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Daily aspirin reduced the risk of recurrent blood clots significantly for patients who had stopped anticoagulant therapy after a first unprovoked venous thromboembolism, investigators reported in the New England Journal of Medicine.
About a 40% reduction was accomplished without an increase in major bleeding, in the 402-patient Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) study. Adverse events were similar whether patients were randomized to 100 mg of aspirin daily or placebo.
New blood clots occurred at a rate of 6.6% per year in patients randomized to aspirin, compared with 11.2% per year in those given placebo, Dr. Cecilia Becattini and her associates reported. At a median treatment period of 23.9 months, the recurrence rates while taking the study drug were 5.9% and 11.0% per year, respectively, with 1 patient in each group having a major bleed (N. Engl. J. Med. 366;21:1959-67).
All patients had completed 6-18 months of oral anticoagulant treatment with a vitamin K antagonist before randomization in the multicenter, double-blind trial. Patients were not enrolled if they had cancer, thrombophilia, or bleeding during the period of anticoagulant treatment, but the authors wrote that they "estimate that a substantial proportion (probably the majority) of patients with an initial episode of venous thromboembolism would be eligible for aspirin therapy as secondary prevention."
Dr. Becattini of the University of Perugia (Italy) presented results in December 2011 at the annual meeting of the American Society of Hematology. (Click here for our report, including a video interview with Dr. Becattini.)
The trial received support from the University of Perugia, a grant-in-aid from Bayer HealthCare, and an Aventis Fellowship for Clinical Research from the International Society of Thrombosis and Haemostasis (to Dr. Becattini). Dr. Becattini and several coauthors disclosed relationships with various drug companies, including Bayer.
In an accompanying editorial, Dr. Richard C. Becker wrote, "The findings of the Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) study are compelling and may signal an important step in the evolution of care; however, confirmatory studies will be required to establish a role in daily clinical practice for the use of aspirin among patients who are at high risk for bleeding due to anticoagulant therapy or for whom ongoing investigations identify and subsequently validate a clinical or biomarker-based profile associated with a low risk of recurring venous thromboembolism."
He called attention to the ongoing Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) study (Australian New Zealand Clinical Trials Registry number ACTRN012605000004662). "A prospectively planned, combined analysis of the ASPIRE and WARFASA trials (ACTRN12611000684921) may provide more reliable evidence of the effect of aspirin in patients with first unprovoked venous thromboembolism," said Dr. Becker (N. Engl. J. Med. 366;21:2028-30).
Dr. Becker is at the Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C. He disclosed relationships with seven pharmaceutical companies.
In an accompanying editorial, Dr. Richard C. Becker wrote, "The findings of the Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) study are compelling and may signal an important step in the evolution of care; however, confirmatory studies will be required to establish a role in daily clinical practice for the use of aspirin among patients who are at high risk for bleeding due to anticoagulant therapy or for whom ongoing investigations identify and subsequently validate a clinical or biomarker-based profile associated with a low risk of recurring venous thromboembolism."
He called attention to the ongoing Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) study (Australian New Zealand Clinical Trials Registry number ACTRN012605000004662). "A prospectively planned, combined analysis of the ASPIRE and WARFASA trials (ACTRN12611000684921) may provide more reliable evidence of the effect of aspirin in patients with first unprovoked venous thromboembolism," said Dr. Becker (N. Engl. J. Med. 366;21:2028-30).
Dr. Becker is at the Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C. He disclosed relationships with seven pharmaceutical companies.
In an accompanying editorial, Dr. Richard C. Becker wrote, "The findings of the Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) study are compelling and may signal an important step in the evolution of care; however, confirmatory studies will be required to establish a role in daily clinical practice for the use of aspirin among patients who are at high risk for bleeding due to anticoagulant therapy or for whom ongoing investigations identify and subsequently validate a clinical or biomarker-based profile associated with a low risk of recurring venous thromboembolism."
He called attention to the ongoing Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) study (Australian New Zealand Clinical Trials Registry number ACTRN012605000004662). "A prospectively planned, combined analysis of the ASPIRE and WARFASA trials (ACTRN12611000684921) may provide more reliable evidence of the effect of aspirin in patients with first unprovoked venous thromboembolism," said Dr. Becker (N. Engl. J. Med. 366;21:2028-30).
Dr. Becker is at the Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C. He disclosed relationships with seven pharmaceutical companies.
Daily aspirin reduced the risk of recurrent blood clots significantly for patients who had stopped anticoagulant therapy after a first unprovoked venous thromboembolism, investigators reported in the New England Journal of Medicine.
About a 40% reduction was accomplished without an increase in major bleeding, in the 402-patient Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) study. Adverse events were similar whether patients were randomized to 100 mg of aspirin daily or placebo.
New blood clots occurred at a rate of 6.6% per year in patients randomized to aspirin, compared with 11.2% per year in those given placebo, Dr. Cecilia Becattini and her associates reported. At a median treatment period of 23.9 months, the recurrence rates while taking the study drug were 5.9% and 11.0% per year, respectively, with 1 patient in each group having a major bleed (N. Engl. J. Med. 366;21:1959-67).
All patients had completed 6-18 months of oral anticoagulant treatment with a vitamin K antagonist before randomization in the multicenter, double-blind trial. Patients were not enrolled if they had cancer, thrombophilia, or bleeding during the period of anticoagulant treatment, but the authors wrote that they "estimate that a substantial proportion (probably the majority) of patients with an initial episode of venous thromboembolism would be eligible for aspirin therapy as secondary prevention."
Dr. Becattini of the University of Perugia (Italy) presented results in December 2011 at the annual meeting of the American Society of Hematology. (Click here for our report, including a video interview with Dr. Becattini.)
The trial received support from the University of Perugia, a grant-in-aid from Bayer HealthCare, and an Aventis Fellowship for Clinical Research from the International Society of Thrombosis and Haemostasis (to Dr. Becattini). Dr. Becattini and several coauthors disclosed relationships with various drug companies, including Bayer.
Daily aspirin reduced the risk of recurrent blood clots significantly for patients who had stopped anticoagulant therapy after a first unprovoked venous thromboembolism, investigators reported in the New England Journal of Medicine.
About a 40% reduction was accomplished without an increase in major bleeding, in the 402-patient Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) study. Adverse events were similar whether patients were randomized to 100 mg of aspirin daily or placebo.
New blood clots occurred at a rate of 6.6% per year in patients randomized to aspirin, compared with 11.2% per year in those given placebo, Dr. Cecilia Becattini and her associates reported. At a median treatment period of 23.9 months, the recurrence rates while taking the study drug were 5.9% and 11.0% per year, respectively, with 1 patient in each group having a major bleed (N. Engl. J. Med. 366;21:1959-67).
All patients had completed 6-18 months of oral anticoagulant treatment with a vitamin K antagonist before randomization in the multicenter, double-blind trial. Patients were not enrolled if they had cancer, thrombophilia, or bleeding during the period of anticoagulant treatment, but the authors wrote that they "estimate that a substantial proportion (probably the majority) of patients with an initial episode of venous thromboembolism would be eligible for aspirin therapy as secondary prevention."
Dr. Becattini of the University of Perugia (Italy) presented results in December 2011 at the annual meeting of the American Society of Hematology. (Click here for our report, including a video interview with Dr. Becattini.)
The trial received support from the University of Perugia, a grant-in-aid from Bayer HealthCare, and an Aventis Fellowship for Clinical Research from the International Society of Thrombosis and Haemostasis (to Dr. Becattini). Dr. Becattini and several coauthors disclosed relationships with various drug companies, including Bayer.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE