Cited by 855Atrial Fibrillation Management and OutcomesAntiplatelet Therapy and Cardiovascular DiseasesBlood Coagulation and Thrombosis Mechanisms

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Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in Patients With Atrial Fibrillation

Hansen, Morten L., Sørensen, Rikke, Clausen, Mette T., Fog-Petersen, Marie Louise, Raunsø, Jakob, Gadsbøll, Niels, Gislason, Gunnar H., Folke, Fredrik, Andersen, Søren S., Schramm, Tina K., Abildstrøm, Steen Z., Poulsen, Henrik E., Køber, Lars, Torp-Pedersen, Christian·2010·Archives of Internal Medicine

DOI 10.1001/archinternmed.2010.271

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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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Background
2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
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BackgroundResultInfluential
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Background
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Antiplatelet Therapy for Stable Coronary Artery Disease in Atrial Fibrillation Patients Taking an Oral Anticoagulant
Lamberts, M., Gislason, G., Lip, G. Y. H., Lassen, J. F., Olesen, J. B., Mikkelsen, A. P., Sørensen, R., Køber, L., Torp-Pedersen, C. T., & Hansen, M. L. (2014) · Circulation · doi:10.1161/circulationaha.113.004834 · Cited by 286
“Prednisolone 295 (9) 43 (10) 145 (8) 74 (8) 91 (6) 17 (5) 35 (7)”
Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin
Majeed, A., Hwang, H.-G., Connolly, S. J., Eikelboom, J. W., Ezekowitz, M. D., Wallentin, L. C., Brueckmann, M., Fraessdorf, M., Yusuf, S., & Schulman, S. (2013) · Circulation · doi:10.1161/circulationaha.113.002332 · Cited by 276
“Concomitant antiplatelet therapy has been shown to increase the risk of bleeding in patients on warfarin and dabigatran.(26,27) The higher prevalence of these risk factors in patients treated with dabigatran compared with warfarin who experienced major bleeding suggests that dabigatran is associated with a higher thre…”
Old and new oral anticoagulants: Food, herbal medicines and drug interactions
Minno, A. D., Frigerio, B., Spadarella, G., Ravani, A. L., Sansaro, D., Amato, M., Kitzmiller, J. P., Pepi, M., Tremoli, E., & Baldassarre, D. (2017) · Blood Reviews · doi:10.1016/j.blre.2017.02.001 · Cited by 247
“When combined with low-dose aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or clopidogrel, warfarin acts cumulatively, and risk of bleeding is significantly increased [8,9].”
Background
Comprehensive risk reduction in patients with atrial fibrillation: emerging diagnostic and therapeutic options—a report from the 3rd Atrial Fibrillation Competence NETwork/European Heart Rhythm Association consensus conference
Kirchhof, P. F., Lip, G. Y. H., Gelder, I. C. V., Bax, J. J., Hylek, E. M., Kääb, S., Schotten, U., Wegscheider, K., Boriani, G., Brandes, A., et al. (2011) · EP Europace · doi:10.1093/europace/eur241 · Cited by 247
“after stenting or acute coronary syndrome), there is no published trial experience available, and guidance is dependent upon case series and cohort data.(211,212) The data on combining acetylsalicylic acid with dabigatran (40% of patients in RELY received aspirin at baseline(187)) also show that a combination of antip…”
Triple therapy with aspirin, prasugrel, and vitamin K antagonists in patients with drug-eluting stent implantation and an indication for oral anticoagulation
Sarafoff, N., Martischnig, A., Wealer, J., Mayer, K., Mehilli, J., Sibbing, D., & Kastrati, A. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.02.036 · Cited by 236
“Data from retrospective studies has revealed that there is a 3-5 fold increase in bleeding rates associated with this triple therapy as compared to various combinations of dual therapy (2-8).”
Association of Warfarin Therapy Duration After Bioprosthetic Aortic Valve Replacement With Risk of Mortality, Thromboembolic Complications, and Bleeding
Mérie, C., Køber, L., Olsen, P. S., Andersson, C., Gislason, G., Jensen, J. S., & Torp-Pedersen, C. T. (2012) · JAMA · doi:10.1001/jama.2012.54506 · Cited by 230
Shear-Dependent Platelet Aggregation: Mechanisms and Therapeutic Opportunities
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“Triple therapy, including aspirin, P2Y12 antagonist and oral anticoagulant has shown a 3-fold increase in bleeding events, as compared to oral anticoagulant alone (44, 45).”
