APX | | | | | |
ADVANCE-1 [16] | VTE prophylaxis after TKR | 3195 | APX 2.5 mg twice daily, 10–14 days versus ENX 30 mg twice daily, 10–14 days | VTE and all-cause cause death: APX 9.0% versus ENX 8.8% (p=0.06, noninferiority) | Major bleeding: APX 0.7% versus ENX 1.4% (p=0.03) |
ADVANCE-2 [17] | VTE prophylaxis after TKR | 3057 | APX 2.5 mg twice daily, 10–14 days versus ENX 40 mg once daily, 10–14 days | VTE and all-cause cause death: APX 15.0% versus ENX 24.0% (p<0.0001, superiority) | Major bleeding: APX 0.6% versus ENX 0.9% (ns) |
ADVANCE-3 [18] | VTE prophylaxis after THR | 5407 | APX 2.5 mg twice daily, 32–38 days versus ENX 40 mg once daily, 32–38 days | VTE and all-cause cause death: APX 1.4% versus ENX 3.9% (p<0.001, superiority) | Major bleeding: APX 0.8% versus ENX 0.7% (ns) |
ADOPT [19] | VTE prophylaxis in medically ill patients | 4495 | APX 2.5 mg twice daily, 30 days versus ENX 40 mg once daily, 6–14 days | VTE and VTE-related death: 2.7% versus 3.1 (ns, superiority) | Major bleeding: APX 0.5% versus ENX 0.2% (p=0.04) |
Botticelli [20] | DVT treatment | 520 | APX 5 mg twice daily or 10 mg twice daily or 20 mg once daily (3 months) versus ENX 1 mg·kg−1 twice daily (≥ days), WAR (3 months) | Recurrent VTE: APX 4.7% versus ENX/WAR 4.2% | Major bleeding and clinically relevant non-major bleeding: APX 7.3% versus ENX/WAR 7.9% |
AMPLIFY [21] | VTE treatment | 5385 | APX 10 mg twice daily (7 days), 5 mg twice daily (6 months) versus ENX 1 mg·kg−1 twice daily (≥ days), WAR (6 months) | Recurrent VTE: APX 2.3% versus ENX/WAR 2.7% (p<0.001, noninferiority) | Major bleeding: APX 0.6% versus ENX/WAR 1.8% (p<0.001) |
AMPLIFY-EXT [22] | VTE treatment | 2486 | APX 2.5 mg twice daily or 5 mg twice daily (12 months) versus placebo | Recurrent VTE: APX 1.7% versus placebo 8.8% (p<0.001, superiority) | Major bleeding: APX 2.5 mg 0.2%, APX 5 mg 0.1% versus placebo 0.5% (ns) |
DAB | | | | | |
RE-MODEL [23] | VTE prophylaxis after TKR | 2076 | DAB 150 mg once daily or 220 mg once daily, 6–10 days versus ENX 40 mg once daily, 6–10 days | VTE: DAB 150 mg 40.5% (p=0.017, noninferiority) or DAB 220 mg 36.4% (p=0.0003, noninferiority) versus ENX 37.7% | Major bleeding: DAB 150 mg 1.3% or DAB 220 mg 1.5% versus ENX 1.3% (ns) |
RE-NOVATE [24] | VTE prophylaxis after THR | 3494 | DAB 150 mg once daily or 220 mg once daily, 28–35 days versus ENX 40 mg once daily, 28–35 days | VTE: DAB 150 mg 8.6% (p<0.0001, noninferiority) or DAB 220 mg 6.0% (p<0.0001, noninferiority) versus ENX 6.7% | Major bleeding: DAB 150 mg 1.3% or DAB 220 mg 2.0% versus ENX 1.6% (ns) |
RE-MOBILIZE [25] | VTE prophylaxis after TKR | 2715 | DAB 150 mg once daily or 220 mg once daily, 28–35 days versus ENX 30 mg twice daily, 12–15 days | VTE: DAB 150 mg 33.7% (p=0.0009, inferiority) or DAB 220 mg 31.7% (p=0.002, inferiority) versus ENX 25.3% | Major bleeding: DAB 150 mg 0.6% or DAB 220 mg 0.6% versus ENX 1.4% (ns) |
RE-COVER I [26] | VTE treatment | 2564 | DAB 150 mg twice daily, 6 months versus WAR, 6 months | Recurrent VTE: DAB 2.4% versus WAR 2.1% (p<0.001 non-inferiority) | Major bleeding: DAB 1.6% versus WAR 1.9% (ns) |
RE-COVER II [27] | VTE treatment | 2568 | DAB 150 mg twice daily, 6 months
