In final draft guidance published today NICE has confirmed its earlier positive draft decision recommending rivaroxaban (Xarelto, Bayer Healthcare), in combination with clopidogrel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is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the draft guidance recommends that before starting treatment doctors should carry out a careful assessment of a person's bleeding risk.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 Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the draft guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months."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.