Background
ESC Guidelines for the Management of Acute Myocardial Infarction in Patients Presenting With ST-Segment Elevation
Steg, P. G., James, S. K., Atar, D., Badano, L. P., Lundqvist, C. B., Borger, M. A., Mario, C. D., Dickstein, K., Ducrocq, G., Fernández‐Avilés, F., et al. (2012) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2012.10.010 · Cited by 215
“cationsand should therefore be used for the shortest possible duration.(252,253) This is an area of controversy, with missing evidence,”
2018 Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology Focused Update of the Guidelines for the Use of Antiplatelet Therapy
Mehta, S. R., Bainey, K. R., Cantor, W. J., Lordkipanidzé, M., Marquis‐Gravel, G., Robinson, S. D., Sibbald, M., So, D. Y. F., Wong, G. C., Abunassar, J. G., et al. (2017) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2017.12.012 · Cited by 213
Open-Label Randomized Trial Comparing Oral Anticoagulation With and Without Single Antiplatelet Therapy in Patients With Atrial Fibrillation and Stable Coronary Artery Disease Beyond 1 Year After Coronary Stent Implantation
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Major Bleeding Rates in Atrial Fibrillation Patients on Single, Dual, or Triple Antithrombotic Therapy
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Consensus Document: Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting
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“While observational studies have shown an equal degree of bleeding with both regimens, one large national registry from Denmark with over 82,854 patients has shown a three-fold higher risk of major bleeding with warfarin plus clopidogrel as compared to warfarin plus aspirin (6, 89).”
Bleeding risk in ‘real world’ patients with atrial fibrillation: comparison of two established bleeding prediction schemes in a nationwide cohort
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Method
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“In addition, our definition of bleeding varies from the definition used in the RE-LY trial,(4) but at least it includes serious bleedings leading to hospitalisation, as has been used previously.(18)”
BackgroundMethodInfluential
The critical care management of spontaneous intracranial hemorrhage: a contemporary review
Manoel, A. L. D. O., Goffi, A., Zampieri, F. G., Turkel‐Parrella, D., Duggal, A., Marotta, T. R., Macdonald, R. L., & Abrahamson, S. (2016) · Critical Care · doi:10.1186/s13054-016-1432-0 · Cited by 185
“Because it remains controversial whether APT influences hematoma expansion or functional outcome, the clinical utility of its reversal is uncertain [105].”
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S2k-Leitlinie Gastrointestinale Blutung
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“[90] Hansen ML, Sorensen R, Clausen MT et al.”
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Management of Antithrombotic Therapy in Atrial Fibrillation Patients Undergoing PCI
Capodanno, D., Huber, K., Mehran, R., Lip, G. Y. H., Faxon, D. P., Granger, C. B., Vranckx, P., Lópes, R. D., Montalescot, G., Cannon, C. P., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.05.016 · Cited by 178
“In WOEST, the rationale for withdrawing aspirin was due to the observation that the risk of bleeding is highest in the first month after PCI, likely as the consequence of the procedure itself and of stacking multiple oral and parenteral antithrombotic medications (30).”
Background
Safety and efficacy of dual vs. triple antithrombotic therapy in patients with atrial fibrillation following percutaneous coronary intervention: a systematic review and meta-analysis of randomized clinical trials
Golwala, H. B., Cannon, C. P., Steg, P. G., Doros, G. D., Qamar, A., Ellis, S. G., Oldgren, J., ten Berg, J. M., Kimura, T., Hohnloser, S. H., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy162 · Cited by 170
“%) received DAT.”
BackgroundResultInfluential
Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naive atrial fibrillation patients: Danish nationwide descriptive data 2011-2013
Olesen, J. B., Sørensen, R., Hansen, M. L., Lamberts, M., Weeke, P. E., Mikkelsen, A. P., Køber, L., Gislason, G., Torp-Pedersen, C. T., & Fosbøl, E. L. (2014) · EP Europace · doi:10.1093/europace/euu225 · Cited by 165
“The ICD-10 codes applied to this study for defining comorbidities are listed in Supplementary material online, Table S1 and have been used in previous studies.(14,15) CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, history of stroke/transient ischaemic attack/systemic thromboembolism)…”
Method
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Schmidt, M., Lamberts, M., Olsen, A.-M. S., Fosbøll, E., Niessner, A., Tamargo, J., Rosano, G., Agewall, S., Kaski, J. C., Kjeldsen, K., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehv505 · Cited by 164
The Golden Age of Minimally Invasive Cardiothoracic Surgery: Current and Future Perspectives
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“Minimally invasive atrial fibrillation ablation Atrial fibrillation is the most common cardiac arrhythmia and carries a risk of increased morbidity through its untoward effects, including thromboembolic stroke [94], anticoagulationrelated hemorrhage [95] and tachycardiainduced cardiomyopathy [96].”
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Use and Associated Risks of Concomitant Aspirin Therapy With Oral Anticoagulation in Patients With Atrial Fibrillation
Steinberg, B. A., Kim, S., Piccini, J. P., Fonarow, G. C., Lópes, R. D., Thomas, L. E., Ezekowitz, M. D., Ansell, J., Kowey, P. R., Singer, D. E., et al. (2013) · Circulation · doi:10.1161/circulationaha.113.002927 · Cited by 154
“When previously published data on ischemic outcomes are combined with the present analysis demonstrating increased bleeding, the available evidence suggests that concomitant antiplatelet therapy is associated with increased risk and minimal evidence of benefit.(15,19) The use of antiplatelet therapy alone for secondar…”
Result
Reversal of anticoagulants: an overview of current developments
Thiele, T., Selleng, K., & Greinacher, A. (2015) · Thrombosis and Haemostasis · doi:10.1160/th14-11-0982 · Cited by 150
Antithrombotic drugs and risk of hemorrhagic stroke in the general population
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“The current finding that ICH risk is of similar magnitude in patients receiving warfarin monotherapy and dual therapy is in line with the Danish study.(29) Nevertheless, it is clear that additional quantification of hemorrhagic stroke risk in this patient population would be worthwhile, especially given that the only…”
BackgroundResult
Adverse Drug Events as a Cause of Hospitalization in Older Adults
Salvi, F., Marchetti, A., D’Angelo, F., Boemi, M., Lattanzio, F., & Cherubini, A. (2012) · Drug Safety · doi:10.1007/bf03319101 · Cited by 153
“Finally, triple therapy (aspirin, clopidogrel and warfarin), used when DAT is required for coronary stenting and anticoagulation is required for atrial fibrillation or mechanical heart valves, was shown to be associated with up to a fivefold higher risk of bleeding in different studies,([48-50]) whereas a recent metaa…”
Background
Stroke and recurrent haemorrhage associated with antithrombotic treatment after gastrointestinal bleeding in patients with atrial fibrillation: nationwide cohort study
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Bleeding Risk of Patients With Acute Venous Thromboembolism Taking Nonsteroidal Anti-Inflammatory Drugs or Aspirin
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2015 ESC Guidelines for the Management of Acute Coronary Syndromes in Patients Presenting Without Persistent ST-segment Elevation
Roffi, M., Patrono, C., Collet, J., Mueller, C. E., Valgimigli, M., Andreotti, F., Bax, J. J., Borger, M. A., Brotons, C., Chew, D. P., et al. (2015) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2015.10.009 · Cited by 139
Warfarin and Antiplatelet Therapy Versus Warfarin Alone for Treating Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Altisent, O. A., Durand, É., Muñoz-García, A. J., y, L. N.-F., Cheema, A. N., Kefer, J., Gutiérrez, E., Benitez, L. M., Amat-Santos, I. J., Serra, V., et al. (2016) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2016.06.025 · Cited by 135
“Data from AF studies failed to show any beneficial effect for ischemic stroke prevention using a DT strategy (aspirin plus VKA) versus a VKA alone strategy, whereas more frequent bleeding were evident in all studies using DT (4,20).”