versus WAR, 6 months | Recurrent VTE: DAB 2.3% versus WAR 2.2% (p<0.001, noninferiority) | Major bleeding: DAB 1.2% versus WAR 1.7% (ns) |
RE-MEDY [28] | VTE treatment | 2856 | DAB 150 mg twice daily, 36 months versus WAR, 36 months | Recurrent VTE: DAB 1.8% versus WAR 1.3%. (p=0.01, noninferiority) | Major bleeding: DAB 0.9% versus WAR 1.8% (ns) |
RE-SONATE [28] | VTE treatment | 1343 | DAB 150 mg twice daily, 6 months versus placebo, 6 months | Recurrent VTE: DAB 0.4% versus placebo 5.6% (p<0.0001) | Major bleeding: DAB 0.3% versus placebo 0% (ns) |
EDX | | | | | |
STARS-E3 [29] | VTE prophylaxis after TKR | 716 | EDX 30 mg once daily, 11–14 days versus ENX 20 mg twice daily, 11–14 days | VTE: EDX 7.4% versus ENX 13.9% (p=0.010) | Major bleeding: EDX 1.1% versus ENX 0.3% (ns) |
STARS-J5 [30] | VTE prophylaxis after THR | 264 | EDX 15 mg once daily or 30 mg once daily, 11–14 days versus ENX 20 mg twice daily, 11–14 days | VTE: EDX 15 mg 3.8% or EDX 30 mg 2.8% versus ENX 4.1% (p=1.000) | Major bleeding: EDX 15 mg 2.2% or EDX 30 mg 1.2% versus ENX 2.3% (ns) |
Hokusai-VTE [31] | VTE treatment | 8292 | EDX 60 mg once daily or 30 mg once daily, 3–12 months versus WAR, 3–12 months | Recurrent VTE: EDX 3.2% versus WAR 3.5% (p<0.001, noninferiority) | Major bleeding: EDX 1.4% versus WAR 1.6% (ns) |
RVX | | | | | |
RECORD-1 [32] | VTE prophylaxis after THR | 4541 | RVX 10 mg once daily, 35 days versus ENX 40 mg once daily, 35 days | VTE and all-cause death: RVX 1.1% versus ENX 3.7% (p<0.001, superiority) | Major bleeding: RVX 0.3% versus ENX 0.1% (ns) |
RECORD-2 [33] | VTE prophylaxis after THR | 2509 | RVX 10 mg once daily, 35 days versus ENX 40 mg once daily, 10–14 days | VTE and all-cause death: RVX 2.0% versus ENX 9.3% (p<0.001, superiority) | Major bleeding: RVX 0.08% versus ENX 0.08% (ns) |
RECORD-3 [34] | VTE prophylaxis after TKR | 2531 | RVX 10 mg once daily, 10–14 days versus ENX 40 mg once daily, 10–14 days | VTE and all-cause death: RVX 9.6% versus ENX 18.9% (p<0.001, superiority) | Major bleeding: RVX 0.6% versus ENX 0.5% (ns) |
RECORD-4 [35] | VTE prophylaxis after TKR | 3148 | RVX 10 mg once daily, 10–14 days versus ENX 30 mg twice daily, 10–14 days | VTE and all-cause death: RVX 6.9% versus ENX 10.1% (p=0.012, superiority) | Major bleeding: RVX 0.7% versus ENX 0.3% (ns) |
EINSTEIN-DVT [36] | VTE treatment | 3449 | RVX 15 mg twice daily (3 weeks), 20 mg once daily (3, 6 or 12 months) versus ENX 1 mg·kg−1 twice daily (≥ days),WAR (3, 6 or 12 months) | Recurrent VTE: RVX 2.1% versus ENX/WAR 3.0% (p<0.001, noninferiority) | Major bleeding: RVX 0.8% versus ENX/WAR 1.2% (ns) |
EINSTEIN-PE [37] | VTE treatment | 4832 | RVX 15 mg twice daily (3 weeks), 20 mg once daily (3, 6 or 12 months) versus ENX 1 mg·kg−1 twice daily (≥ days),WAR (3, 6 or 12 months) | Recurrent VTE: RVX 2.1% versus ENX/WAR 1.8% (p=0.003, noninferiority) | Major bleeding: RVX 1.1% versus ENX/WAR 2.2% (p=0.003) |
EINSTEIN-Extension [36] | VTE treatment | 1197 | RVX 20 mg once daily, 6–12 months versus placebo, 12 months | Recurrent VTE: RVX 1.3% versus placebo 7.1% (p<0.001, superiority) | Major bleeding: RVX 0.7% versus placebo 0% (ns) |