DVT prophylaxis - new oral anticoagulant
- elective major knee surgery trial results systematic overview and meta-analysis
Main characteristics of the included studies
Trial |
Treatments |
Patients |
Methods |
RE-MOBILIZE (220mg), 2008
|
dabigatran etexilate 220 mg for 12-15 days
versus
Enoxaparin 30 BID
|
Total knee replacement
|
follow-up 12-15 days, median 14d
n=862/876
double blind
US, Canada, Mexico, UK
|
RE-MODEL (220mg), 2007
|
dabigatran etexilate 220 mg q.d. 6-10 days
versus
Enoxaparin 40 mg q.d.
|
Total knee replacement
|
follow-up 6-10 days, mean 8 days
n=694/699
double blind
Europe, Australia, South Africa
|
RE-MODEL (150mg), 2007
|
dabigatran etexilate 150 mg q.d. for 6-10 days
versus
Enoxaparin 40 mg q.d.
|
Total knee replacement
|
follow-up 6-10 days, mean 8 days
n=708/699
Parallel groups
double blind
Europe, Australia, South Africa
|
RE-MOBILIZE (150mg), 2008
|
dabigatran etexilate 150 mg q.d. for 12-15 days
versus
Enoxaparin 40 mg q.d. for 12-15 days
|
Total knee replacement
|
follow-up 12-15 days, median 14d
n=877/876
Parallel groups
double blind
US, Canada, Mexico, UK
|
BISTRO II (225mg bid), 2005
|
dabigatran etexilate 225 mg twice daily for 6�10 days
versus
subcutaneous enoxaparin 40 mg once daily
|
patients undergoing total hip or knee replacement
|
follow-up
n=393/392
Parallel groups
double blind
Europe and South Africa (2 centres)
|
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
|
follow-up 5-9 days
n=102/105
Parallel groups
double blind
North America
|
RECORD 3, 2008
NCT00361894
|
rivaroxaban 10 mg once daily for 10- 14 days
versus
enoxaparin 40 mg subcutaneous once daily
|
patients undergoing total knee arthroplasty
|
follow-up 13-17 days
n=1254/1277
Parallel groups
double blind
19 countries worldwide
|
RECORD 4, 2009
NCT00362232
|
rivaroxaban 10mg once daily for 10 to 14 days
versus
enoxaparin 30 mg twice daily by subcutaneous injection for 10 to 14 days
|
patients who had undergone total-knee-replacement surgery
|
follow-up 40 days
n=1584/1564
Parallel groups
double blind
12 countries
|
ADVANCE-1, 2008
NCT00371683
|
apixaban 2.5 mg orally twice daily for 10 to 14 days
versus
enoxaparin 30mg subcutaneously every 12 hours
|
patients undergoing knee-replacement surgery
|
follow-up 10-14 days
n=1599/1596
Parallel groups
double blind
14 countries
|
ADVANCE 2 (CV185-047), 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 replacement
|
follow-up 12 days
n=1528/1529
Parallel groups
double blind
27 countries
|
CV185-010, 2007
NCT00097357
|
apixaban 2.5mg BID, 5mg BID, 10mg BID, 5mgQD, 20mg QD for 12 days
versus
enoxaparin 30mg twice daily for 12 days
|
patients undergoing elective total knee replacement surgery
|
follow-up 12 days
n=-9/-9
Parallel groups
double blind
|
References
RE-MOBILIZE (220mg), 2008 :
The Oral Thrombin Inhibitor Dabigatran Etexilate vs the North American Enoxaparin Regimen for the Prevention of Venous Thromboembolism after Knee Arthroplasty Surgery.
J Arthroplasty 2008;:
[PMID 18534438]
RE-MODEL (220mg), 2007 :
Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, K�lebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, B�ller HROral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial.
J Thromb Haemost 2007 Nov;5:2178-85
[PMID 17764540]
RE-MODEL (150mg), 2007 :
Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, K�lebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, B�ller HROral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial.
J Thromb Haemost 2007;5:2178-85
[PMID 17764540] 10.1111/j.1538-7836.2007.02748.x
RE-MOBILIZE (150mg), 2008 :
Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, Lieberman JR, Muntz JE, Raskob GE, Clements ML, Hantel S, Schnee JM, Caprini JAOral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.
J Arthroplasty 2009;24:1-9
[PMID 18534438] 10.1016/j.arth.2008.01.132
BISTRO II (225mg bid), 2005 :
Eriksson BI, Dahl OE, B�ller HR, Hettiarachchi R, Rosencher N, Bravo ML, Ahnfelt L, Piovella F, Stangier J, K�lebo P, Reilly PA new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial.
J Thromb Haemost 2005 Jan;3:103-11
[PMID 15634273]
ODIXa-KNEE, 2005 :
Turpie AG, Fisher WD, Bauer KA, Kwong LM, Irwin MW, K�lebo P, Misselwitz F, Gent MBAY 59-7939: an oral, direct factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study.
J Thromb Haemost 2005 Nov;3:2479-86
[PMID 16241946]
CV185-010, 2007 :
Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman DThe efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement.
J Thromb Haemost 2007 Dec;5:2368-75
[PMID 17868430]
RECORD 3, 2008 :
Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AGRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty.
N Engl J Med 2008 Jun 26;358:2776-86
[PMID 18579812]
RECORD 4, 2009 :
Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WDRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial.
Lancet 2009;:
[PMID 19411100]
ADVANCE-1, 2008 :
Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJApixaban or enoxaparin for thromboprophylaxis after knee replacement.
N Engl J Med 2009;361:594-604
[PMID 19657123]
CV185-034, :
Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJApixaban or enoxaparin for thromboprophylaxis after knee replacement.
N Engl J Med 2009;361:594-604
[PMID 19657123]
ADVANCE 2 (CV185-047), 2010 :
Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick PApixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial.
Lancet 2010 Mar 6;375:807-15
[PMID 20206776] 10.1016/S0140-6736(09)62125-5