1.1 Rivaroxaban plus aspirin is recommended within its marketing authorisation, as an option for preventing atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events.
1.2 For people with coronary artery disease, high risk of ischaemic events is defined as:
aged 65 or over, or
atherosclerosis in at least 2 vascular territories (such as coronary, cerebrovascular, or peripheral arteries), or
2 or more of the following risk factors:
kidney dysfunction with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min (note that rivaroxaban is contraindicated if the eGFR is less than 15 ml/min)
previous non-lacunar ischaemic stroke.
1.3 Assess the person's risk of bleeding before considering rivaroxaban. Treatment should only be started after an informed discussion with them about the risks and benefits of rivaroxaban, weighing up the risk of atherothrombotic events against the risk of bleeding. The risks and benefits of continuing treatment with rivaroxaban should be regularly reviewed.
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 at 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.