Aspirin for preventing the recurrence of venous thromboembolism

Cecilia Becattini, Giancarlo Agnelli, Alessandro Schenone, Sabine Eichinger, Eugenio Bucherini, Mauro Silingardi, Marina Bianchi, Marco Moia, Walter Ageno, Maria Rita Vandelli, Elvira Grandone, Paolo Prandoni

Research output: Contribution to journalArticle

Abstract

BACKGROUND: About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown. METHODS:In this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome. RESULTS:Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups. CONCLUSIONS: Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by the University of Perugia and others; WARFASA ClinicalTrials.gov number, NCT00222677.)

Original languageEnglish
Pages (from-to)1959-1967
Number of pages9
JournalNew England Journal of Medicine
Volume366
Issue number21
DOIs
Publication statusPublished - May 24 2012

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Venous Thromboembolism
Aspirin
Recurrence
Anticoagulants
Hemorrhage
Placebos
Therapeutics
Confidence Intervals
Double-Blind Method
Research Personnel
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Becattini, C., Agnelli, G., Schenone, A., Eichinger, S., Bucherini, E., Silingardi, M., ... Prandoni, P. (2012). Aspirin for preventing the recurrence of venous thromboembolism. New England Journal of Medicine, 366(21), 1959-1967. https://doi.org/10.1056/NEJMoa1114238

Aspirin for preventing the recurrence of venous thromboembolism. / Becattini, Cecilia; Agnelli, Giancarlo; Schenone, Alessandro; Eichinger, Sabine; Bucherini, Eugenio; Silingardi, Mauro; Bianchi, Marina; Moia, Marco; Ageno, Walter; Vandelli, Maria Rita; Grandone, Elvira; Prandoni, Paolo.

In: New England Journal of Medicine, Vol. 366, No. 21, 24.05.2012, p. 1959-1967.

Research output: Contribution to journalArticle

Becattini, C, Agnelli, G, Schenone, A, Eichinger, S, Bucherini, E, Silingardi, M, Bianchi, M, Moia, M, Ageno, W, Vandelli, MR, Grandone, E & Prandoni, P 2012, 'Aspirin for preventing the recurrence of venous thromboembolism', New England Journal of Medicine, vol. 366, no. 21, pp. 1959-1967. https://doi.org/10.1056/NEJMoa1114238
Becattini C, Agnelli G, Schenone A, Eichinger S, Bucherini E, Silingardi M et al. Aspirin for preventing the recurrence of venous thromboembolism. New England Journal of Medicine. 2012 May 24;366(21):1959-1967. https://doi.org/10.1056/NEJMoa1114238
Becattini, Cecilia ; Agnelli, Giancarlo ; Schenone, Alessandro ; Eichinger, Sabine ; Bucherini, Eugenio ; Silingardi, Mauro ; Bianchi, Marina ; Moia, Marco ; Ageno, Walter ; Vandelli, Maria Rita ; Grandone, Elvira ; Prandoni, Paolo. / Aspirin for preventing the recurrence of venous thromboembolism. In: New England Journal of Medicine. 2012 ; Vol. 366, No. 21. pp. 1959-1967.
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abstract = "BACKGROUND: About 20{\%} of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown. METHODS:In this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome. RESULTS:Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6{\%} vs. 11.2{\%} per year; hazard ratio, 0.58; 95{\%} confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9{\%} vs. 11.0{\%} per year; hazard ratio, 0.55; 95{\%} CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups. CONCLUSIONS: Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by the University of Perugia and others; WARFASA ClinicalTrials.gov number, NCT00222677.)",
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AU - Agnelli, Giancarlo

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AU - Bucherini, Eugenio

AU - Silingardi, Mauro

AU - Bianchi, Marina

AU - Moia, Marco

AU - Ageno, Walter

AU - Vandelli, Maria Rita

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AU - Prandoni, Paolo

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N2 - BACKGROUND: About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown. METHODS:In this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome. RESULTS:Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups. CONCLUSIONS: Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by the University of Perugia and others; WARFASA ClinicalTrials.gov number, NCT00222677.)

AB - BACKGROUND: About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown. METHODS:In this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome. RESULTS:Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups. CONCLUSIONS: Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by the University of Perugia and others; WARFASA ClinicalTrials.gov number, NCT00222677.)

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