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Warfasa: Aspirin associated with 40% reduced risk for unprovoked VTE recurrence
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53rd ASH Annual Meeting
SAN DIEGO — Aspirin, when administered 6 to 12 months after anticoagulant therapy, was associated with a significant reduced risk for recurrence of unprovoked venous thromboembolism, according to results from the Warfasa study.
As many as 20% of patients with unprovoked VTE have recurrence within 2 years of discontinuing treatment with oral anticoagulants.
Cecilia Becattini, MD, assistant professor of internal medicine in the internal and cardiovascular medicine and stroke unit at Italy’s University of Perugia, said the results show that aspirin can be a valid alternative to oral anticoagulants for the extended treatment of VTE.
“With aspirin, a drug that is low-cost, safe and available worldwide, we can reduce incidence of recurrence of by 40%,” she said. “For its safety, practicality and low cost, aspirin is a valid alternative to oral anticoagulants for the extended treatment of venous thromboembolism.”
Becattini noted that Warfasa researchers did not observe an increase in major bleeding associated with aspirin. She added that aspirin is a very well-known drug that does not require lab monitoring, and it is safer than oral anticoagulation with a risk for bleeding complications of less than 1% per year.
Warfasa is a double-blind randomized placebo-controlled event-driven study. Patients with a first-ever unprovoked VTE who had completed 6 to12 months of oral anticoagulant treatment were randomized to receive 100 mg daily aspirin (n=205) or placebo (n=197) for at least 2 years.
Eleven percent of patients had recurrence in the placebo group vs. 6.3% for patients assigned to aspirin (HR=0.57; 95% CI, 0.35-0.93) during the study period. While on study treatment, 10.7% of patients assigned to placebo had recurrence compared with 5.7% of the placebo group (HR=0.54; 95% CI, 0.32-0.91). The mean on-treatment period was 22 months.
One patient in each treatment group had a major bleed, with a similar incidence of clinically relevant non-major bleeding. – by Jason Harris
Disclosure: Dr. Becattini reported no relevant financial disclosures.
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There's always uncertainty about what to do after the first 6 months to 18 months on warfarin. Ideally, we'd like to treat all patients with warfarin to prevent recurrent thrombosis, but there are some patients who may be at increased risk for bleeding, such as elderly patients. Aspirin offers a safer alternative, especially when it is unclear whether the patient should be treated. The standard of care is to treat initial DVT with warfarin or some other anticoagulant for 3 to 6 months and then evaluate the patient to determine if further anticoagulation is indicated. For patients in the "gray" area, this study demonstrates that aspirin indeed reduces the risk of recurrent thrombosis; while its efficacy is not as great as that of warfarin, its safety profile in terms of bleeding risk is superior. So this study establishes aspirin as an agent with the potential to reduce venous thrombosis over the long term, although additional confirmation of these results is warranted.
Keith McCrae, MD
Staff physician in hematologic
oncology and blood disorders
Cleveland Clinic Taussig Cancer Center
Disclosure: Dr. McCrae reports no relevant financial disclosures.
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