Background
Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention
Alexander, J. H., WOJDYLA, D. M., Vora, A. N., Thomas, L. E., Granger, C. B., Goodman, S. G., ARONSON, R. S., Windecker, S., Mehran, R., & Lópes, R. D. (2020) · Circulation · doi:10.1161/circulationaha.120.046534 · Cited by 144
Oral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needs
Verheugt, F. W. A., & Granger, C. B. (2015) · The Lancet · doi:10.1016/s0140-6736(15)60245-8 · Cited by 137
Aspirin Instead of Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Risk for Stroke
Hsu, J. C., Maddox, T. M., Kennedy, K. F., Katz, D. F., Marzec, L., Lubitz, S. A., Gehi, A. K., Turakhia, M. P., & Marcus, G. M. (2016) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2016.03.581 · Cited by 133
Thromboembolic risk in 16 274 atrial fibrillation patients undergoing direct current cardioversion with and without oral anticoagulant therapy
Hansen, M. L., Jepsen, R. M. H. G., Olesen, J. B., Ruwald, M. H., Karasoy, D., Gislason, G., Hansen, J., Køber, L., Husted, S., & Torp-Pedersen, C. T. (2014) · EP Europace · doi:10.1093/europace/euu189 · Cited by 136
The role of aspirin for stroke prevention in atrial fibrillation
Lip, G. Y. H. (2011) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2011.112 · Cited by 136
Management of Antithrombotic Therapy after Acute Coronary Syndromes
Rodríguez, F., & Harrington, R. A. (2021) · New England Journal of Medicine · doi:10.1056/nejmra1607714 · Cited by 133
Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study
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Drug–drug interactions with warfarin: A systematic review and meta‐analysis
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Assessment and Mitigation of Bleeding Risk in Atrial Fibrillation and Venous Thromboembolism: Executive Summary of a European and Asia-Pacific Expert Consensus Paper
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Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF‐TIMI48 Trial
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Practical Management of Anticoagulation in Patients With Atrial Fibrillation
Kovacs, R. J., Flaker, G. C., Saxonhouse, S. J., Doherty, J. U., Birtcher, K. K., Cuker, A. C., Davidson, B. L., Giugliano, R. P., Granger, C. B., Jaffer, A. K., et al. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.01.049 · Cited by 114
“PATIENTS IN CONVALESCENT PHASE OF ISCHEMIC STROKE TREATED WITH VKAs In theory, patients presenting with an ischemic stroke and a therapeutic INR represent a drug failure of VKA and may be candidates for DOACs.”
BackgroundInfluential
Shared Decision Making in Atrial Fibrillation
Seaburg, L., Hess, E. P., Coylewright, M. J., Ting, H. H., McLeod, C. J., & Montori, V. M. (2014) · Circulation · doi:10.1161/circulationaha.113.004498 · Cited by 109
“Warfarin as a sole agent can increase the risk of major bleed to 4% per patient-year in some groups (even greater with certain comorbidities and medications), and if a patient is also taking antiplatelet agents, this risk can triple.(44) Other options include aspirin and newer anticoagulants (dabigatran, apixaban, and…”
Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Coronary Stenting
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Outcomes of Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention Receiving an Oral Anticoagulant and Dual Antiplatelet Therapy
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“Prior studies have shown the risk of bleeding to be higher with triple therapy compared with DAPT (18,22).”
Background
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Lamberts, M., Lip, G. Y. H., Hansen, M. L., Lindhardsen, J., Olesen, J. B., Raunsø, J., Olsen, A. S., Andersen, P. K., Gerds, T. A., Fosbøl, E. L., et al. (2014) · Annals of Internal Medicine · doi:10.7326/m13-1581 · Cited by 97
“It de creases the risk for thromboembolic complications and death (1) and should be prescribed after in-depth assess ment of thromboembolic risk factors; however, it has also been found to increase the risk for bleeding (2, 3).”
BackgroundMethod
Bleeding and antidotes in new oral anticoagulants
Majeed, A., & Schulman, S. (2013) · Best Practice & Research Clinical Haematology · doi:10.1016/j.beha.2013.07.001 · Cited by 99
Addressing the Challenge of Polypharmacy
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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: Hansen, Morten L.
Sørensen, Rikke
Raunsø, Jakob
Gislason, Gunnar H.
Folke, Fredrik
Poulsen, Henrik E.
Køber, Lars
Torp-Pedersen, Christian
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)
DOI: 10.1001/archinternmed.2010.271
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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Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in Patients With Atrial Fibrillation

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