Table 2 Efficacy and safety outcomes and net clinical benefit in all patients and selected patient subgroups
Mean duration of treatment | Recurrent venous thromboembolism | Nonmajor clinically relevant and major bleeding | Major bleeding | Net clinical benefit | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patient group | Rivaroxaban | Enoxaparin/VKA | Rivaroxaban n/N (%) | Enoxaparin/VKA n/N (%) | HR (95% CI) | Rivaroxaban n/N (%) | Enoxaparin/VKA n/N (%) | HR (95% CI) | Rivaroxaban n/N (%) | Enoxaparin/VKA n/N (%) | HR (95% CI) | Rivaroxaban n/N (%) | Enoxaparin/VKA n/N (%) | HR (95% CI) |
Days ± SD | Days ± SD | |||||||||||||
All | 207.6 ± 95.9 | 204.0 ± 97.2 | 86/4150 (2.1) | 95/4131 (2.3) | 0.89 (0.66–1.19) | 388/4130 (9.4) | 412/4116 (10.0) | 0.93 (0.81–1.06) | 40/4130 (1.0) | 72/4116 (1.7) | 0.54 (0.37–0.79) | 134/4150 (3.2) | 169/4131 (4.1) | 0.77 (0.61–0.97) |
Fragile | 196.8 ± 97.5 | 187.2 ± 102.5 | 21/791 (2.7) | 30/782 (3.8) | 0.68 (0.39–1.18) | 97/788 (12.3) | 109/779 (14.0) | 0.85 (0.64–1.11) | 10/788 (1.3) | 35/779 (4.5) | 0.27 (0.13–0.54)* | 36/791 (4.6) | 66/782 (8.4) | 0.51 (0.34–0.77)† |
Nonfragile | 210.1 ± 95.4 | 208.0 ± 95.5 | 65/3359 (1.9) | 65/3349 (1.9) | 0.98 (0.69–1.38) | 291/3342 (8.7) | 303/3337 (9.1) | 0.95 (0.81–1.12) | 30/3342 (0.9) | 37/3337 (1.1) | 0.80 (0.49–1.29) | 98/3359 (2.9) | 103/3349 (3.1) | 0.93 (0.71–1.23) |
Cancer | 179.0 ± 96.9 | 167.7 ± 103.1 | 16/316 (5.1) | 20/281 (7.1) | 0.69 (0.36–1.33) | 48/316 (15.2) | 44/278 (15.8) | 0.93 (0.62–1.41) | 9/316 (2.8) | 14/278 (5.0) | 0.53 (0.23–1.23) | 26/316 (8.2) | 37/281 (13.2) | 0.60 (0.36–0.99) |
No cancer | 209.3 ± 95.6 | 205.8 ± 96.6 | 70/3834 (1.8) | 75/3850 (1.9) | 0.93 (0.67–1.29) | 340/3820 (8.9)‡ | 368/3832 (9.6)‡ | 0.92 (0.79–1.06) | 31/3820 (0.8)‡ | 58/3832 (1.5)‡ | 0.53 (0.34–0.82) | 108/3834 (2.8) | 132/3850 (3.4) | 0.81 (0.63–1.05) |
Previous DVT/PE | 259.0 ± 102.0 | 252.6 ± 107.1 | 11/791 (1.4) | 25/819 (3.1) | 0.45 (0.22–0.91)§ | 70/788 (8.9) | 91/813 (11.2) | 0.77 (0.57–1.06) | 7/788 (0.9) | 14/813 (1.7) | 0.51 (0.21–1.27) | 20/791 (2.5) | 39/819 (4.8) | 0.52 (0.31–0.90) |
No previous DVT/PE | 195.4 ± 90.3 | 192.0 ± 90.8 | 75/3359 (2.2) | 70/3312 (2.1) | 1.04 (0.75–1.45) | 318/3342 (9.5) | 321/3303 (9.7) | 0.96 (0.82–1.12) | 33/3342 (1.0) | 58/3303 (1.8) | 0.54 (0.35–0.83) | 114/3359 (3.4) | 130/3312 (3.9) | 0.84 (0.66–1.08) |
Clot burden (limited)¶ | 197.6 ± 93.2 | 197.1 ± 94.1 | 10/799 (1.3) | 19/815 (2.3) | 0.51 (0.24–1.10) | 73/796 (9.2) | 76/813 (9.3) | 0.97 (0.70–1.34) | 8/796 (1.0) | 11/813 (1.4) | 0.75 (0.30–1.87) | 20/799 (2.5) | 30/815 (3.7) | 0.65 (0.37–1.16) |
Clot burden (intermediate)¶ | 215.0 ± 94.5 | 206.1 ± 96.4 | 41/1873 (2.2) | 49/1881 (2.6) | 0.82 (0.54–1.24) | 181/1864 (9.7) | 189/1876 (10.1) | 0.95 (0.78–1.17) | 20/1864 (1.1) | 32/1876 (1.7) | 0.62 (0.36–1.09) | 65/1873 (3.5) | 81/1881 (4.3) | 0.79 (0.57–1.10) |
Clot burden (extensive)¶ | 205.8 ± 97.8 | 205.2 ± 100.0 | 35/1364 (2.6) | 26/1327 (2.0) | 1.29 (0.78–2.15) | 126/1359 (9.3) | 134/1326 (10.1) | 0.90 (0.71–1.15) | 11/1359 (0.8) | 28/1326 (2.1) | 0.36 (0.18–0.73) | 48/1364 (3.5) | 56/1327 (4.2) | 0.81 (0.55–1.19) |