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ASPIRE: VTE recurrence similar with aspirin, placebo
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LOS ANGELES — Aspirin failed to reduce venous thromboembolism recurrence but was linked to reductions in CV events compared with placebo, according to findings presented here.
Researchers cited the high risk for recurrence of venous thromboembolism (VTE) after an initial unprovoked VTE event has been treated and anticoagulants have been discontinued.
The ASPIRE study included 822 patients who had an unprovoked VTE and completed initial anticoagulant therapy. Half of the cohort received aspirin at 100 mg daily and the other 411 patients received placebo for up to 4 years.
VTE recurrence served as the primary endpoint. Secondary endpoints included a composite rate of VTE, MI, stroke or CV death, and a composite of VTE, MI, stroke, major bleeding or all-cause death.
The median follow-up duration was 37.2 months.
There were 57 events (4.8%) in the aspirin group and 73 events (6.5%) in the placebo group (HR with aspirin=0.74; 95% CI, 0.52-1.05; P=.09).
Aspirin was linked to a reduction in the first composite endpoint of 34% (a rate of 8.0% per year with placebo vs. 5.2% per year with aspirin; HR with aspirin=0.66; 95% CI, 0.48-0.92; P=.01). Aspirin also reduced the second composite endpoint by 33% (HR=0.67; 95% CI, 0.49-0.91; P=.01).
No differences were observed between the two groups in the rates of major or clinically relevant non-major bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per year with aspirin; P=.22), according to the results. Adverse event profiles also were similar.
“The ASPIRE study, in conjunction with other data, provides consistent evidence that low-dose aspirin prevents recurrent VTE and major vascular events in patients with first unprovoked VTE,” Timothy A. Brighton, MD, of South Eastern Area Lab Services (SEALS), Price of Wales Hospital, Sydney, Australia, said at a press conference.
“These results substantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapy for a first episode of unprovoked [VTE],” the researchers wrote in the New England Journal of Medicine. – by Rob Volansky
For more information:
Brighton TA. Late-breaking clinical trials: Practice implications for CAD and VTE. Presented at: the American Heart Association Scientific Sessions; Nov. 3-7, 2012; Los Angeles.
Disclosure: See study for full disclosure information.