Low-dose aspirin for preventing recurrent venous thromboembolism

Brighton, Timothy A., Eikelboom, John W., Mann, Kristy, Biostat, M., Mister, Rebecca, Gallus, Alexander, Ockelford, Paul, Gibbs, Harry, Hague, Wendy, Xavier, Denis, Diaz, Rafael, Kirby, Adrienne, Simes, John, The ASPIRE Investigators and Colquhoun, D. (2012) Low-dose aspirin for preventing recurrent venous thromboembolism. New England Journal of Medicine, 367 21: 1979-1987. doi:10.1056/NEJMoa1210384

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Author Brighton, Timothy A.
Eikelboom, John W.
Mann, Kristy
Biostat, M.
Mister, Rebecca
Gallus, Alexander
Ockelford, Paul
Gibbs, Harry
Hague, Wendy
Xavier, Denis
Diaz, Rafael
Kirby, Adrienne
Simes, John
The ASPIRE Investigators
Colquhoun, D.
Title Low-dose aspirin for preventing recurrent venous thromboembolism
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2012-11-22
Sub-type Article (original research)
DOI 10.1056/NEJMoa1210384
Open Access Status File (Publisher version)
Volume 367
Issue 21
Start page 1979
End page 1987
Total pages 9
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Formatted abstract
BACKGROUND: Patients who have had a first episode of unprovoked venous thromboembolism have a high risk of recurrence after anticoagulants are discontinued. Aspirin may be effective in preventing a recurrence of venous thromboembolism.
METHODS: We randomly assigned 822 patients who had completed initial anticoagulant therapy after a first episode of unprovoked venous thromboembolism to receive aspirin, at a dose of 100 mg daily, or placebo for up to 4 years. The primary outcome was a recurrence of venous thromboembolism.
RESULTS: During a median follow-up period of 37.2 months, venous thromboembolism recurred in 73 of 411 patients assigned to placebo and in 57 of 411 assigned to aspirin (a rate of 6.5% per year vs. 4.8% per year; hazard ratio with aspirin, 0.74; 95% confidence interval [CI], 0.52 to 1.05; P = 0.09). Aspirin reduced the rate of the two prespecified secondary composite outcomes: the rate of venous thromboembolism, myocardial infarction, stroke, or cardiovascular death was reduced by 34% (a rate of 8.0% per year with placebo vs. 5.2% per year with aspirin; hazard ratio with aspirin, 0.66; 95% CI, 0.48 to 0.92; P = 0.01), and the rate of venous thromboembolism, myocardial infarction, stroke, major bleeding, or death from any cause was reduced by 33% (hazard ratio, 0.67; 95% CI, 0.49 to 0.91; P = 0.01). There was no significant between-group difference in the rates of major or clinically relevant nonmajor bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per year with aspirin, P = 0.22) or serious adverse events.
CONCLUSIONS: In this study, aspirin, as compared with placebo, did not significantly reduce the rate of recurrence of venous thromboembolism but resulted in a significant reduction in the rate of major vascular events, with improved net clinical benefit. These results substantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapy for a first episode of unprovoked venous thromboembolism. (Funded by National Health and Medical Research Council [Australia] and others; Australian New Zealand Clinical Trials Registry number, ACTRN12605000004662). 
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Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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