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direct antithrombins
systematic review
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atrial fibrillation
thrombosis prevention
All type of patient
orthopedic surgery
oral direct thrombin inhibitor
dabigatran
ximelagatran
vs anticoagulant
vs Low molecular weight heparin
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Description
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Characteristics
Method
Risk of bias
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All result tag
NCT results
Major bleeding (17)
All cause death (10)
Coronary event (7)
total VTE and all-cause mortality (7)
distal DVT (7)
Venous thromboembolism (6)
proximal DVT (6)
major VTE (fatal and non fatal DVT,PE) (6)
stroke (fatal and non fatal) (5)
systemic thrombo-embolic complication (5)
ischemic stroke (5)
Haemmorhagic stroke (5)
Fatal stroke (5)
thrombo-embolic event (cerebral or systemic) (4)
major or clinically relevant non-major bleeding (4)
asymptomatic DVT (4)
Symptomatic deep-vein thrombosis (4)
non-fatal pulmonary embolism (4)
Cardiovascular death (3)
TE event or ischemic stroke or systemic embolism (3)
Non fatal stroke (2)
Lifethreatening major bleeding (2)
Non-lifethreatening major bleeding (2)
Gastrointestinal major bleeding (2)
hypertransaminasemia (1)
Fatal bleeding (1)
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medians
Trial
Studied trt
Control trt
patients
tags
ROB
Trial result
Major bleeding
All cause death
atrial fibrillation
dabigatran
RE-LY (110mg), 2009
NCT
dabigatran 110mg
warfarin standard dose
Risk of bias
suggesting
-20%
-9%
PETRO (150mg), 2007
dabigatran 150mg
warfarin standard dose
Exploratory
-
RE-LY (150mg), 2009
NCT
dabigatran 150mg
warfarin standard dose
Risk of bias
suggesting
-7%
-12%
ximelagatran
SPORTIF II (ximelagatran vs warfarin standard dose), 2002
ximelagatran
warfarin standard dose
Risk of bias
-
SPORTIF III, 2003
ximelagatran
warfarin standard dose
Risk of bias
suggesting
-29%
-1%
SPORTIF V, 2005
ximelagatran
warfarin standard dose
Low risk of bias
suggesting
-25%
-6%
thrombosis prevention
dabigatran
RE-NOVATE (150mg), 2007
NCT
dabigatran 150mg
enoxaparin
hip surgery
Low risk of bias
negative
-17%
RE-NOVATE (220mg), 2007
NCT
dabigatran 220mg
enoxaparin
hip surgery
Low risk of bias
negative
29%
∞%
RE-NOVATE 2
NCT
dabigatran 220mg
enoxaparin
hip surgery
Low risk of bias
negative
RE-MODEL (150mg), 2007
dabigatran 150mg
enoxaparin (europe regimen)
knee surgery
Low risk of bias
negative
-1%
-2%
RE-MODEL (220mg), 2007
dabigatran 220mg
enoxaparin (europe regimen)
knee surgery
Low risk of bias
negative
14%
1%
RE-MOBILIZE (150mg), 2008
dabigatran 150mg
enoxaparin (US regimen)
knee surgery
Low risk of bias
negative
-58%
∞%
RE-MOBILIZE (220mg), 2008
dabigatran 220mg
enoxaparin (US regimen)
knee surgery
Low risk of bias
negative
-58%
ximelagatran
METHRO I, 2002
ximelagatran
Dalteparin
negative
METHRO II, 2002
ximelagatran
Dalteparin
Low risk of bias
suggesting
101%
Phase II (Heit), 2001
ximelagatran
Enoxaparin
Low risk of bias
negative
-100%
Platinum (Colwell), 2003
ximelagatran
Enoxaparin
Low risk of bias
negative
-12%
METHRO III, 2002
ximelagatran
Enoxaparin
Low risk of bias
negative
-14%
EXPRESS, 2003
ximelagatran
Enoxaparin
Low risk of bias
suggesting
189%
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