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Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in Patients With Atrial Fibrillation
Abstract
BACKGROUND: Patients with atrial fibrillation (AF) often require anticoagulation and platelet inhibition, but data are limited on the bleeding risk of combination therapy. METHODS: We performed a cohort study using nationwide registries to identify all Danish patients surviving first-time hospitalization for AF between January 1, 1997, and December 31, 2006, and their posthospital therapy of warfarin, aspirin, clopidogrel, and combinations of these drugs. Cox proportional hazards models were used to estimate risks of nonfatal and fatal bleeding. RESULTS: A total of 82,854 of 118,606 patients (69.9%) surviving AF hospitalization had at least 1 prescription filled for warfarin, aspirin, or clopidogrel after discharge. During mean (SD) follow-up of 3.3 (2.6) years, 13,573 patients (11.4%) experienced a nonfatal or fatal bleeding. The crude incidence rate for bleeding was highest for dual clopidogrel and warfarin therapy (13.9% per patient-year) and triple therapy (15.7% per patient-year). Using warfarin monotherapy as a reference, the hazard ratio (95% confidence interval) for the combined end point was 0.93 (0.88-0.98) for aspirin, 1.06 (0.87-1.29) for clopidogrel, 1.66 (1.34-2.04) for aspirin-clopidogrel, 1.83 (1.72-1.96) for warfarin-aspirin, 3.08 (2.32-3.91) for warfarin-clopidogrel, and 3.70 (2.89-4.76) for warfarin-aspirin-clopidogrel. CONCLUSIONS: In patients with AF, all combinations of warfarin, aspirin, and clopidogrel are associated with increased risk of nonfatal and fatal bleeding. Dual warfarin and clopidogrel therapy and triple therapy carried a more than 3-fold higher risk than did warfarin monotherapy.
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“Approximately 15% of AF patients in contemporary trials 513 and registries [514][515][516] have a history of myocardial 1498 infarction.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [514]
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“de FA, au cours des dix années qui avaient suivi leur première hospitalisation motivée par cette affection.(11) Sur les 118 606 patients de l’étude, 50 919 avaient reçu uniquement de la”
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“In addition, the need for clopidogrel discontinuation after the first month following PCI is not rare in clinical practice (eg, need for surgery) and is still a critical decision for physicians, especially after DES implantation.(17,40,42) Finally, while severe internal bleeding often requires a prompt interruption of…”
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“[18] found in patients with AF that combinations of warfarin, aspirin, or clopidogrel were associated with an increased risk of fatal and nonfatal bleeding.”
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“However, combining OAC with other antithrombotic agents is associated with a high risk of bleeding complications.(5,6) Previous studies have shown that the guidelines are being experienced as complex, especially in patients with several indications who require multiple antithrombotic medications.”
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“However, concomitant antiplatelet therapy in patients on warfarin due to atrial fibrillation increases the risk of hemorrhage: the combination of warfarin and aspirin is associated with an almost twofold bleeding risk and the combination of warfarin and clopidogrel or a triple therapy consisting of warfarin, aspirin,…”
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“However, this triple antithrombotic strategy has been scrutinized because it increases the risk of serious bleeding [4].”
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“Recent studies show that the risk of bleeding increases almost 2-fold in patients using ASA plus VKA and increases 4-fold in patients using VKA, clopidogrel and ASA, as compared to patients using ASA alone.(9,10) Numbers needed to harm (number of patients needed to be treated for 1 year to cause one fatal or non-fatal…”
ResultLeft atrial appendage occlusion in valvular atrial fibrillation following MitraClip implantation
Jabs, A., Hink, U., Warnholtz, A., von Bardeleben, R. S., Nikolai, P., Münzel, T. F., & Gori, T. (2012) · Clinical Research in Cardiology · doi:10.1007/s00392-012-0416-6 · Cited by 8
“excessive bleeding risk that a triple anticoagulant therapy would have been associated with [3], neither phenprocou-”
BackgroundImpact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF
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Utility of Repeat Head CT in Patients on Preinjury Antithrombotic Medications
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Anti-thrombotic strategies in patients with atrial fibrillation undergoing PCI
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“When a patient with AF requires PCI with consecutive DAPT, combining ASA + OAC + clopidogrel can increase the risk of bleeding by 3–4-fold compared to OAC alone [10, 40].”
BackgroundInfluentialParticipation of Iatrogenically Coagulopathic Patients in Wilderness Activities
Hawkins, S. C., Caudell, M. J., DeLoughery, T. G., & Murray, W. S. (2013) · Wilderness and Environmental Medicine · doi:10.1016/j.wem.2012.12.002 · Cited by 7
“With the combination of aspirin and lopidogrel there is potential for severe bleeding equivlent to that of warfarin.(9) Recently, novel oral anticoag-”
BackgroundAnti-thromboembolic strategies in atrial fibrillation.
