Table 2 Recurrent VTE and bleeding in relation to renal function, treatment, and treatment period: EINSTEIN DVT and EINSTEIN PE patients combined*
Entire analysis period | Period up to 14 days | Period after 14 days | ||||
|---|---|---|---|---|---|---|
Rivaroxaban | Enoxaparin/VKA | Rivaroxaban | Enoxaparin/VKA | Rivaroxaban | Enoxaparin/VKA | |
n = 4150 | n = 4131 | n = 4150 | n = 4131 | n = 4054 | n = 4001 | |
Recurrent VTE n/N (%) | ||||||
Total of recurrent VTE | 86 | 95 | 38 | 37 | 48 | 58 |
Normal renal function | 50/2772 (1.8) | 52/2797 (1.9) | 23/2772 (0.8) | 26/2797 (0.9) | 27/2720 (1.0) | 26/2716 (1.0) |
Mild renal impairment | 25/1036 (2.4) | 31/1001 (3.1) | 10/1036 (1.0) | 8/1001 (0.8) | 15/1009 (1.5) | 23/974 (2.4) |
Moderate renal impairment | 11/323 (3.4) | 10/313 (3.2) | 5/323 (1.5) | 2/313 (0.6) | 6/307 (2.0) | 8/296 (2.7) |
Severe renal impairment | 0/10 (0) | 1/11 (9.1) | 0/10 (0) | 1/11 (9.1) | 0/10 (0) | 0/8 (0) |
Missing | 0/9 (0) | 1/9 (11.1) | 0/9 (0) | 0/9 (0) | 0/8 (0) | 1/7 (14.3) |
Major bleeding n/N (%) | ||||||
Total of major bleeding events | 40 | 72 | 13 | 27 | 27 | 45 |
Normal renal function | 23/2763 (0.8) | 29/2786 (1.0) | 8/2763 (0.3) | 11/2786 (0.4) | 15/2689 (0.6) | 18/2704 (0.7) |
Mild renal impairment | 14/1030 (1.4) | 30/1002 (3.0) | 5/1030 (0.5) | 10/1002 (1.0) | 9/985 (0.9) | 20/954 (2.1) |
Moderate renal impairment | 3/320 (0.9) | 12/310 (3.9) | 0/320 (0) | 5/310 (1.6) | 3/305 (1.0) | 7/285 (2.5) |
Severe renal impairment | 0/9 (0) | 1/11 (9.1) | 0/9 (0) | 1/11 (9.1) | 0/9 (0) | 0/6 (0) |
Missing | 0/8 (0) | 0/7 (0) | 0/8 (0) | 0/7 (0) | 0/8 (0) | 0/7 (0) |
Major and clinically relevant nonmajor bleeding n/N (%) | ||||||
Total of major and clinically relevant nonmajor bleeding events | 388 | 412 | 129 | 134 | 259 | 278 |
Normal renal function | 239/2763 (8.7) | 245/2786 (8.8) | 75/2763 (2.7) | 73/2786 (2.6) | 164/2627 (6.2) | 172/2646 (6.5) |
Mild renal impairment | 110/1030 (10.7) | 123/1002 (12.3) | 40/1030 (3.9) | 40/1002 (4.0) | 70/957 (7.3) | 83/927 (9.0) |
Moderate renal impairment | 37/320 (11.6) | 43/310 (13.9) | 14/320 (4.4) | 20/310 (6.5) | 23/291 (7.9) | 23/272 (8.5) |
Severe renal impairment | 2/9 (22.2) | 1/11 (9.1) | 0/9 (0) | 1/11 (9.1) | 2/9 (22.2) | 0/6 (0) |
Missing | 0/8 (0) | 0/7 (0) | 0/8 (0) | 0/7 (0) | 0/8 (0) | 0/7 (0) |