Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation: An exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials

Greg C. Flaker, Michael Gruber, Stuart J. Connolly, Steven Goldman, Sandra Chaparro, Alec Vahanian, Matti O. Halinen, Jay Horrow, Jonathan L. Halperin

Research output: Contribution to journalArticle

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Abstract

Background: Aspirin is used in combination with anticoagulant therapy in patients with atrial fibrillation (AF), but evidence of additional efficacy is not available. Methods: We compared ischemic events and bleeding in the SPORTIF III and IV randomized trials of anticoagulation with warfarin (international normalized ratio 2-3) or fixed-dose ximelagatran. Low-dose aspirin (<100 mg/d) was allowed based on prevailing guidelines. Results: The 14% of patients receiving aspirin more often had diabetes (27.5% vs 23%, P < .01), coronary artery disease (69% vs 41%, P < .01), previous stroke or transient ischemic attack (26% vs 20%, P < .01), and left ventricular dysfunction (41% vs 36%, P < .01). Addition of aspirin to either warfarin or ximelagatran was associated with no reduction in stroke or systemic embolism. Major bleeding occurred significantly more often with aspirin plus warfarin (3.9% per year) than with warfarin alone (2.3% per year, P < .01), aspirin plus ximelagatran (2.0% per year), or ximelagatran alone (1.9% per year). The rate of myocardial infarction with aspirin and warfarin (0.6% per year) was not significantly different from that with ximelagatran alone (1.0% per year), warfarin alone (1.0% per year), or aspirin and ximelagatran (1.4% per year). Conclusions: Aspirin combined with anticoagulant therapy was associated with no reduction in stroke, systemic embolism, or myocardial infarction in patients with AF. Aspirin combined with warfarin was associated with an incremental rate of major bleeding of 1.6% per year. No increased major bleeding occurred with aspirin and ximelagatran. These results suggest that the risks associated with addition of aspirin to anticoagulation in patients with AF outweigh the benefit.

Original languageEnglish (US)
Pages (from-to)967-973
Number of pages7
JournalAmerican Heart Journal
Volume152
Issue number5
DOIs
StatePublished - Nov 2006
Externally publishedYes

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Thrombin
Anticoagulants
Atrial Fibrillation
Aspirin
Stroke
Warfarin
Therapeutics
Hemorrhage
Embolism
Myocardial Infarction
International Normalized Ratio
Transient Ischemic Attack
Left Ventricular Dysfunction
ximelagatran
Coronary Artery Disease
Guidelines

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation : An exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials. / Flaker, Greg C.; Gruber, Michael; Connolly, Stuart J.; Goldman, Steven; Chaparro, Sandra; Vahanian, Alec; Halinen, Matti O.; Horrow, Jay; Halperin, Jonathan L.

In: American Heart Journal, Vol. 152, No. 5, 11.2006, p. 967-973.

Research output: Contribution to journalArticle

Flaker, Greg C. ; Gruber, Michael ; Connolly, Stuart J. ; Goldman, Steven ; Chaparro, Sandra ; Vahanian, Alec ; Halinen, Matti O. ; Horrow, Jay ; Halperin, Jonathan L. / Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation : An exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials. In: American Heart Journal. 2006 ; Vol. 152, No. 5. pp. 967-973.
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title = "Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation: An exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials",
abstract = "Background: Aspirin is used in combination with anticoagulant therapy in patients with atrial fibrillation (AF), but evidence of additional efficacy is not available. Methods: We compared ischemic events and bleeding in the SPORTIF III and IV randomized trials of anticoagulation with warfarin (international normalized ratio 2-3) or fixed-dose ximelagatran. Low-dose aspirin (<100 mg/d) was allowed based on prevailing guidelines. Results: The 14{\%} of patients receiving aspirin more often had diabetes (27.5{\%} vs 23{\%}, P < .01), coronary artery disease (69{\%} vs 41{\%}, P < .01), previous stroke or transient ischemic attack (26{\%} vs 20{\%}, P < .01), and left ventricular dysfunction (41{\%} vs 36{\%}, P < .01). Addition of aspirin to either warfarin or ximelagatran was associated with no reduction in stroke or systemic embolism. Major bleeding occurred significantly more often with aspirin plus warfarin (3.9{\%} per year) than with warfarin alone (2.3{\%} per year, P < .01), aspirin plus ximelagatran (2.0{\%} per year), or ximelagatran alone (1.9{\%} per year). The rate of myocardial infarction with aspirin and warfarin (0.6{\%} per year) was not significantly different from that with ximelagatran alone (1.0{\%} per year), warfarin alone (1.0{\%} per year), or aspirin and ximelagatran (1.4{\%} per year). Conclusions: Aspirin combined with anticoagulant therapy was associated with no reduction in stroke, systemic embolism, or myocardial infarction in patients with AF. Aspirin combined with warfarin was associated with an incremental rate of major bleeding of 1.6{\%} per year. No increased major bleeding occurred with aspirin and ximelagatran. These results suggest that the risks associated with addition of aspirin to anticoagulation in patients with AF outweigh the benefit.",
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T1 - Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation

