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Apixaban in Patients with Atrial Fibrillation
Open accessAbstract
BACKGROUND: Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients. METHODS: In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism. RESULTS: Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups. CONCLUSIONS: In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).
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“It is superior to no treatment or aspirin in patients with different profiles for stroke risk.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [354]
In the citing paper
“apixaban significantly reduced stroke or systemic embolism by 55% compared with aspirin, with no significant difference in rates of major bleeding or intracranial haemorrhage.354,403”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [354]
In the citing paper
“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 [354]
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“Apixaban also showed better tolerability than aspirin and a similar risk of major bleeding [62].”
BackgroundTemporal Trends in Medication Use and Outcomes in Atrial Fibrillation
Pilote, L., Eisenberg, M. J., Essebag, V., Tu, J. V., Humphries, K. H., Yinko, S. S. L. L., Behlouli, H., Guo, H., & Jackevicius, C. A. (2013) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2012.09.021 · Cited by 34
Zhang, C., Gu, Z., Ding, Z., Shen, L., Pan, M.-M., Zheng, Y., Lin, H., & Pu, J. (2018) · Thrombosis Research · doi:10.1016/j.thromres.2018.12.010 · Cited by 36
The Non-Vitamin K Antagonist Oral Anticoagulants in Heart Disease: Section V—Special Situations
Caterina, R. D., Ageno, W., Agnelli, G., Chan, N., Diener, H., Hylek, E. M., Raskob, G. E., Siegal, D. M., Verheugt, F. W. A., Lip, G. Y. H., et al. (2018) · Thrombosis and Haemostasis · doi:10.1055/s-0038-1675816 · Cited by 35
Embolic strokes of undetermined source: theoretical construct or useful clinical tool?
Tsivgoulis, G. K., Katsanos, A. H., Köhrmann, M., Caso, V., Lemmens, R., Tsioufis, K. P., Paraskevas, G. P., Bornstein, N. M., Schellinger, P. D., Alexandrov, A. V., et al. (2019) · Therapeutic Advances in Neurological Disorders · doi:10.1177/1756286419851381 · Cited by 34
Clinical Management of Pharmacokinetic Drug Interactions with Direct Oral Anticoagulants (DOACs)
Herink, M. C., Zhuo, Y. F., Williams, C. D., & DeLoughery, T. G. (2019) · Drugs · doi:10.1007/s40265-019-01183-0 · Cited by 35
Sawant, A. C., Kumar, A., McCray, W., Tetewsky, S. J., Parone, L., Sridhara, S., Prakash, M. P. H., Tse, G., Liu, T., Kanwar, N., et al. (2019) · Europe PMC (PubMed Central) · doi:10.11909/j.issn.1671-5411.2019.09.006 · Cited by 34
Anticoagulation in atrial fibrillation. A large real-world update
Bo, M., Fumagalli, S., Esposti, L. D., Perrone, V., Dovizio, M., Poli, D., Marcucci, R., Verdecchia, P., Reboldi, G., Lip, G. Y. H., et al. (2023) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2023.10.010 · Cited by 33
“We also hypothesized that investigating the effectiveness and safety of DOACs vs. ASA in our real-world population, might extend our knowledge in this area, beyond that provided by RCTs [18].”
Dose Reduction of Edoxaban in Patients 80 Years and Older With Atrial Fibrillation
Zimerman, A., D, E. B. M., Steffel, J., Mieghem, N. M. V., Palazzolo, M. G., Murphy, S. A., Chen, C. Z., Unverdorben, M., Ruff, C. T., Antman, E. M., et al. (2024) · JAMA Cardiology · doi:10.1001/jamacardio.2024.1793 · Cited by 33
Yang, E. (2014) · Vascular Health and Risk Management · doi:10.2147/vhrm.s68117 · Cited by 33
“57).(12) A trend toward lower risk of mortality was observed with apixaban (P=0.”
