NICE recommends new treatment for heart attacks
In guidance published today (27 July), NICE has recommended bivalirudin (Angiox, The Medicines Company) in combination with aspirin and clopidogrel for the treatment of adults who have had a type of myocardial infarction ( MI or 'heart attack') called a ST-segment-elevation myocardial infarction or 'STEMI' who are undergoing primary percutaneous coronary intervention.
STEMI is caused by narrowing and blockage of the main blood vessel (the coronary artery) that delivers blood to the heart. Each year around 180,000 people in the UK are admitted to hospital with an MI and nearly 30,000 people in England and Wales die. The condition occurs most frequently in people aged over 50 years, and becomes more common with increasing age. MI is three times more common in men, and South Asian men are at higher risk. Current standard treatments for STEMI aim to re-open the blocked artery. They include primary PCI, a surgical procedure where fine wires, balloons or stents are inserted into the arteries to disrupt the blood clot and to open the coronary artery.
Treatments used in conjunction with primary PCI for people with STEMI are anticoagulants (heparin and low-molecular-weight heparin), which prevent the blood from clotting, and anti-platelet drugs (these include a class of anti-platelet drugs called glycoprotein IIb/IIIa inhibitors, as well as aspirin, clopidogrel and prasugrel) to prevent platelet aggregation and blood clot formation. Bivalirudin is a type of anticoagulant, and is given intravenously at the time of the PCI, together with aspirin and clopidogrel, to prevent blood from clotting during the procedure. The NICE appraisal compared bivalirudin with the commonly used anticoagulant heparin, used in conjunction with glycoprotein IIb/IIIa inhibitors.
Dr Carole Longson, NICE Health Technology Evaluation Centre Director, said: "With the number of PCIs being carried out increasing each year, this guidance provides the NHS in England and Wales with another important tool to enable it to treat people who have had a heart attack more effectively. The independent committee that advises NICE considered that, on the basis of the available evidence, bivalirudin, in combination with clopidogrel and aspirin, is both more effective and less expensive than treatment with a glycoprotein inhibitor plus heparin. It is also associated with a lower incidence of major bleeding events compared with heparin and glycoprotein inhibitors."
Notes to Editors
About the guidance
1. The guidance is available (from 27 July) on the NICE website at www.nice.org.uk/guidance/TA230.
2. Myocardial infarction (MI) occurs when part of the heart muscle loses its blood supply, and without prompt treatment it can lead to heart damage or death. There are two types of MI, non-ST segment elevation MI (known as NSTEMI), which is due to an unstable plaque with aggregation of platelets, and ST-segment elevation MI (known as STEMI) which occurs as a result of sudden thrombotic occlusion (formation of a blood clot) of a coronary artery. With a STEMI, a thrombus (a solid mass made up of the constituents of blood) forms on a ruptured atheromatous plaque (a swelling on the inner surface of an artery, produced by the deposition of lipids) and blocks a coronary artery.
3. Other treatments that may be used in conjunction with primary PCI for people with STEMI are glycoprotein IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban), which work by preventing platelet aggregation and thrombus formation and heparin, an anticoagulant, which prevents blood from clotting. Bivalirudin (Angiox, The Medicines Company) has a marketing authorisation ‘as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI'. Bivalirudin is administered by injection or infusion. This indication is an extension of the original indication and was approved in November 2009. The summary of product characteristics states that bivalirudin should be administered with aspirin and clopidogrel.
4. Bivalirudin costs £310.00 per 250-mg vial (excluding VAT; British national formulary [BNF] edition 61]). A median of one vial (mean = 1.23 vials) of bivalirudin is expected to be used per patient.
5. The Committee concluded that treatment with bivalirudin dominated treatment with heparin plus a glycoprotein inhibitor because the evidence showed that it is a more effective treatment as well as being less costly.
6. The National Institute for Health and Care 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 sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical 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 services
- Quality 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 patients
9. 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: 26 July 2011