New study presented at the American Heart Association (AHA) Scientific Sessions 2016

Published
Monday, November 14, 2016

New study investigates comprehensive anticoagulation strategy for high risk heart attack patients with coronary artery disease and atrial fibrillation who undergo a stent procedure

  • Atrial fibrillation (an abnormal heart beat) is the leading cause of stroke in the UK[i]
  • Up to half of people with AF also have coronary artery disease (CAD),[ii] which is treated using a procedure called percutaneous coronary intervention (or angioplasty with a stent)
  • To date, there have been no randomised clinical trials involving NOACs to guide the management of patients undergoing percutaneous coronary interventions (PCI) with non-valvular atrial fibrillation (AF)[iii] – which significantly increases the risk of clots and strokei
  • The PIONEER AF-PCI study has shown that Xarelto® (rivaroxaban) 15mg once-daily with clopidogrel reduced the rate of clinically significant bleeding by 41% compared to standard warfarin triple therapyiii
  • Data including patients from the UK were presented at a late-breaking clinical trial session at AHA and published simultaneously in New England Journal of Medicine (NEJM)iii
  • The study was not powered for statistical significance on efficacy, however, similar rates for the exploratory efficacy endpoint (cardiovascular death, MI, stroke, and stent thrombosis) were observed

Newbury, UK, Monday 14 November, 2016: The PIONEER AF-PCI trial has been presented today at AHA showing that Bayer’s Xarelto® (rivaroxaban) 15mg once daily in combination with a single antiplatelet therapy reduces the risk of clinically significant bleeding by 41% (the equivalent of a 9.9% absolute risk reduction) in patients at high risk of stroke (concomitant AF and CAD undergoing PCI), compared to standard vitamin K agonist (warfarin) plus dual antiplatelet therapy over 12 months of randomised treatment.iii In fact, the phase IIIb PIONEER AF-PCI study demonstrated that two different treatment strategies using rivaroxaban significantly reduced the risk of bleeding compared to standard treatment.iii

This is the first time that clinicians in the UK have evidence from a randomised clinical trial involving NOACs on which to base treatment decisions for this high risk group.iii While 1 in 100 UK patients will have a heart attack, stroke or die following PCI;[iv] having AF increases the risk of clots and stroke 6-fold.i Current practice relies on limited evidence which may provide conflicting advice for this group of patients with concomitant problems.iii The current recommendations of a combination of antiplatelet and anticoagulant therapy post-PCI may increase the risk of bleeding in patients with AF. iii This is the first reported randomised clinical trial using a novel oral anti-coagulant (NOAC) in this high risk group of patients with AF and acute coronary syndrome.iii A further sub-analysis showing significantly fewer re-hospitalisations for patients taking rivaroxaban compared to those on VKA has also been published in Circulation.[v]

Professor Keith Fox, Professor of Cardiology of the University of Edinburgh and Co-Chair of PIONEER AF, commented: "Patients with atrial fibrillation and the need for stenting present a challenge to define the safest treatment strategy, because of the need to reduce stroke risk and to reduce bleeding risks. For the first time, we now have treatment strategies using a non vitamin K antagonist (rivaroxaban) combined with single or dual antiplatelet therapies. Both of these rivaroxaban strategies reduce the risks of bleeding compared to the current guideline therapy of warfarin and antiplatelet treatment. Only 12 patients need to be treated to prevent a clinically significant bleeding event. This is good news for our patients in the UK and worldwide."

In the UK, AF affects around 1.5 million people[vi] and many have concomitant coronary artery disease given the overlapping risk factors including age.vi Coronary artery disease (CAD) is estimated to occur in 20-30% of patients with AF and this is set to rise as the UK population ages.[vii] The number of patients with AF and CAD that will have to undergo coronary revascularisation, like PCI, has doubled in the last decade, putting them at an increased risk of blood clots and stroke.[viii]

Dr Luis Felipe Graterol, UK Medical Director, Bayer said: "Xarelto is already the most widely used NOAC in the UK and worldwide, however we understand that clinicians often face the challenge of patients with complex and concomitant conditions. PIONEER AF-PCI is a significant step forward in improving evidence-based outcomes in high risk patients with non-valvular AF undergoing PCI."

Contact

Hayley Knight
Tel. 01635 563 523
E-Mail: hayley.knight@bayer.com

Jessica Smith
Tel. 0208 939 1294
E-Mail: jessica.smith@virgohealth.com

References

[i] ABPI Stroke in Atrial Fibrillation Initiative (SAFI). One Year On: Why are patients still having unnecessary AF-related strokes? 2016. Available at: http://www.abpi.org.uk/media-centre/newsreleases/2016/Documents/Embargo9May_ABPI_OneYearOn_FINALREPORT.pdf. [Last accessed November 2016]
[ii] Kralev, S. et al. Incidence and Severity of Coronary Artery Disease in Patients with Atrial Fibrillation Undergoing Firt-time Coronary Angiography. PLoS ONE 2011;6:1-7
[iii] Gibson, M. et al. Prevention of bleeding in patients with atrial Fibrillation Undergoing PCI. The New England Journal of Medicine. 2016;1-12
[iv] NHS Choices. Coronary angioplasty and stent insertion – the risks. Available from: http://www.nhs.uk/Conditions/Coronary-angioplasty/Pages/Risks.aspx. Last accessed: November 2016
[v] Authors TBC on publication in Circulation simultaneous with presentation at AHA Scientific Sessions 2016. [Full reference citation to be added on publication]
[vi] Atrial Fibrillation Association & Anticoagulation Europe (UK). The AF Report. 2012. Available at: http://www.preventaf-strokecrisis.org/files/files/The%20AF%20Report%2014%20April%202012.pdf. [Last accessed November 2016]
[vii] Carpodanno, D. & Angiolillo, D.J. Management of Antiplatelet and Anticoagulant Therapy in Patients With Atrial Fibrillation in the Setting of Acute Coronary Syndromes or Percutaneous Coronary Interventions. Circulation: Cardiovascular Interventions. 2014;7:113–124
[viii] Bhatnagar, P. et al. The epidemiology of cardiovascular disease in the UK 2014. Heart Journal. 2015;0:1-8