NICE recommends Xarelto to prevent atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral arterial disease

The National Institute for Health and Care Excellence (NICE) in the UK has published a positive draft final appraisal determination recommending the use of rivaroxaban (Xarelto) by the National Health Service (NHS) in England. The NICE recommendation sets out a dose of 2.5mg twice daily, combined with 75–100mg aspirin once daily, as an option for preventing atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral arterial disease (PAD) who are at high risk of ischaemic events.

Publication of this NICE draft is based on evidence from the COMPASS study, the largest Phase III study with rivaroxaban (27,395 patients). This study showed that rivaroxaban vascular dose, 2.5mg twice daily combined with aspirin 100mg once daily, statistically significantly reduced the risk of the composite of cardiovascular (CV) death, stroke or myocardial infarction (major adverse cardiovascular events; MACE) by 24% (relative risk reduction, ARR: 1.3%) compared with aspirin 100mg once daily alone amongst patients with stable atherosclerotic vascular disease (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; p<0.001). In the COMPASS trial, for patients with stable CAD, addition of rivaroxaban 2.5mg twice daily with aspirin 100mg once daily lowered major adverse cardiovascular events compared with aspirin once daily (347 [4%] of 8313 vs. 460 [6%] of 8261; HR 0·74, 95% CI 0·65–0·86, p<0·0001). Moreover, patients with PAD who received rivaroxaban 2.5mg twice daily combined with aspirin 100mg once daily, also had fewer major cardiovascular events compared with the aspirin 100mg once daily alone group (126 [5%] of 2492 vs. 174 [7%] of 2504; HR 0·72, 95% CI 0·57-0·90, p=0·0047).