NICE backs secondary prevention drug for patients with stable cardiovascular disease

NICE has recommended the direct Factor Xa inhibitor rivaroxaban (Xarelto), in combination with aspirin, as an option to prevent atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk of ischaemic events.

For people with coronary artery disease, a high risk of ischaemic events is defined as:

• age 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:
  • current smoking
  • diabetes
  • kidney dysfunction with an estimated glomerular filtration rate (eGFR) of less than 60ml/min (NB rivaroxaban is contraindicated if the eGFR is less than 15ml/min)
  • heart failure
  • previous non-lacunar ischaemic stroke.

NICE says prescribers should 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.

Rivaroxaban is given at a low dose of 2.5mg twice daily for patients with coronary artery disease or symptomatic peripheral artery disease, together with aspirin 75—100mg daily.

Cardiovascular events

In the large COMPASS trial in 27,395 individuals with stable atherosclerotic vascular disease, those assigned to rivaroxaban 2.5mg twice daily plus aspirin 100mg once daily had better cardiovascular outcomes than those assigned to aspirin alone.

They also had more bleeding but this was outweighed by the reduction in major cardiovascular events, which occured in 4.1% of the rivaroxaban–aspirin group compared with 5.4% of the aspirin-only group (hazard ratio 0.76, 95% CI 0.66–0.86, p<0.001).

Major bleeding events occurred in 3.1% of the rivaroxaban–aspirin group and 1.9% of the aspirin-only group (hazard ratio 1.70; 95% CI 1.40 to 2.05; p<0.001).

Commenting on the draft version of the NICE guidance published in July, COMPASS investigator Derek Connolly, consultant interventional cardiologist and honorary senior clinical lecturer at Birmingham City Hospital, said 'Rivaroxaban vascular dose in combination with aspirin is the first treatment of its kind for this patient population and this recommendation from NICE provides clinicians with an important additional option for treating patients at risk of major adverse cardiac events such as cardiovascular death, stroke or myocardial infarction.'