Cocco, G., Amiet, P., & Jerie, P. (2016) · Cardiology Journal · doi:10.5603/cj.a2016.0004 · Cited by 7
OVERVIEW OF NON-VITAMIN K ORAL ANTICOAGULANTS
Cirstea, I. (2020) · FARMACIA · doi:10.31925/farmacia.2020.2.3 · Cited by 9
“antiplatelets, especially prasugrel and ticagrelor, increases the risk of bleeding at least three times [32, 33].”
BackgroundHigh On-Treatment Platelet Reactivity: Aspirin versus Clopidogrel
M’Pembele, R., Ahlbrecht, S., Helten, C., Mourikis, P., Naguib, D., Zako, S., Trojovsky, K., Huhn, R., Petzold, T., Hohlfeld, T., et al. (2022) · Pharmacology · doi:10.1159/000527816 · Cited by 8
A Guidance Pathway for the Selection of Novel Anticoagulants in the Treatment of Atrial Fibrillation
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Antithrombotic therapy in elderly patients with non-valvular atrial fibrillation: a pilot study
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How do we manage serious gastrointestinal adverse events associated with anti-thrombotic therapy?
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“32), respectively [12].”
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“warfarin or single antiplatelet monotherapy [16].”
Individualising Anticoagulant Therapy in Atrial Fibrillation Patients
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“However, patients treated with aspirin have an increased bleeding risk similar to that of vitamin K antagonist (VKA)-treated patients.(5,6) The use of aspirin for stroke prevention has been superseded by VKAs, and aspirin is not recommended for this indication.”
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“org July 2020 • Volume 48 • Number 7 antiplatelet agents as outpatient therapy have been associated with increased risk of bleeding (6, 7).”
BackgroundComplexity of Antiplatelet Therapy in Coronary Artery Disease Patients
Sabouret, P. F., Savage, M. P., Fischman, D. L., & Costa, F. (2020) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-020-00414-0 · Cited by 10
Management of Anticoagulant Treatment and Anticoagulation-Related Complications in Nonagenarians
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“A large cohort study conducted in Denmark, found that TAT with warfarin, aspirin, and clopidogrel had a more than 3-fold higher risk of bleeding compared to OAC monotherapy [40].”
BackgroundRossini, R., Casula, M., & Ferlini, M. (2021) · European Heart Journal Supplements · doi:10.1093/eurheartj/suab109 · Cited by 7
“The risk of these events is closely related to the patient’s risk profile which can be estimated with the aid of numerical ‘scores’ (CHA2DS2VASc), but fundamentally, it is significantly reduced by treatment with oral anticoagulants (OACs); however, treatment with OAC inevitably leads to an increased risk of bleeding e…”
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“Therefore, LBP’s etiology often remains unknown [3,4].”
Kongebro, E. K., Diederichsen, S. Z., Xing, L. Y., Haugan, K., Graff, C., Højberg, S., Olesen, M. S., Krieger, D. W., Brandes, A., Køber, L., et al. (2023) · TH Open · doi:10.1055/a-2202-4296 · Cited by 7
“16,17 The lack of association could, besides too few events, be caused by healthy user bias (or other selection bias) as more risk-prone individuals may less often have accepted the study invitation, 18 the high antiplatelet discontinuation rate upon AF detection and initiation of OAC, or the…”
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Resuming Anticoagulation in the First Week Following Gastrointestinal Tract Hemorrhage
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“Prior studies have shown increased risk of bleeding with no benefits in reducing ischemic events in patients treated with triple therapy [18, 19].”
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“The risk of bleeding with ASA, for example, was comparable to that for warfarin among patients with atrial fibrillation [Hansen et al. 2010].”
ResultAntidepressants, antiplatelets and bleeding: One more thing to worry about?
Juurlink, D. N. (2011) · Canadian Medical Association Journal · doi:10.1503/cmaj.111576 · Cited by 7
“In a large retrospective study involving more than 80 000 Danish patients with atrial fibrillation, those receiving ASA in combination with warfarin had a roughly twofold increase in the risk of hemorrhage relative to warfarin monotherapy, while those receiving “triple therapy” with ASA, clopidogrel and warfarin had a…”
ResultJackson, L. R., Piccini, J. P., Cyr, D. D., Roe, M. T., Neely, M. L., Martínez, F. A., Lüscher, T. F., Lópes, R. D., Winters, K. J., White, H. D., et al. (2016) · Clinical Cardiology · doi:10.1002/clc.22562 · Cited by 7
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“However, a combination of warfarin with (D)APT carries a more than threefold higher risk for non-fatal and fatal bleeding compared with warfarin monotherapy [7].”
