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Q In patients having total knee replacement, is ximelagatran better than warfarin in preventing venous thromboembolism (VTE)?
Clinical impact ratings IM/Ambulatory care ★★★★★★★ Internal medicine ★★★★★★★ Haematology ★★★★★★☆
METHODS
Design:
randomised controlled trial (Exanta Used to Lessen Thrombosis A [EXULT A]).
Allocation:
concealed.*
Blinding:
blinded (clinicians, patients, {data collectors, outcome assessors, and data analysts}†).*
Follow up period:
4–6 weeks.
Setting:
116 centres in the US, Canada, Israel, Mexico, and Brazil.
Patients:
2301 patients who were having primary total knee replacement and weighed between 40 and 136 kg. Exclusion criteria included pneumatic leg compression; immobilisation ⩾3 days; major surgery, stroke, myocardial infarction, or receipt of study drug ⩽30 days before surgery; increased risk of bleeding ⩽90 days before surgery; increased risk of bleeding ⩽90 days before surgery; uncontrolled hypertension; thrombocytopenia; drug or alcohol abuse in the past 6 months; and potential for pregnancy.
Intervention:
twice-daily tablets of ximelagatran (Exanta, AstraZeneca), 36 mg (n = 775); 24 mg (n = 762); or once daily warfarin (Coumadin, Bristol-Myers Squibb) (n = 764). Placebos were given for each study drug. Ximelagatran was started ⩾12 hours after surgery when haemostasis had been achieved and warfarin was started the evening of the …