InfluentialPisters, R., van Vugt, S. P. G., Brouwer, M. A., Elvan, A., ten Holt, W. L., Zwart, P. A. G., Kirchhof, P. F., Crijns, H. J. G. M., & Hemels, M. E. W. (2017) · Netherlands Heart Journal · doi:10.1007/s12471-017-1009-9 · Cited by 33
Armbruster, A. L., Buehler, K. S., Min, S. H., Riley, M., & Daly, M. W. (2014) · PubMed Central · Cited by 31
Tornyos, A., Kehl, D., D’Ascenzo, F., & Komócsi, A. (2015) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2015.12.001 · Cited by 33
Anticoagulation for atrial fibrillation after intracranial hemorrhage
Hawkes, M. A., & Rabinstein, A. A. (2018) · Neurology Clinical Practice · doi:10.1212/cpj.0000000000000425 · Cited by 30
“The APACHE-AF is an ongoing phase II, randomized, multicenter, open-label, parallel-group, clinical trial designed to compare apixaban vs no anticoagulation in patients with AF and a recent ARICH.50 LAAO has been shown noninferior to warfarin for IS prevention in patients with NVAFwith low procedural risks.51–53 Two s…”
InfluentialCaturano, A., Galiero, R., & Pafundi, P. C. (2019) · Medicina · doi:10.3390/medicina55100617 · Cited by 32
“Comparable outcom s merged for major gastrointestinal bleeding [39,40].”
BackgroundAmin, A., García, A. B., Li, X., Dhamane, A. D., Luo, X., Fusco, M. D., Nadkarni, A., Friend, K. E., Rosenblatt, L. C., Mardekian, J., et al. (2019) · PLoS ONE · doi:10.1371/journal.pone.0213614 · Cited by 32
Kaide, C. G., & Gulseth, M. P. (2019) · Journal of Emergency Medicine · doi:10.1016/j.jemermed.2019.10.011 · Cited by 33
Lee, Z. X., Ang, E., Lim, X. T., & Arain, S. J. (2020) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000000925 · Cited by 32
Atrial fibrillation management in Asia: From the Asian expert forum on atrial fibrillation
Chiang, C., Zhang, S., Tse, H., Teo, W. S., Omar, R., & Sriratanasathavorn, C. (2012) · International Journal of Cardiology · doi:10.1016/j.ijcard.2011.12.033 · Cited by 32
“RealiseAF-Taiwan [19], Euro Heart Survey [29], RACE [75], AFFIRM [35], AF-CHF [78], ACTIVE W [79], ACTIVE A [27], GISSI AF [80], RE-LY [81], AVERROES [82], ROCKET AF [83], and”
BackgroundMethodAGE–RAGE interaction and oxidative stress in obesity-related renal dysfunction
Tomino, Y., Hagiwara, S., & Gohda, T. (2011) · Kidney International · doi:10.1038/ki.2011.86 · Cited by 32
Eriksen, C. F., Münster, A. B., & Grove, E. L. (2014) · Acta Anaesthesiologica Scandinavica · doi:10.1111/aas.12319 · Cited by 32
Etiology of Ischemic Strokes of Patients with Atrial Fibrillation and Therapy with Anticoagulants
Purrucker, J. C., Hölscher, K., Kollmer, J., & Ringleb, P. A. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9092938 · Cited by 30
“Oral anticoagulation effectively reduces the risk of ischemic stroke in patients suffering from non-valvular atrial fibrillation (AF) compared to placebo or platelet inhibition [1,2].”
BackgroundJohnson, L., Benz, A. P., Shoamanesh, A., Eikelboom, J. W., Ezekowitz, M. D., Giugliano, R. P., Wallentin, L. C., Ruff, C. T., Lópes, R. D., Jolly, S. S., et al. (2024) · Journal of the American Heart Association · doi:10.1161/jaha.123.034758 · Cited by 31
“3,7,29,38,39 The second limitation is that this selection of patients in randomized trials tends to result in lower-risk populations than registries with higher compliance with therapies; thus these results may not be fully generalizable to the general population.”
