Aspirin for preventing the recurrence of venous thromboembolism.
Details
Serval ID
serval:BIB_42E530ECCC83
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Aspirin for preventing the recurrence of venous thromboembolism.
Journal
New England Journal of Medicine
Working group(s)
WARFASA Investigators
Contributor(s)
Agnelli G., Becattini C., Prandoni P., Becattini C., Agnelli G., Prandoni P., Ageno W., Cimminiello C., Eichinger S., Duranti M., Radicchia S., Guercini F., Vedovati MC., Tormene D., Perlati M., Barbar S., Poggio R., Leischer L., Bucherini E., Galimberti D., Leone MF., Beretta A., Carugati A., Braham S., Romualdi E., Tiscia G., Colaizzo D., Grilli M., Siragusa S., Salvi R., Miccio M., Ria L., Zanatta N., Poli D., Camporese G., Verlato F., Salvi A., Nitti C., Santi R., Cimminiello C., Scannapieco G., Barillari G., Pasca S., De Gaudenzi E., Cappelli R., Di Minno G., Tufano A., Frausini G., Bova C., Pogliani E., Signorelli SS., Testa S., Alatri A., Mancuso G., Grifoni S., Lodigiani C.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
2012
Volume
366
Number
21
Pages
1959-1967
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
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.).
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.).
Keywords
Aged, Anticoagulants/therapeutic use, Aspirin/adverse effects, Aspirin/therapeutic use, Double-Blind Method, Female, Follow-Up Studies, Hemorrhage/chemically induced, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors/adverse effects, Platelet Aggregation Inhibitors/therapeutic use, Pulmonary Embolism/prevention & control, Recurrence/prevention & control, Secondary Prevention, Venous Thromboembolism/drug therapy, Venous Thromboembolism/prevention & control, Venous Thrombosis/prevention & control, Vitamin K/antagonists & inhibitors
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Create date
14/02/2013 12:32
Last modification date
03/06/2020 5:26
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