The National Institute for Health and Care Excellence (NICE) issued its appraisal consultation document (ACD) recommending Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome.
“Patients with acute coronary syndromes remain at risk even though there have been a number of advances in treatment over the past few years, including newer antiplatelet agents. This is evidenced by the high incidence of cardiovascular death, myocardial infarction and stroke in patients following an acute coronary syndrome event. Rivaroxaban offers an option for secondary prevention in this patient group, and we hope that selected patients in the UK will be able to benefit from this advance in therapy,” says Luis Felipe Graterol, medical director, Bayer Plc.
The positive ACD is based on a thorough review of the clinical effectiveness of 2.5mg rivaroxaban twice daily in the randomised controlled landmark ATLAS ACS 2 TIMI 51 trial in which Xarelto has shown significant advantages in the secondary prevention of acute coronary syndromes in patients with elevated cardiac biomarkers without prior stroke or transient ischaemic attack (TIA).
Among patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack, Xarelto 2.5mg twice daily on top of dual antiplatelet therapy demonstrated statistically significant reductions in the primary outcome of death from cardiovascular causes, myocardial infarction or stroke in patients with a recent acute coronary syndrome compared with a placebo (20%) ARR 2.1; HR 0.80(0.68-0.94), P = 0.007; NNT 48) as well as cardiovascular death by 45% RRR (ARR 2.0; HR 0.55 (0.41-0.74), P < 0.001; NNT=50) and all-cause death by 42% RRR (ARR 2.1; HR 0.58 (0.44-0.77), P < 0.001; NNT=49).
The dual pathway treatment strategy tested in ATLAS ACS 2 TIMI 51 recognises the importance of thrombin generation following acute coronary syndrome events, and confirmed the clinical benefits that Xarelto 2.5mg twice daily can deliver on top of dual antiplatelet therapy. This offers an innovative approach in the prevention of atherothrombotic events and delivers an important mortality benefit.
The NICE announcement is in alignment with the current European Guidelines for the treatment of STEMI, set by the European Society of Cardiology and the approval by the European Medicines Agency. The option of treatment with 2.5mg Xarelto twice daily is now available on the NHS.