Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 367, Issue 21, Pages 1979-1987Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1210384
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Funding
- National Health and Medical Research Council [Australia]
- National Health and Medical Research Council (Australia)
- Health Research Council (New Zealand)
- Austral-asian Society of Thrombosis and Hemostasis
- National Heart Foundation of Australia
- Bayer HealthCare
- Boehringer Ingelheim
- Daiichi-Sankyo
- Pfizer
- Amgen Australia
- GlaxoSmithKline
- Bayer
- Bristol-Myers Squibb
- Corgenix
- Eisai
- Eli Lilly
- McNeil
- Sanofi-Aventis
- Haemoscope
- Daichii-Sankyo
- CSL Australia
- Covidien
- AstraZeneca
- Cadila Pharmaceuticals
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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 re-curred 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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