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New RE-LY data presented at ACC

New sub-group analysis from the landmark RE-LY study has shown dabigatran etexilate significantly reduces the risk of stroke compared to warfarin irrespective of a patient’s risk profile for stroke.

Data presented at the 59th Annual Scientific Session of the American College of Cardiology has shown greater stroke reduction in patients with atrial fibrillation (AF) for dabigatran etexilate*  compared to the

current standard of care, warfarin, irrespective of a patient’s risk profile for stroke.1 A new sub-group analysis from the RE-LY study† has assessed the rate of stroke and systemic embolism in patients defined as being at low (n=5,775),

moderate (n=6,455) and high (n=5,882) risk of such events by the validated stroke risk stratification score, CHADS2.1, 2

The RE-LY sub-group analysis showed that dabigatran etexilate 150mg bid reduced the rate of stroke and systemic embolism compared with well-controlled warfarin, irrespective of a patient’s stroke risk.  Dabigatran etexilate 110mg bid resulted in similar reductions as well-controlled warfarin. Both doses were associated with lower major bleeding rates in patients at low risk of stroke.

In detail, the results showed:

  • Dabigatran etexilate 150mg bid reduced the rate of stroke and systemic embolism when compared with well-controlled warfarin across all stroke risk groups with the relative risk (RR) being 0.62 (0.38−1.02) in low, 0.61 (0.40−0.92) in moderate, and 0.70 (0.52−0.95) in high risk patients
  • Dabigatran etexilate 110mg bid showed similar reductions in the rate of stroke and systemic embolism to well-controlled warfarin, with RR being 1.00 (0.65−1.55) in low, 1.04 (0.73−1.49) in moderate and 0.79 (0.59−1.06) in high risk patients
  • Both doses of dabigatran etexilate were associated with lower rates of major bleeding compared to well-controlled warfarin in low risk patients (D110mg RR: 0.67 (0.49−0.90), D150mg RR: 0.73 (0.54−0.98)).
  • Consistent with the overall RE-LY results both doses of dabigatran were associated with substantial reductions in the rates of intracranial hemorrhage in all risk groups

Lead author Dr Jonas Oldgren, Uppsala University Hospital, Sweden said, “For healthcare professionals treating patients with atrial fibrilliation at risk of stroke and systemic embolism, this sub-group analysis is very encouraging as it shows that dabigatran etexilate 150mg bid is the first treatment reducing strokes more than warfarin across the full spectrum of stroke risk in patients with AF.”

Stroke risk stratification scores such as CHADS2 have been developed to guide appropriate use of anticoagulant therapy in patients with AF to maximise its benefit. For patients defined as being at high or moderate risk of stroke, the reduction in stroke risk with vitamin K antagonists (VKAs), such as warfarin, is likely to outweigh the risk of bleeding.3 For patients with a low risk CHADS2 score, the benefits of VKAs are not as clear. Therefore, currently many patients only receive aspirin, which is less effective than warfarin in reducing the risk of stroke, leaving patients insufficiently protected from the threat of severe and highly debilitating strokes.4, 5, 6, 7

Dr Jonas Oldgren continues, “Healthcare professionals and patients have long been waiting for a treatment that can provide stroke prevention across all levels of risk. We have shown that dabigatran etexilate provides greater benefits in stroke reduction across patients at low, medium and high risk, as well as reduced bleeding vs. warfarin in patients at low risk. This provides important evidence of the clear benefit that this novel oral anticoagulant can provide over current treatment with VKAs, such as warfarin.”

Up to three million people worldwide suffer strokes related to AF each year,8, 9, 10 which tend to be especially severe and disabling, with up to half of people dying within one year.11 AF affects more than half a million people in the UK and is a leading cause of stroke.12 Approximately 150,000 people have a stroke in the UK each year13 of which an estimated 15% are caused by AF.14

Dr Adrian Brady, Consultant Cardiologist at Glasgow Royal Infirmary said, “The results of the RE-LY sub-group analysis are exciting and highly significant for all UK patients with AF, regardless of their risk profile. We estimated that 50% of all people with AF in the UK who should be on an anticoagulant are not given warfarin because of concerns about bleeding. The results of this trial not only addresses that concern, they also confirm that dabigatran etexilate has the potential to improve stroke prevention.”


  1. Oldgren J, et al. Dabigatran etexilate versus warfarin in atrial fibrillation patients with low, moderate and high CHADS2 score – a RE-LY® subgroup analysis. Presented at the 59th Annual Scientific Session of the American College of Cardiology, 15th March 2010.
  2. Gage BF, et al. Validation of Clinical Classification Schemes for Predicting Stroke Results From the National Registry of Atrial Fibrillation. JAMA 2001; 285(22):2864-2870
  3. Fuster V, Rydn LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation – executive summary. Circulation 2006; 114:700-52.
  4. Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Arch Intern Med 1994; 154:1449-1157.
  5. Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med 1999; 131:492-501.
  6. The European Atrial Fibrillation Trial Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet 1993; 342:1255-1262.
  7. Laupacis A, Boysen G, Connolly S, et al. The efficacy of aspirin in patients with atrial fibrillation: analysis of pooled data from 3 randomized trials. Arch Intern Med 1997; 157:1237-1240.
  8. Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation: the Framingham study. Stroke 1996; 27:1760-4.
  9. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed July 2009 at:
  10. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991: 22(8);983-8. Communications
  11. Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke 2005; 36:1115-9.
  12. Stewart S, Murphy N, Walker A, et al. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart 2004;90:286–92
  13. The Stroke Association. Facts and figures, available at: Accessed Aug 2009
  14. Lip GYH, Lim HS. Atrial fibrillation and stroke prevention. Lancet Neurol 2007;6:981–93
  15. Connolly SJ, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-51.
  16. Benyoucef S, Hughes M, Mehta N. Atrial Fibrillation. Decision Resources, December 2008.
  17. Kannel WB, Abbott RD, Savage DD, et al. Coronary heart disease and atrial fibrillation:
  18. The Framingham Study. Am Heart J 1983; 106:389-96.
  19. Hart RG, Pearce LA, Aguilar MI, et al. Meta-Analysis: antithrombotic therapy to prevent stroke in patients who have non-valvular atrial fibrillation. Ann Intern Med 2007; 146:857-67.
  20. Hylek EM, DAntonio J, Evans-Molina C, et al. Translating the results of randomized trials into clinical practice. The challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke 2006; 37:1075-80.
  21. Samsa GP, Matchar DB, Goldstein LB, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 communities. Arch Intern Med 2000; 160:967-73.
  22. Di Nisio M, et al. Direct Thrombin Inhibitors. N Engl J Med 2005; 353:1028-40.

Published on: March 22, 2010

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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