NICE Draft Guidance Recommends Rivaroxaban to Prevent Blood Clots in Heart Attack Patients

In draft guidance published 22 October 2014 for consultation, NICE has recommended rivaroxaban (Xarelto, Bayer Healthcare) as an option for preventing blood clots in people who have had a heart attack as a result of a blockage or narrowing in one of the blood vessels in the heart.

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 damaged.

Acute coronary syndrome covers a range of conditions from unstable angina to heart attacks (ST-segment-elevation myocardial infarction (STEMI) and non-ST-segment myocardial infarction (NSTEMI)). The draft guidance considers the use of rivaroxaban to prevent further blood clots in adults who have had a heart attack – either STEMI or NSTEMI. In unstable angina, damage to the heart is not severe enough to result in the release of biomarkers into the blood so this condition is not considered in the draft guidance.

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.

Rivaroxaban is given with aspirin and clopidogrel, another drug that helps to prevent the blood from clotting, or with aspirin alone.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “People who have a heart attack are at higher risk of having further events. This can have a negative impact on the quality of life of the person and their family because of worries over their future health. Any additional treatments to reduce that risk are therefore to be welcomed.

“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Because of a higher risk of bleeding with rivaroxaban, the draft guidance also recommends that before starting treatment clinicians should undertake a careful assessment of a person’s bleeding risk.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 in combination with aspirin and clopidogrel or with aspirin alone, compared with aspirin and clopidogrel or aspirin alone.