NICE recommends rivaroxaban (Xarelto) to prevent blood clots in people who have had a heart attack in final draft guidance

In final draft guidance published today NICE has confirmed its earlier positive draft decision recommending rivaroxaban (Xarelto, Bayer Healthcare), in combination with clopidogrel and aspirin, or with aspirin alone, as an option

An acute coronary syndrome happens when one or more of the blood vessels in the heart become narrowed or blocked. Where the blood supply to the heart is blocked, this can lead to heart attacks (ST-segment-elevation myocardial infarction (STEMI) and non-ST-segment myocardial infarction (NSTEMI)) where there is damage to the heart muscle.

People who have a heart attack are at higher risk of having further events. In 2009/10 there were 57,000 admissions for heart attacks in England, with 28,000 subsequent heart attacks.

Rivaroxaban is licensed for the prevention of blood clots in adults who have an acute coronary syndrome severe enough to result in the release of cardiac biomarkers into the blood that show heart muscle has been damaged1. It is given with aspirin and clopidogrel, another drug that helps to prevent the blood from clotting, or with aspirin alone.

Rivaroxaban is given as a tablet. It prevents the formation of blood clots by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation. Rivaroxaban helps to maintain blood flow to the heart muscle to prevent further damage to the heart.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Based on the evidence considered, the independent Appraisal Committee concluded that rivaroxaban, in combination with aspirin plus clopidogrel or with aspirin alone, was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and heart attacks in people with acute coronary syndrome and raised cardiac biomarkers. The Committee therefore recommended rivaroxaban as a cost-effective use of NHS resources.

"Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the draft guidance recommends that before starting treatment doctors should carry out a careful assessment of a person's bleeding risk. The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the draft guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months."

The draft guidance is now with consultees, who have the opportunity to appeal against it. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

On-Demand Webinar

Leveraging A Medical Record-Enriched Patient Dataset for COVID-19 Research

You are invited to join a webinar that will explore the ways researchers can leverage this enriched dataset for important COVID-19 research. Sign up today for this informative webinar to learn how you can leverage one of the only medical record reviews solely using real-world data from hospitalized COVID-19 patients.

Suggested Articles

Life sciences companies have pivoted quickly during COVID-19 - Syneos Health® is supporting more than 80 active COVID-19 projects, including vaccines.

New York's Covaxx has signed on with three South American nations to provide 140 million doses of its early-stage COVID-19 vaccine.

To get the COVID-19 vaccine out quickly, Pfizer has been running rehearsals at distribution sites, creating "growing confidence," U.S. officials said.