Presentation Outline ICHP Annual Meeting September 13-15

WARFASA
• Primary endpoint
– Symptomatic, objectively confirmed recurrence of
VTE (composite of DVT or nonfatal or fatal PE)
• Secondary endpoints
– Nonfatal MI, unstable angina, stroke, TIA, acute
ischemia of lower limbs, death from any cause
• Safety
– Major bleeding
N Engl J Med. 2012;366(21):1959-1967.
WARFASA
• Demographics
– No significant differences between groups
– Median age: 62 years
– Approximately 2/3 male
– 99% white
– First event: approximately 60% DVT, 40% PE
– Duration of VKA treatment
• >50% took for 12 months
N Engl J Med. 2012;366(21):1959-1967.
WARFASA
• Statistical analysis
• Assumption of 40% RRR with aspirin
• 8.0% expected event rate per year
• 400 patients total to observe expected
number of events
• Estimated that 70 events would provide
power of 80% to show superiority of aspirin
over placebo
N Engl J Med. 2012;366(21):1959-1967.
8/30/2012
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