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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), 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]
In the citing paper
“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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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
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
Management of atrial fibrillation
Lip, G. Y., & Tse, H.-F. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61300-2 · Cited by 229
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 226
“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 224
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
“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. S., Bockeria, L. A., Vasilieva, E., Sp, G., Golukhova, E. Z., Gorev, M. V., Davtyan, K. V., Drapkina, O. M., Станиславовна, К. Е., Kuchinskaya, Е. А., et al. (2021) · Russian Journal of Cardiology · doi:10.15829/1560-4071-2021-4594 · Cited by 258
Lee, S., Shafe, A. C. E., & Cowie, M. R. (2011) · BMJ Open · doi:10.1136/bmjopen-2011-000269 · Cited by 224
“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
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 219
“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
Klijn, C. J. M., Paciaroni, M., Berge, E., Korompoki, E., Kõrv, J., Lal, A., Jukka Putaala, A., & Werring, D. J. (2019) · European Stroke Journal · doi:10.1177/2396987319841187 · Cited by 213
“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
Kansal, A., Connolly, S. J., Peng, S., Linnehan, J. E., Bradley-Kennedy, C., Plumb, J., & Sorensen, S. V. (2011) · Thrombosis and Haemostasis · doi:10.1160/th11-02-0089 · Cited by 202
Perera, V., Bajorek, B. V., Matthews, S. T., & Hilmer, S. N. (2008) · Age and Ageing · doi:10.1093/ageing/afn293 · Cited by 210
Kirchhof, P., Bax, J., Blomstrom-Lundquist, C., Calkins, H., Camm, A. J., Cappato, R., Cosio, F., Crijns, H., Diener, H.-C., Goette, A., et al. (2009) · European Heart Journal · doi:10.1093/eurheartj/ehp235 · Cited by 202
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 206
Severe Renal Impairment and Stroke Prevention in Atrial Fibrillation
Marinigh, R., Lane, D. A., & Lip, G. Y. H. (2011) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.12.013 · Cited by 195
Bleeding Risk in Very Old Patients on Vitamin K Antagonist Treatment
Poli, D., Antonucci, E., Testa, S., Tosetto, A., Ageno, W., & Palareti, G. (2011) · Circulation · doi:10.1161/circulationaha.110.007864 · Cited by 193
New Insights Into Cerebrovascular Pathophysiology and Hypertension
Webb, A. J. S., & Werring, D. J. (2022) · Stroke · doi:10.1161/strokeaha.121.035850 · Cited by 210
Improving Stroke Risk Stratification in Atrial Fibrillation
Lip, G. Y. H., & Halperin, J. L. (2010) · The American Journal of Medicine · doi:10.1016/j.amjmed.2009.12.013 · Cited by 185
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
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
“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
Self-citationAdjusted-dose warfarin versus aspirin for preventing stroke in patients with atrial fibrillation
Hart, R. G., Pearce, L. A., & Aguilar, M. I. (2007) · Annals of Internal Medicine · doi:10.7326/0003-4819-147-8-200710160-00018 · Cited by 173
Katholing, A., Wallenhorst, C., Freedman, S. B., & Martínez, C. (2015) · Thrombosis and Haemostasis · doi:10.1160/th15-04-0350 · Cited by 174
Patti, G., Lucerna, M., Pecen, L., Siller-Matula, J. M., Cavallari, I., Kirchhof, P. F., & Caterina, R. D. (2017) · Journal of the American Heart Association · doi:10.1161/jaha.117.005657 · Cited by 179
Pisters, R., Lane, D. A., Nieuwlaat, R., Crijns, H., & Lip, G. Y. H. (2012) · Cited by 171
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 180
Metadata
- 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 › Clinical Neurology › 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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