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NICE approve Xarelto▼ (rivaroxaban) for use in patients with coronary or peripheral artery disease

Xarelto▼, for Coronary heart disease and Peripheral arterial disease from Bayer

The National Institute for Health and Care Excellence (NICE) have recommended Bayer's anticoagulant treatment rivaroxaban, brand name Xarelto▼, for use in preventing atherothrombotic events in people with coronary or peripheral artery disease.

NICE state that rivaroxaban (Xarelto) with aspirin is available on the NHS. It is a possible treatment for preventing atherothrombotic events (such as stroke or heart attack) in adults who are at high risk because they have:
  • peripheral artery disease or
  • coronary artery disease and they:
    - are 65 or older, or
    - have atherosclerosis (fatty deposits) in at least 2 arteries, or
    - have at least 2 extra risk factors such as smoking, diabetes, certain types of kidney problem, heart failure, or they’ve had a type of stroke called a non-lacunar ischaemic stroke.
Rivaroxaban with aspirin may increase the risk of bleeding. So your risk of bleeding needs to be assessed before deciding whether to start treatment.

If you are not eligible for rivaroxaban but are already taking it, you should be able to continue until you and your doctor decide when best to stop.

You can follow developments with Xarelto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

Why the committee made these recommendations
People with chronic coronary artery disease or symptomatic peripheral artery disease can have atherothrombotic events such as myocardial infarction and stroke.

A clinical trial of people at high risk of ischaemic events shows that, compared with aspirin alone, rivaroxaban plus aspirin reduces the risk of having an ischaemic stroke, myocardial infarction or dying from cardiovascular disease. However, it increases the risk of bleeding.

The benefits and risks of rivaroxaban plus aspirin are only known for the specific population in the trial; that is, people a high risk of ischaemic events as defined by the inclusion criteria of the trial. A person’s risk of bleeding should be assessed before rivaroxaban is considered. The decision to start treatment should be taken after an informed discussion about the risks and benefits, weighing up the risk of ischaemic events against the bleeding risk.

The cost effectiveness of rivaroxaban is within the range that is considered an acceptable use of NHS resources. Aspirin plus rivaroxaban is therefore recommended as a treatment option for people at high risk of having atherothrombotic events, who are not identified as having an increased risk of bleeding.

About Xarelto (source EMA)
Xarelto is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
  • to prevent venous thromboembolism (VTE, the formation of blood clots in the veins) in patients who are undergoing surgery to replace a hip or knee;
  • to prevent stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart);
  • to treat deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occuring.
  • to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) after an acute coronary syndrome. Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack. Xarelto is used together with antiplatelet medicines, which prevent the formation of blood clots.
The active substance in Xarelto, rivaroxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, the levels of thrombin decrease, which reduces the risk of blood clots forming in the veins and arteries, and also treats existing clots.

Xarelto was first made available in the EU in 2008. It is manufactured by Bayer.

Sources
European Medicines Agency website page for Xarelto
Accessed 19/10/19
Links available in External Resources

© NICE [2019]

Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease. Technology appraisal guidance [TA607]. Published date: 17 October 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.


NICE information on Xarelto

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Reporting of suspected adverse reactions

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