BackgroundRuíz, G. E., Martínez, C. C., Flores‐Blanco, P. J., Manchado, J. J. C., Iglesias, H. A., Navarro, A. L., Montoya, F. A., Garcı́a-Alberola, A., Pascual-Figal, D. A., Lorenzo, J. L. B., et al. (2019) · European Journal of Clinical Investigation · doi:10.1111/eci.13161 · Cited by 7
“History of stroke and/or transient ischaemic attack 454 (19) 5 (20) 1.”
BackgroundInhibitory effect of bee venom on blood coagulation via anti-serine protease activity
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Effects of ticagrelor on the pharmacokinetics of rivaroxaban in rats
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“Conventional combination of VKAs with dual antiplatelet therapy (DATP) is associated with increased risk of serious bleeding (Hansen et al. 2010; Lamberts et al. 2012).”
BackgroundOne-Year Risk of Bleeding With Dabigatran in Patients With Atrial Fibrillation
Miyares, M. A. (2015) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2015.1271 · Cited by 7
The Perils of Combination Antithrombotic Therapy and Potential Resolutions
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Aspirin use is safe in patients undergoing transbronchial lung cryobiopsy
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“Although there is a significant decrease in the morbidity and mortality associated with available antiplatelet agents, reocclusion, recurrent ischemia, MI/reinfarction and unwanted bleeding still occur (Choudhry & Desai, 2012; Hansen et al., 2010).”
BackgroundWarfarin therapy in a dog with acute arterial thrombosis and pyometra.
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Management of acute venous thromboembolism in patients taking antiplatelet therapy
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Practical advice for prescribing in old age
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The Current and Future Role of the Novel Oral Anticoagulants—Indications Beyond Atrial Fibrillation
Lee, A., & Rajaratnam, R. (2013) · Heart Lung and Circulation · doi:10.1016/j.hlc.2013.09.007 · Cited by 6
“Traditionally, guidelines have recommended that these patients need to be treated with dual anti-platelet therapy as well as anticoagulation with warfarin [38]; however, such a regimen is associated with a significant bleeding risk [39].”
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New oral anticoagulant agents after ACS
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“[5] found in patients with AF that combinations of warfarin, aspirin, or clopidogrel were associated with an increased risk of fatal and nonfatal bleeding.”
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“TT, however, substantially increases the risk of bleeding [5].”
BackgroundTriple therapy after PCI – Warfarin treatment quality and bleeding risk
Wadell, D., Jensen, J., Englund, E., & Själander, A. (2018) · PLoS ONE · doi:10.1371/journal.pone.0209187 · Cited by 6
Direct oral anticoagulants: a practical guide for the emergency physician
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Metadata
- Authors
- Hansen, M. L., Sørensen, R., Clausen, M. T., Fog-Petersen, M. L., Raunsø, J., Gadsbøll, N., Gislason, G. H., Folke, F., Andersen, S. S., Schramm, T. K., Abildstrøm, S. Z., Poulsen, H. E., Køber, L., & Torp-Pedersen, C.
- Affiliations
- Copenhagen University Hospital (DK)
- ORCID
- Venue
- Archives of Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2010-09-13
- Volume
- 170
- Issue
- 16
- Pages
- 1433-41
- ISSN
- 0003-9926 (ISSN-L)
- OpenAlex
- W2144471064
- Cited by
- 855
- References
- 45
- Citations by year
- 2026: 16 · 2025: 23 · 2024: 23 · 2023: 25 · 2022: 41 · 2021: 37 · 2020: 64 · 2019: 83 · 2018: 63 · 2017: 75 · 2016: 80 · 2015: 68 · 2014: 63 · 2013: 76 · 2012: 63
- FWCI
- 42.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- atrial fibrillation, bleeding risk, warfarin, aspirin, clopidogrel, combination antithrombotic therapy, triple therapy, dual therapy, anticoagulation, platelet aggregation inhibition, fatal bleeding
- MeSH terms
- Clopidogrel, Aged, Anticoagulants, Aspirin, Atrial Fibrillation, Brain Ischemia, Denmark, Drug Therapy, Combination, Female, Hemorrhage, Humans, Male, Registries, Risk, Ticlopidine, Warfarin, Cohort Studies, Comorbidity, Incidence, Proportional Hazards Models, Stroke
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