The National Institute for Health and Care Excellence (NICE) today issued its Final Appraisal Determination (FAD) recommending Xarelto 2.5mg twice daily as an effective treatment option for preventing secondary events, such as death, heart attack or stroke, following acute coronary syndrome in patients with elevated cardiac biomarkers, without prior stroke or transient ischaemic attack.
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 acute coronary syndrome remain at risk, evidenced by the high incidence of cardiovascular death, myocardial infarction and stroke in patients following such an event,” commented Carlo di Mario, professor of cardiology, Imperial College London, UK. “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 acute coronary syndrome.”
The FAD is based on a thorough review of the clinical effectiveness of 2.5mg 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 acute coronary syndrome in patients with elevated cardiac biomarkers without prior stroke or transient ischaemic attack. The FAD also recommends Xarelto as a cost-effective treatment option.
Among patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack, Xarelto on top of dual antiplatelet therapy (in combination with aspirin alone or aspirin plus clopidogrel or ticlopidine) 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). 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 acute coronary syndrome events, and confirmed the clinical benefits that the anticoagulant Xarelto can deliver on top of dual antiplatelet therapy.
The NICE announcement is in alignment with the current European Guidelines for the treatment of ST segment elevation myocardial infarction, set by the European Society of Cardiology and the approval by the European Medicines Agency.
”We are 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 Luis Felipe Graterol, medical director, Bayer HealthCare UK.