Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial
Abstract
Background Anticoagulants are more effective than antiplatelet agents at reducing stroke risk in patients with atrial fibrillation, but whether this benefit outweighs the increased risk of bleeding in elderly patients is unknown. We assessed whether warfarin reduced risk of major stroke, arterial embolism, or other intracranial haemorrhage compared with aspirin in elderly patients.Methods 973 patients aged 75 years or over (mean age 81.5 years, SD 4.2) with atrial fibrillation were recruited from primary care and randomly assigned to warfarin (target international normalised ratio 2-3) or aspirin (75 mg per day). Follow-up was for a mean of 2.7 years (SD 1.2). The primary endpoint was fatal or disabling stroke (ischaemic or haemorrhagic), intracranial haemorrhage, or clinically significant arterial embolism. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN89345269.Findings There were 24 primary events (21 strokes, two other intracranial haemorrhages, and one systemic embolus) in people assigned to warfarin and 48 primary events (44 strokes, one other intracranial haemorrhage, and three systemic emboli) in people assigned to aspirin (yearly risk 1.8%vs 3.8%, relative risk 0.48, 95% CI 0.28-0.80, p=0.003; absolute yearly risk reduction 2%, 95% CI 0.7-3.2). Yearly risk of extracranial haemorrhage was 1.4% (warfarin) versus 1.6% (aspirin) (relative risk 0.87, 0.43-1.73; absolute risk reduction 0.2%, -0.7 to 1.2).Interpretation These data support the use of anticoagulation therapy for people aged over 75 who have atrial fibrillation, unless there are contraindications or the patient decides that the benefits are not worth the inconvenience.
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Antiplatelet therapy increases bleeding risk, especially dual antiplatelet therapy (2.0% vs. 1.3% with antiplatelet monotherapy; P < 0.001), with bleeding rates that are similar to those on oral anticoagulation.
“Antiplatelet therapy increases bleeding risk, especially dual antiplatelet therapy (2.0% vs. 1.3% with antiplatelet monotherapy; P < 0.001), 433 with bleeding rates that are similar to those on OAC.354,362,431,434”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [362]
Good data are available to support the use of anticoagulants in older patients from BAFTA, the NOAC trials, and analyses in elderly Americans (Medicare).
“Good data are available to support the use of anticoagulants in older patients from BAFTA (Birmingham Atrial Fibrillation Treatment of the Aged Study), 362 the NOAC trials, 39 and from analyses in elderly Americans (Medicare).396”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [362]
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EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update
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Vitamin K antagonists in heart disease: Current status and perspectives (Section III)
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Cost-Effectiveness of Dabigatran for Stroke Prophylaxis in Atrial Fibrillation
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EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update
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“The use of OACs in a general practice RCT has demonstrated safety and benefit in older people, including those aged more than 85 years [315].”
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“21 Although more and more studies supported anticoagulation in elder patients (>80years), 22,23 results from present studies reflect that in real-world clinical work, the effort was ineffective to some extent.”
Defining "elderly" in clinical practice guidelines for pharmacotherapy
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Coronary Artery Disease in Patients ≥80 Years of Age
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Managing Medications in Clinically Complex Elders
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Effect of Age on Stroke Prevention Therapy in Patients With Atrial Fibrillation
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Ischemic stroke in the elderly: an overview of evidence
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Atrial fibrillation and stroke prevention
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Sex Differences in Stroke Risk Among Older Patients With Recently Diagnosed Atrial Fibrillation
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Age as a Risk Factor for Stroke in Atrial Fibrillation Patients
Marinigh, R., Lip, G. Y. H., Fiotti, N., Giansante, C., & Lane, D. A. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.05.028 · Cited by 232 · see citing works
Self-citationLip, G. Y. H., Huber, K., Andreotti, F., Arnesen, H., Airaksinen, J. K. E., Cuisset, T., Kirchhof, P. F., & Marín, F. R. (2010) · European Heart Journal · doi:10.1093/eurheartj/ehq117 · Cited by 229 · see citing works
Management of atrial fibrillation
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Kirchhof, P. F., Blank, B. F., Calvert, M., Camm, A. J., CHLOUVERAKIS, G. I., Diener, H., Goette, A., Huening, A., Lip, G. Y. H., SIMANTIRAKIS, E. N., et al. (2017) · American Heart Journal · doi:10.1016/j.ahj.2017.04.015 · Cited by 225 · see citing works
“In summary, stroke rates in patients with AHRE are often close to the threshold for a net clinical benefit of NOAC therapy(2) and appear lower than the stroke rates found in patients with paroxysmal AF detected by ECG.(5,36,37) Also, only a minority of ischemic strokes in pacemaker patients with AHRE occur in relation…”
ResultBleeding with anticoagulation therapy – Who is at risk, and how best to identify such patients
Cosmi, B., & Palareti, G. (2009) · Thrombosis and Haemostasis · doi:10.1160/th08-11-0730 · Cited by 226 · see citing works
The Cox-Maze Procedure for Lone Atrial Fibrillation
Weimar, T., Schena, S., Bailey, M. S., Maniar, H. S., Schuessler, R. B., Cox, J. L., & Damiano, R. J. (2011) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.111.963819 · Cited by 226 · see citing works
“Considering the side effects of Warfarin, including the higher risk of anticoagulation-associated intracranial hemorrhage, this is important in improving quality of life.(32) However, in few patients other indications for anticoagulation therapy were present or developed despite restored sinus rhythm.”
