Design and patient characteristics of the trials comparing NOACs with conventional therapy for acute VTE treatment
| . | Dabigatran . | Rivaroxaban . | Apixaban . | Edoxaban . | ||
|---|---|---|---|---|---|---|
| Trial | RE-COVER I & II | EINSTEIN | AMPLIFY | Hokusai-VTE | ||
| Indication | VTE | DVT | PE | VTE | VTE | |
| Design | Double-blind | PROBE | Double-blind | Double-blind | ||
| Number of patients | 2539 | 2568 | 3449 | 4832 | 5365 | 8240 |
| Mean age ± SD (y) | 54.9 ± 16.0 | 56.1 ± 16.4 | 57.7 ± 7.3 | 57.0 ± 16.0 | 55.8 ± 16.3 | |
| CrCl <30 mL/min, n (%) | 22 (0.4) | 15 (0.4) | 6 (0.1) | 29 (0.5) | n/a | |
| Age ≥75 y, n (%) | 529 (10) | 440 (13) | 843 (17) | 768 (14) | 1104 (13) | |
| Prior VTE (%) | 22 | 19 | 20 | 16 | 18 | |
| Unprovoked VTE (%) | 35 | 62.0 | 64.5 | 89.8 | 65.7 | |
| Index event PE ± DVT (%) | 31 | 0.7 | 100 | 34 | 40 | |
| Noninferiority margin | 2.75 | 2.0 | 1.8 | 1.5 | ||
| Bridge with heparin/LMWH | Yes | No | No | Yes | ||
| Treatment protocol | 150 mg BID | 15 mg BID for 3 wk; then 20 mg OD | 10 mg BID for 7 d; then 5 mg BID | 60 mg OD; 30 mg OD for those with a creatinine clearance of 30-50 mL/min, weight <60 kg, or taking potent P-gp inhibitors | ||
| Duration (mo) | 6 | 3, 6, 12 | 6 | 3-12 | ||
| TTR (%) | 60 | 58 | 63 | 61 | 64 | |
| . | Dabigatran . | Rivaroxaban . | Apixaban . | Edoxaban . | ||
|---|---|---|---|---|---|---|
| Trial | RE-COVER I & II | EINSTEIN | AMPLIFY | Hokusai-VTE | ||
| Indication | VTE | DVT | PE | VTE | VTE | |
| Design | Double-blind | PROBE | Double-blind | Double-blind | ||
| Number of patients | 2539 | 2568 | 3449 | 4832 | 5365 | 8240 |
| Mean age ± SD (y) | 54.9 ± 16.0 | 56.1 ± 16.4 | 57.7 ± 7.3 | 57.0 ± 16.0 | 55.8 ± 16.3 | |
| CrCl <30 mL/min, n (%) | 22 (0.4) | 15 (0.4) | 6 (0.1) | 29 (0.5) | n/a | |
| Age ≥75 y, n (%) | 529 (10) | 440 (13) | 843 (17) | 768 (14) | 1104 (13) | |
| Prior VTE (%) | 22 | 19 | 20 | 16 | 18 | |
| Unprovoked VTE (%) | 35 | 62.0 | 64.5 | 89.8 | 65.7 | |
| Index event PE ± DVT (%) | 31 | 0.7 | 100 | 34 | 40 | |
| Noninferiority margin | 2.75 | 2.0 | 1.8 | 1.5 | ||
| Bridge with heparin/LMWH | Yes | No | No | Yes | ||
| Treatment protocol | 150 mg BID | 15 mg BID for 3 wk; then 20 mg OD | 10 mg BID for 7 d; then 5 mg BID | 60 mg OD; 30 mg OD for those with a creatinine clearance of 30-50 mL/min, weight <60 kg, or taking potent P-gp inhibitors | ||
| Duration (mo) | 6 | 3, 6, 12 | 6 | 3-12 | ||
| TTR (%) | 60 | 58 | 63 | 61 | 64 | |
n/a, not available; OD, once daily; BID, twice daily; P-gp, P-glycoprotein; LMWH, low-molecular-weight heparin; PROBE, prospective, randomized, open-label, blinded endpoint; TTR, time in therapeutic range with warfarin.