Characteristics of included randomised controlled trials and study treatments
| Drug, trial | No in sample | Type of surgery | Trial phase | Dose, treatment duration (timing of first dose in relation to surgery) | Design of randomised controlled trial; adjudicating committee | Jadad score | Day of venography | Follow-up (days) | |
|---|---|---|---|---|---|---|---|---|---|
| Experimental drug | Control drug | ||||||||
| Dabigatran: | |||||||||
| RE-MODEL19 | 2101 | Total knee replacement | III | Dabigatran 220 mg or 150 mg once daily, 6-10 days (1-4 hours) | Enoxaparin 40 mg once daily, 6-10 days (about 12 hours*) | Double blind; Gothenburg | 5 | 6-10 | 90 |
| RE-NOVATE20 | 3493 | Total hip replacement | III | Dabigatran 220 mg or 150 mg once daily, 28-35 days (1-4 hours) | Enoxaparin 40 mg once daily, 28-35 days (aboout 12 hours*) | Multicentre, double blind; Holland | 5 | 33 | 94 |
| RE-MOBILIZE21 | 2615 | Total knee replacement | III | Dabigatran 220 mg or 150 mg once daily, 12-15 days (8-12 hours) | Enoxaparin 30 mg twice daily, 12-15 days (12-24 hours) | Double blind; Gothenburg | 5 | 14 | 90 |
| RE-NOVATE II22 | 2055 | Total hip replacement | III | Dabigatran 220 mg once daily, 28-35 days (1-4 hours) | Enoxaparin 40 mg once daily, 28-35 days (about 12 hours*) | Double blind; Holland | 5 | 32 | 90 |
| Rivaroxaban: | |||||||||
| RECORD123 | 4541 | Total hip replacement | III | Rivaroxaban 10 mg once daily, 35d (6 hours) | Enoxaparin 40 mg once daily, 35 days (about 12 hours*) | Double blind; Gothenburg | 5 | 36 | 66-71 |
| RECORD224 | 2509 | Total hip replacement | III | Rivaroxaban 10 mg once daily, 31-39 days (6 hours) | Enoxaparin 40 mg once daily, 14 days (about 12 hours*)+placebo 30 days | Double blind; Gothenburg | 5 | 32-40 | 62-75 |
| RECORD325 | 2531 | Total knee replacement | III | Rivaroxaban 10 mg once daily, 10-14 days (6 hours) | Enoxaparin 40 mg once daily, 10-14 days (about 12 hours*) | Double blind; Gothenburg | 5 | 11-15 | 41-50 |
| RECORD426 | 3148 | Total knee replacement | III | Rivaroxaban 10 mg once daily, 10-14 days (6 hours) | Enoxaparin 30 mg twice daily, 10-14 days (12-24 hours) | Double blind; Gothenburg | 5 | 11-15 | 40-49 |
| PROOF OF CONCEPT27 | 641 | Total hip replacement | IIa | Rivaroxaban 2.5, 5, 10, 20, or 30 mg twice daily, rivaroxaban 30 mg once daily, 5-9 days (6-8 hours)† | Enoxaparin 40 mg once daily, 5-9 days (about 12 hours*) | Open label; Gothenburg | 3 | 5-9 | 38-68 |
| ODIXA KNEE28 | 621 | Total knee replacement | IIb | Rivaroxaban 2.5, 5, 10, 20, or 30 mg twice daily, 5-9 days (6-8 hours)† | Enoxaparin 30 mg twice daily, 5-9days (12-24 hours) | Double blind; Gothemburg | 5 | 5-9 | 37-67 |
| ODIXA HIP (twice daily)29 | 722 | Total hip replacement | IIb | Rivaroxaban 2.5, 5, 10, 20, or 30 mg twice daily, 5-9 days (6-8 hours)† | Enoxaparin 40 mg once daily, 5-9 days (about 12 hours*) | Double blind; Gothenburg | 5 | 5-9 | 38-68 |
| ODIXA HIP (once daily)30 | 873 | Total hip replacement | IIb | Rivaroxaban 10, 20, or 30 mg once daily, 5-9 days (6-8 hours)† | Enoxaparin 40 mg once daily, 5-9 days (about 12 hours*) | Double blind; Gothenburg | 5 | 6-10 | 35-69 |
| Apixaban: | |||||||||
| ADVANCE-131 | 3195 | Total knee replacement | III | Apixaban 2.5 mg twice daily, 10-14 days (12-24 hours) | Enoxaparin 30 mg twice daily, 12 days (12-24 hours) | Double blind; Hamilton | 5 | 10-14 | 70-84 |
| ADVANCE-232 | 3057 | Total knee replacement | III | Apixaban 2.5 mg twice daily, 10-14 days (12-24 hours) | Enoxaparin 40 mg once daily, 10-14 day (about 12 hours*) | Double blind; Hamilton | 5 | 10-14 | 70-84 |
| ADVANCE-333 | 5407 | Total hip replacement | III | Apixaban 2.5 mg twice daily, 35 days (12-24 hours) | Enoxaparin 40 mg once daily, 35 days (about 12 hours*) | Double blind; Hamilton | 5 | 32-38 | 90-100 |
| APROPOS34 | 1238 | Total knee replacement | 2b | Apixaban 5, 10, or 20 mg once daily, 2.5, 5, or 10 mg twice daily, 10-14 days (12-24 hours)‡ | Enoxaparin 30 mg twice daily, 10-14 days (about 12 hours*) or warfarin (international normalised ratio 1.8-3.0§) | Double blind; Hamilton | 5 | 10-14 | 42 |
*Administered preoperatively; other first doses were administered postoperatively.
†Only data pertaining to 10 mg total daily dose (5 mg twice daily or 10 mg once daily) were included in the meta-analysis.
‡Only data pertaining to 5 mg total daily dose (2.5 mg twice daily or 5 mg once daily) were included in the meta-analysis.
§Only data pertaining to 40 mg once daily dose control group were included in the meta-analysis.