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Anticoagulant Therapy
This section introduces oral anticoagulation and stroke prevention in patients with AF, looking at the options available, the regimens used and the potential benefits and risks involved
In this section:
Introduction
Oral anticoagulation – with either VKAs or NOACs – is the mainstay of stroke prevention strategies in patients with NVAF. Supported by guidelines on the management of NVAF, the use of NOACs has increased markedly since they were first licenced in this indication and are now recommended in preference to VKAs for stroke prevention by the 2020 ESC and 2019 AHA/ACC/HRS guidelines.1-3
Anticoagulant options
VKAs such as warfarin, phenprocoumon and acenocoumarol have been used for stroke prevention in AF for many years. Although highly effective, the management of VKAs can be challenging and underpinned the need for alternatives. The NOACs – apixaban, dabigatran, edoxaban and rivaroxaban – are increasingly prescribed in preference to VKAs because of their potential to improve the quality of care.1,2 All NOACs:4,5
- Offer effective stroke prevention with a good safety profile
- Lack the requirement for routine coagulation monitoring or frequent dose adjustments
- Have fixed-dose regimens, with rivaroxaban showing consistent, dose-dependent plasma levels across a range of patent populations, and pharmacodynamic parameters correlating with rivaroxaban plasma concentrations
- Have a low risk of drug–drug or drug–food interactions
The following anticoagulants are approved in Europe for the prevention of stroke and systemic embolism in patients with NVAF and at least one additional risk factor for stroke:
- VKAs, e.g. warfarin, phenprocoumon and acenocoumarol6-8
- NOACs
- Direct Factor Xa inhibitors:
- Direct thrombin inhibitor:
For detailed dosing information, see our interactive ‘Which anticoagulant?’ table
For more information on these drugs and their targets in the coagulation cascade, click here
Anticoagulant dosing for stroke prevention in atrial fibrillation
When to use a reduced NOAC dose
Patients receiving anticoagulation with a NOAC should receive a reduced dose in certain clinical situations
© 2017, Bayer AG. All rights reserved. Approval number: PP-XAR-ALL-1742-1
VKAs do not have fixed-dose regimens; although taken once daily, the dose taken may vary and is adjusted based on the results of coagulation monitoring to maintain an INR of between 2.0 and 3.0 (target 2.5). A typical initial dose of warfarin is 10 mg once daily for 2 days, followed by 3–9 mg once daily, depending on the INR.6-8
All NOACs offer fixed-dose regimens and do not require routine coagulation monitoring, but in certain key patient populations, these doses can be reduced. Dosing decision trees for each NOAC (according to European summaries of product characteristics) are shown below.
Dosing and adjustments for the NOACs in patients with NVAF, according to the European summaries of product characteristics: apixaban15
Dosing and adjustments for the NOACs in patients with NVAF, according to the European summaries of product characteristics: dabigatran16
Dosing and adjustments for the NOACs in patients with NVAF, according to the European summaries of product characteristics: edoxaban17
Dosing and adjustments for the NOACs in patients with NVAF, according to the European summaries of product characteristics: rivaroxaban18
From ROCKET - AF to real-world evidence
The ROCKET AF study assessed the safety and efficacy of rivaroxaban compared with warfarin in patients with NVAF for the prevention of stroke. Subsequently published real-world evidence from prospective non-interventional studies has provided results consistent with ROCKET AF
© 2017, Bayer AG. All rights reserved. Approval number: PP-XAR-ALL-0097-2
Understanding the risks of anticoagulation
Anticoagulants significantly reduce the risk of stroke,5 but this must be balanced against bleeding safety, persistence and – in the case of VKAs – routine coagulation monitoring issues. Clinical decision making must always balance the benefits and risks of anticoagulant use.
A ‘user-friendly’ score to assess the 1-year risk of major bleeding in a patient with AF has been proposed. The HAS-BLED score predicts the risk of bleeding based on a combination of risk factors.19 Bleeding risk scores should be considered in patients with AF to identify modifiable risk factors for major bleeding.20 Several studies have shown HAS-BLED to have better predictive value than other published risk scores.
