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Aspirin for Preventing the Recurrence
of Venous Thromboembolism

.N Engl J Med 2012; 366:1959-1967May 24, 2012
Cecilia Becattini, M.D., Ph.D., Giancarlo Agnelli, M.D., Alessandro Schenone, M.D., Sabine Eichinger, M.D., Eugenio Bucherini, M.D., Mauro Silingardi, M.D., Marina Bianchi, M.D., Marco Moia, M.D., Walter Ageno, M.D., Maria Rita Vandelli, M.D., Elvira Grandone, M.D., and Paolo Prandoni, M.D., Ph.D. for the WARFASA Investigators

L'aspirine est utilisée dans la prévention des troubles thrombo-emboliques artériels.
Un essai clinique publié dans le NEJM du 24 mai 2012 montre que l'aspirine réduit la récurrence des troubles thrombo-emboliques veineux ( unprovoked) spontanés (thrombose veineuse profonde, embolie pulmonaire), en relai de la warfarine. Des malades ayant été traités pendant 6 à 18 mois par anticoagulant, la warfarine, pour troubles thrombo-emboliques veineux ont été divisés en deux groupes après l'arrêt de la warfarine, l'un recevant 100 mg d'aspirine par jour, l'autre un placebo. La récurrence des troubles thrombo-emboliques veineux a été réduite de près de la moitié chez les malades recevant de l'aspirine sans augmentation des accidents hémorragiques.

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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