected (ischaemia).

ST-segment-elevation myocardial infarction (STEMI) and Non-ST-segment-elevation myocardial infarction (NSTEMI) (the names come from the pattern seen on an ECG, which measures the rhythm and electrical activity of the heart) happens when the plaques tear, forming blood clots that block the coronary artery resulting in damage to the heart muscle. Where the blood supply to the heart is blocked, but there is no evidence of actual damage to the heart muscle, the clinical syndrome is described as unstable angina. ACS becomes more common with increasing age and incidence is higher in men than women.

Ticagrelor belongs to a class of drugs called anti-platelets. These work by reducing or preventing the formation of blood clots. Ticagrelor is licensed for people with acute coronary syndromes who are managed medically or who are having a procedure called a percutaneous coronary intervention to widen narrowed arteries in the heart. The draft guidance recommends ticagrelor in combination with aspirin as a treatment option in adults with acute coronary syndrome, including those with STEMI and NSTEMI. It also recommends ticagrelor in combination with aspirin as a treatment option for unstable angina in hospitalised patients who have changes on an ECG suggestive of ischaemia and a risk factor for cardiovascular disease.

Dr Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Ticagrelor is the latest in an ever increasing number of important new drugs and interventional techniques that have been shown to reduce deaths in patients with ACS. From the evidence considered, the independent Appraisal Committee concluded that, compared with clopidogrel, reductions in MI and death from vascular causes were significant - 16% and 21% respectively - for patients randomised to the ticagrelor group. All anti-platelets, because of their mechanism of action, can cause bleeding. Importantly, the same evidence showed that there was no significant difference in the primary safety endpoint of ‘major' bleeding between ticagrelor and clopidogrel."

NICE has not yet issued final guidance to the NHS. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. NICE's preliminary guidance is available for public consultation on the NICE website until 21 July2011. Feedback received during consultation may result in changes to the preliminary recommendations and will be considered by the Appraisal Committee at their next meeting.


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Notes to Editors
About the draft guidance
1. The appraisal consultation document (ACD) will be available on the NICE website at from Thursday, 30 June. Consultation will take place between 30 June and 21 July 2011.

2. Ticagrelor (Brilique, AstraZeneca) is an oral reversibly bound antagonist of the P2Y12 adenosine diphosphate (ADP) receptor which inhibits platelets aggregation and therefore thrombus formation in atherosclerotic disease. The summary of product characteristics (SPC) states that ticagrelor, co-administered with acetylsalicylic acid (aspirin, ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) defined as people with ST-segment-elevation MI (STEMI), non-ST-segment-elevation MI (NSTEMI) or unstable angina. Patients may be managed medically or revascularised with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

3. According to the SPC, treatment should be initiated with a single 180 mg (2 tablets of 90 mg) loading dose of ticagrelor and then continued at 90 mg twice daily for up to 12 months. Patients taking ticagrelor should also take aspirin daily, unless specifically contraindicated. Following an initial loading dose of aspirin, ticagrelor should be taken daily with a maintenance dose of aspirin of 75-150 mg.

4. The manufacturer stated in its submission that the cost of 90 mg tablets of ticagrelor is £54.60 for a pack of 56 tablets (28 days). Costs may vary in different settings because of procurement discounts.

5. Current NICE guidance (TA182) recommends prasugrel as an option for preventing atherothrombotic events in people with ACS having PCI, only when immediate primary PCI for STEMI is necessary, or stent thrombosis has occurred during treatment with clopidogrel, or the patient has diabetes.

6. NICE clinical guideline 94 (Unstable angina and NSTEMI) recommends that aspirin should be offered as soon as possible to all patients and continued indefinitely unless contraindicated by bleeding risk or aspirin hypersensitivity. For patients with aspirin hypersensitivity, clopidogrel monotherapy should be considered as an alternative. For people with increased risk of mortality and no contraindications who may undergo PCI within 24 hours of admission to hospital, clopidogrel in combination with low-dose aspirin for 12 months after the most recent acute episode of NSTEMI ACS is recommended. Thereafter, standard care, including treatment with low-dose aspirin is recommended.

7. Future revisions of NICE clinical guideline 94 will also consider the final NICE technology appraisal on ticagrelor. In the meantime, healthcare professionals are expected to take the final ticagrelor technology appraisal fully into account when exercising their clinical judgement.

About NICE
6. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

7. NICE produces guidance in three areas of health:

public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sectorhealth technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHSclinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.8. NICE produces standards for patient care:

quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent servicesQuality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 29 June 2011