| Risk factor | Description | Points | |
|---|---|---|---|
| H | Hypertension | Uncontrolled, >160 mmHg systolic pressure | 1 |
| A | Abnormal renal or liver function (1 point each) | Abnormal renal function: chronic dialysis or renal transplantation or serum creatinine ≥200 µmol/l Abnormal liver function: chronic hepatic disease or biochemical evidence of significant hepatic derangement |
1 or 2 |
| S | Stroke | Previous history, particularly lacunar stroke | 1 |
| B | Bleeding history or predisposition | Predisposition could include bleeding diathesis or anaemia | 1 |
| L | Labile INR | Therapeutic time in range <60% | 1 |
| E | Elderly | Age >65 years | 1 |
| D | Drugs/alcohol concomitantly (1 point for drugs plus 1 point for alcohol excess) | Drugs, including antiplatelet agents and NSAIDs | 1 or 2 |
| Maximum: 9 points |
Adapted from Pisters et al. 201019
Link to online HAS-BLED risk calculator
Studies of the HAS-BLED score indicate that the annual risk of bleeding increases with the addition of each risk factor, up to five risk factors. HAS-BLED has demonstrated good predictive accuracy.19 Nevertheless, the score should not be used alone to exclude patients from oral anticoagulant therapy but rather allows clinicians to make an informed judgement as to the risk of bleeding and to identify modifiable bleeding risks that need to be addressed. Patient values and preferences should also be taken into account when making therapy choices.1,2
References
- Hindricks G, Potpara T, Dagres N et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020: doi:10.1093/eurheartj/ehaa612. Return to content
- January CT, Wann LS, Calkins H et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in collaboration with the Society of Thoracic Surgeons. Circulation 2019;140:e125–e151. Return to content
- Bassand JP, Accetta G, Al Mahmeed W et al. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: rationale for comprehensive management of atrial fibrillation. PLoS One 2018;13:e0191592. Bassand JP, Accetta G, Al Mahmeed W et al. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: rationale for comprehensive management of atrial fibrillation. PLoS One 2018;13:e0191592. Return to content
- Eriksson BI, Quinlan DJ, Eikelboom JW. Novel oral Factor Xa and thrombin inhibitors in the management of thromboembolism. Annu Rev Med 2011;62:41–57. Return to content
- Ruff CT, Giugliano RP, Braunwald E et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014;383:955–962. Return to content
- Lip GYH, Tse HF, Lane DA. Atrial fibrillation. Lancet 2012;379:648–661. Return to content
- Novartis Pharmaceuticals UK Ltd. Sinthrome® (acenocoumarol BP) Summary of Product Characteristics. 2018. Available at: https://www.medicines.org.uk/emc/product/2058 [accessed 20 November 2020]. Novartis Pharmaceuticals UK Ltd. Sinthrome® (acenocoumarol BP) Summary of Product Characteristics. 2018. Available at: https://www.medicines.org.uk/emc/product/2058 [accessed 20 November 2020]. Return to content
- Mercury Pharma Group Ltd. Marevan® (Warfarin) Summary of Product Characteristics. 2018. Available at: https://www.medicines.org.uk/emc/product/2803/smpc [accessed 20 November 2020]. Mercury Pharma Group Ltd. Marevan® (Warfarin) Summary of Product Characteristics. 2018. Available at: https://www.medicines.org.uk/emc/product/2803/smpc [accessed 20 November 2020]. Return to content
- Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981–992. Return to content
- Giugliano RP, Ruff CT, Braunwald E et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369:2093–2104. Giugliano RP, Ruff CT, Braunwald E et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369:2093–2104. Return to content
- Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883–891. Return to content
- Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139–1151. Return to content
- Connolly SJ, Ezekowitz MD, Yusuf S et al. Newly identified events in the RE-LY trial. N Engl J Med 2010;363:1875–1876. Connolly SJ, Ezekowitz MD, Yusuf S et al. Newly identified events in the RE-LY trial. N Engl J Med 2010;363:1875–1876. Return to content
- Connolly SJ, Wallentin L, Yusuf S. Additional events in the RE-LY trial. N Engl J Med 2014;371:1464–1465. Connolly SJ, Wallentin L, Yusuf S. Additional events in the RE-LY trial. N Engl J Med 2014;371:1464–1465. Return to content
- Bristol Myers Squibb, Pfizer Inc. Eliquis® (apixaban) Summary of Product Characteristics. 2020. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf [accessed 20 November 2020]. Bristol Myers Squibb, Pfizer Inc. Eliquis® (apixaban) Summary of Product Characteristics. 2020. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf [accessed 20 November 2020]. Return to content
- Boehringer Ingelheim International GmbH. Pradaxa® (dabigatran etexilate) Summary of Product Characteristics. 2020. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf [accessed 20 November 2020]. Boehringer Ingelheim International GmbH. Pradaxa® (dabigatran etexilate) Summary of Product Characteristics. 2020. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf [accessed 20 November 2020]. Return to content
- Daiichi Sankyo Europe GmbH. Lixiana® (edoxaban) Summary of Product Characteristics. 2020. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf [accessed 20 November 2020]. Daiichi Sankyo Europe GmbH. Lixiana® (edoxaban) Summary of Product Characteristics. 2020. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf [accessed 20 November 2020]. Return to content
- Bayer AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. 2020. Available at: https://www.ema.europa.eu/documents/product-information/xarelto-epar-product-information_en.pdf [accessed 20 November 2020]. Return to content
- Pisters R, Lane DA, Nieuwlaat R et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010;138:1093–1100. Return to content
- Camm AJ, Lip GYH, De Caterina R et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012;33:2719–2747. Return to content
See Also
Peripheral Artery Disease: causes and consequences
See Also
Coronary Artery Disease: causes and consequences
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Updated date 10/10/2022
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