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antithrombotics in thrombosis prevention for elective major knee surgery , clinical trials results

apixaban versus enoxaparin (europe regimen)
ADVANCE 2, 2010
NCT00452530
apixaban 2.5mg twice daily during 12 days
versus
enoxaparin 40mg once daily 12 days
patients undergoing elective unilateral or bilateral total knee replacementdouble blind
Follow-up duration: 12 days
27 countries
apixaban versus enoxaparin (US regimen)
APROPOS 2.5mg, 2007
NCT00097357
apixaban 2.5mg BID for 12 days
versus
enoxaparin 30mg twice daily for 12 days
patients undergoing elective total knee replacement surgerydouble blind
Follow-up duration: 12 days
ardeparin versus placebo
Levine, 1996
ardeparin 50/kgx2 +elastic stockings
versus
Placebo+elastic stockings
Kneedouble blind
Follow-up duration: 14 days
Aspirin versus placebo
McKenna-I, 1980
Aspirin 975mg or 3900mg daily
versus
placebo
total knee replacementdouble-blind
Follow-up duration: 2 weeks
dabigatran 150mg versus enoxaparin (europe regimen)
RE-MODEL (150mg), 2007
dabigatran etexilate 150 mg q.d. for 6-10 days
versus
Enoxaparin 40 mg q.d. for 6-10 days
Total knee replacement double blind
Follow-up duration: 6-10 days, mean 8 days
Europe, Australia, South Africa
dabigatran 150mg versus enoxaparin (US regimen)
RE-MOBILIZE (150mg), 2008
dabigatran etexilate 150 mg q.d. for 12-15 days
versus
enoxaparin 30 mg SC BID after surgery for 12-15 days
Total knee replacement double blind
Follow-up duration: 12-15 days, median 14d
US, Canada, Mexico, UK
dabigatran 220mg versus enoxaparin (europe regimen)
RE-MODEL (220mg), 2007
dabigatran etexilate 220 mg q.d. 6-10 days
versus
Enoxaparin 40 mg q.d. for 6-10 days
patients undergoing total knee replacementdouble blind
Follow-up duration: 6-10 days, mean 8 days
Europe, Australia, South Africa
dabigatran 220mg versus enoxaparin (US regimen)
RE-MOBILIZE (220mg), 2008
dabigatran etexilate 220 mg for 12-15 days
versus
Enoxaparin 30mg SC BID after surgery for 12-15 days
Total knee replacement double blind
Follow-up duration: 12-15 days, median 14d
US, Canada, Mexico, UK
enoxaparin versus placebo
Leclerc, 1991
Enoxaparin 3000 x2
versus
Placebo
Kneedouble blind
Follow-up duration: 14 days
fondaparinux versus enoxaparin
L8635, 0
Fondaparinux 2.5mg once daily subcutaneously for 7 days
versus
enoxaparin 40mg once daily SC for 7 days
Taiwanese patients undergoing elective knee replacementopen, blind assessment
Follow-up duration: 10 days
Taiwan
PENTAMAKS (Bauer), 2001
fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery
versus
enoxaparin 30mg twice daily (North america recommendation)
elective major knee surgerydouble blind
Follow-up duration: 11 days
North america
rivaroxaban versus enoxaparin (europe regimen)
RECORD 3, 2008
NCT00361894
rivaroxaban 10 mg once daily for 10- 14 days
versus
enoxaparin 40 mg subcutaneous once daily for 10-14 days
patients undergoing total knee arthroplastydouble blind
Follow-up duration: 13-17 days
19 countries worldwide
rivaroxaban versus enoxaparin (US regimen)
ODIXa-KNEE, 2005
BAY 59-7939 5mg b.i.d. for 5–9 days
versus
enoxaparin 30 mg b.i.d. for 5–9 days
patients undergoing elective total knee replacement double blind
Follow-up duration: 5-9 days
North America
RECORD 4, 2009
NCT00362232
rivaroxaban 10mg once daily for 10 to 14 days
versus
enoxaparin 30 mg twice daily by subcutaneous injection for 10-14 days
patients who had undergone total-knee-replacement surgery double blind
Follow-up duration: 40 days
12 countries
ximelagatran versus Dalteparin
METHRO I, 2002
Melagatran 1–4 mg s.c. immediately before surgery, melagatran at 20.00 hours, then ximelagatran 6–24 mg orally b.d. for 6–9 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 6–9 days
adults undergoing hip or knee replacementopen
Follow-up duration: 6–9 days
Swedish
ximelagatran versus Enoxaparin
METHRO III, 2002
Melagatran 3 mg s.c. 4–12h after surgery, then ximelagatran24 mg orally b.d. for 7–10 days
versus
Enoxaparin 40 mg s.c. o.d. 12 h before surgery for 7–10 days
hip or knee replacementdouble-blind
Follow-up duration: 8–11 days
Europe, South Africa
Phase II (Heit), 2001
Ximelagatran 8, 12, 18 or 24 mgorally b.d., at least 12 h after surgery for 6–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 6–12 days
adults (age>18 years and weight at least 40 kg) undergoing knee replacementsdouble-blind
Follow-up duration: 6–12 days
North American
EXPRESS, 2003
Melagatran 2 mg s.c. up to 30 min before surgery, then melagatran 3 mg at least 8 hafter surgery, then ximelagatran 24 mg orally b.d. for 8–11 days
versus
Enoxaparin 40 mg s.c. o.d.,starting 12 h before surgery for 8–11 days
hip or knee replacementdouble-blind
Follow-up duration: 8–11 days
Europe

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