ResultAtrial Fibrillation and Vascular Disease—A Bad Combination
Olesen, J. B., Gislason, G., Torp-Pedersen, C. T., & Lip, G. Y. H. (2012) · Clinical Cardiology · doi:10.1002/clc.20955 · Cited by 32
Practical issues, limitations, and periprocedural management of the NOAC’s
Connolly, G. C., & Spyropoulos, A. C. (2013) · Journal of Thrombosis and Thrombolysis · doi:10.1007/s11239-013-0911-2 · Cited by 31
Raparelli, V., Proietti, M., Buttà, C., Giosia, P. D., Sirico, D., Gobbi, P. G., Corrao, S., Davı̀, G., Vestri, A. R., Perticone, F., et al. (2014) · Internal and Emergency Medicine · doi:10.1007/s11739-014-1096-1 · Cited by 31
Moving Toward a More Ideal Anticoagulant
King, C. S., Holley, A. B., & Moores, L. K. (2013) · CHEST Journal · doi:10.1378/chest.12-1362 · Cited by 31
Coppens, M., Synhorst, D. P., Eikelboom, J. W., Yusuf, S., Shestakovska, O., & Connolly, S. J. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu048 · Cited by 31
Riess, H. B., Ay, C., Bauersachs, R. M., Becattini, C., Beyer‐Westendorf, J., Cajfinger, F., Chau, I., Cohen, A. T., Khorana, A. A., Maraveyas, A., et al. (2018) · The Oncologist · doi:10.1634/theoncologist.2017-0473 · Cited by 32
Direct Anticoagulants and Risk of Myocardial Infarction, a Multiple Treatment Network Meta-Analysis
Kupó, P., Szakács, Z., Solymár, M., Habon, T., Czopf, L., Haţegan, L., Csányi, B., Borbás, J., Tringer, A., Varga, G., et al. (2019) · Angiology · doi:10.1177/0003319719874255 · Cited by 33
Steinberg, B. A., Ballew, N., Greiner, M. A., Lippmann, S., Curtis, L. H., O'Brien, E. C., Patel, M. R., & Piccini, J. P. (2019) · JACC. Clinical electrophysiology · doi:10.1016/j.jacep.2019.07.011 · Cited by 30
“Importantly, many of these patients may instead be treated with aspirin for stroke prevention, despite evidence that it is inferior to OAC for preventing stroke and may not be of significantly lower bleeding risk compared with OAC (24).”
BackgroundTodo, K., Iwata, T., Doijiri, R., Yamagami, H., Morimoto, M., Hashimoto, T., Sonoda, K., Yamazaki, H., Junpei, K., Okazaki, S., et al. (2020) · Cerebrovascular Diseases · doi:10.1159/000505958 · Cited by 31
Metadata
- Authors
- Connolly, S. J., Eikelboom, J., Joyner, C., Diener, H.-C., Hart, R., Golitsyn, S., Flaker, G., Avezum, A., Hohnloser, S. H., Diaz, R., Talajic, M., Zhu, J., Pais, P., Budaj, A., Parkhomenko, A., Jansky, P., Commerford, P., Tan, R. S., Sim, K.-H., Lewis, B. S., Van Mieghem, W., Lip, G. Y. H., Kim, J. H., Lanas-Zanetti, F., Gonzalez-Hermosillo, A., Dans, A. L., Munawar, M., O'Donnell, M., Lawrence, J., Lewis, G., Afzal, R., & Yusuf, S.
- Affiliations
- Population Health Research Institute (CA)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-03-03
- Volume
- 364
- Issue
- 9
- Pages
- 806-817
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2149388786
- Cited by
- 2,483
- References
- 23
- Citations by year
- 2026: 45 · 2025: 54 · 2024: 99 · 2023: 70 · 2022: 71 · 2021: 111 · 2020: 111 · 2019: 119 · 2018: 139 · 2017: 172 · 2016: 215 · 2015: 239 · 2014: 249 · 2013: 310 · 2012: 303
- FWCI
- 223.65
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- UnissResearch (Università degli Studi di Sassari) (submittedVersion)
- Omeka S (Universidad de La Frontera) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Hamilton Health Sciences
- McMaster University
- Astellas Pharma
- Servier
- Institut de Cardiologie de Montréal
- St. Jude Medical
- Bayer Vital
- Cilag
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
- Keywords
- apixaban, atrial fibrillation, factor Xa inhibitors, aspirin, stroke prevention, systemic embolism, vitamin K antagonists, major bleeding, intracranial hemorrhage, cardiovascular hospitalization, oral anticoagulation, early trial termination, cardiovascular mortality, cardiovascular risk stratification, subgroup analysis, bleeding risk stratification
- MeSH terms
- Aged, Aged, 80 and over, Aspirin, Atrial Fibrillation, Double-Blind Method, Embolism, Female, Fibrinolytic Agents, Hemorrhage, Humans, Male, Middle Aged, Pyrazoles, Pyridones, Risk Factors, Proportional Hazards Models, Stroke, Factor Xa Inhibitors
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