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Table 2 Efficacy and safety outcomes and net clinical benefit in all patients and selected patient subgroups

From: Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies

  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)
  1. *For major bleeding, the p-value for the treatment group × fragility interaction was 0.011, suggesting heterogeneity. †For net clinical benefit, the p-value for the treatment group × fragility interaction was 0.017. ‡In this analysis, six DVT patients were randomized to rivaroxaban but received comparator. §For recurrent VTE, the p-value for the treatment group × previous DVT/PE was 0.032. For all other outcomes and analyses the interactions between treatment group and the subgroups of fragility [yes/no], baseline cancer [yes/no], previous DVT/PE [yes/no], clot burden for outcomes [limited/intermediate/extensive]), the pinteractions were larger than 0.05 (nonsignificant) calculated by the corresponding Cox proportional hazards models. In the clot burden analysis, a total of 71 patients in the rivaroxaban group and 68 patients in the enoxaparin/VKA group had missing data. A further 43 and 40 patients in the rivaroxaban and enoxaparin/VKA groups, respectively, did not have confirmed DVT and PE.
  2. CI Confidence interval, DVT Deep vein thrombosis, HR Hazard ratio, PE Pulmonary embolism, VKA Vitamin K antagonist.
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