2020 Clinical guidelines for Atrial fibrillation and atrial flutter
Arakelyan, M., Bockeria, L., Vasilieva, E., Golitsyn, S., Golukhova, E., Gorev, M., Davtyan, K., Drapkina, O., Kropacheva, E., Kuchinskaya, E. A., et al. (2021) · Russian Journal of Cardiology · doi:10.15829/1560-4071-2021-4594 · Cited by 11 · see citing works
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“However, it has been shown that there is no significant difference in bleeding risk between warfarin and aspirin in patients aged over 75 years.(26) The lower use of anticoagulants in women might also reflect findings from other areas of cardiovascular disease that women are treated less aggressively with drug therapy…”
Oral Anticoagulation in Very Elderly Patients With Atrial Fibrillation
Chao, T., Liu, C., Lin, Y., Chang, S., Lo, L., Hu, Y., Tuan, T., Liao, J., Chung, F., Chen, T., et al. (2018) · Circulation · doi:10.1161/circulationaha.117.031658 · Cited by 223 · see citing works
Lip, G. Y. H., Diener, H., Brueckmann, M., van Ryn, J., Clemens, A., & Huisman, M. V. (2012) · Thrombosis and Haemostasis · doi:10.1160/th11-10-0718 · Cited by 218 · see citing works
“Extensive evidence from randomised trials supports the value of vitamin K antagonists (VKAs) in reducing the risk of stroke by about two thirds, even among elderly AF patients, who are at higher risk (2, 3).”
BackgroundKozar, R. A., Arbabi, S., Stein, D. M., Shackford, S. R., Barraco, R. D., Biffl, W. L., Brasel, K. J., Cooper, Z. R., Fakhry, S. M., Livingston, D. H., et al. (2015) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0000000000000656 · Cited by 217 · see citing works
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“The Birmingham Atrial Fibrillation Treatment of the Aged Study (BAFTA) assessed whether warfarin reduced risk of major stroke, arterial embolism or other intracranial haemorrhage compared with aspirin in elderly patients.(16) For the small secondary prevention cohort (124 patients), data were not reported regarding is…”
ResultPancholy, S. B., Sharma, P. S., Pancholy, D. S., Patel, T. M., Callans, D. J., & Marchlinski, F. E. (2014) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2013.10.035 · Cited by 204 · see citing works
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Self-citationSterne, J. A. C., Bodalia, P. N., Bryden, P. A., Davies, P. A., López-López, J. A., Okoli, G. N., Thom, H. H. Z., Caldwell, D. M., Dias, S., Eaton, D., et al. (2017) · Health Technology Assessment · doi:10.3310/hta21090 · Cited by 201 · see citing works
Severe Renal Impairment and Stroke Prevention in Atrial Fibrillation
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Bleeding Risk in Very Old Patients on Vitamin K Antagonist Treatment
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New Insights Into Cerebrovascular Pathophysiology and Hypertension
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Improving Stroke Risk Stratification in Atrial Fibrillation
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Warfarin Discontinuation After Starting Warfarin for Atrial Fibrillation
Fang, M. C., Go, A. S., Chang, Y., Borowsky, L. H., Pomernacki, N. K., Udaltsova, N. V., & Singer, D. E. (2010) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.110.937680 · Cited by 185 · see citing works
Davis, R. C., Hobbs, F. D. R., Kenkre, J. E., Roalfe, A. K., Iles, R., Lip, G. Y. H., & Davies, M. K. (2012) · Europace · doi:10.1093/europace/eus087 · Cited by 180 · see citing works
“Treatment by anticoagulation with warfarin reduces the risk of stroke in patients with AF by at least two-thirds(1) can be used even in the elderly, and is more effective than aspirin.(2) The new oral direct thrombin inhibitor anticoagulant, dabigatran, has been shown to be superior even to warfarin in stroke reductio…”
Diener, H.-C., Eikelboom, J., Connolly, S. J., Joyner, C. D., Hart, R. G., Lip, G. Y., O'Donnell, M., Hohnloser, S. H., Hankey, G. J., Shestakovska, O., et al. (2012) · The Lancet Neurology · doi:10.1016/s1474-4422(12)70017-0 · Cited by 177 · see citing works
Self-citationAdjusted-dose warfarin versus aspirin for preventing stroke in patients with atrial fibrillation
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Arrhythmias in Patients ≥80 Years of Age
Curtis, A. B., Karki, R., Hattoum, A., & Sharma, U. C. (2018) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.03.019 · Cited by 171 · see citing works
- Authors
- Mant, J., Hobbs, F. R., Fletcher, K., Roalfe, A., Fitzmaurice, D., Lip, G. Y., & Murray, E.
- Affiliations
- University of Birmingham (GB)
- Birmingham City Hospital (GB)
- Corresponding author
- Mant, Jonathan
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2007-08
- Volume
- 370
- Issue
- 9586
- Pages
- 493-503
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2159730165
- Cited by
- 1,556
- References
- 50
- Citations by year
- 2026: 14 · 2025: 15 · 2024: 25 · 2023: 43 · 2022: 35 · 2021: 51 · 2020: 60 · 2019: 53 · 2018: 73 · 2017: 94 · 2016: 124 · 2015: 116 · 2014: 120 · 2013: 142 · 2012: 158
- FWCI
- 72.56
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- warfarin, aspirin, atrial fibrillation, stroke prevention, elderly patients, anticoagulation, antiplatelet therapy, intracranial hemorrhage, arterial embolism, bleeding risk, ischemic stroke, primary care
- MeSH terms
- Aged, Aged, 80 and over, Anti-Inflammatory Agents, Non-Steroidal, Aspirin, Atrial Fibrillation, Female, Follow-Up Studies, Humans, Male, Platelet Aggregation Inhibitors, Severity of Illness Index, Warfarin, International Normalized Ratio, Stroke
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