NICE Recommends Xarelto (Rivaroxaban) as an Effective Treatment Option for Reducing Risk of Secondary Events in ACS

NICE has issued its Final Appraisal Determination (FAD) recommending Xarelto 2.5 mg twice daily as an effective treatment option for preventing secondary events — such as death, heart attack or stroke — following acute coronary syndrome (ACS) in patients with elevated cardiac biomarkers, without prior stroke or transient ischaemic attack (TIA). The FAD is the final phase in a multi-step review process by NICE and recognises the improved patient outcomes using Xarelto as a treatment option on top of dual antiplatelet therapy; publication of guidance is expected to follow in Q1 2015.

“Despite treatment advances in recent years, including newer antiplatelet agents, patients with ACS remain at risk, evidenced by the high incidence of cardiovascular death, myocardial infarction and stroke in patients following an ACS event,” commented Professor Carlo di Mario, Professor of Cardiology, Imperial College London. “The addition of the anticoagulant Xarelto to standard antiplatelet therapy has been shown to reduce risk in this patient group, marking a significant advance in the management of ACS.”

The FAD is based on a thorough review of the clinical effectiveness of 2.5 mg Xarelto 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 ACS in patients with elevated cardiac biomarkers without prior stroke or TIA.5 The FAD also recommends Xarelto as a cost-effective treatment option.

Among patients with elevated cardiac biomarkers and no prior stroke or TIA, Xarelto 2.5 mg 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 ACS 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). Whilst there was an increase in bleeding rates with Xarelto, there was no difference in fatal bleeds or fatal intracranial haemorrhage.

The dual pathway treatment strategy tested in ATLAS ACS 2 TIMI 51 recognises the importance of thrombin generation (as well as the role of antiplatelets) following ACS events, and confirmed the clinical benefits that the anticoagulant Xarelto 2.5mg twice daily can deliver on top of dual antiplatelet therapy.



”We’re delighted with this FAD as it expands the clinical utility of Xarelto across different settings and patient populations, providing even more patients with access and improved outcomes,” said Dr Luis Felipe Graterol, Medical Director, Bayer HealthCare UK. “Xarelto is approved to prevent and treat more thromboembolic conditions than any other novel oral anticoagulant, and is the leader in the market place both in the UK and worldwide. We remain committed to our growing clinical trial and lifecycle management programme to extend use into further areas of unmet need.”