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-NOVATE (220mg), 2007
NCT00168818
|
dabigatran etexilate 220 mg q.d. for 28-35 days
versus
Enoxaparin 40 mg q.d.
|
Total hip replacement
|
follow-up 28-35 days, median 33d
n=1157/1162
Parallel groups
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-NOVATE (150mg), 2007
NCT00168818
|
dabigatran etexilate 150 mg q.d. 28-35 days
versus
Enoxaparin 40 mg q.d.
|
Total hip replacement
|
follow-up 28-35 days, median 33d
n=1174/1162
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-HIP 10mg, 2006
|
rivaroxaban 10mg daily for 5�9 days
versus
once-daily
subcutaneous enoxaparin dose of 40 mg for 5�9 days
|
patients undergoing elective total hip replacement
|
follow-up 5-9 days
n=142/157
Parallel groups
double blind
Europe, Israel
|
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 1, 2008
NCT00329628
|
rivaroxaban 10mg once daily for 35 days
versus
enoxaparin 40mg subcutaneous once daily
|
patients undergoing total hip arthroplasty
|
follow-up 36 days (range 30-42)
n=2209/2224
Parallel groups
double blind
27 countries worldwide
|
RECORD 2, 2008
NCT00332020
|
extended thromboprophylaxis with rivaroxaban 10mg once daily for 31-39 days
versus
short-term
thromboprophylaxis with enoxaparin 40mg subcutaneous once daily for 10-14 days
|
patients undergoing elective total hip replacement
|
follow-up 30-42 days
n=1252/1257
Parallel groups
double blind
21 countries worldwide
|
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
|
RE-NOVATE 2, 2010
NCT00657150
|
dabigatran 220mg once daily for 28-35 Days
versus
enoxaparin 40mg subcutaneous
|
patients undergoing total hip-replacement surgery
|
follow-up 28-35 days (mean 32d)
n=1010/1003
Parallel groups
double-blind
|
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
|
CV185-036,
NCT00457002
|
apixaban 2.5mg twice daily, 30 days
versus
enoxaparin 40mg once daily 6-14 days
|
Acutely ill medical patienst during and following hospitalization
|
follow-up 30 days
n=6524/0
Parallel groups
double blind
|
CV185-035,
NCT00423319
|
apixaban 2.5mg twice daily 5 weeks
versus
enoxaparin 40mg once daily 5 weeks
|
patients undergoing elective total hip replacement surger
|
follow-up 35 days
n=5406/0
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-NOVATE (220mg), 2007 :
Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, B�ller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.
Lancet 2007;370:949-56
[PMID 17869635]
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-NOVATE (150mg), 2007 :
Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, B�ller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.
Lancet 2007;370:949-56
[PMID 17869635]
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-HIP 10mg, 2006 :
Eriksson BI, Borris L, Dahl OE, Haas S, Huisman MV, Kakkar AK, Misselwitz F, K�lebo POral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement.
J Thromb Haemost 2006 Jan;4:121-8
[PMID 16409461]
ODIXa-HIP 10mg, 2006 :
Eriksson BI, Borris LC, Dahl OE, Haas S, Huisman MV, Kakkar AK, Muehlhofer E, Dierig C, Misselwitz F, K�lebo PA once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement.
Circulation 2006 Nov 28;114:2374-81
[PMID 17116766]
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 1, 2008 :
Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts WRivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty
N Engl J Med 2008;358:2765-75
[PMID 18579811] 10.1056/NEJMoa0800374
RECORD 2, 2008 :
Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas SExtended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial.
Lancet 2008 Jun 24;:
[PMID 18582928]
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