Rivaroxaban approved by NICE for secondary prevention of atherothrombotic events

NICE has published final technology appraisal guidance (TA607) recommending rivaroxaban (Xarelto), in combination with aspirin, for the prevention of atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events.

In the case of patients with coronary artery disease, NICE defines high-risk as those aged 65 years or over, or with atherosclerosis in at least two vascular beds (such as coronary, cerebrovascular or peripheral arteries), or with two or more additional risk factors (ie current smoking, diabetes, kidney dysfunction with eGFR <60ml/min, heart failure and previous non-lacunar ischaemic stroke). NICE adds that the patient’s risk of bleeding should be assessed before considering rivaroxaban. Treatment should only be started after discussing the risks and benefits with the patient, and should be regularly reviewed.

Rivaroxaban is a direct-acting oral anticoagulant (DOAC) that works by directly inhibiting factor Xa, interrupting the blood coagulation cascade and inhibiting development of thrombi. It was initially licensed for the treatment or prevention of deep vein thrombosis and pulmonary embolism, as well as for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

In 2018, the indications were expanded to include the prevention of atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk of ischaemic events, at a low dose of 2.5mg twice daily in combination with 75–100mg aspirin daily.

NICE reached its decision using data from the COMPASS clinical trial, in which rivaroxaban reduced the risk of the primary composite outcome of ischaemic stroke, myocardial infarction or cardiovascular death compared with aspirin alone in patients at high risk of ischaemic events (hazard ratio 0.76; p<0.001). However, rivaroxaban did increase the risk of major bleeding, primarily gastrointestinal. Rivaroxaban was also assessed to be a cost-effective treatment option; the cost of a month’s treatment for the indication under review at the list price is currently £50.40.

In February, rivaroxaban was also accepted by the Scottish Medicines Consortium for use within NHS Scotland for the prevention of atherothrombotic events, in combination with aspirin, in patients at high risk of ischaemic events with coronary artery disease or symptomatic peripheral artery disease. However, in patients with coronary artery disease use is restricted to those with stable disease who do not require dual antiplatelet therapy.

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