NICE is currently appraising the use of bivalirudin (Angiox, The Medicines Company) as a treatment option for people who have suffered a type of myocardial infarction (heart attack) called a ST-segment-elevation myocardial infarction or 'STEMI'. In final draft guidance, published today, NICE has recommended bivalirudin in combination with aspirin and clopidogrel for the treatment of adults with STEMI who are undergoing primary percutaneous coronary intervention.

STEMI (the name comes from the pattern seen on an ECG, which measures the rhythm and electrical activity of the heart) happens when cholesterol-rich deposits, or plaques, which have formed within the walls of coronary arteries (atherosclerosis) tear, causing blood clots (thrombus) that block the coronary artery resulting in damage to the heart muscle. Each year around 180,000 people in the UK are admitted to hospital with a myocardial infarction (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 thrombolytic agents, which work by dissolving or reducing the size of the blood clot, and primary percutaneous coronary intervention (PCI). This is 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. Bivalirudin is a type of thrombolytic agent known as an anticoagulant, which is given at the time of the PCI and works by preventing 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: "Although deaths from heart attacks and other cardiovascular causes are declining, unfortunately the incidence of heart attacks is not declining at the same rate. Treatments which reduce the risk of dying from a heart attack often come at the price of increasing the risk of bleeding, which can itself cause death and morbidity. The evidence considered by the Appraisal Committee showed that treatment with bivalirudin was both more effective and less expensive than treatment with a glycoprotein inhibitor plus heparin. As well as reducing the risk of dying following PCI, the Committee noted that the use of bivalirudin was associated with a lower incidence of major bleeding events compared with heparin and glycoprotein inhibitors."

Due to the strength of the evidence for bivalirudin that was presented to the Appraisal Committee, it was deemed appropriate to proceed straight to the final stage of guidance development, which is to give consultees an opportunity to appeal against the proposed recommendation. This is designed to speed up the process of publishing positive guidance to the NHS so that patients can receive new treatments quicker. 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.

Notes

About the draft guidance

1. NICE's preliminary recommendations are available on the NICE website.

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.

Source:
NICE