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 610 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 59 days
versus
once-daily
subcutaneous enoxaparin dose of 40 mg for 59 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, Büller 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, Büller 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, Büller HR, Hettiarachchi R, Rosencher N, Bravo ML, Ahnfelt L, Piovella F, Stangier J, Kälebo 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, Kälebo 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, Kälebo 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]