Main characteristics of the included studies
Trial |
Treatments |
Patients |
Methods |
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-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
|
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
|
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
|
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
|
CV185-035,
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-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-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]
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]
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]