1st author (year) | Treatments | number of patients | Procedure | Efficacyb | Safetyb | ||||
---|---|---|---|---|---|---|---|---|---|
Death during follow-up | Major VTE (DVT + PE)a | DVT | PE | Major bleeding | Minor or non-major bleeding | ||||
I. LMWH vs. placebo (saline) | |||||||||
 Fuji (2008) [29] | Enoxaparin | 251 | THR |  | 66/251 | 66/251 | 0/251 | 6/306 | 12/306 |
20 mg qd | 81 |  | 21/81 | 21/81 | – | 1/100 | 1/100 | ||
40 mg qd | 80 |  | 27/80 | 27/80 | – | 2/102 | 7/102 | ||
20 mg bid | 90 |  | 18/90 | 18/90 | – | 3/104 | 4/104 | ||
Placebo | 86 | Â | 36/86 | 36/86 | 0/86 | 0/101 | 2/101 | ||
Enoxaparin | 236 | TKR | Â | 86/236 | 84/236 | 2/236 | 4/275 | 21/275 | |
20Â mg qd | 78 | Â | 35/78 | 34/78 | 1/78 | 0/89 | 5/89 | ||
40Â mg qd | 74 | Â | 26/74 | 25/74 | 1/74 | 1/91 | 6/91 | ||
20Â mg bid | 84 | Â | 25/84 | 25/84 | 0/84 | 3/95 | 10/95 | ||
Placebo | 79 | Â | 48/79 | 48/79 | 0/79 | 4/89 | 4/89 | ||
 Bergqvist (1996) [38] | Enoxaparin, 40 mg | 131 | THR | 0 | 21/117 | 21/117 | 0/117 |  |  |
Placebo | 131 | THR | 0 | 45/116 | 45/116 | 0/116 | Â | Â | |
 Planes (1996) [39] | Enoxaparin, 40 mg | 90 | THR | 0 |  | 6/85 |  |  |  |
 | Placebo | 89 | THR | 0 |  | 17/88 |  |  |  |
 Kim (2016) [20] | Enoxaparin | 184 | THR | 0 | 11/184 | 11/184 | 0/184 |  |  |
 | Rivaroxaban | 184 |  | 0 | 11/184 | 10/184 | 1/184 |  |  |
 | Placebo | 185 |  | 0 | 13/185 | 12/185 | 1/185 |  |  |
 Zou (2014) [22] | LMWH | 112 | TKA |  |  | 14/112 |  |  |  |
Rivaroxaban | 102 | Â | Â | Â | 3/102 | Â | Â | Â | |
Aspirin | 110 | Â | Â | Â | 18/110 | Â | Â | Â | |
 Kakkar (2008) [RECORD 2] [30] | enoxaparin | 1229 |  | 6/869 | 75/869 | 71/869 | 4/869 | 1/1229 |  |
 | Rivaroxaban | 1228 | THR | 2/864 | 15/864 | 14/864 | 1/864 | 1/1228 |  |
 Eriksson (2008) [RECORD 1] [31] | Enoxaparin | 2224 | THR | 0/1558 | 33/1678 | 53/1558 | 1/1558 | 2/2224 | 129/2224 |
Rivaroxaban | 2209 | Â | 1/1598 | 4/1686 | 12/1598 | 4/1598 | 6/2209 | 128/2209 | |
 Lassen (2008) [RECORD 3] [32] | Enoxaparin | 1239 | TKR | 4/1217 | 24/925 | 160/878 | 4/878 | 6/1239 | 54/1239 |
Rivaroxaban | 1220 | Â | 0/1201 | 9/908 | 79/824 | 0/824 | 7/1220 | 53/1220 | |
 Turpie (2009) [RECORD 4] [27] | Enoxaparin | 1564 | TKR | 3/1508 | 22/1112 | 86/959 | 8/1508 | 4/1508 | 138/1508 |
Rivaroxaban | 1584 | Â | 4/1526 | 13/1122 | 61/965 | 4/1526 | 10/1526 | 155/1526 | |
 Lassen (2009) [ADVANCE-1] [28] | Enoxaparin | 1596 | THR | 3/1554 | 20/1216 | 92/1122 | 7/1596 | 22/1588 | 47/1588 |
Apixaban | 1599 | Â | 0/1562 | 26/1269 | 89/1142 | 16/1599 | 11/1596 | 35/1596 | |
 Lassen (2010a) [ADVANCE-2] [24] | Enoxaparin | 1529 | TKR | 1/1469 | 26/1199 | 248/997 | 0/1529 | 14/1508 | 58/1508 |
Apixaban | 1528 | Â | 1/1458 | 13/1195 | 142/971 | 4/1528 | 9/1501 | 44/1501 | |
 Lassen (2010b) [ADVANCE-3] [25] | Enoxaparin | 2699 | TKR | 1/2577 | 25/2195 | 68/1911 | 5/2699 | 18/2659 | 120/2659 |
Apixaban | 2708 | Â | 2/2598 | 10/2199 | 22/1944 | 3/2708 | 22/2673 | 109/2673 | |
 Eriksson (2014) [21] | enoxaparin | 393 | THA | 0/393 | 48/314 (ITT) | 6/314 | 1/314 | 8/393 (2.0) | 20/393 (5.0) |
