NICE draft guidance recommends Bayer’s Xarelto post heart attack

Draft guidance from UK health watchdog NICE recommends Bayer’s rivaroxaban (Xarelto) for preventing blood clots in people who have had a heart attack as a result of a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 (ACS) severe enough to result in the release of cardiac biomarkers into the blood that show heart muscle has been damaged.

ACS 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 The draft guidance considers the use of rivaroxaban to prevent further blood clots in adults who have had STEMI or NSTEMI.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is not severe enough to result in the release of biomarkers into the blood so this condition is not considered in the draft guidance.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 stops Factor Xa from working. This 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. It is given with aspirin and clopidogrel (Plavix, Bristol-Myers Squibb), 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Because of a higher risk of bleeding with rivaroxaban, the draft guidance also recommends that before starting treatment clinicians should assess the person’s bleeding risk.

Consultation on the draft closes on 13 November.

There are several other treatment options available for ACS. Prasugrel (Efient, Eli Lilly) was recommended for wider use in July, following a NICE review of its 2009 guidance. It can be used in combination with aspirin for preventing blood clots in people who have had a heart attack or who have unstable angina. The committee found that its faster action compared to clopidogrel could be an advantage for people who needed immediate percutaneous coronary intervention (PCI).

Ticagrelor (Brilique/Brilinta, AstraZeneca) is also an option for preventing blood clots, with favourable results from the ATLANTIC study published at the European Society of Cardiology meeting in Barcelona recently.


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