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QUESTION: In patients who have survived an acute myocardial infarction (MI), is warfarin combined with aspirin more effective than aspirin alone?
Design
Randomised (allocation concealed*), unblinded,* controlled trial with a median 2.7 years of follow up.
Setting
78 Department of Veterans Affairs medical centres in the US.
Patients
5059 patients (median age 62 y, 98% men) who had an acute MI within the previous 14 days. Exclusion criteria included comorbid conditions that limited life expectancy to <2 years, ongoing bleeding, drug or alcohol dependence, and hypersensitivity to aspirin or warfarin. Vital status was obtained for 99% of the patients.
Intervention
2522 patients were assigned to warfarin (target international normalised ratio [INR] 1.5 to 2.5 IU) plus aspirin (81 mg/d), and 2537 were assigned to aspirin alone (162 mg/d).
Main outcome measures
The primary outcome was all-cause mortality. Secondary outcomes were recurrent MI, stroke, …
Footnotes
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Sources of funding: Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development; DuPont Pharmaceuticals; Bayer Pharmaceuticals.
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For correspondence: Dr L Fiore, VA Boston Healthcare System, Boston, Massachusetts, USA. louis.fiore{at}med.va.gov