T2 - An exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials

AU - Flaker, Greg C.

AU - Gruber, Michael

AU - Connolly, Stuart J.

AU - Goldman, Steven

AU - Chaparro, Sandra

AU - Vahanian, Alec

AU - Halinen, Matti O.

AU - Horrow, Jay

AU - Halperin, Jonathan L.

PY - 2006/11

Y1 - 2006/11

N2 - Background: Aspirin is used in combination with anticoagulant therapy in patients with atrial fibrillation (AF), but evidence of additional efficacy is not available. Methods: We compared ischemic events and bleeding in the SPORTIF III and IV randomized trials of anticoagulation with warfarin (international normalized ratio 2-3) or fixed-dose ximelagatran. Low-dose aspirin (<100 mg/d) was allowed based on prevailing guidelines. Results: The 14% of patients receiving aspirin more often had diabetes (27.5% vs 23%, P < .01), coronary artery disease (69% vs 41%, P < .01), previous stroke or transient ischemic attack (26% vs 20%, P < .01), and left ventricular dysfunction (41% vs 36%, P < .01). Addition of aspirin to either warfarin or ximelagatran was associated with no reduction in stroke or systemic embolism. Major bleeding occurred significantly more often with aspirin plus warfarin (3.9% per year) than with warfarin alone (2.3% per year, P < .01), aspirin plus ximelagatran (2.0% per year), or ximelagatran alone (1.9% per year). The rate of myocardial infarction with aspirin and warfarin (0.6% per year) was not significantly different from that with ximelagatran alone (1.0% per year), warfarin alone (1.0% per year), or aspirin and ximelagatran (1.4% per year). Conclusions: Aspirin combined with anticoagulant therapy was associated with no reduction in stroke, systemic embolism, or myocardial infarction in patients with AF. Aspirin combined with warfarin was associated with an incremental rate of major bleeding of 1.6% per year. No increased major bleeding occurred with aspirin and ximelagatran. These results suggest that the risks associated with addition of aspirin to anticoagulation in patients with AF outweigh the benefit.

AB - Background: Aspirin is used in combination with anticoagulant therapy in patients with atrial fibrillation (AF), but evidence of additional efficacy is not available. Methods: We compared ischemic events and bleeding in the SPORTIF III and IV randomized trials of anticoagulation with warfarin (international normalized ratio 2-3) or fixed-dose ximelagatran. Low-dose aspirin (<100 mg/d) was allowed based on prevailing guidelines. Results: The 14% of patients receiving aspirin more often had diabetes (27.5% vs 23%, P < .01), coronary artery disease (69% vs 41%, P < .01), previous stroke or transient ischemic attack (26% vs 20%, P < .01), and left ventricular dysfunction (41% vs 36%, P < .01). Addition of aspirin to either warfarin or ximelagatran was associated with no reduction in stroke or systemic embolism. Major bleeding occurred significantly more often with aspirin plus warfarin (3.9% per year) than with warfarin alone (2.3% per year, P < .01), aspirin plus ximelagatran (2.0% per year), or ximelagatran alone (1.9% per year). The rate of myocardial infarction with aspirin and warfarin (0.6% per year) was not significantly different from that with ximelagatran alone (1.0% per year), warfarin alone (1.0% per year), or aspirin and ximelagatran (1.4% per year). Conclusions: Aspirin combined with anticoagulant therapy was associated with no reduction in stroke, systemic embolism, or myocardial infarction in patients with AF. Aspirin combined with warfarin was associated with an incremental rate of major bleeding of 1.6% per year. No increased major bleeding occurred with aspirin and ximelagatran. These results suggest that the risks associated with addition of aspirin to anticoagulation in patients with AF outweigh the benefit.

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