Darexaban | 1529 | 1/1529 | 150/1132 (ITT) | 9/1132 | 4/1132 | 25/1529 (1.6) | 61/1529 (4.0) | ||
15Â mg bid | 374 | Â | 42/269 (ITT) | 3/269 | 2/269 | 5/374 | Â | ||
30Â mg qd | 383 | Â | 39/293 (ITT) | 1/293 | 1/293 | 4/383 | Â | ||
30Â mg bid | 387 | Â | 33/296 (ITT) | 2/296 | 1/296 | 9/387 | Â | ||
60Â mg qd | 385 | Â | 36/274 (ITT) | 3/274 | 0/274 | 7/385 | Â | ||
II. LMWH vs. direct thrombin inhibitor | |||||||||
 Heit (2001) [10] | Enoxaparin | 125 | TKR | 0/125 | 23/97 | 23/97 | 0/97 | 1/125 |  |
Ximelagatran | 475 | TKR | 1/475 | 77/447 | 74/447 | 3/447 | Â | Â | |
8Â mg | 85 | Â | Â | 17/63 | 17/63 | 0/63 | 0/85 | Â | |
12Â mg | 134 | Â | Â | 20/202 | 20/202 | 0/202 | 0/134 | Â | |
18Â mg | 126 | Â | Â | 25/87 | 23/87 | 2/87 | 2/126 | Â | |
24Â mg | 130 | Â | Â | 15/95 | 14/95 | 1/95 | 0/130 | Â | |
 Eriksson (2003b) [37] | Enoxaparin | 957 | THR | 0/957c | 45/823 |  |  | 10/942 | 61/942 |
Ximelagatran, 24Â mg | 966 | Â | 4/966c | 14/773 | Â | Â | 37/915 | 87/915 | |
Enoxaparin | 432 | TKR | Â | 29/355 | Â | Â | 6/445 | 36/445 | |
Ximelagatran, 24Â mg | 433 | Â | Â | 12/365 | Â | Â | 9/463 | 39/463 | |
 Colwell (2003) [36] | Enoxaparin | 910 |  |  | 36/775 | 36/775 | 0/775 | 8/910 |  |
Ximelagatran, 24Â mg | 906 | THR | Â | 62/782 | 62/782 | 0/782 | 7/906 | Â | |
 Eriksson (2003a) [35] | Enoxaparin | 942 (ITT) | THR | 0/942c | 146/801 | 142/801 | 4/801 | 10/942 |  |
Ximelagatran, 24Â mg | 914 (ITT) | Â | 5/914c | 99/765 | 97/765 | 2/765 | 37/915 | Â | |
Enoxaparin | 445 (ITT) | TKR | Â | 169/383 | 167/383 | 2/383 | 6/445 | Â | |
Ximelagatran, 24Â mg | 463 (ITT) | Â | Â | 132/376 | 131/376 | 1/376 | 9/463 | Â | |
 Ginsberg (2009) [RE-MOBILIZE] [26] | Enoxaparin | 868 | TKR | 0 | 163/868 | 158/868 | 5/868 | 12 (1.4) |  |
Dabigatran Etexilate | 1728 | Â | 2 | 405/1728 | 399/1728 | 6/1728 | Â | Â | |
220Â mg | 857 | Â | 1 | 187/857 | Â | 6/857 | 5 (0.6) | Â | |
150Â mg | 871 | Â | 1 | 218/871 | Â | 0/871 | 5 (0.6) | Â | |
 Eriksson (2007a) [RE-MODEL] [33] | Enoxaparin | 694 | TKR | 1/685 (0.1) |  |  | 1/685 | 9/694 (1.3) | 69 (9.9) |
Dabigatran Etexilate | 1382 | Â | 2/763 | Â | Â | 1/1382 | Â | Â | |
220Â mg | 679 | Â | 1/675 (0.1) | Â | Â | 0/675 | 10/679 (1.5) | 60 (8.8) | |
150Â mg | 703 | Â | 1/696 (0.1) | Â | Â | 1/696 | 9/703 (1.3) | 59 (8.4) | |
 Eriksson (2007b) [RE-NOVATE; Europe, Australia, and South Africa] [34] | Enoxaparin | 1154 | THR | 0/1142 | 36/917 | Asymptomatic: 56/894 Symptomatic: 1/1142 | 3/1142 | 18 | 74 |
Dabigatran etexilate | 2309 | Â | 6/2293 | 66/1797 | Asymptomatic: 56/894 Symptomatic: 1/1142 | 6/2293 | 38 | 142 | |
220Â mg | 1146 | THR | 3/1137 | 28/909 | Asymptomatic: 40/874 Symptomatic: 6/1137 | 5/1137 | 23 | 70 | |
150Â mg | 1163 | Â | 3/1156 | 38/888 | Asymptomatic: 63/871 Symptomatic: 9/1156 | 1/1156 | 15 | 72 | |
 11Eriksson (2011), 220 mg [RE-NOVATE II; North America] [23] | Enoxaparin | 1.003 | THR | 1/951 | 4/951 | 67/783 | 2/992 | 9/1003 | 54/1003 |
Dabigatran etexilate | 1010 | Â | 0/942 | 2/942 | 60/791 | 1/1001 | 14/1010 | 61/1010 |